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Identity, Invention, and the Culture of Personalized Medicine Patenting

What are the normative implications of patenting in the area of personalized medicine? As patents on genes and medical diagnoses have increased over the past decade, this question lies at the intersection of intellectual property theory, identity politics, biomedical ethics, and constitutional law. These patents are part of the personalized medicine industry, which develops medical treatments tai-lored to individuals based on race and other characteristics. This book provides an overview of developments in personalized medicine patenting and suggests policies to best regulate such patents.

Shubha Ghosh is a Vilas Research Fellow, Professor of Law, and Associate Director of the Initiatives for Studies in Transformational Entrepreneurship at the University of Wisconsin-Madison School of Law. He is the author of more than fifty articles and book chapters and of two leading casebooks in intellectual prop-erty law. His research is in the area of intellectual property with a focus on social justice in the design of institutions that support innovation and development.

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Identity, Invention, and the Culture of Personalized Medicine Patenting

Shubha GhoShUniversity of Wisconsin-Madison School of Law

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Identity, invention, and the culture of personalized medicine patenting / Shubha Ghosh. pages cmIncludes bibliographical references and index.ISBN 978-1-107-01191-51. Medicine – Patents – Law and legislation. 2. Biotechnology – Patents. 3. Biotechnology – Law and legislation. 4. Pharmacogenetics. 5. Personality (Law) I. Title.K1519.B54G49 2013346.04′86--dc23 2012015680

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vii

List of Figures page viii

List of Tables ix

Preface xi

1. Persons and Patents 1

2. Start-ups, upstarts, and Markets for Personalized Medicine 39

3. The Case of Race-Specific Patents 63

4. Normative Construction of Identity 126

5. Persons, Patents, and Policy 179

6. a business, a Litigant, a Metaphor: The Future of Personalized Medicine Patents 195

Index 215

Contents

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viii

1.1. First page of one of Myriad’s patents page 51.2. Abstract from the Nitromed patent 63.1. Early hair-straightening patent 683.2. Written description from the 1974 patent for “Skin

Depigmentation” 753.3. Drawing from a patent for a device to match skin color 773.4. Drawing from the 1863 patent for a dancing toy, invented

by one James Crow 833.5. The 1969 patent for a doll with plurality of ethnic features 853.6. Drawing from the Match.com patent 903.7. Drawing from the Intellectual Ventures’ patent on

obfuscating identities 923.8. A figure from the Policy Analysis patent setting forth

zip code data by race and ethnicity 966.1. Claims from a 2011 application filed by the Marshfield Clinic 199

Figures

ix

3.1. Inventions involving cosmetics and fashion page 1073.2. Inventions involving skin color 1133.3. Inventions involving toys and games 1163.4. Inventions involving identities and names 1203.5. Miscellaneous inventions 1214.1. Intersecting theories of patent and of race 177

Tables

xi

If I had to identify the Big Bang moment, the conception for this book was sparked by a 2005 news report about the FDA approval of BiDil, touted as the first drug specified for a particular racial or ethnic group. I have always been interested in issues of identity as a consumer of scholarship while pursuing studies of innovation, intellectual property, and the social and cultural con-texts, as well as technical aspects, of markets as a producer. The BiDil news story struck me as interesting, and the topic as a bridge between my habits as a consumer and producer. But looking back over the manuscript and rereading, often painfully, the research I had brought together, I realized I owe a debt to many academic influences. Perhaps the yearning to acknowledge some of the influences reflects my misguided nostalgia. Nonetheless, acknowledge I feel I must.

First are the many teachers at St. Anselm’s Abbey School and Amherst College who exposed me to the right balance of interdisciplinary thinking and rigorous questioning and analysis. Although I moved away from an engage-ment with the economics profession decades ago, moving toward economic analysis of the law and institutions, the graduate training at the University of Michigan formed my thinking about population studies, demography, and the commons that find expression in these pages. Thanks to the Population Studies Center of the University of Michigan, which celebrated its golden anniversary in 2011, for the positive influences. Finally, starting from my time as a student at Stanford Law School and continuing through the various schools at which I have taught, there are many legal scholars and educators from whom I have learned and still learn and whose ideas are reflected with a combination of admiration and detachment in this book. I believe in always paying back my debts in full, but I may have fallen short here.

Second are seminar participants who sat through various presentations and early fumblings as this research project developed. I particularly would like

Preface

Prefacexii

to thank participants in workshops at the University of Wisconsin Business School, University of Wisconsin Law School, SMU Dedman School of Law, Howard University Law School, and sessions at the Annual Meeting of the Law & Society Association for their support. My colleague Anne Miner at the University of Wisconsin has been very supportive of this project and an encouraging colleague in general.

Third is the financial support I have received from the University of Wisconsin as a Vilas Research Fellow and from the Graduate Fellowship Committee. Recently, I had a discussion with a colleague as to whether, as professors, our teaching subsidizes our research or the other way around. I think of the job as a bundled package. But the financial backing from my uni-versity supported research trips and writing time that were not a break from teaching, but enhancements to what I do in the classroom. More important than the financial support is the assistance of Cheryl O’Connor and Bonnie Sucha of the University Wisconsin Law Library for tracking down materials and legal citations. Teresa Evans and Sue Sawatske provided guidance in the technical details of formatting the manuscript. Finally, preliminary work on this project when I was Professor of Law at Southern Methodist University’s Dedman School of Law benefited from the research assistance of Ayse Guner (JD, class of 2008) and Ross Allen (JD, class of 2008).

Fourth is John Berger of Cambridge University Press, who was very patient in guiding me through the proposal process and with my questions about pro-duction. He and the many other editors and production staff at Cambridge have been a delight to work with.

Fifth, I would like to acknowledge the law journals in which preliminary versions of the ideas in this book were tested out. I would like thank the editors of the respective journals for giving me permission to reprint derivative works based on sections from the following articles:

“Why Intergenerational Equity,” 2011 Wisc. L. Rev. 103–109 (2011).

“Patenting Games; or, Baker v. Selden Revisited,” 11(4) Vanderbilt Journal of Entertainment and Technology Law 871–898 (2009).

“Race-Specific Patents, Commercialization, and Intellectual Property Policy,” 56 Buffalo L. Rev. 101–187 (2008).

“The Fable of the Commons: Exclusivity and the Construction of Intellectual Property Markets,” 40 U.C. Davis Law Review 855 (2007).

“Patents and the Regulatory State: Rethinking the Patent Bargain Metaphor After Eldred,” 19 Berkeley Technology Law Journal 1315–1388 (2005).

Writing this book allowed me to revisit the ideas of these earlier works and to synthesize them.

Preface xiii

Sixth is reflected in the dedication to Keith Aoki, Wunderfreund, who passed away unexpectedly in 2011. To describe Keith requires a neologism, a German one at that. Keith was a pathbreaking scholar and remarkable teacher as well as an incredible colleague globally, beyond the boundaries of his home institution. Keith was also the first academic I met after entering law school teaching in 1996. We shared a van ride from LAX to attend a conference at UCLA. His sincerity and inquisitiveness came through from that first encoun-ter in which he was trying to figure me out. I will miss him.

Most importantly, Soma was a constant source of joy and our dog, Chewbacca, provided countless distractions especially when he tried to break me from the laptop with a lick to the hand, sometimes to an oddly appropriate key.

1

. . . it is a story . . . seared into my genetic makeup that this nation is more than the sum of its parts – that out of many, we are truly one.

Barack Obama, Philadelphia, PA, March 18, 2008

In April 2010, Judge Robert Sweet of the Southern District of New York ruled that gene sequences could not be patented.1 The court also ruled that a med-ical diagnostic test requiring comparison of a patient’s gene with an identi-fied breast cancer gene sequence was not patentable because it was a mental process.2 These controversial rulings shook the foundations of many global industries engaged in providing medical services based on genetic informa-tion. Biotechnological research at university and industry labs faced a para-digm change if Judge Sweet’s ruling were upheld. The assumption guiding commercialization efforts and U.S. scientific policy was that patents on gene sequences provided a stable set of legal rights for the development of science and industry in biotechnology.

Although this assumption has been the subject of criticism before and after the U.S. Supreme Court’s landmark 1980 ruling in Diamond v. Chakrabarty, holding that a genetically modified single-cell organism could be patented,3 the availability of patents for gene sequences had not been seriously challenged until 2010. There was an expected sigh of relief from the affected industry inter-ests when in July 2011, the Court of Appeals for the Federal Circuit overruled Judge Sweet’s ruling with respect to the patentability of a gene sequence.4 However, the Federal Circuit upheld Judge Sweet’s ruling that the diagnostic

1

Persons and Patents

1 The Association for Molecular Pathology v. United States Patent Office & Myriad Genetics, Inc., 702 F. Supp. 2d 181 (S.D.N.Y. 2010).

2 Idem. at 235–236.3 447 U.S. 303 (1980).4 The Association for Molecular Pathology v. United States Patent Office & Myriad Genetics,

Inc., 653 F.3d 1329 (Fed. Cir. 2011).

Culture of Personalized Medicine2

method involving comparing gene sequences was not patentable. On March 26, 2012, the Supreme Court vacated the Federal Circuit’s ruling and sent the case back to the appeals court for review in light of the Supreme Court’s decision in Mayo v. Prometheus.5 From the perspective of industry groups, scholars, and policy makers, we are living in interesting times for patents and biotechnology.

In 2002, eight years before Judge Sweet’s ruling, a start-up company called Nitromed received an initial patent on a prescription drug called BiDil that was designed for treatment of hypertension in “black patients,” to adopt the language from the granted patent.6 Like many pharmaceuticals aimed at hypertension, BiDil was a nitrogen dilator, controlling the amount of nitro-gen in the blood. Nitromed obtained a patent on an earlier version of the hypertension drug in the late 1980s. During its clinical trials, testing the effec-tiveness of the drug on actual people, researchers at the company noticed that a certain combination of compounds was particularly effective on the African-American population. The researchers were not looking to target the African-American population in their trials; they were using a population of veterans. African Americans constituted a large proportion of the veteran pop-ulation used in the clinical trials as compared to the U.S. population as a whole. The company decided to patent the findings of its researchers as a new compound that would be particularly effective in treating hypertension in the African-American population. In 2005, Nitromed received approval from the U.S. Food and Drug Administration (FDA) for BiDil as a hypertension treat-ment for African Americans, the first time the agency had approved a drug compound for a particular racial or ethnic group. Although the patent did

5 See 2012 WL 9861819. The Supreme Court ruled in Mayo v. Prometheus that a specific method of personalized medicine was not patentable because it only recited a law of nature without any applications. See Mayo v Prometheus, 132 S. Ct. 1289 (2012).

6 U.S. Patent No. 6465463 (issued Oct. 15, 2002). The first claim reads as follows: “1. A method of reducing mortality associated with heart failure, for improving the oxygen consumption, for improving the quality of life or for improving exercise tolerance in a black patient com-prising administering to the black patient a therapeutically effective amount of at least one hydralazine compound of Formula (I) or a pharmaceutically acceptable salt thereof, and at least one of isosorbide dinitrate and isosorbide mononitrate, wherein the hydralazine com-pound of Formula (I) is wherein a, b and c are each independently a single or a double bond; R1 and R2 are each independently a hydrogen, an alkyl, an ester or a heterocyclic ring; R3 and R4 are each independently a lone pair of electrons or a hydrogen, with the proviso that at least one of R1, R2, R3 and R4 is not a hydrogen” (emphasis added). Claim 2 is a dependent claim that refers to claim 1 but limits it to the case “wherein the black patient has a less active rennin-angiotensin system relative to a white patient.” Finally, claim 3 also depends on claim 1 but limits it to the case “wherein the black patient has hypertension.” This patent was reis-sued in 2004 as U.S. Patent No. 6784177 (issued Aug. 31, 2004).

Persons and Patents 3

not receive much publicity, the decision of the FDA did, bringing the issue of personalized medicine to the forefront of policy debates.7

Judge Sweet’s decision in 2010 and Nitromed’s patenting and commercial-ization strategies with respect to BiDil more than half a decade earlier have much in common. They both bring to the forefront the challenging question of patent law’s relationship to people who use and rely on patented inventions. This question is the central focus of this book. It may appear that juxtaposing an abstraction like a patent with something concrete and living like a person is just an academic exercise. But developments in the marketplace, society, and legal rules have mixed the realm of the abstract with that of the personal.

A patent is a grant from the government that allows the patent owner to keep others from making, using, selling, or importing the invention covered by the patent. With this grant, the owner can, in theory, commercialize and sell the invention to the public. Almost all products, from your car to your smartphone to your microwave, are currently covered by a patent or have been covered by a patent in the past. Through the gadgets we use or purchase, pat-ents affect our personal lives. Patents also cover pharmaceuticals and in that way directly affect our health and our ability to live. One of the biggest con-troversies, still ongoing, is access to medicines in both the developed and the developing worlds. The access-to-medicine debate has many dimensions, and the existence of a patent on these medicines is one of them. A patent is most certainly an abstraction, but it is one that intervenes in the personal sphere in many direct and indirect ways.

The patent at issue in Judge Sweet’s decision, owned by Myriad, covered diagnostic techniques to identify a specific genetic sequence linked with the proclivity to breast cancer in women. Anyone using this particular diagnostic and the genetic sequence identified by Myriad would have to deal with the patent. The lawsuit against Myriad that gave rise to Judge Sweet’s opinion challenged the patentability of the genetic sequence that was the basis for the diagnostic test. The legal argument was that no one can own a gene, espe-cially when it is part of a person. Myriad’s argument was that it did not own a gene as it existed in a person, but a purified, extracted form of the gene as it existed in a laboratory for the purpose of making a medical diagnosis. The distinction would be analogous to distinguishing ownership of a lock of hair from someone’s head from ownership of the purified chemical and material

7 See, e.g., “Getting to the Heart of the Matter,” U.S. News & World Report 14 (June 15, 2005); “Color-Blind Drug Research Is Myopic; More, Not Less, Study Is Needed on Ways Different Races Respond,” Business Week 44 (June 27, 2005); “FDA Approves Heart Drug for African-Americans,” The New York Times C2 (June 24, 2005).


compounds that comprise the lock. Judge Sweet, however, did not entertain such hairsplitting. What Myriad claimed ownership of was not distinguishable from an actual gene as it existed in a human person.8 Therefore, the patent was invalid. The facts of the case illustrate how our understanding of a patent is related to our understanding of a person.

This point is underscored by the Federal Circuit’s decision on appeal. The court held that the patented gene sequence (see Figure 1.1) was different from the one that exists in the person. The patented sequence was not in a natural state, but was rather in a purified state. It had been processed physically by a researcher in a lab to obtain a new composition that could be manipulated and studied. The patented gene sequence was in effect a representation of, and hence different from, the naturally occurring gene.9 Much like a tree differs from a photograph of a tree, the song of a bird differs from synthe-sized bird calls, or color and light differ from hues of paint, so the patented sequence is the product of human endeavor. In a similar vein, the Federal Circuit upheld Judge Sweet’s ruling that the diagnostic method of comparing two gene sequences is not patentable because the act of comparison consti-tutes a mental process.10 The act of comparing occurs inside a person’s brain. Processing information occurs inside a person. Allowing patents on mental processes would be tantamount to patenting thoughts. The reach of patent law seems to depend on the boundaries of a person’s body and mind. The per-son so defined by these boundaries is impermeable to patent ownership.

There has been no legal challenge either in the U.S. Patent Office (USPTO) or in the courts to the Nitromed patent. My research has found no evidence that Nitromed has brought legal actions for infringement or has even sought to license the patent – the usual strategies for enforcing one’s patent rights. It should also be made clear that there is no genetic component to Nitromed’s patent (see Figure 1.2). The patent covers a pharmaceutical compound that is effective for the treatment of hypertension in “black patients.” But blackness is not defined in genetic terms. And, of course, it really cannot be. Nitromed is basing its claim on epidemiological and statistical data. The company’s researchers found that the compound at issue was effective in treating hyper-tension as a statistical matter when tested on a group of self-identified black patients. Blackness is a self-identified category, rooted in sociological under-standings rather than genetic ones. Whereas the decisions in Myriad suggest that the physical and mental dimensions of a person are not subject to patent

8 See note 1 to this chapter at 222–227.9 See note 3 to this chapter at 1349–1350.

10 See note 3 to this chapter at 1355–1356.


Figure 1.1. First page of one of Myriad’s patents.


ownership, the Nitromed patent on BiDil suggests that the sociological con-ception of a person is susceptible to patenting.

As I explain in Chapter 3 the use of the term “black patient” creates a tenu-ous foundation for the patent, certainly more tenuous than Myriad’s claim to the “breast cancer gene.” Nonetheless, the Nitromed patent, like the Myriad patent, illustrates how the abstraction of a patent is used to intersect with understandings of the human person. The motivation is one of commerciali-zation, which opens up the salient question of the relationship between mar-kets and persons – another focus of inquiry for this book. Furthermore, there have been nearly a thousand patents in the wake of the Nitromed patent that purport to cover inventions aimed at particular self-identified racial and eth-nic groups, such as Asian Americans and Latinos. The Myriad and Nitromed patents are useful twins, one covering genetic understanding of the person, the other sociological. Of course these two understandings might intersect. In the European Union, for example, Myriad has a patent covering a special form of the breast cancer gene as it exists in Ashkenazi-Jewish women.11

11 Sabine Steimle, “Critics Question BRCA2 Patent Decision in Europe,” 97 (18) Journal of the National Cancer Institute 1326 (Sept. 21, 2005).

Figure 1.2. Abstract from the Nitromed patent.


The quote by President Obama that begins this chapter shows how the genetic and sociological views of identify can easily be elided. When he refers to his “genetic makeup,” President Obama is not speaking literally. The quote is from his famous speech in which he distanced himself from the racialist views of his minister, Reverend Jeremiah Wright. The brilliance of the speech was to highlight the historical and cultural contingencies of race. President Obama simultaneously questioned the use of race as a fixed, immutable cate-gory and emphasized the reality of race in framing the historical reality of race that shapes contemporary relations. His use of the phrase “genetic makeup” highlights this contingency. President Obama is not saying there is such a thing as a “black gene,” a phrase that confuses the sociological with the bio-logical. Instead, the genetic makeup is a reference to a litany of contingencies. Who we are genetically depends on who our parents are, and their meeting and joining was not inevitable. Conception and fetal development are also subject to accidents, with the early stages of cellular division having several possible pathways. But the final accumulation of these contingencies produces an identity that we take as natural and, at some level, unchanging. The dan-ger, of course, is that some may read a phrase like “genetic makeup” literally, and this book attempts, in part, to prevent dangerous conclusions like that.

My goal is to provide a more coherent framework for assessing the types of patents illustrated by my two starting examples of Myriad and Nitromed. I am not suggesting that such patents should be forbidden. In my opinion, Judge Sweet overstated the case in his decision. My concern is with the casual intrusion of patent law into the realm of personal identity. I am troubled by this intrusion partly because we do not fully understand it. For example, it is too easy conceptually to start reducing a person to one’s genes. As history has shown, this conceptual move is particularly pernicious when a person’s racial or ethnic identity is viewed as genetic.12 At the same time, we are beginning to understand that the gene itself is not fixed and unchanging and can be shaped by environmental factors. Furthermore, certain diseases are more prevalent in certain groups. It is important that scientific and medical communities address these differences. Otherwise, disease prevention will focus solely on the majority. The goal of this project is to open options for improving the lives of persons in a responsible and thoughtful manner. With this goal in mind, this book should be read as the starting point for a discussion, rather than as the final word in it.

12 Victoria F. Nourse, In Reckless Hands: Skinner v. Oklahoma and the Near Triumph of American Eugenics (New York: W.W.Norton & Co., 2008) 124–126.


Why Patents?

I have described patents as an abstraction, but patents can have tangible and concrete effects. Under current usage, a patent is a grant from a national government to an individual or a group of individuals that allows the patent owner to prevent others from making, using, selling, or importing an inven-tion. But patents have deep historical roots. Patents were at one point granted by the sovereign, namely the monarch, on any item. There were patents on different spices, on playing cards, on gaming devices. A grant of land was also referred to as a patent. The key meaning of the word “patent” follows from its Latin roots. A patent is and was an “open” grant, as opposed to a secret one.13 The sovereign made a pronouncement and the individual received this exclusive set of rights, protected by the crown. In 1624, with growing concern over the monopoly and market privileges bestowed by patents and general discontent with the power of the monarch, the English parliament enacted the Statute Against Monopolies, designed to limit the power of the crown to grant the privileges of patents for the manufacture and selling of particular products. The Statute limited these grants to those covering inventions and grants related to copyrights, or the printing privilege. It is from the Statute of Monopolies that the relationship between patents and inventions originates in the Anglo-American legal tradition.14 As this brief history suggests, patents are abstractions, essentially sovereign pronouncements, but they have economic and political implications.

With the formation of nation-states and the development of democratic market economies, the understanding of patent law changed from a strict grant from the sovereign to a property right for which an inventor would apply with a respective government agency that had the responsibility to ensure that property rights were granted to appropriate inventions.15 The agency, or the patent office, would enforce the patent statute that provided the legal requirements for an invention. While there are slight differences across coun-tries in these legal requirements, they generally reduce to five:16 (1) patent-able subject matter, or the product of some useful art or industry; (2) utility, or having some practical application; (3) novelty, or not previously existing;

13 Erich Kaufer, Economics of the Patent System 1 (1989).14 Idem. at 8–9.15 Suzanne Scotchmer, Innovation and Incentives (Cambridge, MA: The MIT Press, 2004)

11–14.16 Shubha Ghosh et al., Intellectual Property: Private Rights, the Public Interest, and the

Regulation of Creative Activity (St. Paul: Thomson West, 2010) 258–260.


(4) nonobviousness, or a substantive step beyond previous inventions; and (5) enablement, or the requirement that the invention be described to the pub-lic. At a very simplistic level, a patent is still a grant from the sovereign, but modern patent grants occur in a technically and legally rich environment of administrative review and decision making. Furthermore, this grant is sup-ported by a judicial system that serves to oversee both the function of the agencies and the enforcement of the patent owner’s rights as defined under the patent statute and its judicial interpretation.

As part of a legislative enactment, the modern patent has many justifi-cations. A common one is that of the quid pro quo: the inventor discloses the invention to the public in exchange for legal protection of rights in the invention from those who make, use, sell, or import the invention without the patent owner’s permission.17 Under this justification, the public benefits from the incremental knowledge, and the patent owner is free to make the disclosure without the concern of having the invention be misappropriated. Another contemporary justification for a patent is as a reward for invention.18 Under this view, the promise of a patent motivates inventors to apply their labor to produce whatever the legislature has deemed worthy of a patent. Once the inventor produces something that meets the requirements of a pat-ent, the resulting grant of legal rights rewards the inventor for his or her efforts. The final justification for a patent is as a tool for commercialization.19 Once an inventor obtains a patent on an invention, the exclusive rights allow the inventor to commercialize the invention and thereby disseminate it to the public. Referred to as a prospecting theory of patents, this justification emphasizes not only the reward that comes to the patent owner in the form of profits from commercialization, but also the benefit to the public that arises from commercial dissemination.

These three modern justifications for patent law – disclosure, reward, and prospecting – frame the legislative debates over the enactment and reform of patent statutes and doctrines. It is possible for each of these separate justifica-tions to be valid. For example, with respect to patents on genetic sequences, the disclosure theory would justify patents as a means of educating the rele-vant research audience about identified genetic sequences. The reward theory would support such patents as an incentive for research on genetic sequences.

17 Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 161 (1989). The Court called it the “congressionally mandated price for disclosure” paid by the public. Idem. at 152.

18 See note 14 to this chapter at 98–99.19 Edmund W. Kitch, “The Nature and Function of the Patent System,” 20 J.L. & Econ. 265,

267–271 (1977).


Finally, the prospecting theory would justify these patents as tools to aid in the commercialization of the invention, such as through the creation of diagnos-tic tools like the ones marketed by Myriad.

Although the three justifications may differ little in the practical implica-tions for patents, they can differ in justifying the scope and details of patent rights. The disclosure justification would focus on patent rules that promote the dissemination of the teaching of the invention. The reward justification would support a sufficient scope that would provide the appropriate reward for the invention. Finally, the prospecting theory would support fairly broad and strong patent rights so as to allow the patent owner to earn a return from as many commercial applications of the invention as possible. Perhaps the one point of patent law on which all three justifications would converge is the time limitation for the rights. Unlike other property rights, such as for land, water, or personal items, each of which recognizes rights that last forever, the patent right is time limited to reflect the fact that ultimately the public is the benefi-ciary of the invention. So, under the disclosure justification, the teaching falls into the public domain for anyone to use after some time. Similarly, under the reward justification, the patent right expires so that the inventor has the incentive to move on to create other inventions. Finally, the prospecting jus-tification also supports time-limited patent rights so that new inventions can come into the market and supplant the old one. In their unique ways, each justification for patent law promotes invention and progress in society and in the marketplace.

The abstraction of patent law has concrete applications and implications for how society is structured and how progress is deemed to occur. But even these concrete implications betray an antihumanistic bias. Innovation and progress are big concepts, hard to bring to human scale. But there is a humanistic side to patent law that informs the policy debates over the scope and limits of patent rights. Judge Sweet implicitly invokes this humanistic element in rejecting patents on genetic sequences as effectively creating property rights in a person. Even the Federal Circuit, which overruled Judge Sweet’s decision in part, recognized the humanistic side of patents in disallowing patents for mental processes, for what goes on in a human mind. The battles over BiDil and personalized medicine, as we will see, also evince the humanistic side of patents by demonstrating the incidence of disease among different demo-graphic groups.

Two broader theories of patent rights encompass the three justifications for patents discussed earlier and also inform a humanistic understanding of inventions and patent law. The first broad theory is the labor theory, which


recognizes invention as the product of human labor.20 A patent serves to either reward this labor or facilitate the dissemination and use of the invention. Furthermore, the teaching or disclosure purpose of a patent is also consis-tent with the labor theory if one understands research and experimentation as types of labor. The second broad theory is the public benefit theory, which recognizes invention as serving the public.21 The public benefit can be under-stood in many ways. It can be a utilitarian theory, of benefiting the most peo-ple in society. It can be a deontic theory, of benefiting certain identifiable groups, such as those who suffer from a particular disease. It can be a con-sequentialist theory, of identifying the possible effects of an invention and avoiding those effects that are deemed harmful. Once again, the three justifi-cations fit under a public benefit theory. The disclosure theory recognizes the teaching function of a patent as bestowing a public benefit. The reward theory recognizes the existence of an invention itself as the source of a public benefit. Finally, the prospecting theory recognizes commercialization as means of dis-semination for the benefit of the public.

The two broader theories support the three justifications for patents, but also provide a framework for debating patent policy. The labor theory is often invoked by patent owners to support a strong set of rights. The public benefit theory, alternatively, is invoked by users of inventions in support of access to patented inventions. Not only do these two broad theories serve to humanize the abstraction of patent law; they also serve to shape and structure debates over the proper scope of patent laws. They help shape the discussion of patents and persons that is the substance of the rest of this book.

Recognizing Persons

This book is not a work of philosophy. But the influence of several sophisticated philosophers informs the following pages. My argument can perhaps be better presented by briefly acknowledging the three scholars whose ideas shaped my own in framing my arguments. They are Margaret Radin, Derek Parfit, and Hannah Arendt. The following is not meant to do justice to the complexity of their thinking. Instead, my goal is to identify elements of their work that are an integral part of the perspective I bring to bear on personalized medicine and patenting. To help guide the reader through the ideas gleaned from these

20 Justin Hughes, “The Philosophy of Intellectual Property,” 77 Georgetown Law Journal 287, 300–302 (1989).

21 Shubha Ghosh, “Patents and the Regulatory State: Rethinking the Patent Bargain Metaphor after Eldred,” 19 Berkeley Technology Law Journal 1315, 1319–1321 (2004).


three thinkers, I will divide this section into three parts, each explaining the critical concept relevant to the argument of this book. Those not interested in these more theoretical inquiries can skip to the next section discussing how the law recognizes personhood without losing the train of my argument. Although the tenor of this book is not philosophical, the examination of the philosophical arguments provides additional background for the policy and legal arguments in this book.

Ten years ago, Francis Fukuyama wrote a prescient book about emerging biotechnologies and their very likely consequences for ethics and human interactions.22 Technologies that permit enhancements of characteristics such as intelligence and physical power, he warned, would challenge any stable and coherent conception of human nature that is at the heart of democratic politics. Human dignity no longer has meaning if the attributes that define a human being can be biologically altered by those who have the most resources to spend on the latest technology. Human beings become commodities. Ten years later, many of the fears that Dr. Fukuyama voiced still persist in light of technological advances. These fears are framed in terms of how we under-stand personhood.

Personhood is distinct from property

Patents in the field of personalized medicine turn aspects of a person into property. Genetic markers associated with proclivity to disease, metabolites that signal adjustments in therapy, and correlations between treatment and diagnostic methods and demographic characteristics transform a dimension of a person and turn it into an element of a patented invention over which an inventor obtains an exclusive legal right. While some critics of genetic and biomedical patenting see these legal rights as akin to slavery, permitting the ownership of one person by another, such a view is misleading and miscon-strues how patenting in these areas operate. A patent does not cover a human being, as I explain in greater detail later. Instead, patents cover a non-naturally occurring chemical composition that is part of a person. The gene in a human body is not patentable, but the chemical compound identified and isolated from the human body can be. Rhetoric that patenting facilitates a new form of slavery misstates the problem. What should be of concern is the blurring of how we conceive of personhood through the transformation of personal characteristics into objects for study and sale.

22 Francis Fukuyama, Our Posthuman Future: Consequences of the Biotechnology Revolution (New York: Farrar, Strauss & Giroux, 2002) 148–150.


As law professor Margaret Radin points out, there is a pun in the word “property”23 and that pun becomes apparent in the domain of personalized medicine. Property refers to a thing that can be owned and marketed by the legal owner. Property also refers to an attribute or a characteristic of a thing, such as its size, its weight, its chemical composition, its color. For conven-tional property such as land or a personal item, like a watch or a bed, legal ownership is one attribute of the thing, but other attributes can be used to define and shape the thing. A parcel of land can be divided and improved. A watch can be broken into pieces or engraved or painted. These attributes illustrate how the thing can become fungible or altered. But the essence of the thing may be unalterable and unchanging, and this essence is the property that is owned by someone.

Persons also have properties, in the sense of attributes. Some of these attri-butes can be altered, like hair color. These attributes also may be severed from the person. A person can cut his hair, clip his nails, draw his own blood, pass on bodily fluids through crying, spitting, and other functions. The resulting detritus are attributes of the person distinct from but part of the person. But once all these attributes are taken away, there may still be some attributes that are inalterable. Redundantly, we can call this inalterable attribute, personality, an attribute that makes the person what he or she is, separate from the markers that constitute the objective elements of a person. However, this inalterable attribute of a person is different from that of parcel land or a personal item, like a watch. Personality cannot be owned; it is different from property in the legal sense.

The challenging question is whether attributes of a person can be owned and be treated as property in the legal sense. When my hair is attached to my head, I can defend against someone trying to pull it or extract it. An interfer-ence by someone attempting to take my hair would be considered a battery or assault, an injury to me as a person. In many jurisdictions, I can sell my hair and thereby turn it into property in the legal sense. How such a transforma-tion affects my personhood is troubling. My hair may reflect my personality, but it is distinct from my personality. Once I decide to cut and sell my hair, I disturb how I think of myself. Once I extract my bodily fluids and study them in a test tube, I recognize that the fluids are not me. Nonetheless, the fluids may provide much information on who I am. Legal restrictions on the sale of the objects of the body, whether bodily fluids or organs, may serve to protect subjective notions of personhood. The policy concern is that the personality

23 Margret Jane Radin, Reinterpreting Property (Chicago: The University of Chicago Press, 1993) 191–193.


becomes subsumed under the objective attributes of a person, which have been transformed into property.

Professor Radin’s identified tension between personhood and property has implications for the legal treatment of land and personality as property.24 Real estate attorneys refer to land as dirt, emphasizing its status as object, distinct from persons. But land and personality can be intimately connected. Land may have been handed down within one’s family for generations. Land may represent one’s cultural heritage. Land may also represent a personal attachment, the pride that comes from settling down and of raising a family. Personality can also imbue personal property. One’s automobile becomes an extension of one’s self. Choice of make, model, and color may reflect person-ality. But the ownership of the car, as with ownership of land, becomes part of a person’s history and in that way melds with one’s personality. To dismiss such attachments as sentimental ignores how property and personality, while distinct, also can shape each other.

Personality affects property in part by altering its attributes. How a landscape is formed from the dirt and green space, what color an automobile is painted, how an object is worn down and shaped by usage are the physical attributes of these various types of property that flow from the personality of the owner. But as I understand Professor Radin’s point, personality affects more than the surface attributes of property.25 Personality can shape the meaning of property, the core that can be separated from the attributes. Persons shape several tracts of land with the result being a neighborhood. This community, which consists of the improved parcels, is greater than the aggregated tracts. It has a person-ality of its own, which flows from the cooperating personalities of the people that acquired the land and shaped it.

The interactions between personhood and property are relevant for legal policy. Courts and legislators pursuing land use regulation, for example, may consider the effect of legal procedures, court rulings, and administrative deci-sions on persons. Technical policy analysis of legal regulation, often based on utilitarianism or one of its variants, is often motivated by engineering of the underlying property interest. Land may be taken by eminent domain, for example, in order to implement a project that affects the greater good. However, such a taking may upset the community that resides on the land and that has acted to develop it. If property and personality affect each other, then regulation and engineering of the first is regulation and engineering of the other. Property rules affect persons in how personalities are shaped and

24 Radin, Reinterpreting, 36–38.25 Radin, Reinterpreting, 47–48.


in how social and cultural commitments are disturbed. A utilitarian policy analysis of property regulation would ignore the impact on persons.

Patents are tools for incentivizing invention, for commercialization, and for disclosure. Personalized medicine patents specifically are tools for invention, commercialization, and disclosure in the area of medical diagnostics and treatment tailored to the particular characteristics of an individual patient. Because such patents take attributes of a person and make them elements of the patented invention, the tension between personhood and property iden-tified by Professor Radin is present. Even though the patents do not create ownership over a human being, they do enable speaking of persons as objects, turning attributes of a human being into elements of a property right. This legal treatment of personal attributes can transform how we understand per-sons. The way in which this transformation occurs and its implications is the subject of this book.

Personal identity is contingent

Margaret Radin alerts us to the existence of personhood as distinct from property. But what constitutes personhood? Historical experience with slav-ery shows how malleable the line between person and property can be. The category of person has also been gendered as well as framed in terms of race. Incorporating personhood into legal policy requires a conception of person-hood that is inclusive and not limited by prior notions of who counts and who does not. Furthermore, one’s view of personhood necessarily should take into account the range of human experiences, even experiences with which one may not be familiar because of differences in circumstances and culture. Professor Radin, in my reading, presents a neo-pragmatist theory of legal pol-icy, one that is not based on idealized notions of personhood.26 She is attuned to context within which law is to be applied.

As the examples of Myriad and Nitromed illustrate, personalized medi-cine deals with persons in terms of physical attributes like genes or skin color. How these attributes aid in our understanding of a person is problematic. The approaches of these two companies isolate individual characteristics in order to formulate their respective diagnostic and treatment methods. The choice of one characteristic is not surprising, because scientific research is special-ized. But the choice of attributes has implications for how patients are identi-fied and how the inventions are applied. A person cannot be reduced to one attribute such as skin color or a genetic sequence. We may also ask whether

26 Radin, Reinterpreting, 38–40.


a person is separate from these attributes. How we conceptualize the person affects how we gauge the policies related to personalized medicine patenting. Our concern may be that a particular personalized medicine patent may be misidentifying the relevant attributes of a person and may be ignoring alto-gether who a person is for the purposes of medical diagnosis and treatment. For these reasons, how we understand personhood is relevant for the issues presented in this book.

Derek Parfit presents a useful thought experiment to illustrate how to under-stand personhood, one that is directly relevant to the topic of personalized medicine.27 I will reformulate the experiment so that is immediately relevant to the theme of this book. Imagine all the attributes that constitute how you think of your physical self: the parts of your body, your form, your shape, and so forth. Now imagine changing each of these one at a time. At what point do you stop being the person that you are? A change in hair color may not do it. Perhaps a loss in weight? An increase or decrease in height? A loss of a limb? One may be tempted to think that throughout the change in the body, one’s mind remains constant and that fixed point is what is the person or the self. But arguably one’s mind changes as well even throughout the thought exper-iment. To imagine one’s self with different bodily attributes changes how the mind perceives of itself. One can imagine other versions of one’s self that did not exist before. To call these alternative states imaginary does not address the issue. The imagination is part of how this allegedly fixed, unchanging mind operates and is part of the attributes of one’s self. As Parfit puts it: “Most peo-ple have beliefs about these imaginary cases. As I have argued, these beliefs imply that we are separately existing entities, distinct from our brains and bodies, and entities whose existence must be all-or-nothing.”28 Parfit rejects these beliefs. Changing the attributes at some point changes the very self that is undergoing the thought experiment.

Parfit calls the alternative view that he espouses the Reductionist view.29 Under this view, one’s self is not separate from one’s body, brain, and experi-ences. At an intuitive level, there is an appeal to this position. One can think back on one’s life and imagine some path not taken. One can spin from that alternative path other options that might have emerged. One may be tempted to say that regardless of the path taken, one would have remained the same in terms of values, perspectives, or other attributes imprinted at birth. But that conclusion rests on the implicit assumption of starting the clock at an

27 Derek Parfit, Reasons and Persons (Oxford: Oxford University Press, 1984) 202–204.28 Parfit, Persons, 273.29 Idem.


arbitrary time. One can equally imagine a time before one’s birth and wonder what would have happened if one’s parents or grandparents had not met. One would have been imprinted very differently, or more likely one might not have been born at all. If one accepts these points, each of which strikes me as valid scenarios, one would proceed to an even stronger conclusion, which is Parfit’s point. To talk about the self as a separate, independent, unchanging entity is misleading. One can only speak about a self in terms of particular attributes, a specific brain, a specific body, a specific set of experiences. The self does not exist. What we call the self reduces to the various attributes and experiences we find in our lives.

To deny the existence of the self may appear to lead to a sort of nihilism. Self-abnegation and self-denial appear life-denying. The Reductionist view leads to the view that the self is contingent on particular attributes and experi-ences and is not absolute. This loss of absolutism would lead to the conclusion that anything goes. But that is not Parfit’s point at all. To deny the existence of the self is not to deny the existence of moral principles that guide and restrain conduct.30 What is denied is basing these principles on some absolute notion of the self. As pointed out at the beginning of this section, the danger arising from the concept of personhood is that the person can be construed too nar-rowly, in racialized or gendered terms. The error is that articulated in song by Dr. Henry Higgins in the musical “My Fair Lady”: “Why Can’t a Woman Be More Like a Man?” Why should she? The song is assuming that the male self, however constructed, is the absolute against which others are to be judged. But if one accepts the view that a self, and hence a person, is contingent on cir-cumstances, then why is any particular self a standard for any others? Because a self reduces to a brain, body, and experiences, it is these elements that would provide the basis for making judgments that pertain to other people.

To follow the logic of the previous paragraph, one might be tempted to say that, as with Professor Higgin’s question, it would be as equally incorrect to ask “Why Can’t a Man Be More Like a Woman?” At many levels, the sym-metric question multiplies the errors of the original. The problem in seeking symmetry here would be the implicit assumption that experiences are iden-tical across gender or other category. That assumption would be incorrect. Perhaps there are superficial similarities shared by the experiences of different groups of persons, but on a daily basis, and in the aggregate, experiences will differ both in terms of actual encounters and in one’s reaction to them. Donna J. Haraway, a historian of science, touches on this point in her discussion of

30 Parfit, Persons, 330; Derek Parfit, On What Matters (Oxford: Oxford University Press, 2011) 87–90.


the social construction of science and what I would describe as the quandary of the death of objectivity. She admonishes that “social constructivism cannot be allowed to decay into the radiant emanations of cynicism.”31 As to personal identity, “[h]uman nature, encoded in its genome and its other practices, is a vast library of Umberto Eco’s secret labyrinth in The Name of the Rose (1980). The stabilization and storage of this text of human nature promise to cost more than its writing.”32

Haraway represents the social constructionist view that identity and other categories have no natural foundation, but are the result of human choice. But the difficult question for a social constructionist view, as she points out, is determining how categories and institutions are constructed. The answer to that question requires understanding the human made processes through which institutions are created and the ethical and normative viewpoints embedded in them.33

If Parfit is correct in his reductionist view of the person, Haraway’s descrip-tion of the weight and accumulation of human experiences reveals the chal-lenge in recognizing other persons and making judgments about actions. Haraway takes us toward the world of metaphor and context, that latter she certainly shares with Parfit. But Parfit’s reductionist view is a first step to moral action that throws into the question the meaning of the pursuit of self-interest. If the self reduces to a set of contingencies, then so must self-interest.

Parfit’s thought experiment does not take us to nihilism, or even self- abnegation. He does not deny the body or experiences. Instead his experiment invites us to think about principles that guide how we order society and relate to others in terms that are separate from the notion of an unchanging, fixed self. Personhood is contingent, and moral principles should acknowledge and respect these contingencies.

One particular direction in which Parfit’s views take us is to consider-ations of future generations.34 If our own conception of ourselves is con-tingent on past events and choices, the same must be true for how future generations will view themselves. Our current acts have consequences in the future, whether these acts are personal like marriage or career or these

31 Donna J. Haraway, Simians, Cyborgs, and Women: The Reinvention of Nature (New York: Routledge, 1991) 184.

32 Idem. at 185.33 Thomas P. Hughes, Human-Built World: How to Think About Technology and Culture

(Chicago: The University of Chicago Press, 2004) 154–156. See also, Kwame Anthony Appiah, The Ethics of Identity (Princeton: Princeton University Press, 2005) 145–146 (setting forth the often misinterpreted role of culture in defining the person).

34 Parfit, Persons, 376–379.


acts are political and social like whom to elect president. All selves are con-tingent, so no particular self can serve as a template for establishing moral principles, including the present generation of selves with respect to future generations. Therefore, in determining what course of actions to follow, we need to take account of future generations much like we would take account of other selves.

How to do this accounting is the difficult question. Parfit presents several moral quandaries of how the existence of other selves, especially future gen-erations of selves, complicate current decision making, particularly on policies regarding the environment or new technologies. I do not have the capacity to address all of these quandaries here, except to point out that personalized medicine patenting is just one example of the difficulties that Parfit leaves to his readers. A difficult problem does not make for an impossible problem, and the arguments in this book present practical approaches to the relationship between personhood and patents. What Parfit’s ideas do is provide one fram-ing device to acknowledge personhood in patent policy.

Personalized medicine, as the name suggests, recognizes the existence of persons. But if one accepts the notion that a person is contingent, then this contingency needs to be incorporated in the personalized medicine policy, specifically the policies of patent law. On the one hand, these policies would lead to the very goals of personalized medicine: the development of diagnostic and treatment methods for persons, which have been ignored by the medi-cal research community. At the same time, personalized medicine practice should not turn these individuals into fixed, unchanging categories. As I argue more fully in Chapter 4, the use of the term “black patient” in Nitromed’s patent makes this mistake. Furthermore, personalized medicine practice has effects on future generations. These effects should be recognized in patent policy. To do so requires some elaboration of the concept of intergenerational equity, building on Parfit’s ideas.

The term “intergenerational” encompasses two concepts, one that I will refer to as synchronic and the other as diachronic. Synchronic refers to dif-ferent generations coexisting at one point in time when intellectual property policy is made. Diachronic refers to different generations across different periods of time. One key difference between these two uses of the word “intergenerational” is that diachronic consists of generations that may yet to be in existence as well as generations that have passed on. The two concepts are distinct and serve to highlight the different functions of the term “inter-generational” in helping us understand the goals of equity.

The word “generation” has many meanings. One is biological, referring to the average length of time between a mother’s first offspring and her


daughter’s first offspring. One is anthropological, referring to a line of descent. One is technological and refers to a version of an invention. I use the word “generation” in a cultural sense to refer to a group of people alive at some his-torical moment such as World War II, the introduction of the Pill, 9/11, or the 2008 financial meltdown. This definition is made popular by Tom Brokaw35 and reflects technological realities as well as other social and economic mile-stones. This notion of generation can also reflect biological realities, such as death and sickness, or events affected by technological developments such as pharmaceuticals and medical devices. The term “generation” captures, in my mind, a rich array of meanings that implicate the various dimensions of intellectual property law, from branded products to copyrighted music to bio-technology patents.

To think of equity in terms of generation requires recognizing both the coexistence of generations, called synchronic earlier in the chapter, and the existence of future generations, referred to as diachronic earlier. Recognizing the coexistence of generations highlights the diversity of viewpoints, experi-ences, and interests that intellectual property law touches. Constructing intel-lectual property rules that allow coexisting generations to communicate and build with the awareness of both shared experiences, historic continuity, and lifetime goals and ambitions reflects an interest convergence on which legal reform can be built.36 Different generations have in common the roles of users and consumers, educators and students, creators and readers. Although I do not want to paint too harmonious a picture of the battles over intellectual prop-erty law and policy, the interests that generations share may provide a basis for compromise in specific battles over the scope and structure of intellectual property rights, whether achieved through the legislature or the courts.

The existence of future generations poses a bigger problem for intellectual property policy. Whereas in the area of environmental law consideration of future generations has been a quite powerful force in conservation efforts, appeals to future generations in intellectual property can readily support stronger intellectual property rights in the present, often at the expense of living users and creators who build on existing works. Extensions of the copy-right term are justified superficially by benefits for future generations. Heirs, often yet to be born, are the beneficiaries of the efforts of living authors. The

35 Tom Brokaw, The Greatest Generation (New York: Random House, 1998) xxv.36 For an analysis of the concept of “interest convergence,” see Derrick A. Bell, Jr., “Brown v.

Board of Education and the Interest-Convergence Dilemma,” 93 Harv. L. Rev. 518 (1980). For a discussion in the context of intergenerational equity, see Norman Daniels, Am I My Parents’ Keeper?: An Essay on Justice Between the Young and the Old (Oxford: Oxford University Press, 1988).


corporate entity, in theory infinitely alive, bridges present and future gen-erations and serves as a receptacle for trade secrets, trademarks, copyrights, and patents that are deemed to serve the imagined future. Being conscious of future generations as well as past generations can cure a presentism that assumes that we are in the best of all possible worlds and that things could never be better or different. The danger is that future generations serve as a fiction and lure for present interests. The challenge is to avoid treating future generations as merely a foil for one’s current needs and goals. To engage with notions of intergenerational equity, at some level, is to move beyond cur-rent conditions and think seriously about how our present cultural and legal choices affect the future landscape.

To summarize, the proposition that personhood is contingent expands the normative basis for decision making, including the formulation of policy. Admittedly, how to account for other selves, including future generations of selves, is a challenging problem. But once personhood is recognized as a crit-ical factor in policy making, this challenge must be confronted. One dimen-sion of this challenge is recognizing what human experiences are the relevant contingencies that shape personhood. On this question, Hannah Arendt pro-vides the third philosophical prong supporting the argument of this book.

The human condition is one of activity

How the decisions of policy makers affect persons is a complex inquiry. Consequences are far-reaching and often indeterminate. To require an exam-ination of all the consequences of one’s choices would invariably lead to inac-tion. In many instances, a rule may guide behavior without an inquiry into all the possible consequences of an act. The formulation of these rules may involve the consideration of consequences or the recognition that such conse-quences are obvious. Rules against killing are one example. Rules restricting driving or the use of water are others. The formulation of such simple rules may not always be possible. In considering problems of new technologies or of innovation, consequences may be complex and simple rules would be unfath-omable. Inquiry into how persons are affected by decisions is needed to gauge the various dimensions of a person.

Parfit adopts a reductionist view, which holds that a person is a sum of his brain, body, and experiences. The determination of which of these aspects of a person might be most relevant to assessing consequences itself needs to be guided by some principles. Personalized medicine identifies aspects of a person’s body that can serve as a basis for designing innovative diagnostic and treatment methods. How these aspects of a person’s body are identified is


the source of controversy. Part of the argument of this book is the lack of an effective vocabulary to categorize persons and their physical attributes. The Nitromed invention, for example, rests of a person’s skin color – a troubling, misleading, and meaningless indicator. Myriad’s patent description points to genetic markers, which constitute an emerging and alternative set of catego-ries to capture the person. Our policies toward personalized medicine rest on how we think of the person. Personalized medicine reduces the person to the body without the full vocabulary to describe what aspects of the person are relevant to medical diagnosis and treatment. As the science develops, perhaps this new vocabulary will emerge. In the interim, policy makers need some guidelines for assessing how persons are recognized under the law.

The dimension of personhood that offers a more concrete and immediate focus for policy makers is a person’s experiences. Certain experiences can be shared across persons. Others that may appear strange and unusual can be communicated and explained. In the realm of personalized medicine, the pain and hardship associated with many diseases can be understood by many sufferers. The experience of dealing with medical institutions, with doctors and nurses, with hospital administrators, and with certain common medical techniques can be recognized across a range of social and cultural contexts. The meanings may differ. The institutional arrangements and con-texts are diverse. But the experiences create common bonds across persons.

Philosopher Hannah Arendt describes the human condition as a set of spe-cific types of activities that are uniquely human.37 She uses the phrase “human condition” rather than “human nature” because the latter phrase is more con-troversial and has some religious connotations.38 The human condition refers to the set of experiences that engage human beings across social and cultural contexts. The forms of these experiences may be different, reflecting the var-ied contexts. These common experiences are fundamental to the range of organizations and institutions within which humans exist and interact with each other.

Arendt identifies three activities that constitute the human condition, labor, work, and action.39 She refers to these as parts of vita activa, the active life, in contrast with vita contemplitiva, or the contemplative life. By labor, Arendt means physical tasks, the day-to-day acts like eating, cleaning, household maintenance, and other chores that constitute human life.40 Work, by contrast,

37 Hannah Arendt, The Human Condition (Chicago: The University of Chicago Press, 1958) 7–8.

38 Arendt, Human, 9–10.39 Arendt, Human, 12–13.40 Arendt, Human, 79.


means an avocation, tasks that give one’s life meaning and fulfillment. They can include one’s job and career, child care and parental care responsibilities, hobbies, creative endeavors like writing and musical performance, or research and study in the pursuit of scientific breakthroughs.41 The third part of the vita activa is action, which encompasses activities in the public sphere such as political activism, voting, or engagement in public discourse.42 Human orga-nizations are made up of these three types of activities in which all members of the organization participate in varying combinations. These various activi-ties are experiences that we consider human.

The types of activities identified by Arendt have parallels in the arena of personalized medicine patenting. With respect to patenting, the activity of inventing has elements of labor and work. Researchers engaged in conceptu-alizing the invention and developing its elements are engaged in work. Lab assistants and those who participate in more physical aspects of the research and development are engaged in labor. The distinction between work and labor that Arendt describes has analogues in patent law, and intellectual property more broadly. Although Arendt did not write about patents or about intellectual property, her distinction between work and labor parallels the dis-tinction between conceptual or creative activity and manual activity, more colloquially called “sweat of the brow.”43 Intellectual property law only covers the first type of activity but not the second. An example of this distinction is the ownership of a patent, which vests in the inventor, the person who con-ceived of the invention.44 An assistant who provided manual labor, but did not aid in the conception, has no patent rights. The second party is compen-sated for his services but has no legally protected interested in the invention that he or she helped produce. For Arendt, the distinction between work and labor reflected the types of activities in which humans engage, tasks that bring fulfillment and those that are necessary as chores for day-to-day living. For patent law, and intellectual property law more broadly, the distinction illus-trates who benefits from the award of the patent and whom the patent grant is designed to incentivize for the purposes of invention, commercialization, and disclosure. The treatment of work and labor under patent law shows how different types of human experiences translate into different sets of legal rights and policies.

41 Arendt, Human, 136.42 Arendt, Human, 175.43 Abraham Drassinower, “Sweat of the Brow, Creativity, and Authorship: On Originality in

Canadian Copyright Law,” 1 U of Ottawa L. and Tech. J. 10 (2003–2004).44 Alain Potage & Brad Sherman, Figures of Invention: A History of Modern Patent Law (Oxford:

Oxford University Press, 2011) 22–23.


Action, the third type of activity identified by Arendt, also has parallels in patent law. While a patent, like other forms of intellectual property, is viewed as a private property right, it has a public dimension as well. Not only does pat-ent law require public disclosure of the invention for a patent to issue, but the inventor must also undergo an administrative review to determine the validity of the patent. In addition, the patent owner will often proceed to litigation in order to enforce the rights. Patent litigation is a public procedure that allows for further review of the validity of the patent. So the pursuit and enforcement of a patent is inherently an action, as Arendt would describe, that implicates the public sphere.

A patent can also be held up to public scrutiny through challenges by pub-lic interest groups. These challenges have been more common in countries other than the United States, as Kali Murray and Ester van Zimmerman have pointed out in their study of an emerging patent civil society.45 The European Patent Office permits oppositions from groups, like Greenpeace, that chal-lenge the validity of a patent and question the social value of patents on genet-ically modified crops or on stem cells. In developing countries, particularly India, nongovernmental organizations scrutinize patenting activities and publicly challenge them in the press or through social media and blogs.46 In the United States, the growth of a patent civil society has been slow because of procedural mechanisms in the patent office and in the courts that have limited such challenges.47 The Myriad case is one recent example of chal-lenges from public interest groups. However, criticisms of the patent system in the United States have been rampant over the past decade, with growing concerns over frivolous software patents and potentially harmful medical and biotechnological patents. Patent reform enacted in 2011 may further expand patent civil society by permitting oppositions to a patent immediately after the grant. Such patent activism, both existing and emerging, is an example of what Arendt means by action.

The practice of personalized medicine also illustrates labor, work, and action outside the realm of patenting. Medical practitioners engage in labor and work in various proportions, with some engaging in the chores the com-prise the practice of medicine and others engaging in the tasks that may

45 Kali N. Murray & Esther van Zimmerman, “Dynamic Patent Governance in Europe and the United States: The Myriad Example,” 19 Cardozo J. Int. and Comp. L. 287, 321 (2011); Giorgio Resta, “The Case Against the Privatization of Knowledge: Some Thoughts on the Myriad Genetics Controversy,” in Biotech Innovations and Fundamental Rights, eds., Roberto Blin, Sara Lorenzon, & Nicola Lucchi (Milan: Springer, 2011) 11–36.

46 Murray & van Zimmerman, “Dynamic Patent,” 308–313.47 Murray & van Zimmerman, “Dynamic Patent,” 326–328.


perhaps be satisfying and meaningful. Patients also participate through labor and work as the subject of diagnostic methods and the recipient of treatment. Medicine also constitutes the public-minded activity that Arendt calls action because it is a profession that is obviously public directed but also subject to public regulation and scrutiny. Furthermore, personalized medicine is the subject of public controversy. As a purely technical matter, there is debate about the validity and efficacy of the scientific research that underlies its prac-tice. In addition, research in personalized medicine raises questions of human experimentation and ethical medical treatment. Personalized medicine, in its various dimensions, exemplifies all parts of what Arendt calls vita activa.

To summarize, human experience provides a basis for examining the con-sequences of policy dimensions on persons. In the case of personalized med-icine patenting, the relevant activities are the labor and tasks associated with patenting and with the practice of medicine. Also relevant are the political scrutiny of patents and medical practice. These activities will be the focus of much of the policy discussion of this book as it assesses policy in terms of its effects on persons.

Summary

The philosophical underpinnings of this book are in theoretical studies that first identify personhood as a distinct concept from property and sec-ond attempt to understand what we mean by personhood. Once personhood is acknowledged, the appropriateness of decisions and actions rests on their effects on persons. These effects are, needless to say, complex, but the per-tinent focus is provided by paying attention to the effects of decisions and actions on human experiences, which can be understood in terms of the activ-ities in which humans typically engage. The law’s treatment of persons reflects in practical ways these theoretical understandings.

Persons in the law

Persons play a key role in the law.48 Statutes, constitutions, judicial opinions, and other legal texts are drafted by persons. Their substance is debated by persons. More to the point, the impact of the law is gauged by their effect on persons. Although the mantra of rule of law is designed to depersonalize law and make its application neutral, impartiality of the law is distinct from

48 John T. Noonan, Jr., Persons and Masks of the Law: Cardozo, Holmes, Jefferson and Wythe as Makers of the Masks (Berkeley: University of California Press, 1976) 4–5.


its impersonality. If the law at some point does not recognize its impact on persons, the law itself can lose its legitimacy and become disrespected. Even a law that applies equally to everyone may be an absurd law if the effects on persons are ignored. Consider a rule that everyone must sing the national anthem at a particular time of the day. Or that everyone must tithe a certain percentage of their income to a federal agency. Even if no exception is made for the law, one would wonder about the function of singing the anthem or of the tithed money. Does the anthem lose meaning if sung repetitively at a specially designated time? And what is the punishment for failing to sing? Where does the tithed money go? Who benefits? The effect of laws on persons become more striking when they have unequal effect, when, for example, one is exempted from signing or one has to pay twice as much as someone else. Perhaps these differences can be justified, but these justifications are gauged in terms of persons.

Who is a person is a difficult, foundational question. Slaves, women, those from outside a particular geographic boundary were each thought of as non-persons at one point in time. Sometimes the exclusion was made explicit through designations such as chattel or property or implicit through the denial of rights, associated with citizenship or membership of a polity. A corporation is deemed a person, expressly under glosses on certain constitutional provi-sions or implicitly through legal enforcement and assignation.

For the purposes of this book, I consider human persons as the correct category. Human persons are those with certain biological characteristics and communicative abilities. One can think of the application of a Turing test, a procedure through which a human subject can distinguish between an artificial intelligence and a human brain. But my hypothetical Turing test is not simply about identifying and communicating intelligence. The test also entails identifying and communicating needs and wants. Under this test, a person is recognizable if it can communicate to another person, who is willing to hear the communication. The content of the communication can consist of an expression of one’s ideas or of one’s wants and desires. This communication can transcend language because translation is always possible. This commu-nication can include any system of signs or symbols, including facial expres-sions or ideographs. Even someone who is incapacitated or comatose would fit my definition, I would argue. Such individuals can communicate through written directives drafted before the incapacity. There is also evidence that they can communicate in some means through brain waves and other bodily signals. The key is that the communication is possible in some fashion.

Under this proposed approach, corporations and other business entities would not be deemed persons because they can communicate only through


persons. A business entity is sometimes thought of as “speaking” and its First Amendment right of free speech is recognized. But this assignation is just legal shorthand. In fact, the stronger point about corporations and other busi-ness entities is that they are not persons because they are tools by which one person communicates to another person. When a business entity is formed, the purpose is to communicate certain functions to other persons. A particu-lar business form communicates choices about liability and ownership struc-ture. A particular entity serves as a vehicle for advertising through trademarks and other expressive media. One can think about a business entity like the gas gauge of a car. Is this gauge a way of the car telling the driver: feed me? More likely, the gauge is a way for the driver to communicate to oneself that the car needs refueling. Like a gas gauge, the beep of a laser printer in need of ink, or the guiding cadences of a GPS navigator, a business entity may metaphor-ically communicate something, but it is more accurately understood as a tool for communication.

Defining persons in terms of the ability to communicate is useful for the purposes of my argument because it limits the scope of persons who can be considered normatively to human persons and not artificial persons. Because this book focuses on the biological and sociological dimensions of identity, particularly the gene and social categories like race, limiting the conception of persons to humans is important. If persons included business entities, then Myriad and Nitromed as well as those afflicted with breast cancer or hyperten-sion would have to be considered equally. This leveling would make the nor-mative analysis meaningless and would displace the central point of this book that there is a humanistic dimension to patents. But to recognize a humanistic dimension does not mean that business entities are irrelevant to the assess-ment of patent policy. The point is the business entities are instruments, like patents, to reach certain human ends. Legal policy should not confound the instrument with the ends.

But does my modified Turing test for identifying a person expand the notion of personhood to include animals? By application of my modified Turing test, an animal would be a person because an animal can communicate to a per-son its wants and needs, whether it is feeding or relieving time. An animal can communicate anger, fear, and other emotions. Nonetheless, this book largely ignores patents relating to animals, and there are several. Many cases about gene sequence patents dealt with the DNA of nonhuman life forms. The classic Diamond v. Chakrabarty dealt with bacteria. Mouse genes show up in many patent controversies as well. Certainly the court decisions in the Myriad case do not make a discussion between human and nonhuman genes. They both would be naturally occurring and defeat patenting of sequences


that were similar in character and use. So the blunt answer is that the question does not matter for my purposes. I will leave that topic for another book, most likely another author.

What aspects of a person are relevant for assessing patent policy? Respecting a person as a whole is an important guiding principle, but practical policy will often require making distinctions among persons. Law and policy limit what distinctions are permissible. The Fourteenth Amendment of the U.S. Constitution does not permit the state to make distinction based on race unless there is a compelling state interest.49 Distinctions based on alienage are also subject to strict scrutiny by the judiciary. A slightly lesser standard applies to distinctions based on gender and even a lower standard for distinctions based on age. When distinctions among persons affect fundamental rights, such as, for example, the right to marry, to travel, to speak, or to practice one’s religion, these distinctions are also subject to a strict scrutiny. The Equal Protection Clause of the Fourteenth Amendment delineates characteristics of the person that are impermissible bases for distinctions by the state in defining and applying its laws. At one point, the U.S. law limited the grant of patents to U.S. citizens. John Boyle, a patent attorney, noted an interesting exchange between the USPTO and a slave owner in 1857 over the rights of the owner’s slave to patent an invention. The USPTO denied the slave the right to patent because he was not a U.S. citizen under the Dred Scott decision.50

Patent law also delineates various dimensions of personhood. A prominent delineation is based on the capacity of a person to invent. Patent law’s benefits often are bestowed based on the work of the class of persons that are desig-nated as inventors. This class may consist of professionals, such as research scientists in universities or industry, and of tinkerers, amateurs who work on inventions as a hobbyist or out of curiosity. This class may also consist of lucky inventors, those who come upon a patentable invention by pure chance. The point is that the inventive capacity is one dimension of personhood informing patent law. Another dimension is that of the consumer, or user of an inven-tion. This class consists of those who purchase new gadgets or keep up with

49 “All persons born or naturalized in the United States, and subject to the jurisdiction thereof, are citizens of the United States and of the State wherein they reside. No State shall make or enforce any law which shall abridge the privileges or immunities of citizens of the United States; nor shall any State deprive any person of life, liberty, or property, without due process of law; nor deny to any person within its jurisdiction the equal protection of the laws.” U.S. Constitution, 14th Amend., Section one.

50 John Boyle, “Patents and Civil Rights in 1857–8,” 42 J. Pat. Off. Soc’y 789, 791–94 (1960). The Dred Scott decision, among its many errors, held that African Americans were not citizens of the United States. The case was overruled by the Fourteenth Amendment. Dred Scott v. Sandford, 19 How. 393, 15 L.Ed. 691 (1857).


developments in technology as a matter of interest. A consumer is also some-one who relies on technological developments to sustain one’s life and health, for example, through the acquisition of pharmaceuticals or of medical devices. The person as consumer is an ideal that informs certain aspects of patent law, particularly those that facilitate the dissemination of inventions through com-mercialization or other forms of distribution.

But inventors and consumers are only two classes of persons. A focus solely on these two categories ignores the various dimensions of a person that might be relevant for policy making. A person loves and nurtures. A person engages in battle. A person develops business models and information systems for shar-ing messages, photos, videos, and other expressive media for memories. Patent law, like all constructed institutions, is guided by its consequences for persons in all dimensions. This point is the central assumption of this book. I do not take it as an inalienable truth. But I find the principle helpful in assessing the ways in which the person intrudes on the personal sphere, whether through the genetic sequence, as in the Myriad case. or through sociological categories as in the Nitromed business strategy.

But the danger is in reducing the person to one dimension. Is a person defined by his or her genes? The answer has to be no. Genes have an influ-ence, but to say that a person lives on genetically – say, through biological children – is no consolation if the person’s death could have been avoided. Similarly, the special treatment of human genetic matter as a matter of uni-versity and government regulations reflects the fact that the genes embody certain inalienable aspects of the person that live on perhaps through the genes but also transcend them. The tension, as we will see many times in this book, is between treating a person as a whole and treating a person along cer-tain dimensions. A person is the sum total of race, ethnicity, gender, genetic makeup, experiences, and beliefs. But often we need to focus on one of these dimensions at the risk of ignoring others.

Accommodating Persons and Patents

How is the person to be accommodated into patent policy? For some, this may be a meaningless question. Patent law, like its cousins in other areas of intellectual property law, and like its close ally business law, is instrumental. It is filled with technical rules used to make sure that the plumbing of our economy operates well. While the plumbing is important for people to live and pursue their goals and ambitions, the instruments are quite distinct from what is really important in human life: play, family, making and producing. For much of the life of patent law, that wall between the instrument and the


person has been a viable one. In the law school curriculum, for instance, pat-ent law often has been relegated to the back of the catalog. Sometimes the subject was not even taught, and when taught, patent law was viewed as a nar-row field serving specialized interests. As the two examples at the beginning of this chapter illustrate, the wall between patents and persons is blurring. As the field of invention has moved decidedly, albeit controversially, into the realm of the personal, it is not meaningful to simply acknowledge patent law as a tech-nical, narrow field. Patent law has moved to the forefront of policy that affects people’s lives. The question posed asks how policy makers, academics, and concerned thinkers can make the blurring between the instrumental world of patents and the realm of the person meaningful.

The direct answer is to recognize that whereas patent law is an instrument, persons are the ends. As patent law protects inventions that intrude on the personal realm, whether defined in genetic or sociological terms, the danger is that persons will become instruments, tools for experimentation and com-mercial appropriation. In any society, perhaps especially in a democratic free market one, persons may already be instruments. They are viewed as votes, sources of revenue, eyeballs for advertising. But countering these tendencies are values that prevent the reduction of persons to things. Health and safety regulations, privacy rules, consumer protection – all attempt to assert human agency against tendencies to mask the person as a means to obtain self-inter-ested goals. My point is that persons should also be understood as the ends that patent law serves. Although patent law might recognize certain aspects of the person, such as the capacity to invent or to consume, these instances of the person are instrumental ones that do not fully address how promoting progress through patent law can meet human needs and wants.

Martha Nussbaum and Amartya Sen have developed the capabilities approach to supplement measures of progress based on economic factors, such as gross national product or labor productivity.51 This book is a step toward introducing that approach to patent law (and intellectual property law, more broadly, as well as other policies aimed at promoting innovation). By capabil-ities, Nussbaum and Sen mean the full dimension of what it means to be a person: one’s health, one’s personal relationships, one’s education, one’s work. This list could be continued, and it should be in order to address the full-ness of what we aspire for ourselves and for other persons. While these claims might appear vague and unwieldy, the claim at one level is a modest one: look beyond income and prices as the sole measure of progress. At another

51 Martha Nussbaum & Amartya Sen, eds., The Quality of Life (Oxford: Oxford University Press, 1993) 1–3.


level, Professors Nussbaum and Sen develop metrics that can make the pur-suit of capabilities more objective and the subject of policy debate and analy-sis. Measures of political liberties, educational attainment, and morality and morbidity are some examples of how we can start to broaden the discussion to include more dimensions of the person than their willingness (as gauged by price) and ability as gauged by income) to pay for goods and services.

My goal in this book is not to introduce metrics analogous to those devised by Nussbaum and Sen to aid in assessing the success of patent law. Instead, I look deeper into the stories behind Myriad and Nitromed to provide more context to their business and patenting strategies. By this form of qualitative analysis, I illustrate not only how the line between the instrumental and the person has become blurred in patent law, but also how to rethink the person within the parameters of patent law and policy. Because much of the appli-cation of patent law is a qualitative one, with agents and judges assessing whether an invention meets various standards under the law, the approach I adopt is consistent with the way in which discussions occur in legal domains, whether the legislature or the judiciary. Although the book eschews quantita-tive analysis of capabilities, it presents an approach grounded in the pursuit of capabilities as a guide for policy making.

As illustration of these points, and as foundation for later analysis, consider the three justifications for patents presented earlier in terms of seeing persons as ends and not means. The disclosure justification grounds patents in a quid pro quo, the disclosure of an invention in exchange for some limited rights of exclusion. From a capabilities perspective, the disclosure justification is about furthering human knowledge and enriching the scope of learning that is available to interested and informed persons. Of course, in reality, nobody actually reads patents (except perhaps authors of books like this one), and even patent searchers scan them quickly to see if an invention has been preempted by a prior patent. This point does not obviate the role of patents in expand-ing the scope of knowledge. Lots of important works get read by only a few people.

Where the disclosure justification fails from a capabilities perspective is in the emphasis, under patent doctrine, that the relevant audience for a patent should be the “person having ordinary skill in the art,” or PHOSITA.52 A capa-bilities approach might support a different standard for invention disclosure, one that allows for general intelligibility or clarity. The approach might also support more openness during patent prosecution, the process of reviewing the invention by the patent office, or after the patent grant as a check on

52 35 USC § 112.


the administrative process. While there are many arguments in favor of such reforms, a capabilities approach would justify them in terms of their benefits to persons through disclosure and expansion of knowledge. In addition, the openness of process ensures that the interests of persons can be represented and addressed in the granting of patent rights.

The pursuit of capabilities can also inform the reward justification. As conventionally understood, the reward justification supports a patent grant as a benefit to a person who has invented a novel product or process, whether through extensive labor or by chance. This formulation seemingly just empha-sizes the person as inventor. But the rules for novelty and other patent law requirements address other dimensions of the person. To receive a patent, for example, the inventor must have come up with something that has practi-cal application. This practical application can be understood in terms of the wants and needs of persons. The invention must also be nonobvious, or inven-tive, in order to warrant a patent. Once again, the capabilities of persons can define the nonobviousness standard.

One point worth emphasizing is the reward justification bases the grant of a patent right on the creation of an invention, not its commercialization. The implication is that an inventor, or someone buying from an inventor, can receive a patent, decide not to commercialize it, and instead choose to engage in litigation in order to obtain settlements or judgments. This picture depicts the “patent troll” or “nonpracticing entity” (NPE). The NPE is currently the subject of much criticism and debate. From a capabilities perspective, the NPE is arguably not serving the needs of persons by simply using the patent as an instrument for extortion. But of course this analysis can be complicated as many nonprofit entities, like universities, would be classified as NPEs. In favor of this type of NPE’s is the use of the patent as a source of licensing revenue, which benefits the university and the public, particularly in state universities. A capabilities approach would provide a basis for more close scrutiny of the type of reward a patent enables and a check on uses that might be deemed an abuse of patent rights.

Finally, the commercialization justification lends itself to analysis under the capabilities approach. A patent is a tool for commercialization through licensing and distribution of the invention via a potentially wide range of markets. Such commercialization can enrich persons by providing life-saving drugs and medical devices or, more trivially, by providing conveniences such as appliances and other tools that provide for more leisure and enjoyment. Heart stents and smart phones are twin examples of patent’s bounty under the commercialization justification as framed by the capabilities approach. At


the same time, the commercialization justification may result in a distortion of choices as inventors pursue the most profitable ventures at the expense of those that might be more beneficial, such as the development of drugs that service orphan diseases. Patent law and policy can temper these tendencies by targeting the patent grant to different ends, ones that may be more aligned in developing capabilities. Recent efforts to target green technologies through patenting are one example of patent policy that views commercialization through the lens of capabilities.53

These three examples illustrate how patent law can, and perhaps already does, accommodate the person. In terms of the two broad theories of patents – the labor theory and the public use theory – the capabilities perspective can lend support to a wide range of patent reforms that see persons as ends rather than as means. The labor theory views a patent as the fruit of pro-ductive labor, a property right arising from the application of labor to the natural world. The capabilities approach would look beyond the immediate protection for the inventor’s labor, but recognize that the patent grant can affect persons as a whole, whether inventor or consumer. To assert property rights over a gene sequence, as in Myriad, or over treatment of a particular class of persons, as in Nitromed, has an impact on how medical practitioners operate, how patients deal with their afflictions, and how researchers pur-sue cures and treatments. All these persons are engaged in human activity of different sorts, and a labor theory informed by the capabilities perspective will need to balance these different types of productive labor. Similarly, the public benefit approach would look upon the consequences of a patent as they affect a wide range of persons and would assess these consequences in terms of needs and wants that go beyond the mere economic gains from a patent grant.

I could spend many more pages detailing these theoretical arguments. Instead, what would be more useful is to see how these arguments about per-sons and patents, ends and means, capabilities and instruments, play out in practice. That strategy is the basis for the rest of this book, which takes the cases of the breast cancer gene patent and the treatment of hypertension in black patients as the critical examples through which to understand how capa-bilities inform patent policy. With the road map presented in the last section, I turn to this more detailed presentation of how to accommodate persons into our understanding of patents.

53 Matthew Rimmer, Intellectual Property and Climate Change: Inventing Clean Technologies (London: Edward Elgar, 2011) 160–162.


Two Additional Illustrative Legal Developments

The relevance of personhood to patent law and policy is made more strikingly apparent by two developments in 2011 in U.S. and European patent law. The first is in the context of reforms under the Leahy-Smith America Invents Act of 2011 (AIA), signed into law by President Obama on September 16, 2011.54 The second is a decision by the European Court of Justice (Grand Chamber) on the patentability of stem cells under the European Patent Directive.55 Both together illustrate how issues of personhood inform patent law.

Among its many substantive and procedural changes to the 1952 Patent Act, the AIA added a new Section 33(a), which reads as follows: “Notwithstanding any other provision of this statute, no patent shall issue on claims directed to or encompassing a human organism.” 56 This new statutory provision, the product of Congressman David Weldon from Florida, makes clear that a “human organism” cannot be patented. Although the provision is an addi-tion to the Patent Act, it has been part of the Commerce, Science, and Justice Appropriations Bill since 2004 as a limitation on the use of Congressional funds.57 In the annual Appropriations Bills, the amendment stated that “[n]one of the funds appropriated or otherwise made available under this Act may be used to issue patents directed to or encompassing a human organism.”58 Given that the USPTO budget came largely from Congress, the effect of the Amendment from 2004 to 2011 was to limit the issuance of patents pertain-ing to human organisms despite any statutory limitation within the Patent Act. However, the AIA includes among its provisions a shift in funding of the USPTO from Congressional appropriations to patent fees. Consequently, the Weldon Amendment was made part of the Patent Act as part of the AIA revisions to reflect the new source of funding. With the shift to the use of pat-ent fees to fund the USPTO activities, Congressional purse strings could not serve to limit the patenting decisions of the agency.

The Weldon Amendment could potentially expand the power of the USPTO to deny patents pertaining to human organisms. The literal language of Section 33(a) would permit a denial of a patent to any invention that touches upon a human organism. Such denials could extend to methods of treating

54 Leahy-Smith America Invents Act, Pub. L. No. 112–29, 125 Stat. 284, 325 (2011).55 Brüstle v. Greenpeace e.V., Judgment of the Court (Grand Chamber) (October 18, 2011).56 “Codify the Weldon Ban on Patenting Humans,” FRC Action Newsletter (June 14, 2011),

available at http://downloads.frcaction.org/EF/EF11F02.pdf (last viewed January 17, 2012).57 FY2011 Omnibus spending bill (Department of Defense and Full-Year Continuing

Appropriations Act, 2011 (H.R. 1473,P.L. 112–10)).58 Idem.


human beings and to human stem cell patents. In practice, the Weldon Amendment reflected USPTO practice as of 2004. Actual practice may limit an expansive interpretation of Section 33(a). In a September 20, 2011 memo to the corps of patent examiners of the USPTO, Robert W. Bahr, Senior Patent Counsel and Acting Associate Commissioner for Patent Examination Policy, clarified that Section 33(a) did not change long-standing policy that a claim encompassing a human being is not patentable.59 According to Mr. Bahr, the USPTO has had a policy since 1987 of not granting claims that, when read in the broadest terms, would encompass a human being. This policy was part of the Manual of Patent Examination Procedures (MPEP), used by patent examiners to review patent applications.60 The 1987 policy placed limits on the U.S. Supreme Court ruling in Diamond v Chakrabarty, decided in 1980, that life forms were patentable. Although the 1980 precedent applied expressly to single-cell organisms (specifically a bacteria in that case), patent office prac-tice extended the ruling to multicellular life forms, like genetically modified mice. Attempts by researchers to patent human chimeras and hermaphroditic human embryos placed limits on the 1980 Supreme Court ruling on ethi-cal and constitutional grounds. Allowing patents on human organisms would pose ethical quandaries relating to human experimentation and commodifi-cation and would turn human beings into property – a possibility inconsistent with the abolition of slavery under the Thirteenth Amendment to the U.S. Constitution.61

Interpretations of the Weldon Amendment also put boundaries on when an invention encompasses a human organism. The Weldon Amendment would disallow patents on human organisms at any stage of development, including embryos and fetuses, as well as patents on chimeras and entities created by combining materials from embryos. However, supporters of the Amendment emphasize that it would not prevent patents on methods of creating human embryos, including clonings, and patents pertaining to nonhuman animals. In addition, the Amendments would not prevent patents on human tissues and cells, including stem cells. Presumably, the Amendment would not pre-vent patents on methods of treating human organisms for disease or patents on pharmaceuticals or medical devices that would be used in such treatment.

59 “Claims Directed to or Encompassing a Human Organism,” Memorandum to Patent Examining Corps from Robert W. Bahr (September 20, 2011), available at http://www.uspto.gov/aia_implementation/human-organism-memo.pdf (last viewed on January 17, 2012).

60 MPEP § 2105 (2010).61 “Neither slavery nor involuntary servitude, except as a punishment for crime whereof the

party shall have been duly convicted, shall exist within the United States, or any place sub-ject to their jurisdiction.” U.S. Constitution, Thirteenth Amend., Section One.


As I discuss in more detail in Chapter 4, it is an open question whether the Weldon Amendment would prevent patents such as the one issued to Nitromed for treating a “black patient.” While such a patent is a method for treatment, the claim is written to specifically apply to a category of human organism. Therefore, arguably the Nitromed patent may be inconsistent with the limita-tion on patenting imposed by the Weldon Agreement.

Developments in Europe offer an illustrative contrast with the changes to patentable subject matter under the Weldon Amendments in the AIA. In October, 2011, the Grand Chamber of the European Court of Justice addressed the question of the patentability of human stem cells under German patent law. The Grand Chamber reviewed a challenge raised by Greenpeace to a patent covering human stem cells owned by a German research scien-tist. At issue was the compatibility of the patent on human stem cells with the Directive of the European Parliament on biotechnological research of 1998, the Trade Related Intellectual Property Systems (TRIPS) Agreement of 1996, and the Convention on the Grant of a European Patent of 1973. The Grand Chamber concluded that patents relating to human stem cells could be excluded under the Directive, the TRIPS Agreement, and the Convention. Stated briefly, the Grand Chamber based its decision on the effects that the commercialization of human embryos would have on morality and the pub-lic order. The following language from the 1998 Directive on Biotechnology informed the Chamber’s decision:

Whereas patent law must be applied so as to respect the fundamental princi-ples safeguarding the dignity and integrity of the person; whereas it is impor-tant to assert the principle that the human body, at any stage in is formation or development, including germ cells, and the simple discovery of one of its elements or one of its products, including the sequence or partial sequence of a human gene, cannot be patented; whereas these principles are in line with the criteria of patentability proper to patent law, whereby a mere discov-ery cannot be patented.62

Against these policy commitments of the Directive, the Grand Chamber ruled that the use of human embryos for industrial and commercial purposes was not patentable. The Court concluded, however, that use for therapeutic and diagnostic purposes was not industrial or commercial. According to the Court, a “human embryo” included “any human ovum after fertilization, any non-fertilized human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilized human ovum whose division

62 See note 55 at ¶ 16.


and further development have been stimulated by parthenogenesis.”63 The Court left it to the national courts to determine whether a stem cell obtained from a human embryo at the blastocyst stage was a “human embryo,” in light of scientific developments.

When the U.S. Supreme Court ruled in 1980 that a living organism can be patented, the unavoidable question was whether a human being can be an invention subject to patent protection. Patent systems throughout the world largely follow the approaches exemplified in the 2011 legal developments in the United States and the European Union. Patentability of living organisms stops at human beings. Respect for human autonomy and dignity is inconsistent with creating a property right in a human being. This principle, embodied in various legal forms from the Thirteenth Amendment of the U.S. Constitution to prefatory language in European conventions, recognizes that personhood, in its various guises, limits patents. What is challenging is defining what con-stitutes a person. The approach illustrated by the Weldon Amendment and the Grand Chamber decision frames the question of personhood in biolog-ical terms. Human tissue does not have the characteristic of personhood. A human embryo that is potentially developed into a human being does. Stem cells extracted from human embryos may or may not be persons depending on contemporary scientific understanding, or so the Grand Chamber says. In drawing a line that reflects normative judgments, the new legislation in the United States and the court ruling in the European Union is an attempt to balance protection of human dignity with the medical benefits that arise from the use of human tissue and other products derived from human beings. The results are pragmatic ones, a balance of principle and practical reality. But pragmatism resolves some questions and opens others, as the ongoing debate over the Myriad patents illustrates.

From the perspective of the capabilities approach, the 2011 legal develop-ments rest on human needs for medical developments that can dramatically curb, if not eradicate, many diseases. These benefits are, without question, great. At the same time, the removal of human organisms from patentable subject matter rests on notions of human autonomy and freedom from own-ership of the person that is consistent with the capabilities approach. What is missing in the legal judgments, whether legislative or adjudicative, is a con-cern with distribution. While patents on medical diagnostics and treatments may benefit human beings as a group, it is no doubt the case that some will be benefitted more than others. This distributive concern may best be addressed with policies outside of patent law, such as policies to redistribute income

63 See note 55 at ¶ 38.


and make health care more affordable. What is missing in both the Weldon Amendment and the Grand Chamber decision is an examination of patent policy. As I argue in this book, both the legislation and the judicial decision emphasize the patent policy of commercialization over other goals, particu-larly that of reward. A balance between respect for human dignity and the benefits of medical advance perhaps creates perverse incentives for medical research and marketing. The stories of Myriad and Nitromed in the following chapter provide test cases for how patent law and actual marketing decision intersect to create a social and commercial environment in which persons readily become commodities. The 2011 legal developments on either side of the Atlantic illustrate the contemporary relevance of asking the question of how patents and persons relate. But they also show that a full and satisfying answer is yet to be found.

Roadmap for Book

The exploration of patents and persons moves through four steps. Chapter 2 presents the business and legal background to the Myriad and Nitromed pat-ents. This background provides context for the policy debates surrounding patents relating to genes and personalized medicine. Chapter 3 expands on this context by analyzing patents relating to personalized medicine as well as related patents touching on culture, religion, and other aspects of the person. These two chapters together demonstrate how patents and persons intersect in practice through business and legal decision making and the patents granted by the U.S. government. Chapters 4 and 5 assess these practices and patents through the various approaches presented in this chapter. These chapters demonstrate how notions of the person can be accommodated within patent law and policy. The concluding chapter integrates the various strands of argu-ment into a theory of personhood and patents that illustrate how the instru-ment of law can be designed to treat persons as ends and not means. The case of Mayo v. Prometheus, before the U.S. Supreme Court in its 2011–2012 term dealing with a patent for method of personalized treatment of Crohn’s disease, provides the backdrop to the discussion in Chapter 6, in which the different parts of the work come together to show how patents and law can function with persons in mind.

39

Two types of inventions feed the market for personalized medicine. The first type consists of inventions based on identification of genetic markers for the diagnosis and treatment of diseases. The second consists of diagnostics and treatments that are targeted at particular demographics. Myriad’s patent illus-trates the first; Nitromed’s, the second. What both types share is research and development pertaining to human persons. If companies seek to patent these inventions, agencies, courts, and legislatures must confront turning human persons or attributes of persons into legally protected property.

The previous chapter presented examples of the tension between per-sons and patents and attempts by legal decision makers – agencies, courts, and legislatures – to resolve the tension. This chapter goes beyond the high-level policy and theoretical dilemmas to examine the processes of research and development and commercialization that have blurred the boundaries between patentable inventions and persons. Myriad and Nitromed are the case studies, each illustrating a different type of invention and dynamic of commercialization. The two case studies together show how to shape pat-ent policy to guide the incentives for commercialization of inventions that encompass human beings.

Scientific research as a basis for commercial success motivates the actors that form companies like Myriad and Nitromed. Although only a small per-centage of patented inventions in the United States are actually the subject of litigation and less than half are not renewed before the end of the twenty-year term, patents are conceptually legal tools that allow the creation of new markets.1 By providing exclusivity from potential and actual competitors, pat-ents allow their owners to develop and sell their inventions at a premium. The

2

Start-Ups, Upstarts, and Markets for Personalized Medicine

1 Kimberly A. Moore, “Worthless Patents,” 20 Berkeley Technology Law Journal 1521, 1530 (200).


bounty is particularly beneficial to universities and other research-oriented institutions, which develop basic and applied research that can be translated into marketable products. Myriad and Nitromed are companies that arose in part as the fruits of university research and are examples of the transition from scientific knowledge in the laboratory to consumer product on the drugstore shelf.

Pragmatic interests, and perhaps exclusively commercial ones, informed the Grand Chamber decision on human embryonic stem cells. While the European court limited patents on human embryos and cells derived from such embryos on ethical grounds, the court permitted patents on resulting diagnostic methods and medical treatment. Such fruits have pragmatic ends, designed to benefit human beings. Medical diagnosis and treatments are also several steps removed from embryos and other biological materials whose source is human. The ethical concerns are attenuated. Nonetheless, a deeper question of whether medical diagnoses and treatments should be the basis for commercialization often obtains lesser attention than it perhaps should. Viewing patents as a tool for commercialization assumes that a market system, however designed, is the appropriate mechanism for distributing all products and services. Perhaps the role of patents as a means for disclosure of new knowledge has greater salience when life-saving medical technologies are at issue. Once the patent is procured, for example, the state could purchase the patent from the owner and distribute it at low or no cost to the public. Under this view, the patent serves as a means of revealing the knowledge, but not marketing it. This disclosure function of patents, as an alternative to com-mercialization, would be consistent with the reward function. The inventor obtains the reward not through exclusive marketing, but through the purchase by the state at a negotiated rate. It is worth emphasizing that the view of a patent as a tool for commercialization is just one of several possible ways for procuring inventions and distributing them.

Nonetheless, as the following two case studies demonstrate, the assumption that patents should lead to commercialization as a means for dissemination of new technologies is an accepted one. There are of course practical reasons for this assumption even when compared with alternatives. Patent owners may develop the capacity to produce and distribute the protected technol-ogy through licensing of the technology to manufacturers and distributors. Such techniques expand the network for the patented invention, allowing for effective competition among licensees (assuming the market is structured cor-rectly). Rival inventors can invent around existing inventions, spurring more innovation. Whereas the example of Jonas Salk, who refused to patent his

Start-Ups, Upstarts 41

polio vaccine,2 shows that dissemination of life-saving technologies can occur without commercialization, companies like Myriad and Nitromed see the market system as the link between the work of a scientist in a laboratory and the treatment of a patient in a hospital.

Not only do these two case studies show the link between patents and com-mercialization, they also show how persons can quickly be forgotten in the economic logic. Even if a patent on a form of medical treatment or diagnosis does not encompass a human being, such an invention is targeted at human beings, specifically at alleviating the suffering of disease. Human beings are the means for profit by patent owners. This discomfiting result is pervasive in the market system. One can raise similar concerns with the markets for food or for housing. But in light of the tension between patents and persons that we see in recent legal debates, the concern may be particularly salient for patents relating to human life. The responses to Myriad and Nitromed dem-onstrate how these concerns are voiced whether through the legal process (as with Myriad) or through financial markets (as with Nitromed). What might be the final lesson from these two case studies is that the patent system, and the political, economic, and legal systems within which it is embedded, provides mechanisms for debate, deliberation, and perhaps even resolution.

Myriad as Start-Up

As of December 2011, Myriad Genetics was the owner of about forty patents issued by the U.S. Patent and Trademark Office.3 These include the twenty-three patents relating to the breast cancer and ovarian cancer genes that were at issue in the 2010 case as well as patents on inventions relating to diagnosis and treatment of prostate cancer, diabetes, and depression. On its corporate Web site, Myriad describes its mission as developing diagnostic techniques and treatment methods for personalized medicine.4 Even without the spotlight cast by its legal disputes, the company would be a paragon for the delivery of medical services tailored to the genetic and personal history of patients.

Myriad is also an example of the university start-up, the product of the research acumen and entrepreneurial ambitions of its founders. Started in 1991 by University of Utah geneticist Michael Skolnick, Harvard molecular

2 David M. Oshinsky, Polio: An American Story (Oxford: Oxford University Press, 2006) 211–212.

3 The figure was based on a search of patents assigned to Myriad Genetics, Inc., performed on the USPTO Web site in December 2011.

4 http://www.myriad.com/about/ (last visited on January 17, 2012).


biologist and Nobel Laureate Walter Gilbert and two venture capitalists, Kevin Kimberlin and Peter Meldrum, the company grew out of the research efforts aimed at identifying the genes associated with breast cancer. The situs of this research in Utah was not coincidental. Utah is home to the Mormon community that maintains meticulous genealogical records for cultural and religious reasons. Such genealogical data was important to developing family profiles useful in identifying correlations at the genetic level and isolating gene sequences associated with particular diseases. Working with research-ers at the National Institute of Health, Dr. Skolnick developed techniques to aid in the identification and isolation of the breast cancer gene. Much of this research originated in the university setting. Myriand Genetics was estab-lished to develop the practical applications of the university research and to develop the medical products that could be the subject of commercialization. To quote the words of Dr. Skolnick:

So I came up with the idea of using a industrial answer to the question, so we created Myriad, myself and Peter Meldrum, specifically with the goal of isolating the breast cancer susceptibility gene, believing that we then as a company could serve a great social purpose of bringing a diagnostic test, an extremely high quality commercial level diagnostic test, and the education that’s required to change doctors’ practices, to the world if we were able to discover that gene. And we in fact were able to convince investors that we had a reasonable chance of finding that gene, or other genes if we lost that race, given the resources that I had developed here in Utah.5

Success soon followed the founding with the cloning of the first breast can-cer gene (BRCA-1) in 1994 and of the second one (BRCA-2) in 1995. Patent applications for the two gene sequences were filed in the United States and Europe soon after their respective clonings. An initial public offering (IPO) for Myriad soon followed in 1995 resulting in a market capitalization of $40 million. In 2011, Myriad Genetics reported a net worth of approximately $340 million.

Myriad received its first patent on the breast cancer gene (for the cloning of BRCA-1) in 1997.6 A patent on the cloning of BRCA-2 followed in 1998.7 The company’s U.S. patent portfolio relating to the breast cancer genes consists of twenty-three patents in total, comprising the cloning of BRCA-1 and BRCA-2 and their mutations. The patents cover clones of the genetic sequence as

5 http://www.dnalc.org/view/15244-Why-he-formed-Myriad-Mark-Skolnick.html (last visited on January 17, 2012).

6 “Linked Breast and Ovarian Cancer Susceptibility Gene,” U.S. Patent No. 5,693,473.7 “Linked Breast and Ovarian Cancer Susceptibility Gene,” U.S. Patent No. 5, 709, 999.


identified in the human body as well as methods for identifying the gene sequence and diagnosing susceptibility to breast cancer. Myriad has a simi-lar patent portfolio in Europe, although these patents were found invalid on technical grounds in 2004, as I explain in the next section. Perhaps the most notorious patent was the one on identifying breast cancer in Ashkenazi Jewish women, which Myriad obtained in Europe in 2005. Whereas Myriad’s other patents cover the breast cancer gene without regard to racial or ethnic clas-sification, the 2005 patent covers the gene as it arises within a specific ethnic subpopulation. The parallels to the Nitromed patent on treatment of “black patients” are noteworthy.

Myriad has used its patent portfolio to commercialize diagnostics of breast cancer. The costs of such diagnosis as well as the implications of patenting the human genetic sequence, particularly one associated with a life-threaten-ing disease, created a public outcry throughout the late 1990s and the 2000s. Some of the outcry reflected a misunderstanding that Myriad was somehow, through its patents, owning a part of a person.8 Others focused on the costs of Myriad’s patents on the health care system and the inequities of a company owning the key to identifying and diagnosing information that was personally encoded in one’s body.9 Even if Myriad did not in fact own a person through its patents, its proprietary invention gave the company access to one’s procliv-ities toward disease, information that even the person could not discern. Not surprisingly, Myriad’s patents received close scrutiny both on technical legal grounds and on broader principles and policies.

Myriad Patents and Technicalities

A key tool in the commercial exploitation of gene sequences is patent law. By giving an inventor exclusive rights to make, use, and sell an invention for twenty years, a patent allows an inventor to recoup large investments in research and development. The costs in terms of time and money to decode a gene sequence are compensated for by the marketing of the sequence through such commercialized uses as diagnostic testing and research tools. But this same exclusivity, it is argued, prevents some needy individuals from having access to patented inventions. And many argue that something as fundamen-tal as gene sequences should not be patented, because researchers should

8 Michael Crichton, “Patenting Life” New York Times (February 13, 2007) A23; Lori Andrews, The Clone Age: Adventures in the New World of Reproductive Technology (New York: Henry Holt, 2000).

9 Emily Marden et al., “Genomics and Intellectual Property: Considering Alternatives to Traditional Patenting,” 17(1) Health Law Review 12 (2008).


have free access to these building blocks of nature. The Australian govern-ment articulated this position in its study on reforms to its patent laws with regards to gene patenting.10 These issues first came to prominence with two rulings in 2004 by the European Patent Office (EPO) invalidating Myriad’s patents in BRCA-1 and BRCA-2, sequences for the oncogenes associated with breast cancer.11 In 2008, after an appeal, Myriad’s patent for diagnosing for the propensity to breast cancer was reinstated by the EPO Technical Board of Appeal.

The EPO’s decision to invalidate Myriad’s patents came after opposition from clinicians and academic researchers who argued that Myriad in fact had not invented what it claimed. Challengers to the patent were ultimately concerned with the commercialization of vital and important research tools and were hoping that the EPO would invalidate the patents on the principle that genetic sequences, particularly ones that were a key ingredient of basic research and diagnostic tools, could not be patented categorically. Instead, the EPO invalidated Myriad’s patents on what has been described as narrow technical grounds under patent law. What the EPO found was that Myriad’s patents were not novel and nonobvious and that it was not the first to file for the patent. A consideration of some patent law basics will clarify the EPO’s reasoning.

To obtain a patent, an inventor must file a patent application with the national patent office. The date of filing is important for establishing the appli-cant’s rights in the invention. After the application is filed, a patent examiner in the office will begin review of the patent. The review process is a determi-nation of whether the invention is useful, novel, and nonobvious and that the applicant has provided an adequate description of the invention. This review process averages about two years, and upon completion the patent is issued to the applicant. The patent can be challenged after it is issued through a pro-cedure called an opposition, which is a legal action within the patent office raised by someone who believes the patent should be invalidated.

In Myriad’s case, there were several bases for invalidation. Its patent on BRCA-2 was invalidated in February 2004 because the charity Cancer Research UK had filed the application first.12 In all countries other than the United States and the Philippines, a patent is granted to the party who is the

10 Community Affairs References Committee, Gene Patents (Canberra: Senate Printing Unit, 2010) 5–8.

11 Edmund Pitcher & Brian Fairchild, “The Perilous State of Patent Protection for Molecular Diagnostics-Part 1,” Mondaq Blog (October 23, 2010).

12 EP0699754 (June 3, 1996); E. Richard Gold & Julia Carbone, “Myriad Genetics: In the Eye of the Policy Storm,” 12(4) Genetic Medicine S39–S70 (2010).


first to file the application. In the United States and the Philippines, a patent is granted to the party who is the first to invent. Cancer Research UK’s applica-tion, it turned out upon closer examination, had disclosed the invention first, and therefore it took priority over Myriad’s. The major issue was the correct filing date of Myriad’s application. The company claimed that the appropriate filing date was August 1994, when it had first filed a patent application in the United States. Under international treaties, a patent applicant can use a prior filing date from another country if the second application is filed within a year of the first. The problem for Myriad was that it had not adequately disclosed its invention in August 1994. A closer examination of the facts showed that Myriad had not filed a correct description of the sequence until a March 1995 application in the United States. Cancer Research’s application was filed prior to March 1995, and therefore its application trumped Myriad’s under the first-to-file rule. The loss of priority in Europe, however, does not affect the status of Myriad’s U.S. patents because under U.S. patent law it is the first to invent who has priority, not the first to file.

The problem with Myriad’s filing date also affected its patent on BRCA-1, which was invalidated in May 2004. Once it was established that March 1995 was the correct filing date, the question under European patent law is whether the invention was novel – that is, was the invention publicly known or used prior to the filing date. It turned out that the sequencing of BRCA-1 had been established and published by research scientists prior to March 1995, invalidat-ing Myriad’s patent in BRCA-1. This finding does not affect Myriad’s patents in the United States because it has a flexible approach to determining novelty. In the United States, there are two relevant dates: the date of filing and the date of invention. An invention is novel if it was not publicly known or used before the date of invention. In addition, an invention can be deemed not to be novel of the inventor makes a public use of the invention more than one year before the date of filing. This slightly more complicated rule for novelty most likely would save Myriad’s patents from being invalidated in the United States because the publication of the sequence occurred after Myriad’s inven-tion date.

It may seem frustrating that such critical questions as the patenting of gene sequences rest on the happenstance of filing date, invention date, and publi-cation date. Gene sequences are crucial ingredients to research and medical diagnostic tools, and the decision to allow patents for gene sequences perhaps should rest on deeper consideration than dates. The problem is that courts have had the opportunity to review the question of patenting of genetic sequences and life forms, and the consensus is that patent extends to “anything under the Sun that is manmade,” to quote language from the landmark Supreme


Court decision, Diamond v. Chakrovarty. That famous quotation was itself taken from the legislative history of the 1952 Patent Act. When Congress and the Supreme Court have spoken on the issue, it is difficult to put the genie back in the bottle. Patents on gene sequences and life forms are here to stay. But so is the controversy.

The Myriad cases demonstrate how the controversy over biotechnology pat-ents can be resolved through more careful examination of patents. Professor Arti Rai, as part of her broader research on biotechnology patenting and uni-versity research, has written about the problem that gene sequence patents pose for research.13 She writes that we need to be particularly concerned about broad patents on the subset of research tools that have been called broadly enabling research platforms. As Professor Rebecca Eisenberg confirms, too broad a patent on research tools can inhibit upstream research and can hinder progress.14 Both the U.S. National Academy of Science and the Federal Trade Commission have within the past year issued reports that warn about the harmful effects of patents to competition and technological innovation.15 The growth in personalized medicine patenting after the Myriad decision sup-ports the need for patent reform in order to protect medical practitioners and researchers. These policies are discussed in Chapters 4 and 5.

Ironically, paying attention to the technical details, rather than broad prin-ciples, may have a greater effect in changing some of the problems with pat-ents as they affect persons, whether researchers or medical practitioners, and perhaps even patients. Professors Mark Lemley and Dan Burk refer to these technical details as patent policy levers, or tools that moderate the potential harms caused by patents.16 One lever they emphasize is the requirements of novelty and nonobviousness. They point out that U.S. patent law has a very low standard for nonobviousness, especially when applied to genetic sequences. The accepted reasoning is that because there are so many possible nucleotides

13 Arti Rai, “The Information Revolution Reaches Pharmaceuticals: Balancing Innovation, Costs, and Access in a Post-Genomics Age,” 2011 University of Illinois Law Review 173, 175–176 (2001).

14 Rebecca S. Eisenberg, “Noncompliance, Nonenforcement, Nonproblem? Rethinking the Anticommons in Biomedical Research,” 45 Hous. L. Rev. 1059, 1084–1085 (2008).

15 National Research Council, National Academy of Sciences, A Patent System for the 21st Century (Stephen A. Merrill ed al. eds., 2004) [hereinafter NAS Study], available at http://www.nap.edu/books/0309089107/html; Federal Trade Commission, To Promote Innovation: The Proper Balance of Competition in Patent Law and Policy (2003) [hereinafter FTC Report], available at http://www.ftc.gov/os/2003/10/innovationrpt.pdf. These two reports are discussed in detail in Chapter 4.

16 Dan L. Burk & Mark A. Lemley, The Patent Crisis, and How to Fix It? (Chicago: The University of Chicago Press, 2009) 109–112.


for a given gene, identifying the correct sequence cannot be obvious. At the same time, however, patent law restricts the patentee’s rights to the particu-lar sequence identified, allowing trivial variations to obtain a separate patent owned by another inventor. Professor Lemley and Burk argue that biotechnol-ogy patents can be improved by raising the standard for nonobviousness and broadening the scope to include not only the specific identified sequence, but trivial variations as well. Through these technical improvements in the law, the quality of biotechnology patents can be strengthened. In some instances, these improvements may avoid grants of patents to critical research and diag-nostic tools like Myriad’s.

As biotechnology expands, the tension between principles and legal tech-nicalities will become more apparent. But as the invalidation of the Myriad patents shows, more careful attention to the technicalities of patent law may make the awarding of patents better aligned with our principles.

Persons and Principles

Challenges to Myriad’s European patents illustrate the reach of public interest litigation directed at invalidating patents that go against public policy and the sense of a just social order. The patent laws of the several European coun-tries as well as the European Patent Convention allow patent offices to deny patents on inventions that are counter to l’ordre publique, which roughly trans-lates as normative conceptions of the public good or a just society. U.S. patent law does not have such limitations. Under U.S. patent law, an invention must meet certain technical requirements for a patent to issue covering the inven-tion. These technical requirements, however, often mask policy debates about the goals of patent law and innovation.

Such was the case with the Myriad litigation.17 Shortly after its patents were issued in 1997 and 1998, Myriad was concerned about unauthorized uses of its patented technology. These uses consisted of both comparisons of the iso-lated BRCA-1 and BRCA-2 gene sequences and diagnostic methods to deter-mine susceptibility to breast and ovarian cancers and potential treatment. The University of Pennsylvania Genetic Diagnostic Lab was the principal offender, in Myriad’s eyes, and was the recipient of cease-and-desist letters demanding that the lab either licensed the technology from Myriad or stop making the unauthorized uses. Myriad did file a number of patent infringement lawsuits

17 The following history of the litigation is distilled from the opinion, The Association for Molecular Pathology v. United States Patent Office & Myriad Genetics, Inc., 702 F. Supp. 2d 181 (S.D.N.Y. 2010).


against the lab and Oncomed, a private company spun off from the University. The defendants settled these lawsuits, promising not to make use of the pat-ented technologies. These lawsuits created a chilling effect in the industry for genetic screening for cancer and created an environment for challenges to Myriad’s patents by universities, medical diagnosticians, and various public interest groups.

Patent law is often described as private law, involving disputes between two entities whose rights conflict. These rights are often categorized as commer-cial. However, patent law, like all areas of intellectual property law, affects the public interest. Given that patent law’s aim is to promote innovation and disseminate technology, even a private lawsuit can have direct and substantial implications for the public at large. Competition to improve the quality and price of products and services, access to life-saving or life-enhancing technol-ogies, the ability to experiment and engaged in research – each is an example of the spillover from seemingly narrow private disputes to the broader public.

The Myriad case is a striking example of the blend of public and private interests that permeates patent law. In 2009, the American Civil Liberties Union was a named plaintiff in a lawsuit seeking to invalidate Myriad’s pat-ents on the breast cancer genes and the diagnostic and therapeutic methods that utilized the cloned genetic sequences. Several doctors, universities, med-ical labs, and diagnostic facilities were also named plaintiffs. The threshold problem these parties faced in bringing the lawsuit was whether they were the right party to challenge the patents. A plaintiff must have standing to sue, meaning that the plaintiff bringing a lawsuit has an injury, recognized under the law, that the court can remedy. Myriad argued that the plaintiffs did not have standing to challenge the patents because they could not establish any injury. The plaintiffs were not using the patented technology. Furthermore, they were not the object of lawsuits brought by Myriad. In effect, the plaintiffs were bringing the challenge, according to Myriad, because they did not like the patents. Such generalized grievances cannot be the basis for a lawsuit.

Judge Sweet, the district court judge hearing the case, disagreed. Several of the plaintiffs had concrete injury from Myriad’s patents. The companies had enforced its patents and had done so successfully. Several doctors, medical facilities, and university research labs had promised not to make unauthorized use of Myriad’s inventions. The patents posed the threat of a lawsuit, which in turn could deter and alter behavior of those practicing in areas related to diagnosis and treatment of breast and ovarian cancers. Furthermore, research in these fields could be altered, if not hindered, by these potential lawsuits. Consequently, some of the named plaintiffs did have standing to bring the suit, and it could go forward. On appeal, the U.S. Court of Appeals for Federal


Circuit upheld Judge Sweet’s ruling. The challenge to the patents was more than a generalized grievance.

Threshold issues like standing highlight the mixed public and private nature of these disputes. Law always has some effect on the public. Sometimes that affect may be more attenuated than others. A boundary dispute between two neighbors seemingly affects only the parties involved, but the issues in the dispute may have implications for boundary lines around other parcels of land. Conflicts over proper waste disposal on one’s private property may on the surface immediately affect neighbors. But disposal of such waste can have ramifications for neighborhoods and broader communities. Adjudication in the United States avoids broad claims of harm to the public from being determined in the courts. Broad public harms are in the domain of the leg-islature. Parties who are directly injured by the acts of the defendant provide concrete cases for testing the law. Advocates can point to actual harms, rather than abstract ones, and judges can better wrap their minds around specific facts and details as opposed to broad principles. The adjudication of private disputes, at the same time, provides a context for addressing the public interest harms that might arise from the defendant’s actions. So, in the Myriad case, the harms arising from the threat of lawsuits served as a test for addressing the broader policies stemming from the patenting of isolated human genes and of medical diagnostic methods.

But even with the correct set of plaintiffs, the issue still arises as to how to decide the dispute. The challenge in the Myriad litigation was to the validity of Myriad’s patents. The USPTO, it was argued, was acting outside the law in granting the patents. Recall that an invention has to meet five technical legal requirements in order to be protected by a patent. The invention must con-stitute patentable subject matter, must be useful, novel, and nonobviousness, and must be enabled through specifications in the patent application. The European court had reviewed Myriad’s European patents on these technical grounds and found them lacking.

Judge Sweet took a more dramatic approach, relying on the technical requirements to construct a broader policy argument for why Myriad’s patents were invalid. He ruled that the inventions were not patentable subject matter because they were natural phenomenon. The gene sequences Myriad patented were identical to the gene sequences that existed in the human body. Patent law prohibits patenting of products that exist in nature, or mere discoveries of nature. Instead, patent law protects the products of human invention, not discovery. Therefore, Myriad’s inventions are not patentable subject matter, Judge Sweet concluded. The Federal Circuit, on appeal, reversed this ruling, with two of the three judges ruling that Myriad’s isolated genetic sequences


were different from what exists in nature.18 Judge Bryson, the third appellate judge, would have upheld Judge Sweet’s ruling.

What is striking about the opinions, both Judge Sweet’s and those of the appellate judges, is the appeal to the technicalities of genetics and biochem-istry to support the respective rulings. Given the technical subject matter, the extensive use of diagrams depicting the double helix of DNA sequences and the detailed analysis of the chemical composition of DNA are not surprising elements of what perhaps would otherwise be a methodical court opinion. Such technical detail shows that the judges are understanding the facts of the case in enough detail to support their legal conclusions. If the decision hinged on whether Myriad’s inventions were natural phenomenon, the decision maker has to have an understanding of what comprises natural phenomenon against which the inventions compare. The judges engage in this scientific technical detail in order to support their conclusions.

Judge Sweet, for example, finds that the cloned genetic sequence has to be identical to what exists in a human body as a logical matter for the diag-nostic test to perform as it is supposed to. Differences between the isolated sequence and the naturally occurring sequence might affect the reliability of the comparison. Judges Lourie and Moore, writing separately, disagree, point-ing out that the isolated sequence and naturally occurring sequence need only be identical with respect to the key markers for susceptibility to breast and ovarian cancers. As Judge Moore, a PhD chemist from MIT, carefully demonstrates, there will be chemical material missing from the naturally occurring sequence in the isolated one. The naturally occurring one can, for example, replicate in a way that the isolated sequence cannot. The purpose of the isolated sequence is for comparison purposes only, to aid in diagnosis and treatment. Judge Moore’s point can be understood if one views the isolated sequence as a template based on the naturally occurring sequence. The tem-plate will have elements of the underlying work from which it is derived, but will have elements missing in order to distill the work into its essential form. Reading Judge Sweet’s opinion, one might infer that he would find these dif-ferences trivial.

Whereas Judges Sweet, Lourie, and Moore in their respective opinions focus on the technical scientific detail, Judge Bryson argues from analogy to uphold the invalidity of Myriad’s patents as unpatentable natural phenomenon. Judge Bryson compares the cloning of the genetic sequences to the extraction of a mineral from the ground. Extraction of the material, Judge Bryson reasons,

18 The Association for Molecular Pathology v. United States Patent Office & Myriad Genetics, Inc., 653 F.3d 1329 (Fed. Cir. 2011).


does not by itself constitute patentable subject matter. The extraction is an example of a discovery, as opposed to an invention, that is not protected by patent law. Only when the inventor has worked on the extracted material has the inventors produced an invention that is patentable subject matter. Judge Bryson concludes that Myriad has done nothing more than extraction of a natural substance when it sequenced BRCA-1 and BRCA-2.

Judge Moore engages in a lively and critical exchange with Judge Bryson in her opinion. She emphasizes that Myriad did not simply extract BRCA-1 and BRCA-2 from the naturally occurring sequence. Instead, Myriad worked on the naturally occurring sequence to obtain the cloned sequence for the patented genes. According to Judge Moore, Myriad was engaged in invention. Her analogy is to the sculptor who extracts the marble from the ground and then shapes it into a work of art. As support of this analogy, she points to differ-ences in chemical composition between the patented sequence and the natu-rally occurring one. These differences show that Myriad did something to the naturally occurring sequence to obtain the patented one. More than discovery was occurring. The differences in composition that Judge Moore emphasizes are irrelevant for Judge Bryson’s argument. What matters for his position is that Myriad is doing little other than copying what exists in nature.

Analogies to extraction, of course, are misleading in the context of Myriad’s invention. In cloning the relevant genes, Myriad was not simply removing nat-urally occurring DNA from a human body. Part of the process involved study-ing the naturally occurring DNA to identify the sequences that would most likely be associated with susceptibility to breast and ovarian cancers. Based on this identification of the sequences, Myriad was able to construct the sequence that would indicate susceptibility to breast and ovarian cancers. The company was able to create a chemical composition constituting this sequence, which could be used to compare with a patient’s personal genetic sequence. This comparison would provide a basis for determining whether the patient was susceptible to breast and ovarian cancers. Nonetheless, the metaphor is a use-ful one to identify the critical question that divides the judges, namely what constitutes an invention for the purposes of patent law. Unlike Judges Lourie and Moore, Judges Bryson and Sweet would require additional evidence of invention beyond only isolating the sequence. But the qualitative differences as to what constitutes an invention is not clear from the set of opinions that we have in the Myriad case.

The underlying problem is that the question of what is an invention is a normative question about what should be patented in order to promote inno-vation. The opinions of Judges Sweet and Bryson illustrate a profound skepti-cism of applying patent law to the type of inventions that Myriad has patented.


Judges Lourie and Moore are perhaps more neutral or perhaps strongly sup-portive of the role of patent law in the area of human genetic diagnostics and treatment. These differences reflect differences in policy and principles, which are masked behind the technical details of the law.

To demonstrate these points, consider Judge Moore’s analogy of the sculp-tor extracting marble. Her view is that the sculptor who works on the extracted marble has engaged in activity that would be protected by intellectual prop-erty law. To put her example within the purview of copyright law (which would be the relevant body of law with respect to sculptures), the sculpture would obtain copyright protection if it were original. Under copyright law, originality requires that the work be the product of the author’s creativity. On this basis, Judge Bryson’s argument holds ground. If all the sculptor did was extract a piece of marble from the ground and proclaimed that piece his sculp-ture, the work would not be the result of creativity. The work is a discovery that stemmed from the sculptor’s “sweat of the brow.” But what if the sculptor extracted the marble and painted it mauve? Would the work be creative at that point? Without question, if the sculptor took the extracted marble and made an elaborate bust of his patron, the work would be original. As a test of the law, however, the critical question is how little does the sculptor have to do to have produced a creative work. The copyright cases analyzing this question suggest that the sculpture has to do very little. So perhaps the mauve-colored marble would be a copyrighted work. The avoidance of aesthetic judgments of crea-tivity is a mantra in copyright law, so it tends to be very favorable to creative individuals. Should there be a comparable low standard for patent law?

The problem with the comparison to copyright law is that patent law has several requirements for an invention to be protected by a patent. The judges in the Myriad case are addressing only one of these requirements – patentable subject matter. Under this requirement, the USPTO (and courts) consider whether there are some inventions that are per se not patentable because the patent system does not want to encourage them. In the United States, there are very few inventions that are per se not patentable. Consequently, the USPTO (and courts) look to the four other requirements of patent law to limit patents on inventions. In the case of Myriad’s patented inventions, Judges Lourie and Moore find that they meet the first requirement. But the inventions may well not be novel or nonobvious or even useful or enabled. That is another tech-nical inquiry. Remember in Europe, Myriad’s patents were found to be not novel and not nonobvious. But those findings were based on the technical details of patent law in Europe. The USPTO, by granting the patents, was concluding that the inventions met the technical requirements of U.S. pat-ent law. But closer scrutiny by the courts or the patent office might lead to a


different conclusion. The decision of the Federal Circuit does not reach these other technical issues.

Patent validity entails a battle between technical rules and principles. In Europe, Myriad was defeated by technical rules. In the United States, the technical rule of patentable subject matter revealed the principles about what inventions should or should not be patented in order to encourage innovation. The judges were divided about these principles. But instead of engaging them directly, the judges looked to the technical rules of science to bring some light to the heated controversy. Judge Moore attempts to recognize these principles by pointing out that while she might, under some circumstances, be willing to invalidate genetic sequences like those at issue in the Myriad dispute, she would also defer to settled expectations in the industry about patentability. As she points out, the expectations are that patentable subject matter is broad, and genetic sequences, as long as they are useful, novel, nonobvious, and enabled, have been patentable since the 1980s. The need to preserve these expectations may be the premise that underlies the upholding of Myriad’s inventions as patentable subject matter. On March 26, 2012, the Supreme Court vacated the Federal Circuit’s decision and asked the appeals court to reconsider the case in light of the Supreme Court’s ruling in Mayo v. Prometheus.19 The Supreme Court has paved the path for its eventual review of the Myriad patents. We will see whether other expectations, such as those seeking diagnosis for life-threatening diseases, should matter for the decision seems to be underem-phasized, if not ignored. Can patent law accommodate the expectations of persons other than inventors, of persons as patients in addition to companies as owners? I address this question in later chapters.

Nitromed as an Upstart

Nitromed’s patent covering a method of treatment specifically designed for “black patients” provides a more striking example of personalized medicine inventions than Myriad’s. Inventions covering human gene sequences are abstracted from human persons. Although such inventions can affect human well-being, human gene sequences do not get to the heart of how we iden-tify as humans, at least not as of 2011. Nitromed’s invention, by contrast, does encompass treatment of a human person. More to the point, the invention seems to make distinctions among human persons based on the arbitrary and illusory category of race. In terms of developments of personalized medicine,

19 2012 WL 986819. The Supreme Court’s decision in Mayo is discussed in detail in Chapter 6.


Myriad’s invention targets the biological roots of disease; Nitromed’s is seem-ingly confounded by misguided sociological categories.

As with Myriad’s inventions, Nitromed began in a university laboratory.20 Dr. Jay Cohn, a research scientist at The University of Minnesota Medical Center, undertook a study of medical data from the Veteran’s Administration (VA) to identify the use of nitrous oxide in treatment of hypertension and heart disease in the early 1980s. The focus of Dr. Cohn’s research was the use of a compound called BiDil, which was a combination of hydralazine and isosorbide dinitrate. The chemical compound BiDil was a vascular dila-tor to combat heart failure, which was found to be more effective than ACE inhibitors, an alternative method for treatment. Dr. Cohn published his findings from the Veteran Administration studies in 1986 and applied for a patent a year later. The patent was issued in 1989. This patent was the first one covering BiDil and was not limited by race. Dr. Cohn applied for trade-mark on BiDil in 1992 and began negotiations with MedCo Research Inc., a North Carolina company, to manufacture and market BiDil at around the same time. In 1995, Dr. Cohn transferred its trademark and patent associated with BiDil to MedCo., which began clinical testing of BiDil for bioequiva-lence with the use of hydralazine and isosorbate dinitrate separately. In 1996, MedCo completed its clinical trials and applied for approval from the Food and Drug Administration. However, because of problems identified in Dr. Cohn’s VA studies, the FDA denied approval for marketing BiDil. As a result of the denial, MedCo decided not to pursue the marketing of BiDil and let all intellectual property rights revert back to Dr. Cohn. At the point, Nitromed enters the narrative.

Nitromed was formed in 1992 by two research scientists from Harvard Medical School and Brigham and Woman’s Hospital. Its primary goal was to investigate and identify medical uses of nitrous oxide therapy. The founders’ focus in the early to mid-1990s was on the development of treatments for erec-tile dysfunction, the subject of one of its first patents. The introduction and success of Viagra by Pfizer in 1995 caused Nitromed to seek out other applica-tions. In 1999, Nitromed obtained intellectual property rights and a new drug application (NDA) from Dr. Cohn who had resumed research on BiDil after th FDA rejection. What motivated Nitromed’s interest were published studies by Dr. Cohn, who had found a more refined application for BiDil therapy.

20 The background presented later in the chapter is distilled from Jonathan Kahn, “Patenting Race,” 24(11) Nature Biotechnology 1349 (2006) and the description in the 2002 and 2004 patents.


In response to the FDA rejection of the BiDil applicaton in 1997, Dr. Cohn revisited his VA studies. Pursuing growing interest in race-specific treatments for disease, Dr. Cohn focused on the oversample of African Americans in the original VA studies. His review of the VA data from 1997 to 1998 helped Dr. Cohn identify a drug therapy specific to the African-American popula-tion. Dr. Cohn’s studies were timely in many ways. In 1997, Congress passed the FDA Modernization Act, asking the Secretary of Health and Human Studies to develop guidelines for the appropriate inclusion of race and gender in clinical trials. Health care scholars and advocates called public attention to diseases and demographic groups ignored by medical researchers. Given this climate and the shared focus on nitrous oxide therapies, a relationship between Nitromed and Dr. Cohn was predictable.

The company agreed to fund Dr. Cohn’s clinical trials for a race-specific use of BiDil to address the needs within the African-American community for effective treatment of hypertension. In 2001, Nitromed obtained more than $30 million in venture capital funding to support the clinical trials in col-laboration with the Association of Black Cardiologists. After the first patent on a race-specific use of BiDil issued in 2002, Nitromed went public with a proposed market cap of $305 million. The path was paved for marketing the new therapy with the grant of second patent (as a continuation of the 2002 patent) issued in 2004 and the FDA approval of race-specific uses of BiDil in 2005. Nitromed’s stock price quadrupled after the patent issuance in 2004 from about $5 per share to a level of $20 per share. Despite this initial spate of good news, Nitromed confronted resistance from medical providers who were reluctant to prescribe the drug. Therapies were developed that were able to work around Nitromed’s patent with similar effectiveness. Consequently, Nitromed’s stock price fell to between $2 and $3 a share in 2007, where it has stayed until the time of this writing.

Despite criticism of the race-specific drug, Nitromed’s patents were never challenged. Unlike Myriad, Nitromed never attempted to enforce its patent against competitors. Whereas the patent on a human genetic sequence, one associated with such intimate diseases as breast and ovarian cancers, raised the specter of ownership of a human being and the denial of access to life-saving therapies, an invention aimed specifically at the African-American population was a response to neglected diseases and treatments. Nonetheless, the Nitromed patent illustrates controversies over patenting of treatments that were personalized along racial lines. A look at how a race-specific patent was issued provides a telling story of patent strategies in the area of personalized medicine.


Patent Strategies

The pursuit of a patent starts with the filing of a patent application, which is reviewed by a patent examiner at the USPTO or other appropriate national patent office, in a process called patent prosecution. The examiner finds rea-sons under the Patent Act to reject the application, and the applicant responds to these rejections. The process is a matter of give and take and involves stra-tegic decision making on the part of the applicant. The pursuit of the patent on BiDil provides a good example of this dynamic. There are two patents on the chemical composition for BiDil, one issued in 2002 with fifty-four claims21 and one in 2004, from a continuation application, with eighty-four claims.22 The race-specific claims are the same for the two patents, and therefore by the rules against double-patenting, the claims in the patent issued in 2002 would be effective.23 The abstracts for both patents use identical language in describ-ing the composition: “The present invention provides methods or [sic] treating and preventing mortality associated with heart failure in an African-American patient with hypertension and improving oxygen consumption, quality of life and exercise tolerance by administering a therapeutically effective amount of at least one is isorbinate dinitrate and isorbinate mononitrate.”24 The first claim echoes this race-specific aspect of the invention through the following language: “A method of reducing mortality associated with heart failure in a black patient in need thereof comprising administering to the black patient hydralizine . . . in an amount about 30 milligrams per day to about 300 milli-grams per day and isosorbinate dinitrate in an amount of about 20 milligrams per day to about 200 milligrams per day.”25

A challenging question is why the claim is limited to a “black patient.”26 The written description presents the clinical trials administered to test the efficacy and the safety of the chemical composition. According to the descrip-tion, “the placebo group mortality . . . did not differ between white and black patients. . . . The inventors unexpectedly discovered that black patients exhib-ited a significant survival benefit . . . from treatment with the combination of hydralazine and isosorbide dinitrate.”27 The inventors speculate on why there

21 U.S. Patent No. 6465463 (issued Oct. 15, 2002).22 U.S. Patent No. 6784177 (issued Aug. 31, 2004).23 Double-patenting is not allowed under 35 USC § 101, which states that “a patent shall issue to

an inventor whose application meets the requirements of patentability.” See Miller v. Eagle Manufacturing Co., 151 U.S. 186 (1894) (establishing rule against double-patenting).

24 See note 18 to this chapter.25 Idem.26 Idem.27 Id.


is this observed difference in response between black and white patients. They cite literature showing the black patients are less responsive to ACE inhibitors than white patients, and this difference in turn reflects a less active rennin-angiotensin system among black patients.28 Although the inventors could not identify the source of the difference, the statistical difference uncovered in the clinical trials was the basis for the racially limited claim.

The racial limitations reflect another important dimension to the develop-ment of the invention. Both the 2002 and the 2004 patents cite a 1989 patent issued to one of the inventors for a “Method of Reducing Mortality associated with Congestive Heart Failure Using Hydralizine and Isosorbide Dinitrate.”29 The patent expired in 2003.30 It is instructive to read the first claim of the 1989 patent and compare it with the more recent ones:

A method of reducing the incidence of mortality associated with chronic congestive heart failure in a patient with impaired cardiac function and con-comitant reduced exercise tolerance, comprising the oral administration to said patient in need of the same of a combination of (a) between about 75 and about 300 milligrams of hydralazine, or a pharmaceutically acceptable acid addition salt thereof, per day, and (b) between about 40 and about 160 milligrams of isosorbide dinitrate, per day.31

The two obvious differences between the 1989 claim and the 2002/2004 claim are the differences in dosages and the absence of any racial limitations. A consideration of these two differences illustrates three points about the role of racial categories in patent law.

The first point is that the 1989 patent would allow the patent owner to pre-vent uses of the chemical composition on any patient, without regard to race or other characteristic. Perhaps the broad applicability of the invention reflects an assumption that a pharmaceutical invention, or more broadly any inven-tion, can be used by all members of the population absent some evidence, such as the clinical trials documents in the 2002/2004 written descriptions, that the invention empirically is suitable for only one group.32 Whether this assertion is true, I argue in the next section, rests on the normative founda-tions of patent law. If it is true, however, the conclusion suggests a baseline rule of race neutrality in patent law, with the inventor being permitted to draw

28 Idem.29 U.S. Patent No. 4868179 (issued Sept. 19, 1989).30 Id. The patent term at the time of the issuance of this patent was fourteen years from the date

of issuance.31 Idem.32 See note 17 to this chapter, at 1350.


racial lines if there is some empirical basis to support the limitation. Because the inventor could not explain the racial disparity in the 2002/2004 patent, the racial imitation arguably need not be explained and can be supported by statistical disparities.

The second point is the role of race-specific studies in support of the claimed invention. It is telling that the 1989 written description does not dis-close any racial disparities or racial differentiation in clinical trials, whereas the 2002/2004 trials do. This difference may reflect a heightened sensitiv-ity to racial differences in the incidence and treatment of diseases that has arisen in the thirteen-year period. Although the National Institute of Health did implement guidelines for race-specific clinical trials and funding incen-tives for research in previously underserved populations and diseases in the 1990s,33 these incentives may have been less important for private, commercial researchers working for industry, such as the inventors of the chemical compo-sition in the BiDil patent. A more likely explanation is that the inventors were seeking to find some additional commercial exploitation of the invention and discovered the strategy of targeting the invention to a racially defined market.34 Hence, the clinical trials demonstrated how the chemical composition could be tailored to a racial enclave of the market based on differential efficacy.

Building on the ways in which race seemingly entered into the experimen-tation on and marketing of a chemical composition, I turn to the third, and most crucial, point that follows from a comparison of the two patents. The second invention builds on the first invention by identification of different dosage levels and of different efficacy for a racially defined group. The ques-tion is why these two together, or separately, would be sufficient to warrant a second patent on the chemical composition. By itself, discovering a different dosage level of a chemical compound would not be enough to satisfy the non-obviousness requirements of patentability, unless there was some “unexpected

33 In 1994, the National Institute of Health issued the National Institutes of Health Guidelines on the Inclusion of Woman and Minorities as Subjects in Clinical Research, which outlined “a wide range of new responsibilities for clinical researchers funded by the NIH and for insti-tutional review boards.” Under these guidelines, “all NIH-funded clinical research must now include representative numbers of women and members of racial or ethnic minority groups.” Charles Weijer & Robert A. Crouch, “Why Should We Include Women and Minorities in Randomized control Trials?,” in Ezekiel J. Emanuel et al., eds., Ethical And Regulatory Aspects of Clinical Research: Readings and Commentary 171–172 (2003).

34 See note 17 to this chapter, at 1351; Michael D. Ruel, “Using Race in Clinical Research to Develop Tailored Medications: Is the FDA Encouraging Discrimination or Eliminating Traditional Disparities in Health Care for African Americans?” 27 The Journal of Legal Medicine 225, 227–229 (2006).


result” from what was in the prior art.35 The racial limitation, however, is more problematic. If the inventor in fact discovered a new or different chemical composition that worked solely for a discrete group, there may be an argu-ment that she has found something new and nonobvious in light of the prior art.36 The problem is determining why this distinction occurs as an empirical matter in a way that would warrant generalization from a few clinical trials. Demonstrating that the chemical composition was found not to work on some groups in some cases does not warrant a claim, either as a matter of logic or of patentability, for the use of the exclusive use of the chemical composition in all cases.

Even if this logical gap could be resolved, there is still the question of whether modifying an invention for a specifically defined group meets the nonobviousness requirement. The racial tailoring of the 1989 invention also explains the nonobviousness of the 2002/2004 invention. On December 5, 2001, the patent examiner rejected the race-specific claims in the applica-tion supporting the 2002 patent for being obvious in light of the 1989 pat-ent.37 The patent applicant responded on May 6, 2002, arguing that there was nothing in the 1989 patent that would “disclose or suggest” the race-specific claims.38 In addition, the applicant argued that the efficacy in the African-American population was an “unexpected result” that supported a conclusion of nonobviousness.39 The patent examiner accepted this argument and, in an office action on May 18, 2002, concluded that the claims were nonobviousness in light of the unexpected result.40 This exchange illustrates, in part, the appli-cation of the “teach, suggest, motivate” (TSM) test to the legal question of nonobviousness. Under TSM, an invention is nonobvious if a disclosure in the

35 See, e.g., Ortho-McNeil Pharmaceuticals v. Kali Laboratories, Inc., 482 F.Supp. 2d 478 (D.N.J. 2007) (change in dosage level not sufficient for nonobviousness), citing Merck & Co. v. Bocraft Labs, Inc., 874 F.2d 804, 805–806 (Fed. Cir. 1989) (changes in conditions for using invention, such as temperature or concentration, not enough to establish nonobviousness unless there is some unexpected result); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed. Cir. 2007) (altering chemical formulation not enough to show nonobviousness).

36 See Takeda Chemical Industries, Ltd. v. Alphapham Pty., Ltd., 2007 WL 1839698 (Fed. Cir. 2007) (discussing the issue of patentability of species claims over genus claims in the prior art and proposes allowing such claims if there is evidence of unexpected results).

37 Memorandum from Raymond Henley, Jr. Primary Examiner, to Edward D. Grieff, Registration No. 38,898 (December 5, 2001) (on file with author).

38 Memorandum from Edward D. Grieff, Registration No. 38,898 to Raymond Henley, Jr., Primary Examiner (May 6, 2002) (on file with author).

39 Idem.40 Memorandum from Raymond Henley, Jr. Primary Examiner, to Edward D. Grieff,

Registration No. 38,898 (May 18, 2002) (on file with author).


prior art taught, suggested, or motivated the elements that make the invention different from those disclosed in the prior art. In other words, a party challeng-ing the patentability of an invention on nonobviousness grounds must show what in the past taught, suggested, or motivated the invention. If the party fails to produce such a teaching, suggestion, or motivation, it has not met the bur-den to show obviousness. In the case of the 2002 patent, the applicant asserted that the patent examiner failed to meet the TSM test and furthermore pointed to the unexpected result – a secondary consideration to support the conclu-sion that the invention was nonobvious.

There might be a question as to whether the racially tailored invention would be found nonobvious in light of the U.S. Supreme Court’s 2007 deci-sion in KSR v. Teleflex.41 In this decision, the Court cautioned against a mechanical application of TSM and acknowledged that common sense of the person having ordinary skill in the art can serve to distinguish obvious from nonobvious inventions. Under this “common sense” approach, a patent exam-iner could look at Nitromed’s application for a treatment aimed at African Americans and ask whether someone skilled in medical treatment of hyper-tension would view Nitromed’s invention as common knowledge regardless of whether the prior art would have suggested such a treatment. Dr. Cohn’s investigations show that conventional treatment of hypertension was less effec-tive in African-American populations. Furthermore, identifying more effec-tive treatments for African Americans suffering from hypertension had not been the object of research. Consequently, Nitromed’s treatment likely would have been found nonobvious even under the more stringent test announced by the Court in Teleflex.

Pharmaceutical inventions examined under the Teleflex standard have often failed to meet the nonobviousness requirement if the inventor has sim-ply changed the dosage level to increase effectiveness or changed the delivery method from a pill to a capsule. Examiners have found these changes to be commonsensical to someone with knowledge in the field. As a policy mat-ter, these changes were deemed as attempts to extend the life of the patent without improving or altering the original pharmaceutical patent issued in 1989 and that expired in 2003. Dr. Cohn’s patent could also be seen as an attempt to alter the original treatment for hypertension by altering the under-lying chemical composition. The innovation, however, is finding a new dos-age that more effectively treats a subpopulation. As pointed out in the previous paragraph, that may be sufficient to meet the requirements of patentability. Whereas other changes to inventions covered by expiring pharmaceutical

41 550 U.S. 398 (2007).


patents raised policy concerns of extending the life of a patent without any substantial new benefit, Dr. Cohn’s modifications arguably did add benefit by serving the needs of an ignored population. The policy question raised by the BiDil patent is whether innovation targeted at particular groups characterized by a racial category should be encouraged. That question is addressed in the next several chapters. However, as with Myriad, the legal institutions focused on the technical details without considering the broader principles.

Patents, Principles, and Persons

The focus of this chapter is on commercialization, inventions, and the legal institutions of patent law. These three intersect not quite to form an iron tri-angle, but to shape the market and social environment for personalized medi-cine. Myriad’s marketing a diagnostic screen for breast and ovarian cancer and Nitromed’s hypertension treatment targeted at “black patients” illustrate how the commercialization efforts function and the legal response they invoke. They provide a background against which to understand the legal policy argu-ments developed in the remaining chapters.

The two case studies offer insights in the contemporary stages of person-alized medicine that we are witnessing. They will be serve as examples for future commercial efforts and policy debates. Myriad has faced a legal obsta-cle from the district court’s decision invalidating its patents, but has seemingly recovered with the Federal Circuit decision. Nitromed, on the other hand, has not been successful in marketing its new drug treatment. The medical establishment, consisting of doctors, pharmacies, and insurance companies, has not embraced the drug in part because of the public reaction to race-specific therapies. Also responsible for the company’s failure is the ease with which the patent can be worked around. Whether Nitromed’s lack of success is attributable to a moral response or to the technical weakness of its patent can be debated. The two companies acquired patent protection a little more than a decade ago. Their troubles illustrate how the institutions of the law and the institutions of the market respond to the current types of personalized medicine. For Myriad, the response has been voiced in the domain of law; for Nitromed, in the domain of the market.

Both domains, however, have determined success in largely technical terms. With Nitromed, the battles over demonstrating nonobviousness in the patent office and the weakness of the final patent bespeak technical weak-nesses in Nitromed’s invention. Myriad’s battles in the courts, on either side of the Atlantic, are ones over the technical details of patent law. These tech-nical details are important, perhaps even critical to the public debate over the


desirability of patents and personalized medicine. But the technical details displace consideration of persons and their relationship to property and mar-kets. Although no one advocates turning persons into property, and patent law is careful in not making that transformation, the technical debates do not acknowledge that patents on, and markets for, personalized medicines affect persons. Of course, the effects on persons may be a subtext to the technical discussion. In addition, a technical solution can reach the right result with respect to the correct treatment of persons. Nonetheless, the sophisticated legal debates seem to hinge on arcane matters of law without express consid-eration of the impact on persons.

The overemphasis on technique at the expense of persons in part reflects a lack of vocabulary of how to analytically and normatively include consider-ation of persons into what is inevitably a debate over the technical details of law. My goal is to remedy this problem by illuminating the place of persons in patent law. By providing a historical and social context for patents, by nor-matively assessing how patent law has and should incorporate patents, and by presenting a proposal plan for policy reform, I present a case for integrating persons into patent law. My case will, I hope, provide a richer vocabulary and grammar for understanding the commercialization efforts in personalized medicine described in this chapter.

63

Patents and persons intersect as companies develop and commercialize the products of personalized medicine. Myriad and Nitromed provide two examples of how patents are pursued that cover aspects of persons critical for marketing new diagnostics and treatments. Whether at the genetic level or through the use of sociological and cultural categories, patents define market places within which inventions can be commodified.

This chapter provides a broader context for the contemporary efforts by exploring what I call race-specific patents. These are patents covering inven-tions that are defined in race-specific terms. Nitromed’s patent on BiDil is one example; several others are presented in this chapter. While Myriad’s inven-tions in the United States are not race-specific, its European patent on diagno-sis of breast cancer in Ashkenazi Jewish women would be. In fact, if patenting trends in personalized medicine continue, we may well see patents on genes that are defined along racial terms.

Race-specific patents are problematic because they incorporate a sociolog-ical category that is of dubious value and of possibly pernicious implications. As a descriptive category, race isolates particular phenotypes and turns them into characteristics that reduce persons to one dimension. Such phenotypes are subsequently given cultural denotations that presume a hierarchy of desirable and undesirable traits. Furthermore, when combined with a superficial under-standing of genetics, race is made indelible, dividing people along seemingly fixed and predetermined identities sanctioned by the authority of science. Race-specific patents reify these tendencies by having the government approve inventions that incorporate these views of race. As a reward, race-specific pat-ents create incentives for the wrong types of invention. As a tool for commer-cialization, race-specific patents create racialized marketplaces. As a means for disclosure, race-specific patents provide a lens to see how identity and invention intersection. This chapter starts with the third point to illustrate the first two.

3

The Case of Race-Specific Patents


One question that critics of this study may have is why I focus on race and not gender. After all, Myriad’s European patent covered an invention target-ing Ashkenazi Jewish women, and, as I report later, some medical research in the field of personalized medicine is centered on Asian-American women. There is, however, an emerging and rich scholarly literature on patent law and feminism, but not a substantive analogous literature on race and patents. This study fills that gap. Furthermore, as both Nitromed and Myriad are the cen-tral case studies in this book, the common feature of these two studies – the use of race and ethnicity – would be an appropriate choice in defining the body of patents analyzed in this chapter.

More importantly, the critical analysis of race and patent law supports and is consistent with the emerging literature on feminism and patent law. Professor Laura Foster’s work, for example, takes a critical perspective on the public domain and asks whether the gendered power relationships within law are rep-licated within the public domain. In other words, are the freedoms associated with the public domain unequally distributed between men and women?1 Kara Swanson effectively shows assumptions about the gendered division of the public and private spheres influence patent law, particularly with the doc-trine of public use that prevents the grant of a patent if the invention was used during a certain period before the filing of the patent application.2 In a case involving a patent on a corset, Swanson shows, a use of the corset by the fian-cée of the inventor constituted such a public use.3 The effect of patent law on women’s health and decision making is the subject of scholarship on repro-ductive technologies and patenting.4 Dan Burk explores the dualisms in intel-lectual property between mind and body and intellectual labor and physical effort using feminist theory. His identification of these dualisms shows how domination and suppression along gender lines is constructed within various fields of intellectual property, including patent law.5 His more recent scholar-ship raises a seemingly more skeptical question: Do patents have gender? But this provocative question prompts an analysis of how masculinized norms of

1 Laura Foster, “Situating Feminism, Patent Law, and the Public Domain,” 20 Columbia J. Gender & Law 262 (2011).

2 Kara W. Swanson, “Getting a Grip on the Corset: Gender, Sexuality, and Patent Law,” 23 Yale Journal of Law & Feminism 57 (2011).

3 Egbert v. Lippmann, 104 U.S. 333 (1881).4 Kara W. Swanson, “Patents and Abortion: The Politics of Life in the United States Patent

Office,” paper presented at Conference on Law and Society Perspectives on IP Law and Policy, The IP Law Center at the Golden Gate University School of Law, November 2011; Torrance, Andrew W., 2011, “Family Law and the Genomic Revolution,” 79 UMKC Law Review 271–282 (2011).

5 Dan Burk, “Feminism and Dualism in Intellectual Property,” 15 American University J. Gender, Society, Policy, & Law 183 (2007).

The Case of Race-Specific Patents 65

science and observation arise within patent law.6 Much like these explorations into feminism and patent law, the study of race and patent law highlights the social context of patents and the effect of patent policy on personal identity. One key difference is that the starting point for the analysis is an examination of race-specific patents that serve as an empirical foundation for the theoreti-cal and policy analysis.

Identifying race-specific patents entails a search of the public records avail-able at the United States Patent and Trademark Office. My search involved identifying patents where the terms “African-American” or “Negro” were used in the patent document, either in the specification or the claims. The results of the search and my analysis are presented in the rest of this chapter. The search of “African-American” in either the specifications or the claims resulted in about 3,000 patents, with the most recent in December 2010 and dating back to July 1989. The search term “Negro” in either the specifications or claims resulted in more than 700 patents, with the most recent in July 2006 and the earliest in April 1842. I divided these patents into six categories: (1) patents involving hair, usually making reference to “Negro hair”; (2) patents involving skin color; (3) patents involving toys; (4) patents involving methods of sorting identities and names; (5) miscellaneous; and (6) patents involving epidemio-logical data from the African-American population. The tables at the end of the chapter summarize the patents found in categories one through five, with further discussion following later (see tables 3.1–3.5).

Narrowing my analysis in this study to the racial categories of African American and Negro was the most difficult research choice I had to make. This decision was motivated in part by the BiDil patent’s focus on “black patients,” a focus that influenced my desire to study this topic more deeply. The focus on African American and Negro as the relevant categories was also motivated by the rich set of patents I uncovered in my research. I should point out that many of the epidemiological patents I discuss also included Asian-American and Hispanic-American as racial categories to stratify the sample. Asian Americans have been a target population for study in the biomedical community, particularly Asian-American women.7

6 Dan Burk, “Do Patents Have Gender?,” 19 Am. U J. Gender, Social Policy, & the Law 881 (2011).

7 See Denise Grady, “Researchers Find Distinctive Patterns of Cancer in Five Groups of Asian-Americans,” The New York Times (July 11, 2007) A12; Cynthia Ozawa et al., “Culturally Sensitive Treatment of Metabolic Syndrome in Asian Americans,” 18(5) Home Health Care Management & Practice 394 (2006). For an epidemiological analysis of health issues facing the Hispanic-American population, see Carolina Reyes et al., Genes Culture, and Medicines: Bridging Gaps in Treatment for Hispanic Americans (Washington, DC: National Alliance


A search of the term “Asian-American women” in the database of patent applications and issued patents on the USPTO Web site uncovered seven filings from 2001 to 2010 in which the invention covered in part treatment of Asian-American women. For example, McGill University, The Hong Kong Institute of Science, and Wayne State University were named as assignees in a 2010 patent application that covered a method for inhibiting proteosomal activity and treating cancer. Proteosomal activity means the breaking down of unneeded or damaged proteins that result from degenerative diseases like cancer. The application makes reference to a study that shows the benefits of green tea to Asian-American women, the benefits stemming from reactions similar to proteosomal activity.8 Another application covering a method for using algae to treat cancer made reference to studies of breast cancer inci-dence among Asian-American women.9 Not all of the seven applications were from the field of personalized medicine. A computer software patent applica-tion covered a method of sorting members of a computer network into catego-ries based on user-supplied personal characteristics. Asian-American woman was one personal characteristic used as an example in the application.10 Expanding the search to the term “Asian-American” uncovered 73 utility patents granted from 1995 through 2011 and 212 applications from 2001 to 2011, almost all of which were from the field of personalized medicine. The patents cited as prior art epidemiological studies that involve Asian-American population. Finally, the use of the term “Asian” yielded many spurious pat-ents, covering Asian species of plants or animals rather than persons within the demographic group.

for Hispanic Health, 2004) 11–14 (a joint publication of the National Alliance for Hispanic Health and the National Pharmaceutical Council that focuses on four diseases: asthma, diabetes, heart disease, and Alzheimer’s). My focus on race should not be read as neglecting or minimizing the category of gender. For preliminary studies on gender and patenting, see Ethlie Ann Vare & Greg Ptacek, Patently Female: From AZT to TV Dinners, Stories of Women Inventors and Their Breakthrough Ideas (New York: Wiley, 2001); Autumn Stanley, Mothers and Daughters of Invention: Notes for a Revised History of Technology (New Brunswick: Rutgers University Press, 1995). In 1994, the National Institute of Health issued the National Institutes of Health Guidelines on the Inclusion of Woman and Minorities as Subjects in Clinical Research, which outlined “a wide range of new responsibilities for clinical research-ers funded by the NIH and for institutional review boards.” Under these guidelines, “all NIH-funded clinical research must now include representative numbers of women and members of racial or ethnic minority groups.” Charles Weijer & Robert A. Crouch, “Why Should We Include Women and Minorities in Randomized Control Trials?” in Ezekiel J. Emanuel et al., eds., Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary (Baltimore: Johns Hopkins University Press, 2003) 171–172.

8 U.S. Patent App. No. 12968759 (filed Dec. 15, 2010).9 U.S. Patent App. No. 12002451 (filed Dec. 17, 2007).

10 U.S. Patent App. No. 1102246 (filed Dec. 23, 2004).


The search term “Hispanic-American” appeared in forty-six issued patents from 1999 through 2011. Most of these patents covered personalized medicine related to inventions for treating and diagnosing diabetes and various forms of cancer. There were also 121 patent applications from 2001 through 2010, which were from the field of personalized medicine. Reflecting the recent coinage and usage of the descriptor “Hispanic-American,” no patents or applications were found with the term before 1999. While many of the policy issues ana-lyzed here in the context of race-specific patents relating to African Americans would apply to other demographic categories, language places limits on the thoroughness and saliency of searches. Hence, my narrow focus on inventions that refer to the African-American or Negro population arises from the preva-lence of terms to denote blackness and to capture the African-American pop-ulation as opposed to other racial or ethnic group. With this explanation for the search choices in this study, I turn now to a discussion of the race-specific patents themselves.

Patents on Cosmetics and Fashion

There were eighty-six patents in this category, covering the period between 1904 and 2010. The inventions covered by these patents included combs, pins, methods for straightening hair, treatments for dermatitis and pseudofolliculi-tis barbae, and methods for hair styling and coloring. For example, one pat-ent, in July 2006, was for a “Braid Removal Device.”11 The most recent patent in this category, over the time frame for the search, was issued in February 2010, to duPont for a hair conditioner suitable to African-American hair.12 It is interesting to trace the dates of these patents. The first was in 1904. The next was in 1922. A breakdown by decades is as follows: 1920s: three; 1930s: zero; 1940s: two; 1950s: three; 1960s: three; 1970s: five; 1980s: seven; 1990s: eighteen; 2000s: forty-four. As is well documented, there has been an active market for products designed to limit traditional African-American features, and these products were directed to facilitating passing. The patents from the 1950s to the 1970s are consistent with that market. The patents after the 1970s cover a range of medical and cosmetic issues involving hair.

The first hair-straightening patent that makes reference to a racial category (see Figure 3.1) is the 1904 patent issued to Gael Miller.13 The patent claimed a combination of a comb and a heating device, which allowed the comb to be

11 U.S. Patent No. 70733516 (issued Jul. 11, 2006).12 U.S. Patent No. 7666397 (issued Feb. 23, 2010).13 U.S. Patent No. 763012 (issued Jun. 21, 1904).


Figure 3.1. Early hair-straightening patent.


heated and remove waves from hair. The claims were for the resulting product and did not cover a method for straightening hair that would be limited to a particular racial or ethnic group. However, the specifications did make use of racial categories:

It is a well-known fact that persons of the black or negro race generally and quite a number of persons outside of this race, some even of the white race, have hair which curls so tightly or closely that it cannot be combed into the desired form or parted by any ordinary means or treatment.

By my invention I provide a simple device by the use of which this intensely curly hair may be quickly and easily straightened more or less, and thereby put into condition so that it may be combed and parted. By the use of the said device the hair will not usually be entirely straightened, nor is such a result desired, it being preferred rather simply to remove the intense curl from the hair, so that it may be easily controlled, but leaving the same with a wavy appearance.14

The description recognizes that the patented product could be useful for mem-bers of the white race as well as those of the “black or negro race.” Despite this emphasis on broad applicability, the language of the written description sug-gests that the product was targeted toward the African-American community. The 1922 patent for a specially designed comb for the purpose of straightening hair was more obvious of the targeted group.15 The specifications for this comb patent stated: “My invention has for its object to provide a simple and efficient device for combing and straightening the hair of persons of the Negro race and especially designed for women’s hair.”16 The two 1926 patents also specifi-cally state that the inventions were designed for use by members of the Negro race, without placing any specific racial limitations in the claims.17

To the extent that the passage of the Civil Rights Act of 1964 marks a watershed in consciousness of the stigmatizing and offensive use of racial categories,18 the uses of racial categories in the hair-straightening patents reflect these changing attitudes only gradually. The ten patents on hair-related inventions issued on or before 1964 consistently make reference to the Negro race as having particularly kinky or curly hair, creating a close association between the attributes of hair and membership of the group. The written

14 Idem.15 U.S. Patent No. 1425757 (issued Aug. 15, 1922)16 Idem.17 U.S. Patent No. 1593055 (issued Jul. 20, 1926) (“Device and Process for Straightening Hair”);

U.S. Patent No. 1607674 (issued Nov. 23, 1926) (“Pomade comb”).18 See “Recent Statute: Civil Rights Act of 1964,” 78 Harv. L. Rev. 684 (1965).


description of one of these ten patents in fact makes reference to the hair of the Negro and Semitic people.19 The association between hair and race con-tinues to be emphasized in the 1968 patent for a method of dyeing human hair, which allowed the chemical composition of the dye to be stored more effectively as well as applied for a longer duration.20 The written description singles out an experiment on the hair of an “elderly Negro” on whom the dye worked as intended.21 Two points are striking about the 1968 patent. The first is the general applicability of the invention beyond the needs of any one par-ticular racial group. The second is the use of the racial category as a specific example of the efficacy of the invention. Whether the choice of Negro hair was conscious or accidental, the use of racial category serves to support the universal applicability of the invention. Through the written description, by pointing out the example of the Negro hair, the inventor is emphasizing that the invention works on all types of hair, not just the straight hair that may be the default assumption of someone evaluating the invention for patentability.

The universality of the patented invention becomes an important feature of many of the hair-related inventions following the passage of the Civil Right Act. But the trend toward targeting inventions at a particular group also continued. For example, the 1975 patent for a “Method and Apparatus for Doing Afro Hairdos” makes specific references to particular type of hair-style, “most often worn by persons who are of the Black or Negro races, or their descendants, and whose hair naturally has a high degree of curl in it.”22 But the written description also emphasizes that “this invention is not lim-ited to use by Black persons as it has equal applicability to any other person who may wish to wear their hair in the so-called Afro style.”23 By contrast, the 1982 and 1983 patents for “Hair Straightening Process and Curling Process and Composition” specifically mentions the problems of previous hair-straightening processes to straighten the “unstraight hair” of the Negro race and proposes a solution that is less abrasive and harmful to the scalps.24 The examples discussed in the written description emphasize experiments of the new process on the hair of Negro subjects.25 In this case, the inventor recog-nizes that the hair-straightening process is most likely to be used by a person

19 U.S. Patent No. 2238544 (issued Apr. 15, 1941) (referred to Negroid and Semitic strains of kinky hair).

20 U.S. Patent No. 3369970 (issued Feb. 20, 1968).21 Idem.22 U.S. Patent No. 3892246 (issued Jul. 1, 1975).23 Idem.24 U.S. Patent No. 4324263 (issued Apr. 13, 1982); U.S. Patent No. 4373540 (issued Feb. 15, 1983).25 Idem.


who is African American, and therefore attempts to establish its efficacy with respect to that group.

Racial categories mediate between the universal and the particular in patent law. No inventor limited the claims for hair-related invention to a specific race, showing that inventors – or their attorneys drafting the claims – recognized the applicability of the invention across individual consumers, despite their individual racial or ethnic affinity. At the same time, racial categories did play a role in the specifications for two distinct reasons. In some cases, the racial cat-egory indicated that the invention was targeted toward a particular subclass of consumers as the likely beneficiary of the inventions. In other cases, the racial category serves as evidence that the invention works across groups and that the inventor had tested the product or process beyond a narrow group. Racial categories seem to provide context for the invention, demonstrating that the new product or process would have a demand in the marketplace and that this demand would exist beyond certain enclaves of the population.

What is striking is that racial categories seem to continue in this medi-ating function after the 1980s, and in many ways have become even more salient for patenting since 1990. Of course, dividing patents by decades is arti-ficial and may not be the best way to reflect changing social attitudes and historical changes. But the decade breakdown is quite striking in showing the continuing viability of racial categories. Patenting for hair-related inventions increased sharply from 1990 to 2006 as compared to the period from 1900 to 1989. I counted forty-six hair-related patents from 1990 to 2006 in which the racial category of African-American, Negro, or black was used. This is nearly double the twenty-seven hair-related patents utilizing one of these three racial categories from 1900 to 1989. This increase reflects the general increase in patenting that has occurred over the past two decades. The increase may also reflect the lowering of patentability standards that some scholars have argued occurred with the lowering of the standard for nonobviousness by the Federal Circuit.26 To the extent that patentability also stimulates or reflects increased innovative activity, the increase in patents may reflect an expansion of inven-tions stemming from a more prosperous legal and economic environment.27 Whatever the explanation for the increase in patenting, one clear trend is that the use of racial categories did not abate.

26 See Christopher Cotropia, “Nonobviousness and the Federal Circuit: An Empirical Analysis of Recent Case Law,” 82 Notre Dame L. Rev. 911 (2007) (assessing the thesis of the lowering of the standard for nonobviousness by the Federal Circuit.)

27 See Adam Jaffe & Josh Lerner, Innovation and Its Discontents: How Our Broken Patent System Is Endangering Innovation and Progress, and What to Do About It 11–13 (Princeton: Princeton University Press, 2004) (documenting the patent explosion in the last two decades).


The function served by racial categories, however, does seem to change even though as a general matter racial categories continued to serve their mediat-ing function. For example, many patents for hair relaxers, hair straighteners, hair loss treatment, and hair maintenance are intended for the wide market, with racial categories mentioned as specific examples of the universality of the product. A striking example of this use of racial categories is provided by a pat-ent for an “Adjustable Hand Held Shower Apparatus,” in which the inventor states in the written description: “Damaged hair due to chemical treatments is a problem for many women, especially for African-American women whose hair is inherently delicate and prone to breakage.”28 Putting aside the truth of this statement, the interesting question is why is it relevant. The reference to the hair or African-American women emphasizes the universal applicability of the invention and its benefits across racially defined markets.

However, certain inventions are targeted for the needs of the racially delin-eated group. For example, several patents are for the treatment of pseudofol-liculitis barbae, a skin condition resulting from ingrown hair follicles that is particularly prevalent among African-American males.29 These patents are specifically targeted to address a condition, and a market need, that had been previously ignored or underserved. Patents for certain types of razors and scis-sors to deal with the problems of ingrown hair follicles and sensitive skin con-ditions among the African-American population also reflect this targeting of inventive activity.

The 2006 patent for a “Braid Removal device” offers a final example of how racial categories mediate the boundaries of racially defined markets.30 The patent is for an invention that allows removal of braids from human hair in an expedited fashion with minimal damage. The written specification states:

African-Americans genetically have hair that resists the formation of lon-ger lengths. Still these longer length styles can enhance the appearance. Accordingly, it is common for African-American people to attach braids to their own natural hair.

These braids are formed of either natural hair (from any source) or they are formed of a synthetic material and are attached to the African-American’s hair by weaving a length of the person’s natural hair into an end of the braid, which is then suspended from the natural hair. Several strands of natural hair are used to secure each braid.31

28 U.S. Patent No. 6264121 (issued Jul. 24, 2001).29 See, e.g., U.S. Patent No. 4775530 (issued Oct. 4, 1988).30 See note 11 to this chapter.31 Idem.


Despite this emphasis on the genetic inclinations of African-American hair, the inventor clarifies:

In use, a braid is cut at a location that is below where a person’s natural hair ends using the cutting device 30. The natural hair was previously woven into the braid so as to secure it (the braid) in position. This is well known in the art of adding braids to people’s hair. It is especially common among African-Americans, but can of course be used with people of any race or ethnic background.32

The inventor uses the example of African Americans to delineate the purpose and function of the invention, but is also very quick to emphasize the universal applicability. Given the asserted universal applicability, the interesting ques-tion is why mention the racial category at all. The answer seems to be that the racial category helps delineate the particular market that the invention serves, while also illustrating how the invention can be universalized beyond the racial enclave. Racial categories serve to advertise the market for the invention while avoiding any narrowing of the claims to particular uses or markets.

As in the case of biomedical and pharmaceutical patents, racial catego-ries in hair-related patents serve to support the patentability of the invention by demonstrating the utility and potential nonobviousness of the invention in meeting an unmet need in the marketplace. But the use of racial cat-egories serves to mediate the particular impetus for the invention with its potentially universal marketability. The hair-related patents illuminate once again the ways in which background social factors like race can affect the process of inventorship and of patenting. A similar pattern can be observed in the five remaining categories of patents: those involving skin color, those for toys, those for profiling, the miscellaneous category, and epidemiological inventions.

Patents Involving Skin Color

There were twenty-five patents in this category, covering the period from 1941 to 2004. The inventions covered by these patents included methods for correcting skin color in photographs and color television, methods for cur-ing keloid scars and types of aftershave and skin gels particularly suitable to “Negro” or “African American” skin. The breakdown by decade is as follows: 1940s: one; 1950s: zero; 1960s: one; 1970s: three; 1980s: four; 1990s: five; 2000s: eleven.

32 Idem.


Given that race consciousness has focused consistently on skin color as both the basis for stigmatization and for affirmation, the reference to Negro or African-American skin color provides insights into how racial categories are used in patent law.33 As with hair, skin color serves often as a descriptive market to identify potential beneficiaries of the invention. This descriptive use of a racial category aids in both particularizing the invention – defining a specific market enclave to be served by the invention – and universalizing the invention – demonstrating how the invention does not serve only the majority racial group in the market. This latter use is arguably more recent, consistent with the change in attitudes arising from the civil rights movement era. What is interesting is to gauge the stigmatizing uses of the racial category. The pat-ent documents do not explicitly invoke stigmatizing or stereotypical uses of racial categories, as, for example, we will see in the toy patents in the next subsection.

However, many of the inventions implicitly suggest the stigma resulting from racial categories. A striking example of this implicit stigma is provided by the 1974 patent for “Skin Depigmentation”34 (see Figure 3.2), which shocked me when I first discovered it, for two reasons. First, the invention invoked the history of passing and the necessity of passing through blanching one’s skin for the purposes of assimilation and avoidance of discrimination. Second, the patent was issued in 1974, ten years after the passage of the Civil Rights Act and twenty years after Brown v. Board of Education, providing stark evi-dence that the need for skin depigmentation perhaps had not abated after the changes in race consciousness.35 Upon closer inspection of the patent, how-ever, I discovered that the written description, while making use of a racial category, emphasized the biomedical uses of the invention to aid those who had suffered from certain debilitating skin disease. The 1974 patent, as well as the other patents in this category, illustrates the ambiguity in the use of racial categories for inventions involving skin color.

The 1941 patent for an “Apparatus for comparing, matching, or detecting colors” is the most striking of this group of patents for illustrating the com-plex attitudes toward skin color existing at the time and continuing to the

33 See Ian Haney Lopez, White by Law: The Legal Construction of Race (New York: NYU Press, 1996); John Howard Griffin, Black Like Me (New York: Signet Books, 1960) 190–192; Robert Bonazzi, Man in the Mirror: John Howard Griffin and the Story of Black Like Me (Maryknoll: Orbis Books, 1997) 37–41.

34 U.S. Patent No. 3856934 (issued Dec. 24, 1974).35 See Joseph L. Graves, Jr., The Race Myth: Why We Pretend Race Exists In America (New

York: Penguin, 2004) 86–87.


Figure 3.2. Written description from the 1974 patent for “Skin Depigmentation.”


present day.36 The inventor’s written description paints a broad scope for the invention:

This invention related to an apparatus for comparing, matching or determin-ing colors, such as human skin colors, pain colors, dye and fabric colors, and all other colors, for the purpose of identifying an unknown color or color shade of a 5 general color, or comparing one color or shade of a color with another for the purpose of determining and recording the specific shade or color classification of any particular color shade with relation to a standard or established color scale or an arbitrarily prescribed scale.37

The apparatus allows for the side-by-side comparison of a given color with a template that allows for the matching and categorizing of a particular color shade (see Figure 3.3). Descendants of this device can be seen in hardware stores, used to identify particular colors of paint to match existing samples.

Fans of the novelist Ralph Ellison, however, will appreciate the juxtapo-sition of human skin color with paint and fabric colors. In Ellison’s novel Invisible Man, published about twelve years after the grant of this patent, the eponymous hero works in a pain factory where the whiteness of the colors used to decorate the national memorials in Washington, DC functions as a metaphor for racial homogeneity and the fear of blackness and difference that haunt the novel.38 The written description of the patent, however, shifts quickly from the casual linking of human skin color to paint color toward a more ominous turn:

The invention provides an apparatus designed and adapted for general uses of the character described, but which is particularly designed and adapted, in the exemplified form shown, for the purpose of determining and indicat-ing the skin colors of human beings so as to furnish a valuable and important aid to police authorities in the detection, apprehension and conviction of persons guilty of criminal offenses, or, conversely, showing the innocence of persons charged with such offenses.39

The invention could easily have been included in the later discussion of pat-ents having to do with sorting identities and names because it serves as a

36 U.S. Patent No. 2248148 (issued Jul. 8, 1941).37 Idem.38 Here’s an illustrative passage from the novel: “I watched him kneel and open one of the

buckets, stirring a milky brown substance. A nauseating stench arose. I wanted to step away. But he stirred it vigorously until it became glossy white, holding the spatula like a delicate instrument and studying the paint as it laced off the blade, back into the bucket.” Ralph Ellison, Invisible Man (New York: Random House, 1952) 195.

39 See note 37 to this chapter.


Figure 3.3. Drawing from a patent for a device to match skin color.


tool for racial profiling and identification. But I discuss it under this category because of the blunt discussion of skin color and race, as indicated in the fol-lowing description of how the invention can aid in the organization of police records:

Such records are generally defective, however, in merely specifying the gen-eral color of the individual as “black,” or “white,” for example, which gives no exact information as to the color of the individual’s skin. A black man, or individual of the colored race, for example, may be of any color ranging from a light brown to a deep black. Furthermore, an individual classed as belonging to the colored race may have a skin color as white as some individ-uals among those classed as white, so that his color designation from a racial standpoint is not an aid toward identification. Similarly individuals of the white, yellow, brown and other races vary in skin color, so that the general identification data of the character commonly employed with respect to race and race color, does not give satisfactory information in this respect.

My invention provides an apparatus and system of identification which over-comes this objection and by means of which the exact color or color shade of the skin of any individual may be determined and a record thereof made, thus giving accurate information of a valuable sort for use in apprehend-ing and convicting persons guilty of offenses against the law or proving the innocence of persons taken upon suspicion or unjustly charged with such offenses.

My invention also provides an apparatus which may also be used by manu-facturers, military, naval and immigration authorities and others in com-paring, determining and recording colors, as hereinbefore set forth and as hereinafter more fully described.40

The written description has been quoted in full to provide the general flavor of this particular patent and to emphasize how it reflects striking attitudes toward skin color as a marker for race and a tool for law enforcement. Some of these attitudes continue to be demonstrated in the patents for sorting identi-ties of individuals, discussed later in the chapter.

The equivalence between human skin color and the color of paints and dyes used on manufactures and textiles has a parallel in the contemporary discussion over trademark protection for colors as a form of trade dress.41 In that context, color serves as a marker that cannot be inherently distinctive but can gain distinction through association or the creation of secondary

40 Idem.41 Qualitex Co. v. Jacobson Products Co., Inc., 514 U.S. 159 (1995) (holding that color can pro-

tected as a trademark only if it has acquired distinctiveness in the marketplace through asso-ciation with a company’s product or service).


meaning.42 This discussion in trademark is paralleled in the patent area by the recognition that human skin color may also be as artificial or arbitrary as the paint applied to a commodity. But the inventor of the 1941 patent demonstrates some degree of ambiguity to the artifice of human color. The concern with “exact information” on color and the close connection drawn between one’s color status and membership in the “colored race” suggests that the inven-tor views human skin color as in some ways essentializing, as fundamental and immutable to the identity of the person being sorted and categorized.43 Therefore, the skin color patents demonstrate an ambiguity in thinking, per-haps even a confusion, between color as artifice and color as essence. Modern trademark law resolves that confusion in the context of colored commodities in favor of artifice by rejecting inherent distinctiveness for colors. The ambi-guity, however, continues in patent law as illustrated by three subset of skin color patents: (1) skin color and appearance, (2) skin color as a marker for med-ical processes, and (3) skin color as condition requiring treatment.

Several patents make reference to skin color as a dimension of appearance that the inventor recognizes in the construction of the invention. For example, there are several patents involving color photography in which the attributes of the photographic process or the new type of film include the ability to accu-rately represent flesh tones, specifically the skin color of African Americans or Asian Americans.44 These inventions are touted as allowing the user to more accurately capture natural skin colors. Unlike the apparatus described in the 1941 patent, these inventions treat skin color as a cosmetic condition that provides a basis for defining the usefulness and value of the invention. Other examples of these cosmetic patents include patents for different types of cosmetic compositions and products such as for aftershave and skin care creams.45 Skin color for these inventions indicates a cosmetic surface differ-ence that a particular inventor recognizes and incorporates into the design and purpose of the invention.

The second set of inventions recognizes skin color as an aspect of appear-ance but treats color as a marker for identifying certain users of the prod-uct, much like racial categories are used in the biomedical patents discussed

42 The treatment of colors under trademark law is a vivid reminder of how skin color itself can serve as a form of bankable property – a point made eloquently in Cheryl Harris, “Whiteness As Property,” 106 Harv. L. Rev. 1709 (1993) (skin color as a marketable and commodifiable asset).

43 See Richard R. W. Brooks, “Incorporating Race,” 106 Colum. L. Rev. 2023 (2006) (analyzing the racial identities of corporations).

44 See, e.g., U.S. Patent No. 3705762 (issued Dec. 12, 1972) (“Method for Converting Black and White Films to Color Films”).

45 See, e.g., U.S. Patent No. 66340130 (issued Oct. 7, 2003) (“Sunless tanning cream”).


earlier. For example, a 1988 patent for “Devices and methods for treating memory impairment,” a continuation of a 1987 patent,46 describes a treatment for memory loss that involves application of a pharmaceutical composition to human skin.47 In describing clinical trials, the inventor notes in the written description that “[t]here does not appear to be any difference in rate between Caucasian and Negro skin at pH values of 8 and 9. However, differences were observed between these two skin types in experiments at lower pH values.”48 Here, skin type serves as a descriptive marker to help identify the efficacy of the invention much like self-identified ethnicity is used in the area of phar-maceutical invention.

While the cosmetic patents and the biomedical patents support an under-standing of skin color as appearance, patents dealing with treatment of certain conditions involving skin color illustrate a connection between skin color and social status and perception. This connection, however, is ambiguous. Skin color sometimes serves as an indicator of disease, and the reference to skin color in these patents highlights skin color as an aspect of surface appear-ance as opposed to an essentialist dimension of identity. For example, the 1970 patent for a “Method of Treating Hyperpigmentation” covers “compositions of matter useful as depigmenting agents and to processes for utilizing such compositions in the treatment and control of hyperpigmentation.”49 One part of the patented composition was identified from the “leukoderma that was observed in Negro workers was traced to the use of benzyloxphenol as an antioxidant in the protective rubber gloves worn by the workers.”50 Similarly in the 2000 patent for a “Method and Apparatus for Detecting and measuring Conditions Affecting Color,” skin color is a reference to detect and identify disease:

The invention can afford good evidence of jaundice resulting from medical conditions other than hyperbilirubinemia. Liver disorders in adults and chil-dren produce jaundice, for example. These and other skin color character-istics can be factors in diagnosing additional diseases that affect skin color. It has been observed, for example, that at least among dark skinned individ-uals, such as African Americans or others of African descent, skin color is affected by tuberculosis.51

46 U.S. Patent No. 4680172 (issued Jul. 14, 1987).47 U.S. Patent No. 4765985 (issued Aug. 23, 1988).48 Idem.49 U.S. Patent No. 3517105 (issued Jun. 23, 1970).50 Idem.51 U.S. Patent No. 6129664 (issued Oct. 10, 2000).


Whereas these two and other patents present skin color in descriptive terms and avoid treating color in essentialist terms, the 1974 patent for “Skin Depigmentation” reflects a more ambiguous approach to treatment of “hyperpigmented” skin.52 While the written description begins with reference to diseases of the skin, the inventor identifies why depigmentation is some-times desired:

This hyperpigmentation is generally viewed as cosmetically undesirable and psychologically disabling. . . . It is also often desirable to decolorize normally pigmented skin to generally increase “fairness” of appearance or to blend pypopigmented areas into surrounding normal skin, for example in the treat-ment of generally dark-skinned people suffering from vitiligo.53

Here, the written description goes beyond mere treatment of disease to treat-ing “normally pigmented skin,” presumably to deal with the “psychologically disabling” effect of skin color.54 Two views of skin color are apparent in this invention. The first is the conception of skin color in purely cosmetic terms about appearance. The second, however, appeals to an essentializing role of skin color reflecting social stigma associated with dark skin tones and soci-etal preferences for fair colors. Such views would not be surprising in the nineteenth century, but they are quite striking in a government document dated 1974. Even if the language is archaic, reflecting outmoded attitudes in a transition period of race consciousness, the salient question is whether the government should sanction such justifications for inventive activity through the patent grant. This question becomes even sharper in the context of patents involving toys, which arguably illustrate the most striking examples of racial stereotyping in the invocation of racial categories.

Patents Involving Toys

There were sixty-four patents in this category, covering the period from 1863 to 2006. The inventions included card games involving African and African-American culture, educational tools to test knowledge of culture, teaching tools targeted to skills in the African-American population, and a sundry of dolls and apparatuses that incorporated stereotypes of the African-American population. The breakdown by decades is as follows: 1860s: three; 1870s: one; 1880s: four; 1890s: five; 1900s: four; 1910s: six; 1920s: nine; 1930s: two; 1940s: two;

52 See note 34 to this chapter.53 Idem.54 Idem.


1950s: zero; 1960s: one; 1970s: two; 1980s: two; 1990s: seven; 2000s: sixteen. The inventions prior to the 1950s were largely for toys that incorporated ste-reotypical images and caricatures of African Americans, such as an electric target machine that included a “negro carrying a chicken” in 1940. A patent from 1969 was for a “Doll Having a Plurality of Changeable Ethnic Features,” including those of a “Negro.”55 The inventions in the 1990s and 2000s cov-ered educational card games and board games. The most recent patent uncov-ered, from August 21, 2007, was for an “Infant Simulator,” a doll used to teach how to handle infants and adaptable to characteristics associated with African Americans, Asians, Latinos, and other groups.56

Prior to the 1960s, the toy patents were a series of racial stereotypes that reflect then contemporary attitudes of what caricatures consumers found amusing. In the first of this series, a 1863 patent for an Automatic Dancer (see Figure 3.4), one of whose inventors was a fellow named, appropriately enough, James Crow, describes the invention as spring toy, similar to what we would call a bobblehead, which would include “the figure of a negro or any other human figure.”57 The head of the figure, the inventors describe, could be interchanged, “so that the head of the negro can be removed and that of a clown put in its place.”58 The 1947 patent, the last in this series, was for a mov-able toy wagon that included representations of human figures as passengers. According to the inventor, “the heads of these figures, in keeping with the idea of physical attractiveness, may be painted to simulate children of diverse races, such as Caucasian, Mongolian, Negro, and Malay races.”59 The image of inclusiveness in the 1947 patent contrasts with the stereotype of the Negro buffoon represented in the 1863 patent and many of the patents thereafter. For example, the 1907 patent entitled “Target” is for a carnival game in which the target is a “Negro’s head,” at which “the ball may be thrown.”60 The inventor of this game informs us that

the player aims to strike either eye of the head, and the target is so con-structed that the eye may be put out by the ball. In practice, I construct both eyes so that each may be put out independently of the other, and I also pro-vide an opening in the negro’s mouth through which a ball may pass, and a net behind the opening to catch the ball.61

55 U.S. Patent No. 3419993 (issued Jan. 7, 1969).56 U.S. Patent No. 7025593 (issued Apr. 11, 2006).57 U. S. Patent No. 40740 (issued Dec. 1, 1863).58 Idem.59 U. S. Patent No. 2419872 (issued Apr. 29, 1947).60 U. S. Patent No. 844507 (issued Feb. 19, 1907).61 Idem.


Figure 3.4. Drawing from the 1863 patent for a dancing toy, invented by one James Crow.


A 1940 patent for a target game included a target “which may for example sim-ulate a negro carrying a chicken, or any other suitable design.”62 As the written description provides:

We illustrate, however, means for reversing the movement of the target struc-ture in response to every hit so that the negro, if hit, may reverse his direc-tion of movement. It will be understood, of course, that the housing 54 may simulate a negro, a hen house being illustrated at A in Fig. 1. As soon as the target is initially moved, with the negro moving toward the hen house, a successful hit will cause him to reverse his direction of movement and leave the hen house. This of course is merely one example of a practical use of our invention.63

The use of stereotypical imagery should not be too surprising because games and toys illustrate the times. Furthermore, the imagery in these mechanical shooting games are not too far removed from the many stereo-types of drug lords, pushers, and pimps that animate contemporary video games.64 But the prevalence of this imagery in patent documents should be noted as examples of how inventorship and the administrative review of pat-ent applications readily included ethnic stereotypes as illustrative examples of invention.

The image of “children of diverse races” conjured in the 1947 patent serves a watershed from the first set of patents to the second set that begins with the 1969 patent for a “Doll Having a Plurality of Changeable Ethnic Features” (see Figure 3.5).65 Stereotypes still persist, as the reference to “Caucasian, Mongolian, Negro or Malay” races indicates, but the written descriptions suggest that the toys are designed with a broader, more inclusive market in mind. According to the written description, the inventor of the 1969 toy “con-templated that the ethnic doll may be made to represent four basic races of universal man, namely the European white or so-called Caucasian race; the Afro-American or Negroid race; the American Indian race and the Oriental race. However, it will be understood that the present invention is not lim-ited to these four races and that other types of human representation may be

62 U.S. Patent No. 2188292 (issued Jan. 23, 1940).63 Idem.64 See William M. Carter, Jr., “A Thirteenth Amendment Framework for Combating Racial

Profiling,” 39 Harv. C.R.-C.L. L. Rev. 17, (2004) (discussing racial stereotypes in video games), citing Erica Goode, “With Video Games, Researchers Link Guns to Stereotypes,” The New York Times, Dec. 10, 2002.



Figure 3.5. The 1969 patent for a doll with plurality of ethnic features.


exemplified in the ethnic doll of the present invention.”66 The inventor’s dis-cussion of the prior art is telling:

Dolls of the prior art each represent a particular ethnic group. For example, separate dolls are utilized to represent the white or the colored races and, similarly, separate dolls are used to represent European, Oriental or Indian races. If it were desired to acquaint a child with the various different races or ethnic groups, this would therefore require a full set or complement of dolls. For many parents or educational systems or schools this would be a relatively expensive procedure.

In view the foregoing, it is an object of the present invention to provide a single doll, hereinafter designated as an ethnic doll, which can be made representative of the various races or ethnic groups. In accordance with the foregoing object, it is another object of the present invention to provide an ethnic doll which can be manufactured at a relatively low cost and sold at a relatively low price. In accordance with the foregoing objects, it is a further object of the present invention to provide a highly novel doll construction which will have a high appeal to children of various different races or ethnic groups.67

The goal of inclusiveness continues post-1969 in patents for other dolls that have multiple ethnic features, mancala-like games, and board games celebrat-ing Kwanza and African-American civil rights leaders.68

The theme of diversity and pluralism continues in the last two patents in this set, a 2005 patent for “Teaching Cylinder Instruments”69 and a 2006 patent for “Teaching Circumference Instruments,”70 both granted to Gerald Bauldock, Sr., an inventor in the field of education. Both patents are for three-dimensional visual aids that serve as educational toys to help elementary age students learn the relationships among size, shape, area, and volume. Each

66 Idem.67 Idem.68 One unusual mention of race in this set of patents occurs in Patent No. 3940863 (issued Mar.

2, 1976). The patent covered a “psychological testing and therapeutic device” that consisted of series of game cards and dice designed to stimulate storytelling in a patient through “icon-ographic stimuli.” The patient would roll the dice and, based on the roll, pick several game cards that included pictures of different things (such as a racing car, a clown, a sarcophagus, or an animal) and of people. The inventor states that images of “Negro” human figures can be substituted for the images of people included in card deck. The mention of race is casual in the description, and the inventor seems to be suggesting that the card deck can include images of different types of people.

69 U.S. Patent No. 6872078 (issued Mar. 29, 2005).70 See note 56 to this chapter.


invention is justified in terms of benefits to particular ethnically or racially defined communities:

African Americans and Latinos obtain college degrees at only half the rate of white students. The partnerships between government agency, industry, aca-demia and private organization s are trying to address these issues along with many others. This invention provides a method for teaching the geometric concepts of a cylinder and the equations involved.71

Although the patent claims are not limited by race, like the pharmaceutical patents discussed earlier, these two educational toys are defined in terms of unmet needs in racially or ethnically defined target markets. The racial cat-egories serve to identify particular needs in addition to the universal applica-tion and appeal of the invention.

The toy patents offer a snapshot of changing racial attitudes, illustrating a sharp shift from the use of offensive and predictable racial stereotypes to a more inclusive use of racial categories that may contain inherent stereotypical dimensions. Serving both as a portrait of the social context of inventorship and of changing social and cultural attitudes, these inventions, ranging from the prototypical bobblehead to the contemporary educational toy, demon-strate the cultural history and background for the use of racial categories. As with the other set of patents discussed in this section, the question of the nor-mative implications and importance to be given to the use of racial categories requires examining these patents in the broader context of the instrumental goals of patent.

Patents for Methods of Sorting Identities and Names

There were eight patents in this category, covering the period from 1920 to 2005. The breakdown by decade is as follows: 1920s: one; 1930s: zero; 1940s: one; 1950s through 1980s: zero; 1990s: two; 2000s: five. The oldest invention, from 1920, was “Means Employed in the Classification of Names,” covering a punch card system for sorting and classifying individuals in a particular geographic area by particular characteristics, such as race.72 The most recent invention, in 2010, was for a “System for obfuscating identity,” an invention used to hide the nucleic acid or protein component of a genetic sequence associated with a par-ticular target population defined by ethnic ancestry or race.73

71 Idem.72 U.S. Patent No. 1343755 (issued Jun. 15, 1920)73 U.S. Patent No. 7684930 (issued Mar. 23, 2010).


The 1941 patent for an apparatus to match and detect colors, discussed earlier74 provides one example of an invention whose function is to sort iden-tities, at least identity as reduced to skin color. An earlier example is provided by the 1920 patent for a “Means employed in the classification of names,” an invention consisting of a series of punch cards that would allow creators of gazetteers and directories to sort individual citizens and residents by charac-teristics such as last name, place of birth, or race.75 The written description for this patent explicitly provides the “negro race” as one example of a sorting characteristic. The 1942 patent for “Selective Filing and Finding System” cov-ers a variant on this filing and sorting mechanism that also expressly identifies race as one of the characteristics.76 An electronic version of the punch card sorting mechanisms is the subject of the 1998 patents for Attention brokerage.77 This invention is a method for targeting advertising based on the bidding of the participant and his or her self-identified characteristics, such as ethnicity. Finally, the 2005 patent for a “Machine learning method” covers a statisti-cal method to assess the validity of a machine-based problem-solving method in the context of medical diagnosis.78 The written description provides racial composition of the subject population, such as percentage African American, as one factor that can be coded in the algorithm.79

Another patent in this category, from 2005, is less technical than the others in the set, covering a “Patterning system for a selected body type and methods for measuring for a selected body type.” The invention covers a device useful in the garment industry to determine standardized body type. The written description could not be clearer:

This invention pertains to a patterning system and the creation of a standard sizing system for the human body of the Black race. This invention envisages body measurements, size designation, and a patterning system for the Black human body, and specifically, a patterning system incorporating different Black body types in the design of ready-to wear apparel, apparel fitting forms and other articles of clothing, as well as other items worn on the human body for protection or ornamentation. This invention also envisages a method of measuring in order to form a more accurate patterning system for the Black human body type.80

74 See note 35 to this chapter.75 See note 71 to this chapter.76 U.S. Patent No. 2204903 (issued Sep. 8, 1942).77 U.S. Patent No. 5794210 (issued Aug. 11, 1998).78 U.S. Patent No. 6917926 (issued Jul. 12, 2005).79 Idem.80 Idem.


The inventor acknowledges the historic development of different body types associated with ethnicity and the lack of mannequins that reflect differential body type. The invention proposes an ethnicity-based solution to the con-struction of mannequins and other devices in the garment industry to fill in this gap in the garment industry. Even though the written description for this 2005 patent does expressly refer to the “Black race,” the claims are neutral, speaking broadly in terms of an “ethnicity solution” to the patterning of body types.81

Racial categories serve as a means of fixing identity as the patents involving skin color illustrate. The few patents discussed here illustrate that using race to assess identity goes beyond skin color to include membership of a racial group and body type. Whereas the discussion of skin color illustrates an ambiguity between race as an essentializing quality and race as an element of surface appearance, the patents discussed in this section suggest an essentialist view of race in determining identity. Whether in using race to target advertising or in defining body type, the patent recipients use the racial category to capture some predetermining fixed characteristic to aid in segmenting the market-place. The 2010 patent issued to Match.com (see Figure 3.6), which covers a “System and Method for Providing Enhanced Questions for Matching in a Network,” expressly includes questions for racial and ethnic preference as part of the invention.82 In this way, racial categories serve a similar function as in the other patents discussed earlier.

Biomedicine in the United States frequently separates five races: black or African American, white, Asian, native Hawaiian or other Pacific Islander, and American Indian or Alaska native. In an illustrative example, genetic research has shown that the greatest genetic differentiation among humans corresponds with continental groupings. In general, genetic clusters exist that correspond tightly to the census definition of race and to self-identified ances-try. In illustrative embodiments, one or more methods may include obfuscat-ing one or more target biological material identifiers by providing one or more nucleic acid sequences to an environment, wherein the one or more nucleic acids are associated with the same or similar race, ancestry, and/or continental grouping and/or associated with a different or unrelated race, ancestry, and/or continental grouping.

A recently patented invention illustrates how the connection between identity, specifically based on race or ethnicity, and genetic typing are inter-secting. On December 6, 2011, the USPTO issued a patent on a “System of

81 Idem.82 U.S. Patent No. 7676466 (issued Mar. 9, 2010).


Obfuscating Identity” to a Bellevue, WA company called Invention Science Fund I.83 A start-up by Nathan Myrvhold, the founder of Intellectual Ventures, Invention Science Fund I works closely with Microsoft to develop new

83 U.S. Patent No. 7684930 (issued Dec. 6, 2011)

Figure 3.6. Drawing from the Match.com patent.


health-care-related products, particularly those for malarial research. Formed in 2009, Invention Science Fund I was created to counter the negative asso-ciations of Intellectual Ventures, a venture capital firm that is described as a patent troll, or a company that acquires patents simply to sue high-technology companies for patent infringement in order to obtain licensing revenues. By contrast, Invention Science Fund I is actively involved in research and devel-opment and is integral to William Gates’s efforts to combat orphaned diseases in the developing economies.

The patented system for obfuscating identities (see Figure 3.7) is designed to protect privacy by obscuring personal information extractable from genetic and biochemical materials. The procedure masks either nucleic or the protein (or both) content of an environment such as a bathroom shower or some other room in which individuals would leave traces of their genetic material. To appreciate the reach of the invention into the racial and ethnic dimensions of a person’s identity, consider the following extensive excerpt from the written description of the issued patent:

Race is associated with differential disease susceptibility and environmen-tal responses. Many highly penetrant Mendelian diseases that are caused by mutations in a single gene are known to be found at higher frequencies in certain races. The HbS allele that causes haemochromatosis is found at higher frequencies in sub-Saharan Africans and Southern Europeans. Similarly, the ΔF508 allele of CFTR that causes cystic fibrosis is found in higher frequencies in Northern Europeans. In illustrative embodiments, one or more methods may include obfuscating one or more target biologi-cal material identifiers by providing one or more nucleic acid sequences to an environment, wherein the one or more nucleic acids contain, or do not contain, one or more mutations in one or more genes found at higher fre-quencies in certain races.

Race has also been found to be associated with susceptibility to com-plex, multifactorial and multigenic diseases. The incidence and death rate of prostate and breast cancers are significantly higher in African-Americans than European-Americans. Higher proportions of individ-ual African ancestry are associated with increased susceptibility to both obesity and abnormal levels of insulin secretion. Likewise, Hispanic, American Indian, African American, Pacific Island, and South Asian ancestry is considered a risk factor for diabetes. Also, the incidence of heart disease and high blood pressure is higher in African-Americans than European-Americans.

Racial and ethnic groups can exhibit substantial average differences in dis-ease incidence, disease severity, disease progression, and response to treat-ment. Differences in allele frequencies contribute to group differences


in the incidence of some monogenic diseases, and they may contribute to differences in the incidence of some common diseases (Genome Biol. (2002) 3:comment 2007; New England J. of Med. (2003) 348:1170–1175; Nature Genetics Suppl. (2004) 36:S34-S42). FIG. 21 is a table describing diseases that differ in frequency by race or ethnicity (Human Genomics (2003) 1:52–62).

Figure 3.7. Drawing from the Intellectual Ventures patent on obfuscating iden-tities (showing method for cleaning general materials from room).


For the monogenic diseases, the frequency of causative alleles usually cor-relates best with ancestry, whether familial (for example, Ellis-van Creveld syndrome among the Pennsylvania Amish), ethnic (Tay-Sachs disease among Ashkenazi Jewish populations), or geographical (hemoglobinopa-thies among people with ancestors who lived in malarial regions). Even with common diseases involving numerous genetic variants and environmental factors, investigators point to evidence suggesting the involvement of differ-entially distributed alleles with small to moderate effects. Frequently cited examples include hypertension (J. Assoc. Acad. Minor. Phys. (1996) 7:16–21), diabetes (Diabetes (2003) 52:1047–1051), obesity (Obes. Res. (2003) (11):904–911), and prostate cancer (J. National Cancer Inst. (2000) 92:2009–2017).

As used herein the term “demographic group or demographic groups” means a market segment. Market segments optionally include, but are not limited to, age bands, social class bands and/or gender. In illustrative embodiments, one or more methods may include obfuscating one or more target biological material identifiers by providing one or more nucleic acid sequences to an environment, wherein the one or more nucleic acids are associated with the same or similar age, social class, and/or gender, and/or associated with a dif-ferent or unrelated age, social class, and/or gender. Nucleic acids associated with age would include for example, telomeres, which are known to decrease in length as humans age. Nucleic acids associated with gender would include, but not be limited to, a variety of genes on the X or Y chromosomes.84

The written description contains a detailed technical summary of the genetic markers and composition but also presents a generally accessible account of what this invention covers. At the heart of the invention is the ability to infer certain personal characteristics, such as age, race, and ethnicity, from a per-son’s genetic matter. The invention hides these identifiers and thereby makes it more difficult to profile the person who deposited the DNA. While we often think of mapping from a person to a genetic sequence, this invention rests on the ability to work backward from the genetic sequence to broad categories that would describe the person.

This recently issued patent comes closest to exemplifying the possible ways in which race, ethnicity, and other aspects of identity can be grounded in genetic makeup. The written description does not speak to a “race gene,” but it does recognize that certain characteristics, such as susceptibility to disease, hair type, or skin color, are correlated with certain races and eth-nicities. Therefore, a full reading of a genetic sequence can be used to identify general characteristics of the person. Genetic material serves as an eyewitness of the person who had passed through a given environment

84 Idem.


and acts analogous to a surveillance tape that might capture the general features of an individual, which can be used to create a profile. By blocking these nucleic or protein identifiers, the invention makes it more difficult to identify the person captured by blocking these markers, much like a per-son’s face may be obscured in a videotaping by altering the lighting or the framing.

This invention illustrates how the two types of personal information that were identified in the case of personalized medicine may be combined. While the 2011 invention is not targeted toward personalized medicine, it combines the genetic marking of identity with the sociological. As discussed previously, this combination rests on a conceptual error that sociological cat-egories, like black or Asian, have some genetic foundation. What the inven-tors seem to have in mind is not the identification of a race gene per se, but the measure of a correlation between genetic sequences and the sociological category of race and ethnicity. This correlation is determined by identifying genetic markers associated with certain diseases and the prevalence of those markers in particular racial or ethnic groups. Although the invention does not speak to a “race gene,” it comes close through the use of correlation. The danger in conflating genetic and sociological categories is that they can be readily confused in practice. Whether or not this invention for a system of obfuscating identity is representative of the next generation of patents, it does illustrate how genetic and sociological configurations of identity can readily collide.

Also worth emphasizing is the reference to demographic groups, which the drafters of the patent define as market-based characteristics. The principal example of these characteristics is age. By referring to demographic groups, the inventor discloses a wider range of identity categories that are relevant to the genetic masking beyond race and ethnicity. This point illustrates the range of categories for defining identity. Furthermore, defining demographic groups in terms of markets distinguishes demographic categories from race or ethnicity, which are not market-based but rather are sociological or cultural. As many of the previous patents indicate, however, there may be a market dimension to race and ethnicity as well. Nitromed, for example, expressly mar-kets its drug toward African Americans. In addition, the various toys and other patents that have a racial element are meant to target certain market segments either based on negative stereotypes or on positive images. Nonetheless, this most recent patent shows how issues of identity intersect with the realm of invention, expanding the categories of identity and conflating genetic and sociological categories.


Miscellaneous

There were fifty-one patents in this category. The inventions were hard to classify into discrete categories. These patents included an 1842 invention for a plow, in which the specification makes reference to “negro labor,”85 methods for treating sickle cell anemia,86 and the most recent, “Method and System for Distributed Analytical and Diagnostic Software Over the Intranet and Internet.”87 The last invention permits remote diagnosis of disease in patients based on characteristics such as the patient’s race.

The patents represented here illustrate a wide range of reference to racial categories. The 1842 patent for an “Improvement in plows” describes the invention in terms of its efficacy as compared to “Negro labor.”88 The 1881 patent for a “Sponge-Cup”89 and the 1890 patent for a “Motion clock” make use of racially stereotyped icons in their design.90 The cup, for example, is a deskstand for holding pens and other items that includes a “Negro’s head” as the centerpiece.91 The clock includes a mechanical representation of a “negro banjoist.”92 Some of the patents cover inventions to diagnose or treat diseases that may be particularly prevalent among the African-American population, such as the patent for treating sickle cell anemia93 or preventing crib death.94 In many of these patents, racial categories serve as descriptive markers sum-marizing background knowledge or assumptions that are structured in racial terms. For example, in patents covering methods for sorting DNA samples or populations based on genomic information, racial categories serve to delin-eate self-identified groups who are sorted or identified through the patented methods.95 A 2010 patent for a “Policy Analysis and Action Decision Tool” (see Figure 3.8) describes an invention that allows the use of census data, broken down by race and ethnicity, for the purpose of making projections on voting and policy impacts.96 What unites these patents is the way racial categories are

85 U.S. Patent No. 2548 (issued Apr. 11, 1842).86 See, e.g., U.S. Patent No. 4482571 (issued Nov. 13, 1984).87 U.S. Patent No. 6917829 (issued Jul. 12, 2005).88 See note 84 to this chapter.89 U.S. Patent No. 246044 (issued Aug. 23, 1881).90 U.S. Patent No. 439854 (issued Nov. 4, 1890).91 See note 88 to this chapter.92 See note 89 to this chapter.93 See note 85 to this chapter.94 U.S. Patent No. 4851816 (issued Jul. 25, 1989).95 See, e.g., U.S. Patent No. 6291182 (issued Sep. 18, 2001) (“Methods, software, and apparati for

identifying genomic regions harboring a gene associated with a detectable trait”).96 U.S. Patent No. 7800616 (issued Sep. 21, 2010).


Figure 3.8. A figure from the Policy Analysis patent setting forth zip code data by race and ethnicity.


used casually to reflect social understandings of how the benefits of invention may be spread among segmented groups and markets.

One of the last patents in this set, one from 2005, in some ways brings us back to the pharmaceutical patents with which we began this discussion. A “Method and system for a distributed analytical and diagnostic software over the intranet and internet environment” covers a software-based method for tracking patients over a distributed environment such as within a hospital or across hospices.97 The invention permits a medical practitioner to monitor a large set of patients that are geographically dispersed based on medical and demographic characteristics of the patient, including race. The inclusion of race as a characteristic parallels the use of racial characteristics in biomedical and pharmaceutical patents in the first category of inventions. Racial catego-ries serve to ensure that the inventor has tailored the invention as needed to particular racially defined markets. This tailoring, however, allows the inven-tor to expand the scope of the invention in terms of its applicability and nov-elty. Therefore, racial categories reflect social attitudes about race but also function to define the contours of the invention consistent with patent law.

This miscellaneous group of race-specific patents do not fit neatly into any of the other categories and so are presented here to give a sense of the range of patents that make use of racial categories. Three in this group appear on the surface to fit into the next category relating to inventions based on epidemi-ological studies that make use of racial categories. These are the 1984 patent covering “Sickle Cell Anemia Compound and Treatment,” the 2004 pat-ent covering a “Polymorphism in Human Gene Sequences Associated with Disease,” and the 2005 patent covering a “Polymorphism in Human Gene Sequences Associated with Autoimmune Deficiency.” Although each of these patents contains usages of the category “African-American” in the written description, the usage represents something different from those in the pat-ents discussed in the next and final section. For example, the patent covering a form of treatment for sickle cell anemia includes a reference to the fact that the disease is prevalent among African Americans as well as Caucasians from the Mediterranean. But the treatment is not limited to either of these groups. The fact is noted to highlight the importance of the invention and how it would be useful and beneficial to certain subgroups. However, the invention itself was not based directly on epidemiological studies or on the prevalence of the disease within certain demographic groups, unlike the patents to be discussed in the next section.

Similarly, the two patents covering polymorphisms in human gene sequences cover methods for diagnosing certain diseases. Both of these



patents were issued to Craig Vetner and his research group. Craig Vetner, of course, is a leading pioneer in genetic research and a mover in the private side of sequencing the human genome. The inventions deal with methods for detecting certain mutations in the gene sequence and correlating these muta-tions with indicators of proclivities to disease. Although the inventions are not limited in application to any one racial or ethnic group, the written descrip-tion in each of the two inventions makes reference to identified genetic mark-ers that are correlated with disease proclivities within particular racial groups. This information is provided to indicate how the inventions could be tailored based on personal characteristics of the patient. But the inventions themselves are designed as more generalized diagnostic tests that can be applied across demographic groups. To emphasize, the descriptions speak to correlations and should not be read as suggesting the existence or the identification of a “race gene.” These inventions are similar to the one covering a means for obfuscat-ing identity in genetic materials. All three attempt to correlate genetic infor-mation with sociological categories of identity. Finally, the two patents issued to Vetner and his research group, like the sickle-cell-anemia-related invention, make reference to racial and ethnic categories, but are not based on any epi-demiological studies of the incidence of disease or effectiveness of treatment. These epidemiologically based patents are the subject of the next section.

Epidemiological Studies

This category is the largest, containing more than 500 patents from the period between 1989 and 2010. These patents were in the biomedical or pharmaceu-tical field, and the specifications were reporting medical studies considering the efficacy of drugs or medical therapies in various communities. Because there were so many patents in this category, I do not present the details of the individual patents in tabular form. Other authors have discussed these patents in greater detail, and I refer the interested reader to their work, cited here.98 I will, however, discuss a few of these patents as illustration of how racial cate-gories arise in this context.

Two patents illustrate how racial categories are used in the specifications of patents involving pharmaceuticals or medical therapies. In the patent for “Mammalian Selenoprotein Differentially Expressed in Tumor Cells,” the abstract describes the invention as for “a 15 kDA selenium-containing

98 See Jonathan Kahn, “Race-ing Patents/Patenting Race: An Emerging Political Geography of Intellectual Property in Biotechnology,” 92 Iowa L. Rev. 353, 361 (2007) (citing epidemiologi-cal studies).


protein.”99 The abstract continues to state that “[t]here is a correlation between the presence of a polymorphism at nucleotide positions 811 and 1125 of the 15 kDa selenoprotein gene, and the presence of cancer. This polymorphism is more prevalent in the African-American population.”100 The written descrip-tion cites some of the scientific literature and studies that document the prev-alence of this polymorphism.

The purpose of emphasizing the prevalence within the African-American population is to demonstrate the importance of this invention, a factor that could be relevant to the patentability requirements of utility,101 novelty,102 and nonobviousness.103 To meet the utility requirement, the applicant must show that the invention has applications and solves some practical problem.104 The reference to the prevalence of the polymorphism in the African-American population aids in demonstrating the practical application of the invention to aid in identifying the existence of a protein associated with certain types of cancers in a designated population. In addition, illustrating the application of the method to the African-American population indicates a problem that was identified in the scientific literature to which this invention would apply. The use of this invention to identify a prevalent polymorphism aids in distinguish-ing this invention from other identified proteins. Finally, to the extent that this invention is novel, the applicability to a specific population would aid in the argument that the invention is nonobvious based on resolving a previously unmet need or segment of the population, under the secondary considerations articulated by the Supreme Court in Graham v. Deere.105

The second example of a patent whose specification includes a racial cat-egory is one for “Method of Diagnosing and Monitoring Malignant Breast Carcinomas.”106 The method entails identifying certain biomarkers for breast cancer in the saliva of women. The written description provides several examples of clinical trials using the method to identify its efficacy in diag-nosing breast cancer. In one of the examples, the applicant discusses demo-graphic and supplemental data obtained from the patients who were part of the clinical trials. As stated in the description, “[t]here were significant dif-ferences in race, tobacco use, and menopausal status among the [subjects of the trials]. More African Americans experienced carcinoma of the breast and

99 U.S. Patent No. 676718 (issued Feb. 1, 2005).100 Idem.101 See 35 USC § 101 (2004).102 See 35 USC § 102 (2004).103 See 35 USC § 103 (2004).104 See Brenner v. Manson, 383 U.S. 519 (1966).105 383 U.S. 1 (1966).106 U.S. Patent No. 6972180 (issued Dec. 6, 2005).


benign tumor lesions than Causasians.”107 The last sentence is the sole refer-ence to a racial category in the patent.

Racial categories serve different purposes in these two patents. In the Selenoprotein patent, the racial category is used to show relevance of the invention to the particular group. The importance of the invention supports the patentability of the invention in identifying the utility, novelty, and non-obviousness of the identified compound. The racial category serves a purely descriptive purpose in the patent for the diagnosing breast cancer. The appli-cant does not use the differential effects in the two populations as a basis for establishing patentability. Instead, the category is used to summarize one of the clinical trials and to describe the demographic composition of the sam-ple studied. No argument is made to highlight special benefits that might arise for previously underserved or understudied groups. These two patents together illustrate two different ways in which racial categories arise in pat-ent law within the specifications. Racial categories in patent specifications for pharmaceutical or biomedical inventions serve either to support arguments for patentability or to describe background racial characteristics of members of clinical or epidemiological studies.

The third patent is the one for BiDil, Nitromed’s invention for treatment of hypertension in a black patient. Nitromed is the owner through assign-ment of two patents on the chemical composition for BiDil, one issued in 2002 with fifty-four claims108 and one in 2004, from a continuation applica-tion, with eighty-four claims.109 The claims relating to treatment of a black patient are the same for the two patents, and therefore by the rules against double-patenting, which allows only one patent per invention, the claims in the patent issued in 2002 would be effective so as to allow the patent to enter into the public domain earlier.110 The abstracts for both patents, which serve to summarize the inventions, use identical language in describing the composi-tion: “The present invention provides methods or [sic] treating and preventing mortality associated with heart failure in an African-American patient with hypertension and improving oxygen consumption, quality of life and exercise tolerance by administering a therapeutically effective amount of at least one is isorbinate dinitrate and isorbinate mononitrate.”111 The first claim illustrates

107 Idem.108 U.S. Patent No. 6465463 (issued Oct. 15, 2002).109 U.S. Patent No. 6784177 (issued Aug. 31, 2004).110 Double-patenting is not allowed under 35 USC § 101, which states that “a” patent shall issue

to an inventor whose application meets the requirements of patentability.” See Miller v. Eagle Manufacturing Co., 151 U.S. 186 (1894) (establishing rule against double-patenting).



the race-specific aspect of the invention through the following language: “A method of reducing mortality associated with heart failure in a black patient in need thereof comprising administering to the black patient hydralizine . . . in an amount about 30 milligrams per day to about 300 milligrams per day and isosorbinate dinitrate in an amount of about 20 milligrams per day to about 200 milligrams per day.”112

Research and development strategies of the inventor and his luck with the sample used for the clinical study explain why the claim is limited to a “black patient.”113 The written description of the patent explains the clinical trials administered to test the efficacy and the safety of the chemical composition. According to the description, “the placebo group mortality . . . did not differ between white and black patients. . . . The inventors unexpectedly discovered that black patients exhibited a significant survival benefit . . . from treat-ment with the combination of hydralazine and isosorbide dinitrate.”114 The description summarizes the speculation by the inventors as to why there was this observed difference in response between black and white patients. The description includes citations to the literature showing that black patients are less responsive to ACE inhibitors than white patients, and this difference in turn reflects a less active rennin-angiotensin system among black patients.115 Although the inventors could not identify the source of the difference, the sta-tistical difference uncovered in the clinical trials was the basis for the racially limited claim.

The racial limitations in the patent claims are also the result of patenting strategies by the inventor in order to avoid a rejection of the patent application by the USPTO. Both the 2002 and the 2004 patents cite a 1989 patent issued to one of the inventors for a “Method of Reducing Mortality associated with Congestive Heart Failure Using Hydralizine and Isosorbide Dinitrate.”116 The patent expired in 2003.117 It is instructive to read the first claim of the 1989 pat-ent and compare it with the more recent ones:

A method of reducing the incidence of mortality associated with chronic congestive heart failure in a patient with impaired cardiac function and con-comitant reduced exercise tolerance, comprising the oral administration to said patient in need of the same of a combination of (a) between about 75

112 Idem.113 Idem.114 Idem.115 Idem.116 U.S. Patent No. 4868179 (issued Sep. 19, 1989).117 Idem. The patent term at the time of issuance of this patent was fourteen years from the date

of issuance.


and about 300 milligrams of hydralazine, or a pharmaceutically acceptable acid addition salt thereof, per day, and (b) between about 40 and about 160 milligrams of isosorbide dinitrate, per day.118

The two obvious differences between the 1989 claim and the 2002/2004 claim are the differences in dosages and the absence of any racial limitations. A consideration of these two differences illustrates the implications of the use of racial categories in the patent claims for the market for personalized medicine.

A comparison of the 1989 patent with those issued in 2002 and 2004 dem-onstrates an implicit assumption in patent law that inventions are race and gender neutral and are applicable across groups. Inventions that are tailored to a particular group, however, could constitute a new innovation deserv-ing of a separate patent. The 1989 patent would allow the patent owner to prevent uses of the chemical composition on any patient, without regard to race or other characteristic. Perhaps the broad applicability of the invention reflects an assumption that a pharmaceutical invention, or more broadly any invention, can be used by all members of the population. However, with some evidence – such as the clinical trials cited in the written descriptions of the 2002 and 2004 patents – that the invention empirically is suitable for only one group,119 a patent based on a targeted version of the invention may follow. If this assertion about the implicit assumption of general applicability is true, the conclusion suggests a baseline rule of race neutrality in patent law, with the inventor being permitted to draw racial or other lines in the appli-cation of the pharmaceutical if there is some empirical basis to support the limitation. Furthermore, the empirical basis need not be particularly strong, as the BiDil example demonstrates. The inventor could not explain the racial disparity in the 2002 and 2004 patents, so the racial limitation arguably need not be explained and can be supported by statistical disparities.

The story behind the BiDil patent presents a troubling and suspect role of race-specific studies in support of the claimed invention. It is telling that the 1989 written description does not disclose any racial disparities or racial differ-entiation in clinical trials, whereas the 2002 and 2004 written descriptions do. This difference may reflect a heightened sensitivity to racial differences in the incidence and treatment of diseases that had arisen in the thirteen-year period between the patents. While the National Institute of Health in the 1990s did implement guidelines for race-specific clinical trials and funding incentives

118 Idem.119 See Jonathan Kahn, “Patenting Race,” 24(11) Nature Biotechnology 1349, 1350 (2006).


for research in previously underserved populations and diseases,120 these incentives may have been less important for private, commercial researchers working for a particular industry, such as the inventors of the chemical com-position in the BiDil patent. The likelier explanation is that the inventors were seeking to find some additional commercial exploitation of the invention and discovered the strategy of targeting the invention to a racially defined market.121 Hence, the clinical trials demonstrated how the chemical composition could be tailored to a racial enclave of the market based on differential efficacy. In other words, the inventors were not thinking about race or even filling a need for an underserved population, but were willing to see these issues in order to obtain the patent and to find new market niches to serve.

Building on the ways in which race seemingly entered into the experimen-tation on and marketing of a chemical composition, I turn to a more tech-nical, but nonetheless critical, point that follows from a comparison of the 1989 patent with the two issued in 2002 and 2004. The invention described in the 2002 and 2004 patents builds on the first invention described in the 1989 patent by identifying different dosage levels and different efficacy for a racially defined group. The question is why these two together, or separately, would be sufficient to warrant a second patent on the chemical composition. By itself, discovering a different dosage level of a chemical compound would not be enough to satisfy the nonobviousness requirements of patentability, unless there was some “unexpected result” from what was in the prior art.122 The racial limitation, however, is more problematic. If the inventor in fact

120 In 1994, the National Institute of Health issued the National Institutes of Health Guidelines on the Inclusion of Woman and Minorities as Subjects in Clinical Research, which out-lined “a wide range of new responsibilities for clinical researchers funded by the NIH and for institutional review boards.” Under these guidelines, “all NIH-funded clinical research must now include representative numbers of women and members of racial or ethnic minority groups.” Charles Weijer & Robert A. Crouch, “Why Should We Include Women and Minorities in Randomized Control Trials?” in Ezekiel J. Emanuel et al., eds., Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary (Baltimore: Johns Hopkins University Press, 2003) 171–172.

121 See Kahn, supra note 117 at 1351; Michael D. Ruel, “Using Race in Clinical Research to Develop Tailored Medications: Is the FDA Encouraging Discrimination or Eliminating Traditional Disparities in Health Care for African Americans?” 27 The Journal of Legal Medicine 225, 227–229 (2006).

122 See, e.g., Ortho-McNeil Pharmaceuticals v. Kali Laboratories, Inc., 482 F.Supp. 2d 478 (D.N.J. 2007) (change in dosage level not sufficient for nonobviousness), citing Merck & Co. v. Bocraft Labs, Inc., 874 F.2d 804, 805–806 (Fed. Cir. 1989) (changes in conditions for using invention, such as temperature or concentration, not enough to establish nonobviousness unless there is some unexpected result); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed. Cir. 2007) (altering chemical formulation not enough to show nonobviousness).


discovered a new or different chemical composition that worked solely for a discrete group, there may be an argument that he or she has found something new and nonobvious in light of the prior art.123 The problem is determining why this distinction occurs as an empirical matter in a way that would warrant generalization from a few clinical trials. Demonstrating that the chemical composition was found not to work on some groups in some cases does not warrant a claim, either as a matter of logic or of patentability, for the exclusive use of the chemical composition in all cases.

Even if this logical gap could be resolved, there is still the question of whether modifying an invention for a specifically defined group meets the nonobviousness requirement, which requires the inventor to show why a new invention is an advancement of the prior art and not just a trivial reworking of what was already known in the field. Specifically, to meet the nonobvious-ness requirement for the inventions covered by the 2002 and 2004 patents, the inventor would have to show how they were an advancement to the invention in the 1989 patent. The racial tailoring of the 1989 invention is the basis for claiming the nonobviousness of the invention in the 2002 and 2004 patents.

This point is demonstrated by examining the documents that arise during the review process in the USPTO, leading up to the grant of the patents in 2002 and 2004. This set of documents are referred to as the prosecution history of the patent and provide background on the validity and interpretation of the patent. The prosecution history behind the BiDil patents contains the follow-ing critical documents. On December 5, 2001, the patent examiner rejected the race-specific claims in the application supporting the 2002 patent for being obvious in light of the 1989 patent.124 Presumably, the other four requirements for granting a patent had been met by the application. As a result, if the inven-tor could rebut the patent examiner’s rejection for lack of nonobviousness, the invention would meet all five legal requirements for patentability, and a patent would be issued. The patent applicant responded on May 6, 2002, argu-ing that there was nothing in the 1989 patent that would “disclose or suggest” the race-specific claims.125 In addition, the applicant argued that the efficacy

123 See Takeda Chemical Industries, Ltd. v. Alphapham Pty., Ltd., 2007 WL 1839698 (Fed. Cir. 2007) (discussing the issue of patentability of species claims over genus claims in the prior art and proposes allowing such claims if there is evidence of unexpected results).

124 Memorandum from Raymond Henley, Jr. Primary Examiner, to Edward D. Grieff, Registration No. 38,898 (December 5, 2001) (on file with author).

125 Memorandum from Edward D. Grieff, Registration No. 38,898 to Raymond Henley, Jr., Primary Examiner (May 6, 2002) (on file with author).


in the African-American population was an “unexpected result,” which sup-ported a conclusion of nonobviousness.126 The patent examiner accepted this argument and, in an office action on May 18, 2002, concluded that the claims were nonobvious in light of the unexpected result.127

This exchange illustrates, in part, the application of the “teach, suggest, motivate” (TSM) test to the legal question of nonobviousness. Under TSM, an invention is nonobvious if a disclosure in the prior art taught, suggested, or motivated the elements that make the invention different from those dis-closed in the prior art. In other words, a party challenging the patentability of an invention on nonobviousness grounds must show what in the prior art taught, suggested, or motivated the invention. If the party fails to produce such a teaching, suggestion, or motivation, it has not met the burden to show obviousness. In the case of the 2002 patent, the applicant asserted that the patent examiner failed to meet the TSM test and furthermore pointed to the unexpected result – a secondary consideration to support the conclusion that the invention was nonobvious.

There is a serious question as to whether the racially tailored invention would be found nonobvious in light of the U.S. Supreme Court’s decision in KSR v. Teleflex, a ruling that was handed down five years after the 2002 patent. If that decision had been the law in 2002, the patent examiner would have been successful in rejecting the patent application covering BiDil. In its deci-sion in Teleflex, the Court cautioned against a mechanical application of TSM and acknowledged that common sense of the person having ordinary skill in the art can serve to distinguish obvious from nonobvious inventions.128 Put another way, the TSM test implies that if no previous researcher had taught, suggested, or motivated the invention in the prior art, then there is no basis for concluding that an invention is nonobvious. But the Court’s appeal to common sense would interpret this gap in the prior art differently. Sometimes things are too obvious to state. Lack of a teaching, suggestion, or motivation is not necessarily evidence of nonobviousness. In some situations, the silence may be evidence of the exact opposite, namely that the invention is obvi-ous. Only context can tell, and the Court was advising the patent office to pay attention to context and accompanying common sense in applying the TSM test.

126 Id.127 Memorandum from Raymond Henley, Jr. Primary Examiner, to Edward D. Grieff,

Registration No. 38,898 (May 18, 2002) (on file with author).128 KSR Intern. Co. v. Teleflex, Inc. et al., 550 U.S. 398 (2007).


Would racially tailoring an invention pass this new interpretation of the TSM test? Assume for the sake of an argument that the infamous sealed crust-less sandwich patent is a valid one.129 Assume next that an inventor creates a sealed crustless sandwich that includes a spicy mix of peas and potatoes that in some parts of India is called a kachori. Does this modification of the general invention to the specific, ethnically tailored product meet the nonobviousness inquiry? The answer may rest in the ethnic identity, background, and experi-ence of the person having ordinary skill in the art. Whether such elements of identity are relevant to the patentability inquiry rests on how we understand the normative foundations of patent law and the use of racial categories, the focus of Chapter 4, where I argue that racial tailoring should not be a consid-eration in the nonobviousness analysis.

In summary, this section has documented the patents in the pharmaceu-tical and epidemiological areas that make use of racial categories. This set of patents has been the subject of extensive commentary. Here I present some commentary on the underlying normative questions raised by the use of racial categories in these patents. Although I agree with much of the existing lit-erature on racial categories in patents from the biosciences, my goal in this chapter has been to address the use of racial categories in patent law more broadly.

Summary

Racial categories in patent law serve many functions. They can reflect back-ground social attitudes toward race that inform inventorship. These attitudes may be stigmatizing or inclusionary. In addition, racial categories serve a func-tion within patent law allowing the inventor to tailor the invention to racially defined markets and to identify the unmet needs served by the invention. This chapter has, in both a descriptive and an analytical way, presented the uses of racial categories in patent law. The next question is how to assess the use of racial categories within the appropriate normative framework.

129 U.S. Patent No. 6004596 (issued Dec. 21, 1999). The claims of this controversial patent were cancelled by the Board of Patent Appeals and Interferences in September 2006, as Appeal No. 2006–1664 as part of Re-examination Control No. 90/005949.


TABLE 3.1. Inventions involving cosmetics and fashion

Patent Number

Year Patent Name Inventor Name

763012 1904 Brown Miller, Gael E.1425757 1922 Comb Echols, David K.1607674 1926 Pomade comb Ives, Olive de Shazo1593055 1926 Device and process for

straightening hairArnole, Edith

2238544 1941 Method for reducing or removing wave curl or frizziness from hair

Wheatley, Edward

2390073 1945 Hair treatment Calva, Jose B.2576283 1950 Device for permanent waving

of hairSchmidt, Christian

2763270 1956 Hair straightening and rewaving device

Carvey, Talmage G.

2782790 1957 Hair treatment composition and methods for use of same

Bessing, Frank P.; Hersh, Herman I.

3092111 1963 Therapeutic method for abrasion of human skin

Sapaerstein, Rose B.; Stiefel, Werner K.

3182667 1965 Hair curler with heating and cooling hair contacting jaws

Den Beste, Marion

3369970 1968 Dyeing Human Hair McLaughlin, Terence P.; Wilkinson, Twinkenham; Wilkinson, John B.

3644084 1972 Treatment of keratin fibers Yung, Hsiung Du; January, Wolfram Leszek

3837350 1974 Tension (bobby) pin Terrell, James L.; curry, Jerome

3892246 1975 Method and apparatus for doing afro hairdos

Woodard, Robert

3981681 1976 Depilitory formulation De la Guardio, Mario4148329 1979 Process and composition for

treating hairJaskowski, Michael C.

4303085 1981 System and method for hair treatment

De la Guardia, Mario – Savannah, Georgia; Cowsar, Donald R. – Birmingham, Alabama

4324263 1982 Hair straightening process and curling process

De la Guardia, Mario

(continued)


Patent Number


4416296 1983 Composition and method for hair treatment

Meyers, William E.

4373540 1983 Hair straightening process and curling process and composition


4416296 1983 Composition and method for hair treatment

Meyers, William E.

4373540 1983 Hair straightening process and curling process and composition


4524787 1985 Hair relaxer Khalil, Ezzat N. – Oak Park, Illinois; Cheslow, Ernest – Glencoe, Illinois

4605018 1986 Method for treating hair and anhydrous composition related thereto

De la Guardia, Mario; Hendrix, Charles R., Jr.

4775530 1986 Method for treatment and prevention of pseudofolliculitis barbae

Perricone, Nicholas V., M.D.

5034221 1991 Topical agent of method for treatment of pseudofolliculitis barbae

Rosen, Stewarat; Thomas, Robert M.

5477561 1995 Hair maintenance cap Adkins, Jennipher5419344 1995 Razor bump electrolysis DeWitt, Thomas Lee5589163 1996 Permanent wave composition

and methodNeill, Paul – Hinsdale, IL; Brandt, Loralei – Cary, IL; Walling, Priscilla – Darien, IL; Nandagiri, Arun – Libertyville, IL; Meltzer, Norman – Morton Grove, IL

5632975 1997 Composition and method for treatment of dermatitis on the scalp

Earles, R. Martin

5651961 1997 Hair manageability and styling composition

Neill, Paul – Hinsdale, IL; Brandt, Loralei – Cary, IL; Walling, Priscilla – Darien, IL; Nandagiri, Arun – Libertyville, IL; Meltzer, Norman – Morton Grove, IL

TABLE 3.1 (continued)


Patent Number


5656265 1997 Hair styling composition and method

Bailey, Peter Lawrence – Wirral, United Kingdom; Gough, Anthony David – Oakley, United Kingdom; Khoshdel, Ezat-Neston, United Kingdom; Polywka, Robert – Guilden Sutton, United Kingdom

5679327 1997 Hair straightening emulsion Darkwa, Adu Gyamfi – Chicago, Illinois; Wallanueva, Apolonio L. – Northbrook, Illinois

5609859 1997 Hair relaxer composition and methods for preparing same

Cowsar, Donald R.

5728374 1998 Hair manageability and styling composition and method

Neill, Paul – Hinsdale, IL; Brandt, Loralei – Cary, IL; Walling, Priscilla – Darien, IL; Nandagiri, Arun – Libertyville, IL; Meltzer, Norman – Morton Grove, IL

5810023 1998 Method for styling hair using a flat disk

Jones, Marla Vanessa – New York, NY; Ferguson, Angela – Brooklyn, NY; Williams, Pat Grant – Silver Spring, Maryland

5824295 1998 Composition for decreasing combing damage and methods

Syed, Ali N. – Orland Park, IL; Ahmad, Kaleem – Chicago, IL.

5830446 1998 Fluorescent brightening of cosmetic compositions

Berthlaume, Marianne D. – Latham, NY; Raleigh, William J. – Rensselaer, NY; Uriarte, Richard J. – Clifton Park, NY

58492777 1998 Hair relaxer composition and methods for preparing same

Cawsor, Donald R.

5853709 1998 Saving composition and method for preventing pseudofolliculists barbae

Willis, Isaac – Atlanta, GA; Darkwa, Adu Gyamfi – Olympia Fields, IL; Villanueva, Apolonio L. – Northbrook, IL

(continued)


Patent Number


6001340 1999 Topical composition and methods for treating pseudofolliculitis barbae and ingrown hair

Rosen, Steven E.; Brown, Robert Lee

6007585 1999 Hair brightening system Syed, Ali N. – Orland Park, IL; Habib, Wagdi W. – Barrington, IL; Hu, Longsheng – Chicago, IL

5958391 1999 Composition and method for treatment of dermatitis on the scalp

Earles, R. Martin

6009883 2000 Hair straightening noggle Morrow, Willie L.6013249 2000 Hair manageability and styling

composition and methodNeill, Paul – Hinsdale, IL; Brandt, Loralei – Cary, IL; Walling, Priscilla – Darien, IL; Nandagiri, Arun – Libertyville, IL; Meltzer, Norman – Morton Grove, IL

6012463 2000 Shaving method and shaving kit Mitchell, Clarence6325690 2000 Composition for treatment of

pseudofolliculitis barbae and skin irritation

Nelson, Webb

6032365 2000 Slotted rotary shaver Hodges, James L.6217572 2000 Apparatus and method

employing lasers for removal of hair

Tobinick, Edward L.

6080147 2000 Method of employing a flaslamp for removal of hair, veins, and capillaries

Tobinick, Edward L.

6149645 2000 Apparatus and method employing lasers for removal of hair

Tobinick, Edward L.

6156299 2000 Topical composition and methods for treating pseudofolliculitis barbae and ingrown hair

Rosen, Steven E; Brown, Robert Lee

6165171 2000 Apparatus and method employing lasers for removal of hair

Tobinick, Edward L.



Patent Number


6262105 2001 Method of enhancing hair growth

Johnstone, Murray A.

6264121 2001 Adjustable hand-held shower apparatus

McClary, Nobia

6168589 2001 Apparatus and method employing a simple laser for removal of hair

Tobinick, Edward L.

6390101 2002 Self contained applicator for applying fluid

Alexander, Larry Rush

6488920 2002 Gradual hair relaxation composition

Thomas, Lillie C.

6572843 2003 Method for treating hair Sorensen, Niels Henrik – Skaevinge, Denmark; McDevitt, Jason Patrick – Alpharetta, Georgia

6579283 2003 Apparatus and method employment a single laser for removal of hair, veins, and capillaries

Tobinick, Edward L.

6595985 2003 Apparatus and method employing parametrically defined pulse groups for laser hair removal

Tobinick, Edward L.

6602493 2003 Hair relaxer system and method therefore

Akhter, Humanyoun – Hinsdale, IL; Syed, Ali N. – Inverness, Il

6517822̀ 2003 Formulations and methods for straightening hair

Buck, Carol J.

6684887 2004 Hair separator and fluid applicator apparatus with improved fluid retention


6703009 2004 Topical compositions and methods for treating pseudofolliculitis barbae and ingrown hair

Rosen, Steven E.; Brown, Robert Lee

6736145 2004 Hair separator and fluid applicator apparatus


6735871 2004 Electrically heated scissors Todd-Russell, Sammie Jean

(continued)


Patent Number


6893631 2005 Shaving soap and aftershave gel and methods of use thereof

Mitchell, Jr., Clarence – Nashville, TN; Sanders, Willard – Old Hickory, TN

7041636 2006 Composition for counteracting hair loss

Benton, Melody M.

7073516 2006 Braid removal device Beamen, Lawrence McGowan

7021317 2006 Hair clip assembly Nathaniel, Michele7666397 2010 Peptide-based conditioners and

colorants for hair, skin, and nailsHuang, Xueying – Hockessin, DE; Wang, Hong – Kennett Square, PA; Wu, Ying – Wallingford, PA



TABLE 3.2. Inventions involving skin color

Patent Number


2248148 1941 Apparatus for comparing, matching, or detecting colors

Wilson, John

3367253 1968 Multiple image flash camera Kuhns, Roger J.; Macone, Frederick W.

3517105 1970 Method of treating hyperpigmentation

Miskel, John J.; Neary, Edward R.; Schlesinger, Walter

3705762 1972 Method for converting black and white films to color films

3856934 1974 Skin depigmentation Kligman, A.4506293 1985 Independent fleshtone contours Hurst, Robert N.4680172 1987 Devices and methods for

treating memory impairmentLeeson, Lewis J.

4765985 1988 Devices and methods for treating memory impairment

Leeson, Lewis J.

4798790 1989 Monoclonal antibody specific for a pigmentation associated antigen

Thomson, Timothy M. – New York, NY; Mattes, M. Jules – Flushing, New York; Old, Lloyd J. – New York, New York; Lloyd, Kenneth O. – Roux, New York; Roux, Linda – San Diego, California

5461457 1995 Method of determining amount of exposure

Nakamura, Hiroaki

5518728 1996 Cosmetic compositions for non-white pigmented skin

Burdzy, Elisa

5552162 1996 Method for improvement of scar size and appearance

Lee, Raphael C.

5671735 1997 After shave treatment composition

McKenzie, Therman – 647 Watson Bay, Stone Mountain, Georgia; Agard, James – Decatur, Georgia

5869540 1999 Herbal treatments for improving skin appearance

Smith, Walter P.

6111973 2000 Method for producing color-comparable photographs with fleshtone color selections for prosthetic fabrication

Holt, Kenneth Dale; Holt, David Michael

(continued)


Patent Number


6129664 2000 Method and apparatus for detecting and measuring conditions affecting color

Macarlane, Darby Simpson – Hasting-on-Hudson, New York; Macfarlane, David Kenneth – Hastings-on-Hudson, New York; Billmeyer, Fred W. – Schenectady, New York


Macfarlane, Darby Simpson – Hastings-on-Hudson, New York; Macfarlane, David Kenneth – Hastings-on-Hudson, New York; Billmeyer, Fred W. – Schenectady, New York





6169536 2001 Color picture quality compensation circuit and related control method thereof

Lee, Kwang-Chun – Kyungsangbook – Do, south Korea; Ha, Yeong-Ho – Daeku, South Korea; Hong, Kyong-Chul – Kyungsangbook-Do, South Korea





Patent Number


6353226 2002 Non-invasive sensor capable of determining optical parameters in a sample having multiple layers

Khalil, Omar S. – Libertyville, Illinois; Wu, Xiaomao – Gurnee, Illinois; Kanger, Johannes Sake – Enschede, Netherlands; Bolt, Rene Alexander – Enschede, Netherlands; Yeh, shu-Jen – Grayslake, Illinois; Hanna, Charles F. – Libertyville, Illinois; de Mul, Frits Frans Maria – Almelo, Netherlands

6337320 2002 Reparatives for ultraviolet radiation skin damage

Hersh, Theodore – Atlanta, Georgia; Warshaw, Michael A. – Savannah, Georgia

6630130 2003 Sunless tanning cream Grimes, Pearl – Los Angeles, California; Palefsky, Irwin – Clifton, New Jersey; Klein, Ken – Fairlawn, New Jersey

6798921 2004 Method for image designating and modifying process

Kinjo, Naoto


TABLE 3.3. Inventions involving toys and games

Patent Number


40740 1863 Automatic Dancer Crow, Thomas N.; Crow, James

44378 1864 Automatic Dancer Stimets, Cassifs P.; Atwood, James

46997 1865 Dancing Toy Topliff, James M.L.143121 1873 Improvements in automatic toy

dancersBrowee, Henry L.

258772 1882 Toy chariot Kyseb, Louis; Bex, Alfred C.296724 1884 Toy and advertising medium Burridge, Lee S.; Maeshmak,

Newman E.364221 1887 Equipment for theatrical stages Cubby, John366441 1887 Advertising show-stand Wetzell, Louis P.462150 1891 Toy bank Murray, John565450 1896 Toy Gibson, Edward Tinkham568854 1896 Automatic-figure advertising

deviceKenny, Paul T.

601287 1898 Game apparatus Shoemaker, Lockert K.627472 1899 Game device Boyce, Samuel J.659765 1900 Toy Reed, John James672277 1901 Pneumatic toy Maull, James L.859256 1907 Target Shaules, Herbert A.844507 1907 Game apparatus Falvey, Thomas J.976495 1910 Advertising device Beeves, Percy960190 1910 Game Nixon, James Robert990292 1911 Game Rigney, William J.996458 1911 Game apparatus Coleman, Ava R.1154331 1915 Toy Mitchell, Harry J.1193962 1916 Game Aley, John B.1377261 1921 Educational block Bothne, Esther M.; McClain,

Charles A.1395545 1921 Game Aley, John B.1410429 1922 Mechanical toy Vaughan, Thomas M.1474589 1923 Toy Hoddinott, John K.1441055 19223 Climbing figure toy Bellew, Ralph D.1590563 1926 Dancing figure toy Childs, Edward Earle


Patent Number


1588143 1926 Pursuit toy Ross, Joseph A.1589432 1926 Toy carnival Sapp, Philip Allen1717144 1929 Toy bank Cola, William1888005 1932 Amusement apparatus Markey, Fred L. – Lawrence,

MA; Stanton, Joseph R. – Newburyport, MA

2016129 1935 Three dimensional display means

Williamson, Marshall I.

2188292 1940 Electric target maching with reversing target

Hall, Jawn R.; Falkenberg, William P.

2419872 1947 Toy Beder, Samuel L.3419993 1969 Doll having a plurality of

changeable ethnic featuresRodgers, June M.

3830012 1974 Doll with changeable face and belly portions

Franke, Gunter

3940863 1976 Psychological testing and therapeutic game device

Kritzberg, Nathan I.

4569526 1986 Vectorial and Mancala-like games, apparatus and methods

Hamilton, Clarence Q.

4666160 1987 Apparatus for playing Hamilton, Clarence Q.5100140 1992 Wheel of black history game

deviceFoy, Frank E.

5360217 1994 Collectible factspak card board game

Taylor, H. LeBaron

5454569 1995 Afro American educational quiz game

Walker, Donald P.

5377990 1995 Board game incorporating native American symbols and knowledge

Seeney-Sullivan, Sarah E.

5480337 1996 Combination diverse doll and educational activity playset method

Baker, Jennifer K.

5941757 1999 Neck assembly for infant simulator

Jurmain, Mary M.. – Equ Claire, Wisconsin; Fusi, John C. – New Providence, New Jersey

5947791 1999 Gender neutral doll body with replaceable photographic face

Taylor, Joan Senica

(continued)


Patent Number


6071171 2000 Realistic doll head system and method therefor

George, Richard L.; Wilcox, Reed N.; Thiess, W. Kenn; Anderson, Lane

6109921 2000 Make-up mannequin head and make-up mannequin kit for use therewith

Yau, Peter

6024361 2000 Kwanza board game Assoumou, Ngoran6164872 2000 Educational doll Winslow, Andrew R.6238215 2001 Method for training a person to

properly support the head of a young infant

Jurmain, Mary M. – Eau Claire, Wisconsin; Fusi, John C. – New Providence, New Jersey

6220864 2001 Three-dimensional educational role-playing game apparatus and method of use

Walawender, Valerie

6244926 2001 Realistic doll head system and method therefor

George, Richard L.; Wilcox, Reed N.; Thiess, W. Kenn; Anderson, Lane

6428321 2002 Infant simulator Jurmain, Richard N. – Eau Claire, Wisconsin; Jurmain, Mary M. – Eau Claire, Wisconsin; Blackledge, Larry P. – Eau Claire, Wisconsin; Oium, Shelia R. – Alma, Wisconsin; Pelkus, Adrian – San Marcus, California; Rybarczyk, Mary E. – Baldwin, Wisconsin

6454571 2002 Infant simulator Jurmain, Richard N. – Eau Claire, Wisconsin; Jurmain, Mary M. – Eau Claire, Wisconsin; Oium, Shelia R. – Alma, Wisconsin

6457716 2002 Card game having cards with graphic and pictorial illustrations of geographic, historical, and health related facts

Johnson Prillerman, Kathleen O.



Patent Number


6537074 2003 Infant simulator Jurmain, Richard N. – Eau Claire, Wisconsin; Jurmain, Mary M. – Eau Claire, Wisconsin; Oium, Sheila R. – Alma, Wisconsin

6604980 2003 Infant simulator Jurmain, Richard N. – Eau Claire, Wisconsin; Jurmain, Mary M. – Eau Claire, Wisconsin; Blackledge, Larry P. – Eau Claire, Wisconsin; Jones, Douglas B. – Mojave, California; Oium, Shelia Rae – Alma, Wisconsin

6752396 2004 Method and system for playing trivia games

Smith, Tommy R.

6872078 2005 Teaching cylinder instruments Bauldock, Sr., Gerald7025593 2006 Teaching circumference

instrumentBauldock, Sr., Gerald


TABLE 3.4. Inventions involving identities and names

Patent Number


1343755 1920 Means employed in the classification of names

Woods, Joseph P.

2294903 1942 Selective filling and finding system

Griffin, Robert O.

5794210 1998 Attention brokerage Goldhaber, A. Nathaniel; Fitts, Gary

5855008 1998 Attention brokerage Goldhaber, A. Nathaniel; Fitts, Gary

6116652 2000 Learning materials delivery system

Page, Jeanne M.

6917926 2005 Machine learning method Chen, Hung-Han – Watertown, Massachusetts: Hunter, Lawrence – Denver, Colorado; Poteat, Harry Towsley – Boston, Massachusetts; Snow, Kristin Kendall – Somerville, Massachusetts

6978549 2005 Patterning system for a selected body type and methods of measuring for a selected body type

Ellis, Stacey L.

7676466 2010 System and Method for Providing Enhanced Questions for Matching in a Network

Chris S. Terrill; Todd W. Kirby

7684930 2010 System for Obfuscating Identity W. Daniel Hillis, Nathan P. Myhrvold, Richa Wilson


TABLE 3.5. Miscellaneous inventions

Patent Number


2548 1842 Improvement in plows Watt, George246044 1881 Sponge-cup Stellwagen, Edward J.439854 1890 Motion clock Bannatyne, Archibald465044 1891 Stage and scenic effect for

dramatic representationsJefferson, Charles B.

768258 1904 Coin-controlled vending machine

Allis, Abram Q.

1305835 1919 Changeable pictube Saalburg, Charles W.13333782 1920 Automatic stop mechanism

for talking-machinesSheldon, Cecil H.

1561546 1925 Steam generating plant Kennedy, James E.1627414 1927 Bowling pin-setting apparatus

and its method of operatingSchaeffer, Lewis D.

1686317 1928 Mule back duster Feeny, Edmund J.1792396 1931 Novelty windmill Robinett, Harley E.1853124 1932 Cotton picker Gooding, Howard P.; Henderson,

Wiley L.1912021 1933 Macaroni and means for

producing sameTanzi, Guido

2237751 1941 Image for making animated moving pictures

Bunin, Louis

22315220 1943 Process for the manufacture of polyazoic dyestuffs

Petitcolas, Pierre – Rouen, France; Sureau, Robert Frederic Michel – Mon St. Aignan, France

2328465 1943 Metalliferous substantive dyestuffs

Kopp, George

2694958 1954 Selector means for phonograph and picture projections

Gilbert, Jack

3000782 1961 Materials for embalming human corpses

Landau, Argo E. – Westwood Village, MO; Roberts, Eugene C. – Belleville, IL; Zeilmann, Joseph A. – Hillsdale, MO

3549765 1970 1 – (Substituted) – 5 aminotegragoles and treatment of inflammation of the animal organism therewith

Enkoji, Takashi – Park Forest, IL; Bossinger, Charles D. – Olympia Fields, IL

(continued)



Patent Number


3636192 1972 Meningococcal polysaccharide vaccines

Gotschilich, Emil C.

3847482 1974 Apparatus for detecting a change in turbidity of a solution

Sokol, Michael; Kent, Frederick

3891209 1975 Psychological testing and therapeutic game device

Kritzberg, Nathan I.

3898002 1975 Method and apparatus for editing a film strip

Kinder, Claude E.; Jones, Robert L., Jr.; Marsh, Walter W.

4055660 1977 Treatment of warts Meierhenry, Dwight W.4134395 1979 Method of using magnetic

fields to conduct a screening diagnostic examination

Davis, Albert R.

4183048 1980 VIR-controlled hue correction circuit

Isono, Katsuo – Kawagoe, Japan; Sanada, Seiji – Yokosuka, Japan

4482571 1984 Sickle cell anemia treatment and compound

Abraham, Donald J.

4704402 1987 Method for treating sickle cell anemia

Abraham, Donald J. – Murrysville, PA; Witiak, Donald – Mt. Vernon, OH

4782950 1988 Decorative figure article holder

Santoro, Catherine J.

4851816 1989 Crib death (SIDS) warning device

Macias, Helene; Winke Angos

4965074 1990 Method of treating memory impairment

Leeson, Lewis J.

5609159 1992 Method and apparatus for noninvasive determination of a disease state of a human eye

Kandel, Gillray L. – Troy, New York; Schroeder, John – Schenectady, New York

5692500 1997 Pain management and recoding tool and method

Gaston-Johansson, Fannie

5674687 1997 Method for identifying the species origin on a DNA sample

Hershfield, Bennett

5798267 1998 Method for determining alcohol consumption rates

Harasymiw, James W.

5932624 1999 Vitamin supplement composition

Herbert, Victor D.


Patent Number


5954369 1999 Greeting card with kit for health testing

Seabrook, March E.

5971763 1999 Method of teaching, training, and practice cosmetology techniques and a make-up mannequin for use therewith

Yau, Peter

6045502 2000 Analyzing system with disposable calibration device

Eppstein, Jonathan A. – Atlanta, Georgia; Samuels, Mark A. – Norcross, Georgia; Ignotz, Keith D. – Duluth, Georgia; Newman, Gregory J. – Atlanta, Georgia

6013628 2000 Method for treating conditions of the eye using polypeptides

Skubitz, Amy P. N. – Minneapolis, Minnesota; Furcht, Leo T. – Minneapolis, Minnesota; Balles, Mark – Indianapolis, Indiana; Gregerson, Dale S. – Minneapolis, Minnesota; Agarwal, anita – Gainesville, Florida;; Wright, Martha M. – St. Paul, Minnesota; Murali, Shobana – Roseville, Minnesota

6322976 2001 Compositions and methods of disease diagnosis and therapy

Altman, Timothy J. – London, England; Scott, James – London, England; Stanton, Lawrence W. – Redwood City, California

6328760 2001 Pulsed plasma radiation device for emitting light in biologically significant spectral bands

James, Robert G.

6291182 2001 Methods, software, and apparati for identifying genomic regions harboring a gene associated with a detectable trait

Schork, Nicholas J. – Shaker Heights, Ohio; Essioux, Laurent – Paris, France; Cohen-Akenine, Annick – Paris, France; Blemenfeld, Marta – Paris, France; Cohen, Daniel – Neuilly-sur-Seine, France

6452188 2002 Spectral reflectance scale method and apparatus

Chuff, Charles

(continued)


Patent Number


6566065 2003 Method of diagnosing schizophrenia by detecting a mutation in the MTHFR gene

Rozen, Rima

6605646 2003 Vitamin supplement composition

Herbert, Victor D.

6616277 2003 Sequential eye screening method and apparatus

Davenport, Wayne E.

6825336 2004 Polymorphism in human gene association with osteoporosis

Venter, J. Craig – Rockville, Maryland; Zhanag, Jinghui N. – Rockvile, Maryland; Liu, Xiangjun – Olney, Maryland; Rowe, William – Rockville, Maryland; Cravchik, Anibal – Gaithersburg, Maryland; Kalush, Francis – Rockville, Maryland; Naik, Ashwinikumar – Gaithersburg, Maryland; Subramanian, Gangadharan – Columbia, Maryland; Woodage, Trevor – Washington, District of Columbia

6812339 2004 Polymorphism in human gene sequences associated with human disease

Venter, J. Craig – Rockville, Maryland; Zhang, Jinghui N. – Rockville, Maryland; Liu, Xiangjun – Olney, Marylalnd; Rowe, William – Rockville, Maryland; Cravchik, Anibal – Gaithersburg, Maryland; Kalush, Francis – Rockville, Maryland; Naik, Ashwinikumar – Gaithersburg, Maryland; Subramanian, Gangadharan – Columbia, Maryland; Woodage, Trevor – Washington, District of Columbia

6917829 2005 Method and system for a distributed analytical and diagnostic software over the intranet and internet environment

Kwong, Manlik



Patent Number


6900016 2005 Polymorphism in human genes associated with inflammatory autoimmune disease

Venter, J. Craig – Rockville, Maryland; Zhang, Jinghui N. – Rockville, Maryland; Liu, Xiangjun – Olney, Maryland; Rowe, William – Rockville, Maryland; Cravchik, Anibal – Gaithersburg, Maryland; Kalush, Francis – Rockville, Maryland; Naik, Ashwinikumar – Gaithersburg, Maryland; Subramanian, Gangadharan – Columbia, Maryland; Woodage, Trevor – Washington, District of Columbia

7800616 2010 Policy Analysis and Action Decision Tool

Yasmin H. Said, Edward J. Wegman

8039721 2011 Kit and Method for Learning to Play an Instrument

Lisa Wold

126

Patents and markets for personalized medicine transform how we talk about persons. Nitromed in patenting its invention and marketing the pharmaceu-tical product used traditional racial categories, specifically the reference to “black patient,” to define the scope of its legal rights and commercial inten-tions. Through its usage, black may be a reference to skin color or a refer-ence to a sociological, cultural, or ethnographic category that has its own vernacular interpretation.1 Even if a patient self-identifies as black, the pro-cess of self-categorization presumes and subsumes the background sociology and vernacular. Myriad adopted another path to categorize the person, not through skin color but through genetic identifiers. In patenting and marketing its invention, Myriad used the language of biochemistry to specify and cate-gorize persons. What normative implications arise from either of these modes of categorization? What purposes do they serve and what legal, policy, and ethical pathways do we pave by accepting or normalizing these practices?

Categorization serves as a means to understand and impose order on the world, in part for the purposes of scientific inquiry, in part for the implementa-tion of government regulation.2 Several potential dangers, however, stem from the use of racial and ethnic categories. The first is assuming that the categories adopted by a company like Nitromed map onto the genetic identifiers used by a company like Myriad. Racial categories do not map onto any predictable or meaningful way onto genetic sequences. Although there may be a genetic sequence associated with skin pigmentation and other phenotypic attributes,

4

Normative Construction of Identity

1 B. Séguin et al., “Bidil: Recontextualizing the Race Debate,” 8 The Pharmacogenomics Journal 169–173 (2008).

2 Geoffrey C. Bowker & Susan Leigh Star, Sorting Things Out: Classification and Its Consequences (Cambridge: The MIT Press, 1999) 195–226. See also Ron Mallon, “’Race’: Normative, Not Metaphysical or Semantic,” 116 Ethics 525–551 (April 2006) (addressing the normative question, “what are we to do with ‘race’ talk?”).

Normative Construction of Identity 127

terms like “white” or “black” have cultural and sociological meanings that are distinct from a person’s biochemistry. To confuse the two reverts back to prim-itive notions that one’s identity and culture reduces to biology. No one pursu-ing personalized medicine research or marketing has made this argument. It would be incredible and irresponsible to do so. But the two modes of thinking need to be recognized as distinct.

The second related point is that racial categories are themselves archaic, reflecting outmoded and discredited notions of culture and race. Anyone reading the Nitromed patent for the first time would be jarred by the blunt ref-erence to a “black patient.” The use of the term “black” in a personal biomed-ical context alludes to the use of blood quanta in the law to segregate public and private facilities. Nitromed’s use of the term belies principles of color-blindness and of treating individuals as autonomous rather than as members of groups. At the same time, the term “black” serves a sociological function of identifying statistical groups who share certain characteristics as to disease susceptibility and treatment sensitivity. However, the racial term serves this categorizing function crudely and with negative connotations from history. Perhaps genetic markers may serve the epidemiological function more pre-cisely, removing indicia of race from categories of identity. But even the use of genetic identifiers cannot completely erase the use of racial categories, espe-cially if it is possible to correlate genetic traits with the arcane sociological cat-egories. Furthermore, creating a new, genetically based system of categories still raises the question of how identity categories should be constructed and used so as not to undermine commitments to individual autonomy. Whether our categories are based on history or on genetics, the problem remains of how normatively to construct and think about identity.

Chapters 2 and 3 introduced the normative focus of the current chapter by first presenting the inventors pursuing personalized medicine and then presenting inventions that have a racial dimension. The goal was to provide a context for the normative discussion that follows. The narrative about the inventors, Myriad and Nitromed, illustrates the economic motivations for pur-suing research and commercialization in the field of personalized medicine. The narrative about the inventions illustrates the many ways in which notions of personal identity intersect into the definition and identification of inven-tions. The two narratives together highlight the interaction between identity and invention. Inventors, like Nitromed and Myriad, use characteristics of personal identity to define commercialization pathways. The resulting inven-tions incorporate these characteristics and obtain an identity of their own in the marketplace. What are the normative implications of this process of iden-tity appropriation and creation?


The Fourteenth Amendment of the U.S. Constitution assures equal protec-tion under the law. At a minimum, equal protection requires that persons be treated the same under the law. The government shall not make distinctions among persons in the enactment and application of its laws. One may think that the Fourteenth Amendment has no relevance to personalized medicine, because the government is not acting. Personalized medicine is the domain of private researchers and companies. But the relevant question is whether government is violating the Fourteenth Amendment in granting race-based patents like the one issued to Nitromed. Posing the question broader, one may ask whether the government might run afoul of the Fourteenth Amendment when it grants a patent that distinguishes among persons using any category, including a genetic one.

Even with the requisite government action, there is still the question of whether the Fourteenth Amendment is even relevant to personalized med-icine. Equal protection means that Group A and Group B must be treated equally. The Equal Protection Clause places limits on the government in terms of allowing, for example, Group A, but not Group B, to have a particu-lar benefit, such as schooling or participation in an election. To take another example, the Fourteenth Amendment prevents the government from giving a vaccine against a disease to Group A and not to Group B. But what if Group B does not suffer from the disease that the vaccine prevents? Arguably, Group B is not being denied a benefit that Group A has. Personalized medicine rests on the assumption that certain groups, however defined, are more prone to certain diseases or are more sensitive to certain treatments than others. If that assumption is true, what then does equal protection mean when government action guides the identification and treatment of group-specific diseases? That is the first question the next section addresses.

Patent policy, as well as constitutional questions of equal protection, also informs the intersection of identity and invention. As Chapter 1 explained, three broad policies guide patent law: disclosure, reward, and prospecting. These policies explain the functions of a patent system. But these policies structure the practices and actual uses of patents by inventors and compa-nies. In this chapter, I present three sets of practices or uses, looking at cre-ators (or inventors), users, and the distributive issues raised by the patenting of inventions. These central practices or uses cohere into three approaches to patent law and policy, which I refer to as incentive, market, and cultural the-ories of patents. Each of these theories recognize the policies of disclosure, reward, and prospecting with different emphases depending on the partic-ular practices and uses of patents at issue. For example, the incentive theory emphasizes reward; the market theory, prospecting; and the cultural theory,


disclosure. I introduce these theories to analyze the normative framework for understanding identity in the context of personalized medicine.

I conclude this chapter by synthesizing the discussion of constitutional law and patent law with theories of color-blindness and identity more broadly. This synthesis is summarized in Table 4.1, which allows a policy maker to gauge the normative issues at stake in adopting various policies concerning personalized medicine. This table serves as a basis for assessing the policy recommendations presented in Chapter 5.

Constitutional Framework for Race-Specific Patents

Racial categories in patent law may not seem as insidious and as harmful as their use in Jim Crow laws or in the employment or consumer sales context, in which racial stereotyping, bias, and animus serve either individually or col-lectively to deprive individuals and groups access to key resources.3 However, there is arguably at least a symbolic harm that arises from the use of racial cate-gories in patent law, what Timothy Holbrook has called “the expressive impact of patents.”4 By countenancing racial categories in the awarding of patents, the state has acknowledged and aligned itself with racial stereotypes and animus. As a remedy, the state would need to avoid the use of racial categories in a patent document itself and in the review of patent applications. But the harm is arguably more than only expressive. If the granting of a patent by the state promotes invention and innovation, either as an actual consequence or as a justification, then the state is supporting private decisions to create racially tai-lored inventions through the patent grant. Such state action is subject to strict scrutiny under the Equal Protection Clause of the U.S. Constitution to ensure that the racial category is narrowly tailored to serve a compelling interest.5

As an example of this normative quandary, consider the patent for the chemical composition that constitutes BiDil. The claim restricts use of the composition for treatment of hypertension in “black patients.” Suppose a medical practitioner administers the composition to a patient without the

3 See Jody David Armour, Negrophobia and Reasonable Racism: The Hidden Costs of Being Black in America (New York: NYU Press, 1997) 13–18 (analyzing different forms and modes of racial discrimination, but not discussing the role of race in intellectual property); Roy L. Brooks, Atonement and Forgiveness: A New Model for Black Reparations 155–163 (Berkeley: University of California Press, 2004) (detailing the legacy of Jim Crow but not discussing intellectual property).

4 See Timothy R. Holbrook, “The Expressive Impact of Patents,” 84 Wash. U. L. Rev. 573 (2006).

5 See Johnson v. California, 543 U.S. 499, 505 (2005) (affirming strict scrutiny standard for state use of racial category).


authorization of Nitromed, the company to whom the patent is assigned. If the medical practitioner is sued for patent infringement, the court will have to determine whether the patient who received the drug was black. If the patient is black, then there has been infringement of the patent. If the patient is not black, then Nitromed would argue that the racial identity of the patient is equivalent to “black” in order to succeed on its legal claim for patent infringe-ment under the doctrine of equivalents.6 In this hypothetical law suit, the court would have to construe the racial identity of the patient in order to deter-mine patent infringement, much as courts had to construe the racial identity of defendants to see if there had been a violation of the myriad restrictions on activity under Jim Crow laws.

But the analogy to the Jim Crow laws is in many ways a misguided one in the context of determining the infringement of a race-specific patent claim. Under Jim Crow laws, legal entitlements were allocated based on the race with the intention of stigmatizing members of the designated inferior race. In the BiDil context, there is no intention to stigmatize.7 Instead, the goal is to provide incentives for the development of pharmaceutical products that benefit neglected racial or ethnic groups. It is true that a court, in enforc-ing Nitromed’s patent, can enjoin unauthorized users from administering the drug to a black patient but cannot enjoin the administration of the same drug to a nonblack patient, but the distinction arguably is not based on invidious discrimination. Instead, the analogy is more closely made to the review of affirmative action programs, which deny certain benefits to particular races in favor of others. As with affirmative action programs, the legality of racial

6 Under the doctrine of equivalents, the patent owner can sue a party who has used, made, sold, or offered to sell an invention that does not literally fall within the language of the patent claims. The general test is that the defendant’s infringement accomplished the same function through the same way to reach the same result as every element of the claim. See Warner-Jenkinson Co. v. Hilton Davis Chemical Co., 520 U.S. 17 (1997).

7 The BiDil patent and the push for personalized medicine more broadly are examples of “liberal eugenics,” in contrast with the racist or nativist use of eugenics in the nineteenth and early part of the twentieth centuries. Liberal eugenics involves genetic selection or genetic manipulation for the purposes of enhancing individual or even group attributes. See Nicholas Agar, Liberal Eugenics: In Defense of Human Enhancement (New York: Wiley-Blackwell, 2004) 5 (contrasting liberal use of eugenics with the totalitarian and racist uses under the Nazi regime); Michael J. Sandel, The Case Against Perfection: Ethics in the Age of Genetic Engineering (Cambridge, MA: Belknap Press, 2007) 75–83 (contrast-ing liberal eugenics with the “old eugenics” and “free-market eugenics”). For an early, and simplistic, attempt to deal with the ethical and constitutional issues raised by bio-technology, see John B. Attanasio, “The Constitutionality of Regulating Human Genetic Engineering: Where Procreative Liberty and Equal Opportunity Collide,” 53 U. Chi. L. Rev. 1274 (1986) (formulating the issues in terms of a broad tension between liberty and equality).


categories in patent claims may rest on a compelling state interest, analogous to the diversity rationale recognized in the Grutter decision.8

Designation of racial categories as either stigmatizing or beneficial is only one of many potential problems raised by racial categories in patents. The infringement example assumed that the granting of the injunction by the court based on consideration of race constituted state action. The implicit assumption is that the patent infringement case involving a racially specific claim would be analogous to the enforcement of a racially restricted covenant as in Shelley v. Kraemer9 or the allowance of peremptory challenges based on race as in Batson v. Kentucky.10 If patent rights, like contractual rights, area private rights,11 the superficial conclusion would be that state action does not arise. But in the infringement example, the court is seeking to exclude a party based on the consideration of race analogous to the injunction of sale of real property or to the exclusion of a juror based on race. The black patient is in the same position as an African-American purchaser or real property in Shelley or the potential African-American juror being stricken from the pool. In all three instances, the court is complicit in the act of private party seeking to deny a benefit based on race. Therefore, even if a patent is a species of private prop-erty, the existence of state action is not tenuous.12

8 Grutter v. Bollinger, 539 U.S. 306, 326 (2003).9 Shelley v. Kraemer, 334 U.S. 1, 20 (1948).

10 Batson v. Kentucky, 476 U.S. 79 (1986).11 For an analysis of patents as a set of contractual rights, see Shubha Ghosh, “Patents and the

Regulatory State: Rethinking the Patent Bargain Metaphor After Eldred,” 19 Berkeley Tech. L. J. 1315 (2004). See also Jay P. Kesan & Mark Banik, “Patents as Incomplete Contracts: Aligning Incentives for R&D Investment With Incentives to Disclose Prior Art,” 2 Wash. U. J. L. & Pol’y 23 (2000); Vincenzo Denicolo & Luigi Alberto Franzoni, “The Contract Theory of Patents,” 23 Int’l Rev. L. & Econ. 365 (2000).

12 Arguably, the use of racial categories in the granting of a patent would amount to constitu-tional state action under Burton v. Wilmington Parking Authority, 365 U.S. 715, 81 S.Ct. 856, 6 L.Ed. 2d 45 (1961) (finding state action when private discriminatory conduct was “inter-twined” with the state). But see Moose Lodge No. 107 v. Irvis, 407 U.S. 163 (1972) (granting of liquor license did not sufficiently implicate the state in private discriminatory behavior to create constitutional state action). The Court’s analysis in Shelley v. Kraemer has been questioned, but the case offers an important analogy for discussing the role of constitutional state action in patent law because the public entity is quite clearly creating private rights. For a discussion of the controversy over the Shelley decision, see Mark D. Rosen, “Was Shelley v. Kraemer Incorrectly Decided? Some New Answers,” 95 Cal. L. Rev. 451, 473 (2007) (jus-tifying the decision in Shelley under the Thirteenth Amendment, which does not require state action). For a current discussion of the distinction between state action and private action, see Mark Tushnet, “State Action, Social Welfare Rights, and the Judicial Role: Some Comparative Observations,” 3 Chi. J. Int’l L. 435 (2002) (analyzing the place of state action in the social democratic state); Cass R. Sunstein, “State Action Is Always Present,” 3 Chi. J. Int’l L. 465 (2002) (arguing that state action also exists in the classic liberal state, although the state assumes a different set of affirmative obligations).


However, the existence of state action in the recognition of racial categories in patent law can readily be seen once patents are recognized as private prop-erty rights granted by the state.13 In the case of BiDil, a patent examiner – an agent of the state – reviewed the patent application and the available prior art to determine that the use of the chemical compound as limited to black patients is a protected right owned by the patent applicant and secured by the state. Race, therefore, was a factor in the determination by the state to grant the right of exclusion secured through patent law. In this context, however, the consideration of race is different from the use of racial categories in affir-mative action programs,14 in the grant of voting rights,15 or in the selection of employees,16 where the racial identity of persons being denied a benefit by the state is key to the decision. In the case of BiDil, the racial identity of the patent applicant or inventor is irrelevant to the decision.17 Instead, the state is making the decision to grant a right to a specific individual in order to benefit a racially identified group.

This description of state action applies as well to the use of racial categories in the hair-straightening and skin depigmentation patents, where race enters in the specification but not the claims. When state action is understood in this way, there are three possible responses. One is to conclude that this use of racial categories is different from the stigmatizing uses that arise in con-ventional racially discriminatory state action, because the state is not directly targeting certain groups, and therefore is not problematic. The second is to conclude that the state is internalizing and reinforcing private animus and discriminatory attitudes and therefore the state action is suspect. The third is to conclude that the state’s consideration of race can be beneficial if it corrects differences that have been created through the use of racial categories. This third approach is the most problematic because it suggests that there are cer-tain uses of racial categories that may be beneficial, creating the difficult task of distinguishing between beneficial and harmful uses of racial categories. As I elaborate in the rest of this section, distinguishing among these positions requires coordinating the normative goals of patent law with those of the use

13 See Webber v. State of Virginia, 103 U.S. 344 (1880) (Congress’s power to grant patents); James v. Campbell, 104 U.S. 356 (1881) (Congress’s power to define patent rights and make use of patents).

14 See Parents Involved in Community Schools v. Seattle School District No. 1 et al., 551 U.S. 71 (2007).

15 See Baker v. Carr, 369 U.S. 186 (1962).16 See Wygant v. Jackson Board of Education, 476 U.S. 267 (1986).17 For a discussion of racial restrictions on patenting that were imposed in the Nineteenth

Century, see J. S. Butler, Entrepreneurship and Self-Help among African Americans: A Reconsideration of Race and Economics (Albany: SUNY Press, 1991) 55.


of racial categories by the state. These various positions can be understood within the extremes of color-blind and accommodationist positions, presented at the end of this chapter.

Assessing the three prognoses identified at the beginning of this section (no harm, expressive harm, Equal Protection violation) requires addressing the normative foundations for patent law and for the use of racial categories. The remainder of this section analyzes both of these normative foundations by focusing first on patent law and second on race. My goal is to juxtapose three normative justifications for patent law (incentive theory, market theory, and cultural theory) with liberal and critical theories of racial categories.18 By juxtaposing these theories, I present a roadmap for assessing the use of racial categories documented in the second section of this chapter. This road map will be the basis for what I call the left liberal approach to racial categories in patent law, presented in the fourth section of this chapter.

The Perspective of Patent Law

A policy assessment of patent law starts with an identification of the actual and potential effects of the grant of an exclusive right on an invention through the issuance of a patent. This section presents a systematic framework for identify-ing these effects through a consideration of distributive justice goals in patent law and the impact on actors within the patent system, the creators of new technologies, the users of technologies, and the administration of the patent system within the parameters of the modern regulatory state. Setting forth in detail these effects provides the foundation for presenting the three theories of patent law – the incentive theory, the market theory, and the cultural theory – which will serve to assess patent policy.

Distributive Justice and Patent Law

Before proceeding to an analysis of each of these three aspects of distribu-tive justice, let me emphasize that I am being somewhat agnostic about the proper relationship between distributive justice and wealth or welfare maxi-mization as normative guideposts. My modest point is that wealth or welfare maximization alone cannot and should not guide us in creating governance structures for the intellectual property commons. This means that distributive

18 For background on liberal and critical theories of race, see “Kimberle Crenshaw, Neil Gotanda, Gary Peller, and Kendall Thomas” in David Kennedy & William W. Fisher III, eds., The Canon of American Legal Thought (Princeton: Princeton University Press, 2007) 889–897.


justice goals may trump claims based solely on wealth or welfare maximiza-tion. The more difficult question is whether distributive justice goals can be decided separately from wealth or welfare maximization goals. For example, one might argue that the initial allocation of rights should be made solely in order to maximize wealth or welfare, with distributive justice goals being introduced afterward to cure undesirable results from market and political processes. Alternatively, one could argue that initial entitlements are based solely on distributive justice goals with governance institutions, such as mar-kets and courts, designed to allow individuals to trade initial entitlements in order to ensure wealth or welfare maximization. I am skeptical of this separa-tion of distributional goals from efficiency goals. Economic theory teaches us that this separation is appropriate only under some extreme assumptions about preferences and technologies. I adopt the conventional welfarist assumption in normative economics that for most problems we need to consider efficiency and distributive goals together, and design governance institutions to reach a desirable (i.e., politically justifiable) mix of efficiency and distributive justice. What this mix is will depend on the specific governance structures at issue.

Creators

The creative process demands consideration of distributive justice among cre-ators. Intellectual property law can aid in resolving distributional conflicts among creators and in ensuring just and equitable outcomes. Creative works and useful inventions are the result of a mix of individual effort and talent. The problem is determining how the rules of the intellectual property com-mons reward effort and talent.

One purported set of rules reflect the principles of originality and full appropriability. Under these two principles, creators are rewarded fully for wholly original works that are not the product of appropriating from other creators or from artifacts in the public domain.19 By fully rewarded I mean that the creator obtains the full social value of his or her work through both sales of the work and licensing of the rights. The conventional argument is that originality and full appropriability of social value will ensure efficient outcomes by allowing creators to capture the full social benefit of their work without appropriation from other sources. In turn, the introduction of original creations into the marketplace expands the commons. The case is also made that originality and full appropriation are just and fair principles for governing the intellectual property commons, because each creator is able to capture

19 Robert Nozick, Anarchy, State and Utopia (New York: Basic Books, 1974) 150–155.


the fruits of his individual labor. The principles of originality and full appro-priability ignore important distributional conflicts among creators and may undermine the goals of expanding the intellectual property commons.

The first focus of my criticism is on the principle of full appropriability of social value. The argument in favor of full appropriability follows from the Pigovian analysis of externalities. According to the economist Arthur Pigou, externalities arise when social costs or benefits differ from private costs and benefits.20 For example, in the case of pollution, the social costs of harmful waste are greater than the private costs of the waste borne by the producer. If the producer had to bear the full social cost of the waste, then the efficient amount of pollution would occur. Analogously, when a new work is created for the commons, the social benefits are greater than the private benefits. Consequently, the individual creator has to appropriate the full social ben-efit in order to ensure that the efficient level of creation would occur. In this Pigovian mode, the argument for full appropriability is based solely on effi-ciency grounds. Robert Nozick has made the case for full appropriability on distributive justice grounds, arguing that the creator has the right to recoup the gains from the fruit of his labor. Full appropriability is justified, on the one hand, as a means of reaching efficient allocation of benefits and costs and, on the other, as an entitlement to one’s own labor.

The arguments in support of full appropriability fail on both efficiency and distributive justice grounds. The efficiency justification, to the extent that it is based on the Pigovian theory of externalities, is subject to Ronald Coase’s criticism.21 Specifically, Coase argued that externalities can be internalized through bargaining among the affected parties, regardless of who has the right to be compensated or the obligation to pay a fine. In the case of nega-tive externalities – the case that Coase actually considered in The Problem of Social Cost – the social harms of waste can be internalized through contrac-tual negotiations that determine how much waste can be generated and how the generated waste can be cleaned. Although Coase did not directly consider the case where social benefits are greater than private benefits, his insights are equally applicable to that scenario. As long as the creator can negotiate the transfer of rights in his creation, contractual negotiations will allow the cre-ator to appropriate whatever returns society is willing to pay for the use and enjoyment of the creation. Full appropriation is not necessary for the creation and dissemination of the work. As with any other endeavor, as long as the creator earns more than his alternative to being an author or inventor, he will

20 Arthur C. Pigou, The Economics of Welfare (New York: Macmillan & Co., 1932) 192–196.21 R. H. Coase, “The Problem of Social Cost,” 3 J. L. & Econ. 1, 8–9 (1960)


choose the activity of creating. Partial appropriation is more efficient than full appropriation as long as the appropriation is greater than alternative uses of the creator’s time.

The focus on opportunity cost, rather than social benefit, illustrates why the principle of full appropriability can lead to inefficient and unjust outcomes. Imagine the following example. I realize one day that my teaching intellec-tual property law to my students actually makes them better attorneys. I cal-culate from this observation how much more my students earn as a result of my activity. Under full appropriability, I could logically make the claim that I should obtain the surplus that my students will earn as attorneys as a result of the training I have provided. Assuming we could resolve the computational problems that my claim raises (and this is, of course, an implicit assumption of those who advocate for full appropriation), my claim also undermines the claims of my students who seek to become attorneys in the first place. But, of course, the flaw in my reasoning is that efficiency requires only that I obtain enough of a return to make my choice as a law professor more profitable than my alternative opportunities (and as all law professors know, this return may include intangibles, such as job satisfaction, along with monetary returns). The principle of full appropriability would not only derail the goal of effi-ciency by ignoring opportunity cost, but it would also increase transaction costs in market exchange as market participants attempt to appropriate all the relevant surplus in their respective transactions. Ironically, full appropriability would undermine the market, one of the key institutions for the maintenance of efficiency.

Nozick’s distributive justice arguments in favor of full appropriability may cure the anti-efficiency tendencies of Pigovian justifications for full appropri-ability. Nozick bases his justification on the entitlement of individuals to the fruits of their own labor, not efficiency or attendant institutions, such as the market.22 The problem, however, is that the entitlement to one’s labor is inti-mately connected to the institution of the market and exchange. One works to make a living, and unless one finds comfort in simply retaining, rather than exchanging, the fruits of one labors, it is not clear why the entitlement in one’s labor is a desirable normative end. Perhaps there is value in autarky, but it would be difficult to deny that realizing the full value of one’s entitle-ment in the fruits of labor requires engaging in market exchange to some extent. However, full appropriability, as I argued earlier, works against the functioning of the market. Therefore, Nozick’s argument for full appropri-ability is a moral claim rather than one consistent with the instrumentalism

22 See note 19 to this chapter at 151.


of market economics. However, even if full appropriation is made as a purely moral claim, the instrumental role of entitlements implies that at some point full appropriability has to give way in order to make the claim to the fruits of one’s labor a meaningful one.

In short, the principle of full appropriability is neither efficient nor just. The same conclusion applies to the principle of originality. Much has been writ-ten, and rewritten, about the emptiness of originality given the important role of borrowing on the creative and inventive process. I will not rehearse those arguments here, but simply acknowledge their influence in a footnote. My attention here turns to the distributive justice arguments supporting original-ity. The concept of originality advances legal protection to works that originate from the creator without borrowing from the public domain or from other cre-ators. Sanctioning acts of copying through broad definitions of infringement by reproducing, adapting, and performing and through narrow protections such as fair use also promotes originality. The principle of originality rewards creative activities that do not derive from other sources unless these sources are compensated in some fashion, such as licensing or purchase. In this way, originality is derived from the principle of full appropriability and suffers from the same criticisms.

Originality, however, is flawed for reasons distinct from the problems with full appropriablity. Originality requires the identification of one creator or set of creators with a given work. This assumption has been questioned as incor-porating the myth of the romantic author and ignoring the social context of creation. These criticisms are all worth acknowledging, but the more com-pelling difficulty with the principle of originality is the arbitrariness of the conclusion that the author is entitled to the copyright from the perspective of distributive justice. If originality reflects Nozick’s notion of entitlement, then the market-based criticisms apply equally here. If there is some other basis in distributive justice for the mapping, then I am frankly baffled as to what that foundation would be. The most sensible argument is that in order to have an effective system of legal entitlement, originality requires a clearly delineated author or set of authors. However, this is an argument for efficient administra-tion rather than one of distributive justice. At best, this justification is derived from some notion of entitlement, with all the accompanying problems created by that presumption.

My argument has both negative and positive dimensions. The negative portion of my argument questions the justifications for the principles of full appropriability and originality in the normative goals of efficiency and distrib-utive justice. The positive, and more important, part of my argument shows that distributive justice goals do play a role in the design of the intellectual


property commons. Furthermore, some limitations on full appropriability and originality may be necessary for recognizing distributive justice among creators.

Creators and Users

The relationship between creators and users in the intellectual property com-mons is similar to that between suppliers and demanders of resources in other arenas. The conflict between suppliers and demanders is resolved most often through the institution of the market, supplemented by other institutions that aid in allocating resources that cannot be fully commodified (e.g., univer-sities providing education) or that correct inequitable market distributions (e.g., charitable organizations providing humanitarian relief).23 In designing intellectual property regimes, the distributional conflict between creators and users is reflected in three issues: the principles of full appropriability and orig-inality, the tension between willingness and ability to pay, and the problem of pricing.

The set of users include creators, and, given the overlap, it is not surprising that the issues of originality and full appropriability should arise in the dis-tributional conflict between creators and users. There are, of course, important differences. Among creators, the key issue is the allocation and distribution of labor and talent for the creative process. Between creators and users, the key issue is the allocation and distribution of final created products. The criticisms of full appropriability and originality apply even more forcefully to the latter issue. The supplier does not stake a claim appropriating the full value of what he supplies in any market. The supplier charges a price for transferring a com-modity to the demander. The price, by definition, has to be enough to cover the supplier’s costs in producing and distributing his wares and be less than or equal to what the demander is willing to pay for the product. Therefore, any claim of full appropriability might undermine the claims of other participants in the marketplace, as argued earlier.

Furthermore, there may be strong reasons for questioning the use of the mar-ket institution for distributing the benefits of intellectual-property-protected creations. A familiar criticism of the market is its emphasis on willingness to pay rather than ability to pay. A related criticism is the market’s emphasis on the satisfaction of wants rather than needs. These criticisms would also apply to intellectual property markets. For example, in the case of pharmaceuticals,

23 Charles E. Lindblom, The Market System: What It Is, How It Works, and What to Make of It (New Haven: Yale University Press, 2001) 35–40, 266–272.


market mechanisms for the distribution and allocation of life-saving drugs may not ensure equitable distribution and distribution to the most needy. Not surprisingly, the distributional concerns of other markets also confront intel-lectual property markets.

More compelling are the limitations of intellectual property markets, beyond the conventional criticisms of markets for ignoring needs and ration-ing based on willingness to pay. In typical markets, price serves as an impor-tant mechanism for matching buyers and sellers. For specific transactions, the price mechanism serves to match trading partners on differences between willingness to pay and willingness to accept. Taken together, this matching ensures that buyers in the marketplace earn, on the aggregate, a consumer surplus. This result occurs because some consumers would have been willing to pay more than prevailing market price. This matching also ensures a pro-ducer surplus, which results from the willingness of some sellers to accept less than the prevailing market price. The efficiency of the market is reflected in the maximization of consumer and producer surplus. The problem is that in intellectual property markets, the price mechanism may not work the way it is supposed to, for two reasons.

First, there may be a limited number of suppliers of a work protected by intellectual property. It is well accepted that an intellectual property right does not confer a market monopoly, because there may be several substitutes for the product. It is equally true, however, that intellectual property markets will not have homogenous products that are perfect substitutes, as required for perfectly competitive markets. One song will be different from, as well as the same as, another song. Chemical and industrial processes will also have sim-ilarities and differences. As a result, intellectual property markets will clear based not solely on price, but also on other characteristics, such as the quality of the product or service. Therefore, the market may not lead to fully efficient outcomes and may actually exclude individuals who would otherwise be will-ing to pay the prevailing price based on the quality or type of product provided to the marketplace. Pricing mechanisms may not ensure efficient trades and distributional balance between consumer surplus and producer surplus.

Second, intellectual property markets involve not only the transfer of goods and services, but also the licensing of legal rights. These rights are often allo-cated using royalties and other pricing arrangements and through the transfer of subsidiary rights, for example claims as to service or warranties. These con-tractual arrangements serve multiple functions, such as providing insurance or other services in addition to the transfer of rights. Once again, given the dimensions of these contracts in addition to price, licensing arrangements will often suffer from problems of asymmetric information and strategic behavior.


Therefore, there is no reason to think that the licensing markets will lead to the most efficient result or to a desirable distribution of producer and con-sumer surplus in the marketplace.

Distributional justice issues inform the relationship between creators and users. Many of these issues are similar to those that arose among creators and to those that affect markets generally. Furthermore, the price mechanism may not be fully functioning in intellectual property markets, requiring more care-ful scrutiny of markets in the intellectual property commons.

Intergenerational Justice

At the heart of justifications for patents and other forms of intellectual prop-erty is the pursuit of innovation and the expansion of technologies and options, fairly –one hopes – distributed among society’s constituencies. Innovation and expansion are captured by the term “progress” – an admittedly loaded word. The U.S. Constitution speaks of progress, although it may not have the restraining force that some scholars endorse.24 Outside the United States, the term “progress” does not have constitutional valence, but intrudes into intel-lectual property debates through the concepts of innovation and invention. My argument is that progress can and should be understood in terms of inter-generational justice, meaning very broadly the distributional conflict between those who are alive currently and those who will be born. A more practical definition of intergenerational justice would focus on changes in background mores and technology that may make certain established modes of allocating and distributing resources questionable.

Intergenerational justice influences the intellectual property commons in three ways: changed technologies, changed markets, and changed values. New technologies may upset established ways of producing and distributing works of art. The VCR and file sharing are the two most salient examples of this phe-nomenon.25 Intellectual property rules have to deal with new technologies, and the response can range from accommodation to extinction. Considerations of intergenerational justice can inform how intellectual property rules can shape

24 U.S. Constitution, Article I, Section 8, Clause 8. Malla Pollack, “What Is Congress Supposed to Promote? Defining ‘Progress’ in Article I, Section 8, Clause 8 of the U.S. Constitution, or Introducing the Progress Clause,” 80 Nebraska L. Rev. 754 (2002).

25 Ashish Arora et al., Markets for Technology: The Economics of Innovation and Corporate Strategy (Cambridge, MA: The MIT Press, 2001) 8–10. The U.S. Supreme Court addressed the copyright issues raised by the then-new technology of the VCR in Sony Corp. of America v. Universal City Studios, Inc., 464 U.S. 417 (1984), and those raised by file sharing in MGM Studios, Inc. v. Grokster, Ltd. 545 U.S. 913 (2005).


the adoption and diffusion of new technologies. Similarly, as markets change with the introduction of new products, intellectual property rules need to respond in a way that is responsive to the goals of intergenerational justice. Finally, values may change, particularly on the relative merits of entertain-ment versus information or on the merits of different types of technologies. Once again, considerations of intergenerational justice can guide intellectual property rules.

Patentable Subject Matter, Regulation, and Administration

What is potentially patentable under a given patent regime? The problem is not one of patentability, or whether a given invention meets the requirements of novelty, nonobviousness, utility, and enablement, but of whether something qualifies as an invention. In the United States, this problem implicates both the patent statute and the Constitution, which limits Congress’s authority to grant exclusive rights to “inventors” in their “discoveries.” Absent constitu-tional authority, the question would hinge on statutory interpretation, the intent of the legislature, and the language adopted to embody that intent. As a threshold question, patentable subject matter is both illustrative and critical in understanding patent law as a system of regulation as opposed to a quid pro quo grant of exclusivity for progress.

The seminal case on patentable subject matter in the United States is Diamond v. Chakrabarty,26 the 1980 case that allowed for the patentability of genetically altered organisms. The Chakrabarty decision laid the ground-work for the often reviled expansion in patentable subject matter over the past decade. The Court endorsed the principle that patent law extends to everything under the sun that is man-made, based on a single sentence from an extensive legislative history. This principle, based on that single sentence, became the basis in the 1980s and 1990s to extend patent law to include soft-ware, a field that had been excluded from patent law by Supreme Court deci-sions, and business methods, a gray area in the field of patents since the 1900s. The trivial and “patently absurd” patents for such items as a cat hammock, a peanut butter and jelly sandwich, and a method of exercising one’s cat with a laser pointer are arguably the result of the Chakrabarty court’s largesse.27 In

26 447 U.S. 303 (1980).27 U.S. Patent No. 6,209,491 (issued Apr. 3, 2001); U.S. Patent No. 5,567,454 (issued Oct. 22,

1996); U.S. Patent No. 6,701,872 (issued Mar. 9, 2004). Robert P. Merges, “As Many as Six Impossible Patents Before Breakfast: Property Rights for Business Concepts and Patent System Reform,” 14 Berkeley Tech. L. J. 577, 581–582 (1999).


fact, the inclusion of life forms within the world of patents is, according to many, a critical step for the propertization of inventive activity, extending the arm of exclusivity to almost all human activity. By a single decision, according to one argument, the Supreme Court turned a host of human creations – from the banal, such as the cat hammock, to the profound, such as genetically altered organisms – into the legal category of property. This move arguably transformed the trivial into the subject of federally protected rights and life itself into marketable commodities.

It is important to note that Chakrabarty does not use the quid pro quo metaphor. In fact, both the majority and dissent viewed the issues in regula-tory terms: both the majority and dissent framed the debate in terms of how Congress structured patent law to regulate primary conduct and technol-ogy. Both the majority and dissent accepted a version of the conclusion that patent law should be technology-neutral. They disagreed on how to fit the new technology of genetic engineering into the scheme that Congress had adopted. The dissent emphasized the enactment of plant-related statutes as indicative of how Congress intended to regulate genetically altered life forms. The majority, on the other hand, pointed to the broad language of the Patent Act itself and the silence within the plant-related statutes to rule in favor of the technology. Both the majority and dissent, despite their dif-ferences, correctly structured the analysis in terms of regulation rather than property.

By recognizing a broad scope for patentable subject matter, the Supreme Court brings a wide range of inventions under the domain of government reg-ulation. Although a patent is often understood as a property right, the Supreme Court decision considers patent law within the scope of Congressional power, and therefore views patents as the subject of government regulation. One criti-cism of my regulatory interpretation of the majority’s opinion is that it ignores the outcome of the Chakrabarty decision in granting exclusive, private rights to a life form. But this criticism confuses what is potentially patentable from what can actually be patented. By expanding the scope of the subject matter, the Chakrabarty decision brought a wide range of invention and inventive activity within the sunlight of the regulatory system that is patent law. The expansive scope of patentable subject matter does not mean that all inventions are patentable. An applicant always has to meet the requirements of novelty, nonobviousness, utility, and enablement. The broad scope of patentable sub-ject matter means that almost all inventions can be patented and be brought under the policy goals of patent law, which include the regulation of inventive activity and the openness of the government grant to patent-worthy inventions. Arguably, the Chakrabarty decision advanced these precise goals. By bringing


a wide range of inventions into the patent system, the decision exposed these inventions to public scrutiny and debate. Contrary to the dissent’s argument that the decision usurped democratic decision making over a crucial regula-tory function, the majority’s decision was an important step in allowing pub-lic scrutiny of inventions through the patent system and potentially through other regulatory mechanisms. The dissent’s position runs the risk of relegating critical inventions to the realm of secrecy.

The nearly decade-old controversy over the “sick beagle” patent in the United States provides a useful example of these points. The University of Texas Health Sciences Center submitted a patent application for a method of infecting a healthy beagle with a strain of a pulmonary disease for research purposes.28 The application also included a claim for the resulting animal. Animal rights activists protested both the University’s research activities and the patent application, and because of the public pressure, the University of Texas decided to withdraw its application. Needless to say, the mere with-drawal of the application may not be sufficient for those who advocate an end to research use of animals. Furthermore, many will be critical of the censorious use of political activism against scientific research. Regardless of individual positions on the political issues, the lesson for patent law is that allowing broad subject matter permitted public debate over the invention. A broad decision like Chakrabarty brings inventions within the purview of regu-lation and public scrutiny and ultimately can further the goals of science and democracy.

A similar point could be made about business method and other seemingly absurd patents. In 1998, Amazon.com’s enforcement of its one-click shopping patent against Barnesandnoble.com brought the public’s attention to some of the anticompetitive uses of patents.29 Amazon.com eventually lost its suit, and the decision was an impetus for the FTC’s 2003 report on patent law and com-petition policy, discussed later. Once again, my argument here is not that all patents are anticompetitive or that the system needs reform. Rather, the expe-rience with one-click demonstrates how allowing a broad patentable subject matter stimulates public debate and furthers the goals of patent law as a reg-ulatory system. The case of pharmaceutical patents, explored by myself and other scholars, also illustrates patent as regulation. Even the expansion and recognition of trivial patents support my argument. The acquisition of trivial patents opens them to public scrutiny and forces us as a society to confront such fundamental questions as what innovation is and what the administrative

28 “University Gives Up Patents on Sick Dogs,” The Wall Street Journal, May 28, 2004, at B7.29 Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343 (Fed. Cir. 2001).


role of the USPTO is – questions that are the focus of the recent National Academy of Science report,30 discussed later in the chapter.

Although in desuetude for almost two decades as a limitation on patentabil-ity, the doctrine of patentable subject matter has recently made a resurgence in the courts, with the U.S. Supreme Court nearly reviving the doctrine in 2006 and the Federal Circuit giving the doctrine more bite in several recent decisions.31 The new contours of patentable subject matter can place some limitations on patenting games to protect users.

The patentable subject matter doctrine excludes certain categories of inven-tion as undeserving of patenting because the categories are contrary to the goals of the patent system. Some academics and policy makers have proposed immoral subject matter, or other potentially harmful subject matter, as being outside the patent system’s structure of rewards and incentives. As a practical matter, however, agencies and courts have found it difficult to define these categories with any precision. For example, exclusion of software proved dif-ficult as computer programs became integrated into hardware and became impossible to distinguish from other machines that had been traditionally pro-tected by patents. Furthermore, the legislative history, endorsed by the U.S. Supreme Court, extended patentable subject matter to “anything manmade under the Sun” – an oblique way of saying “everything.”

Nonetheless, the Federal Circuit, associated with an expansive notion of patentable subject matter in noteworthy cases such as State Street v. Signature Financial,32 has recently struggled to find some limitations on what can be excluded from patenting as a threshold matter. This watershed holding was a response to concerns that patentable subject matter had expanded too broadly to include questionable items that have contours too difficult to draw within defin-able and meaningful patent scope. One tactic that the Federal Circuit has taken is to read the Patent Act’s definition of “patent subject” narrowly, which under Section 101 includes “process, machine, manufacture, or composition of mat-ter,” or “improvement thereof.” In In re Nuijten, the court used this language to hold that an electronic signal was not patentable subject matter because it was not a process, machine, manufacture, or composition of matter.33

30 Nat’l Research Council, Nat’l Acad. of Scis., A Patent System for the 21st Century (Stephen A. Merrill ed al. eds., 2004) [hereinafter NAS Study], available at http://www.nap.edu/books/0309089107/html (last viewed January 19, 2012).

31 Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc., 548 U.S. 124 (2006) (per curiam); Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 581 F.3d 1336 (Fed.Cir.(Cal.) 2009).

32 149 F.3d 1368 (Fed. Cir. 1998).33 500 F.3d 1346 (Fed. Cir. 2007).


Nonetheless, a strict construction of the statute could potentially narrow the scope of patentable subject matter. In a companion case to In re Nuijten, the Federal Circuit narrowed patentable subject matter through a judicially created doctrine known as the “mental steps doctrine,” which limits patent-able subject matter to inventions that have a physical embodiment. Processes, for example, that are purely mental would be excluded from the reach of the patent law. The Federal Circuit’s decision, In re Comiskey, illustrates this doctrine in action.34 Comiskey sought to patent a method of arbitration. The invention described purely human interaction and did not invoke a physical embodiment (although the patentee unsuccessfully argued that the use of pencil and paper constituted a physical embodiment of the method). The Federal Circuit upheld the USPTO’s rejection of the application under the mental steps doctrine. While this doctrine appears to be a judicious way to limit patenting to physical embodiments, the rule could potentially artificially force inventors to create physical embodiments, such as computer or machine-based applications that may not truly be inventive, as a way to sidestep the rule. Nonetheless, In re Comiskey shows that the Federal Circuit is concerned with limiting the scope of patentable subject matter.

This focus was reinforced by the Federal Circuit granting en banc review of the USPTO’s rejection of an application for a method of hedging financial risk by Bilski.35 On October 30, 2008, the Federal Circuit issued a groundbreaking opinion affirming the rejection of the claims. The court, relying extensively on U.S. Supreme Court precedent in the area of software patents, adopted a “machine-or-transformation” test for determining when a claimed process is patentable subject matter. Under this test, a process is patentable subject mat-ter if it is either implemented in a machine or is a physical transformation. In applying this test to the claims at issue in Bilski, the court found that there was no machine implementation and concluded that the mere shifting of legal obligations or economic risk does not constitute a physical transformation.

The Federal Circuit’s articulation of when a transformation does not con-stitute patentable subject matter is revealing. The court rejected the patent-ability of Bilski’s method of hedging the risk of commodity prices because the method was not machine-implemented and because the method did not transform any article to a different state or thing. Purported transformations or manipulations simply of public or private legal obligations or relationships, business risks, or other such abstractions cannot meet the test because they are not physical objects or substances, and they are not representative of physical

34 499 F.3d 1365 (Fed. Cir. 2007).35 545 F.3d 943 (Fed. Cir. 2008).


objects or substances. Applicants’ process at most incorporates only such ineli-gible transformations.

This newly articulated test has implications for non-machine-implemented gaming patents that apply to mental processes, such as wagering. Such meth-ods do not entail a physical transformation. Instead, they constitute the type of abstract transformations of business relationships that are not patent-eligible. The decision in Bilski reduces patent-eligible processes to those that entail a physical transformation, one that is captured through some physical medium or that occurs through a machine. One striking application of the Bilski ruling is the patenting of gaming devices and the playing of games. Gaming patents would be available for the tools of gaming (gaming apparatus such as boards or dice, for example, or their modern electronic equivalent) or to the rules of the game that are embodied in a physical media. The legal limitation paral-lels the fixation requirement of copyright law, which limits copyrightable sub-ject matter to that which is recorded in a tangible medium.36 Consequently, live performances are excluded from patent protection much like they are excluded from copyright protection.

The Federal Circuit’s decision in Bilski signals some likelihood that the U.S. Supreme Court will grant review of the Federal Circuit’s decision. This prediction is based on the fact that the Court granted review in the case of Laboratory Corp. v Metabolite in 2006.37 At issue in Metabolite was a patent on a diagnostic tool that could, as one of its elements, correlate deficiencies of certain enzymes with a vitamin B-12 deficiency. Academics and practitioners anticipated that the Court would make a pronouncement on the scope of pat-entable subject matter and the mental steps doctrine.38 Instead, the Court con-cluded that certiorari had been improvidently granted, letting stand the lower court’s ruling on infringement. Justice Breyer, joined by Justices Stevens and Souter, authored a strong dissent, arguing that certiorari had been proper and that the patent was invalid as unpatentable subject matter. Specifically, Justice Breyer was concerned with a patent that covered mental activity, namely establishing a mathematical correlation. The strength of Justice Breyer’s dis-sent and the additional scrutiny by the Federal Circuit in Bilski set the stage for recent decisions by the U.S. Supreme Court on the scope of patentable subject matter.39

36 Kelley v. Chicago Park District, 635 F.3d 290 (7th Cir. 2011) (court finding that a landscaped garden was not a copyrighted work).

37 See note 31 to this chapter.38 Jeffrey Kuhn, “Patentable Subject Matter Matters: New Uses For An Old Doctrine,” 22

Berkeley Tech. L. J. 89, 90–91 (2007) (providing background on the Lab. Corp. dispute).39 See note 31 to this chapter.


What can we glean from this about patentable subject matter as a possible limitation on gaming patents? To the extent that the mental steps doctrine has been revived, one might predict that patents on predictive activity, such as the wagering patents described earlier, may be outside the scope of pat-entable subject matter. Wagering is arguably a mental activity, and patents that cover wagering not embodied in a computer or other physical medium should, and will likely, be invalidated like the arbitration patent in Comiskey. Furthermore, method patents that cover the playing of a game should also be invalidated to the extent that playing is seen as a mental activity. This last premise, however, is the difficult linchpin of the argument against patent-able subject matter. The playing of a game is not a purely mental activity. It involves physical motion as well as thought. Consequently, computer embodi-ments of play would likely pass muster as patentable subject matter. However, patents on what I call actual play may be suspect as not falling under statutory subject matter. The Federal Circuit’s decision against Nuijten might support such a holding on the grounds that physical play is not a process, machine, manufacture, or composition of matter. But that conclusion would require a strict construction of the statute.

Patentable subject matter is an evolving doctrine, and definitive conclusions of its effects on patenting games will depend on the meaning of transformation, as articulated in the recent Federal Circuit decision in Bilski. Nonetheless, we can see that there is some limitation on patents in the gaming area and should develop arguments that will build on the incipient case law.

The Federal Circuit’s decision in Bilski arguably resolves the concerns over gaming patents presented in this section. But those seeking even stronger prophylactic measures, or a foundation for the limiting principles articulated in Bilksi, a U.S. Supreme Court decision from 1880 may serve as an impor-tant limitation on patent rights. Baker v. Selden involved a copyright, owned by Selden, on a book that presented a method for conducting accounting.40 The book contained instructions on accounting as well as ledgers and forms with which to practice the art. Baker had distributed a copy of the book that included the ledgers and forms. The lower courts found against Baker, but the U.S. Supreme Court held that copyright protection did not extend to the ledgers and forms depicted in Selden’s book. At the narrowest of levels, Baker has been read to mean that copyright does not extend to blank forms.41 But the decision sets out fundamental policies in copyright law, policies that are also relevant in patent law.

40 101 U.S. 99 (1879).41 37 C.F.R. 202.1(c).


The Court presented an important distinction between copyright and pat-ent law. Copyright, the Court states, protects expressive elements of a work, whereas patent law protects functional or useful elements. This distinction goes beyond subject matter like software. Baker stands for the proposition that there is a difference between the subject matter of copyright and that of pat-ent, and that this difference, very broadly, rests on the difference between aesthetics and functionality. Copyright law, as I show later, has used this dis-tinction to remove certain types of functional expression from the domain of copyright protection. Baker excludes certain types of aesthetic expression from the domain of patent protection. This issue will be addressed first by showing where Baker stands under modern copyright law and, second, by showing the implications for patent law.

The holding of Baker has been codified in Section 102(b) of the Copyright Act,42 which excludes a list of items from copyright protection. This list includes such items as ideas, methods of operation, processes, and other functional expression. Although Section 102(b) does list quite a number of exclusions for copyrightable subject matter, the case law does not provide an extensive analysis of these numerous items.

The primary legacy of Baker, however, is in the principle informing the application of Section 102(b): copyright allows the owner to prevent unautho-rized uses of the expression, but not any uses described in the work. For exam-ple, if I read a book about origami, I can practice origami without infringing the book’s copyright. The book is intended to teach readers how to practice origami, and therefore I am allowed to practice the art taught without violating copyright law. Note that this protection of the user is not a matter of implied license. The protection comes from recognizing that the practice of the art is not within the scope of copyright. This implication is a broad one, but also a subtle one. This principle limits copyright protection to the form in which ideas, methods, or processes are described, but never to the idea, method, or process itself. In Baker, Selden’s copyright on the accounting book did give Selden any right in the practice of accounting, including the use of forms. Copyright protection does not extend to methods, systems, or processes, all of which are the basis for using the practice described in the accounting books.

Throughout the Copyright Act, the holding and reasoning of Baker has wide application, most notably in the area of software copyright. In a typical suit for copyright infringement, the plaintiff has to separate the functional elements of the software from the nonfunctional elements and demonstrate

42 17 USC § 102(b).


infringement of the latter. Anyone is free to copy the functional elements – those elements that are present to allow the software to operate. I have described this separation as the line between functionality and aesthetics, but of course that terminology is misleading because functional expression can be deemed aesthetic under the appropriate theory of beauty. Perhaps a better way to understand the distinction is how the Court in Baker has done it, recogniz-ing that there are different types of expression and different types of uses of works. Copyright law does not permit the owner to control all types of uses and all types of expression. Instead, there are classes of uses and expressions, labeled functional, that are exempt from copyright protection. What this class entails is a matter of practical determination.

Given that the Court in Baker was drawing a distinction between patent and copyright, distinguishing them in terms of functionality and uses, it seems that Baker offers a lesson in patent law as well as in copyright law. Unlike copy-right law, which codifies the holding of Baker in section 102(b), Congress has not provided an analogous codification in patent law. Nonetheless, the U.S. Supreme Court’s reasoning in Baker teaches us the implications for patent law. Just as with copyright, so with patent: there is a class of uses – call them nonfunctional – to which patentable subject matter does not extend. This class of uses places a limitation on the processes a patent can cover. They com-prise the negative space of the Baker decision.

I propose the following statement to describe the implication of the holding of Baker for patent law: patentable subject matter does not include expres-sive activity that is nonfunctional or aesthetic. This statement has immediate application to the patents on games, some of which I presented in Chapter 3, and to other types of patents encompassing human mental and physical activ-ities. It may have a broader application as well, but I leave the exploration of the breadth of this interpretation to future research. In the context of games, patents should not extend to mental activities or to activities that constitute the playing of the game. Patents are limited to functional aspects of the game, such as the hardware, or to processes that are independent of play, such as scoring or the representation of play through broadcast or graphical media. By drawing this distinction, the law respects the separation that the Court recognized more than 150 years ago in Baker and that Congress has codified in copyright law. In this way, the boundaries between two statutory fields are respected and proper protection is given to the expressive values associated with playing.

A comparison with the treatment of patentable subject matter in Europe under the European Patent Convention supports the interpretation of Baker advocated here. In Europe, patents on games, for example, are looked on with


scrutiny analogous to that applied to software and business method patents.43 While patents on gaming tools are recognized, patents on gaming rules and play are generally not allowed. This exception is based on the idea that patents should apply to the “technical arts,” or inventions that have industrial applica-tion. In Bilski, the Federal Circuit rejected such categorical exclusions (articu-lated in the United States as a technological arts exclusion) on the grounds that what constitutes technology is ever changing and ambiguous. More broadly, the Federal Circuit eschews any categorical exclusion for patentable subject matter, such as exclusions for business methods, on similar grounds. Instead, the Federal Circuit has adopted a functional approach to excluding certain types of subject matter, illustrated by its definition of physical transforma-tion or machine implementation. While the physical transformation test may have some bite, by excluding transformations that are merely legal or social, the machine implementation requirement may have no valence whatsoever. Consequently, the scope of gaming patents in the United States may be quite broad, even after the Bilski decision.

Hence, my proposed interpretation of Baker as a restriction on patentable subject matter as well as on copyrightable subject matter may provide a means to supplement the Bilski holding and perhaps even clarify it. As if drawing a line between patent and copyright, Baker seems to relegate aesthetic sub-ject matter to the domain of copyright and functional subject matter to the domain of patent. However, because much subject matter is mixed, includ-ing the accounting book in Baker, this narrow reading is not viable. More importantly, Baker is not simply about allocating subject matter to particular fields of intellectual property, but more broadly concerns subject matter that is excluded from intellectual property protection across the various regimes. The Court’s concern in Baker is with the scope of intellectual property protection and its effects on the use of the protected subject matter. The tension is that patent law does give the patentee the right to exclude others from using the protected subject matter while the copyright holder has the right to exclude only specified uses (copying, adapting, performing publicly, displaying pub-licly, distributing, and digitally audio-transmitting). The Baker decision, how-ever, suggests that we must be wary about how broadly these limitations on use are read. Patents on processes, systems, and methods, in light of Baker, should not interfere with the practice of the arts to which those apply. A patent on the accounting methods at issue in Baker should be narrowly construed to those specific protected processes, methods, and systems.

43 William Cornish & David Llewelyn, Intellectual Property: Patents, Copyright, Trade Marks, and Allied Rights (Cambridge: Cambridge University Press, 2003) 210.


Understood another way, Bilski’s holding relates to the interpretation of “process” in Section 101 of the Patent Act.44 However, Baker is much broader and relates to the meaning of the words “Inventors” and “Discoveries” in Article One, Section 8, Clause 8 of the U.S. Constitution. If the Court in Baker is declaring that processes, systems, and methods do not constitute “Writings” or the subject matter of “Author[ship]” and that these items are instead the provenance of “Inventor[ship]” and constitute “Discoveries,” then the decision invites us to dig deeper into the relationship between inventorship and author-ship. Are these mutually exclusive categories, such that all subject matter is the product of either inventorship or authorship, and never both? More realis-tically, it seems that some subject matter may not be the provenance of either. Trademarks would be the classic example, in light of the U.S. Supreme Court’s own jurisprudence. Live performances would be another example. Clearly excluded from copyright law, live performances, as a subset of the broader cat-egory of use, should also be excluded from patent law. In this way, Baker can be read as an implicit limitation on what uses the patent owner can prevent based on the scope of what the patent owner has actually invented.

It is important to note that my argument here has implications beyond gam-ing. If I am correct that Baker, when applied to patent law, places a limitation on what uses can be prevented by the patentee, my argument would apply to other activities beyond game playing, such as research. More to the point, my argument can be understood as reinforcing the distinction between using tools and learning about those tools. The tool’s patentee can prevent the for-mer use, but the latter is protected as an experimental use. In the context of gaming, patents can extend to certain gaming tools but not to the underlying gaming activities that are involved in a particular game. The argument here is that these limitations on the scope of the patent right follow from the decision of Baker, which on its surface seems to be solely a limitation on copyright. But the Court has stated that the case is about the relationship between copyright and patent; therefore, it is logical that the Court’s reasoning has implications for patent law. In light of the Federal Circuit’s recent attention to patentable subject matter, this inquiry seems even timelier.

A comparison with the European Patent Office’s treatment of patentable subject matter provides further support for the regulatory view of patent law. Under the European Patent Convention, the scope of patentable sub-ject matter is narrower than in the United States.45 The Convention expressly excludes “plant or animal varieties” and “essentially biological processes for

44 35 USC § 101.45 Greenpeace, Ltd. v. Plant Genetic Sys. N.V., 28 IIC 75 (1997).


the production of plants or animals” from patent protection. The Convention also permits the Patent Office to consider morality and ordre publique (health and safety concerns) in determining patentability. The interpretation of these limitations and their application to specific technologies has generated lit-igation and public debate in Europe. However, the judicial review of these disputes indicates a greater awareness of the regulatory purpose behind patent law. The Technical Board of Appeals within the European Patent Office gives particular attention to the regulatory purpose of patent law and the public policy considerations raised by pursuit of certain lines of scientific inquiry and technological advancement. Furthermore, the consideration of morality and ordre publique indicates that patent law is more closely intertwined with general health and safety law in Europe than in the United States. By way of contrast, U.S. patent law restricts its scope to the identification and disclosure of valuable inventions, leaving the other regulatory goals of controlling the development and use of harmful technologies to other agencies.

In summary, the broad view of subject matter of patent endorsed by Chakrabarty brings a broad range of inventions within the regulatory domain of patent law. The Chakrabarty decision itself implicitly acknowledged the view of patents as a system of regulation. Furthermore, in contrast with the European system, the U.S. patent system decouples the regulatory function of patent from other exercises of police power. This difference reflects the differ-ent regulatory structures of technology in the two systems. It also highlights the differences in the systems’ respective judgments about the relative compe-tencies of the patent office and other regulatory bodies.

One important caveat concludes this discussion of patentable subject mat-ter. Whereas the Chakrabarty court appropriately adopted a regulatory view of patents, the Supreme Court recently misstepped in applying the precedent. In its 2001 decision in J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc., the Court addressed a question left open by Chakrabarty: can utility patents be obtained for plants and plant varieties or are the Plant Protection Act and the Plant Variety Protection Act the sole basis for protection?46 The majority concluded that utility patents were not precluded by the alternative system for plant protection and reasoned that this conclusion followed inevi-tably from the Chakrabarty precedent. If, the J.E.M. majority reasoned, the Chakrabarty decision held that patentable subject matter includes everything under the sun that is man-made, then certainly plants and plant varieties have to be included.

46 534 U.S. 124, 142 (2001).


The dissenting opinion was more careful in its application of precedent. Examining the regulatory structure created by the plant protection statutes, the dissent reasoned that Congress intended to have a different system with different standards and different regulations to apply to plants than to utility patents. The dissent concluded that this regulatory structure indicated a clear Congressional intent to exclude plants from the scope of utility patents. The majority ignored the purposes behind the separate plant protection statutes and the implications of their regulatory structure. They also ignored the reg-ulatory view of patents implicit in Chakrabarty and appealed instead to the patent bargain metaphor to further broaden the scope of patentable subject matter. The dissent, however, understood the true lesson of Chakrabarty and followed it appropriately in construing the regulatory system of patent consis-tently with the regulatory system for plants. The J.E.M. decision illustrates the conflict in patent law between the social contract metaphor and the regula-tory view. A more careful consideration of these conflicting metaphors may have avoided a decision that dramatically altered the regulatory landscape created by Congress.

Two additional examples provide the background for understanding pat-ent policy and its potential application to personalized medicine. The first is from the National Academy of Science (NAS)47 and the second is from the Federal Trade Commission.48 Both agencies have produced influential stud-ies that show how patents as incentive, as tool for commercialization, and as basis for disclosure cohere into a model for regulating inventions and inven-tive activity.

In April 2004, the NAS, the research arm of Congress, released a prelimi-nary draft of a report entitled A Patent System for the 21st Century. The report offered detailed suggestions for patent reform, and although I do not agree with all the details, the assumption of the report is consistent with the regu-latory view of patent law advocated in this book. The NAS did not present patent law as a quid pro quo or use the language of social contract. Instead, it presented patent law as a means of regulating primary conduct in the innova-tion process. After describing the report’s recommendations and criteria for evaluating a patent system, I address three points from the report that help structure a regulatory patent law: (1) balancing the role of agencies and courts in regulating the innovation process; (2) reforming current patent doctrines, such as nonobviousness, within a regulatory framework; and (3) creating

47 See note 30 to this chapter.48 Fed. Trade Comm’n, To Promote Innovation: The Proper Balance of Competition in Patent

Law and Policy (2003) [hereinafter FTC Report], available at http://www.ftc.gov/os/2003/10/innovationrpt.pdf


regulatory institutions for the administration of patent law consistent with democratic governance.

The NAS report recommended seven reform measures to improve the existing patent system: (1) preserving an open-ended, unitary, and flexible patent system that accommodates new technologies within a consistent framework that can be adapted to different industries and technologies; (2) strengthening the nonobviousness standard to raise the level of patent qual-ity and to create incentives for research and development in innovative and value-added areas; (3) instituting an open review procedure; (4) expanding the financial and manpower resources of the PTO; (5) reinvigorating doc-trines, like experimental use, to shield research uses of patented inventions from liability; (6) making patent litigation more predictable by removing subjective and manipulable elements from litigation; and (7) harmonizing patent law internationally. These seven proposals can be divided into proce-dural and substantive reforms. Proposals (3), (4), and (5) are procedural; each attempts to correct the manner in which the patent system is administered. The remaining proposals attempt to alter substantive doctrines that currently hinder the efficacy of the patent system. These proposals, both substantive and procedural, were drafted with the aid of law scholars, economists, and research scientists. In fact, an overarching reform initiative that the NAS emphasized is the incorporation of input from a wide range of expertise and interests in designing patent law.

Although the report is not explicitly normative, there are several norma-tive foundations for the reform proposals. The NAS saw the patent system as a key ingredient for technological innovation and economic growth. These normative foundations are described in the report as seven criteria for gauging a patent system. These stated criteria reflect the input of legal and economic scholars as well as researchers into the review process. The criteria are, on the one hand, unsurprising and, on the other, somewhat baroque as a basis for reform. For example, the call for harmonization in criterion six begs the ques-tion of what rule should be the basis for integration. The report points to the need to harmonize the U.S. first-to-invent system with the rest of the world’s first-to-file system. Presumably, transaction costs may be lower if the United States conformed to the rest of the world. This conclusion ignores some of the benefits of a first-to-invent system over a first-to-file system; the former encour-ages a race to invent whereas the latter creates a race to the patent office that may inefficiently shift resources away from research and development. The criteria, however, are consistent with many of the themes emphasized by legal scholars writing about patent reform and, therefore, warrant attention from the scholarly community.


Although the report referred to patents as a reward for innovation, the drafters otherwise eschewed describing the patent grant in terms of a social contract. Instead, the drafters presented a regulatory view of patent law that governs primary behavior in the innovation process. Patent reform is framed partly in terms of institutional reform, specifically the balance between courts and agencies, and partly in terms of the effect of doctrine on behavior, specif-ically the impact of doctrines like experimental use on research activities. But whereas the regulatory perspective is laudable, the lack of a coherent frame-work is troubling. These instrumental goals of patent law aid in interpreting the NAS’s three key regulatory proposals: (1) balancing the role of agencies and courts in regulating the innovation process; (2) reforming current patent doctrines, such as nonobviousness, within a regulatory framework; and (3) creating regulatory institutions for the administration of patent law consistent with democratic governance.

Several of the NAS proposals would restructure the relationship between the courts and the USPTO in patent administration and litigation. Through these proposals, the NAS called for a strengthening of the resources of the PTO, an openness to patent prosecution to allow opposition from those who seek to challenge an application, and a streamlining of patent litigation. If all these proposals were implemented, the patent system would allegedly serve to balance the needs of the inventor in protecting his rights in the invention with the needs of users in having access to the invention for research pur-poses. Implicit in these proposals is a shift in administrative authority from the courts to the agency. Such a shift is motivated by both the Patent Office’s expertise as a finder of fact in technically complex and specialized areas as compared to judges and also by the cost of litigation as compared to prosecu-tion. Some scholars have questioned this presumption, arguing that because so few patents are ever litigated, shifting patent administration toward agen-cies may not really be efficient. These same scholars call for greater emphasis on litigation to identify bad patents and to police patent enforcement.

I have responded to the pro-litigation argument in two ways in previous research. First, the fact that so few patents are actually commercialized indi-cates the low quality of granted patents and the ease with which patents can be obtained. If the USPTO was performing effectively, relatively few patents would go unexploited. The agency’s role is to grant patents to deserving inven-tions, ones that licensors would want to access. The lack of commercialization may be evidence that the agency is acting as an inefficient screen of patents. Second, the screening role of the agency cannot be overemphasized. Given the types of information problems that arise in innovation markets – prob-lems that may make it difficult to realize reciprocity – the USPTO needs to


be proactive in policing patent quality as efficiently as possible. Scholars and practitioners who are skeptical of the USPTO implicitly advocate a registra-tion system for patents without acknowledging the problems of such a system. A registration system would allow the acquisition of a patent with minimal review by the USPTO. This review, however, is important to maintain patent quality and to provide direction as to what types of inventive activity should be incentivized. The NAS’s proposal to shift administration toward the agency level is consistent with the assurances of quality that would come with agency review of applications for patentability.

The shift to a greater role for the agency is also consistent with the call for clarifying patentability doctrines, such as nonobviousness, and the push toward more open patent review processes, such as an opposition system. Implicit in the proposal for strengthening the nonobviousness requirement to improve patent quality is the assumption that the agency should take a greater role in screening patent applications. This implicit assumption is embedded in the second, third, and fourth criteria for patent reform described earlier, but is not justified by the NAS report. In asserting that both judicial and administrative decisions need to be reformed, the fourth criterion leaves ambiguous the proper relationship between judicial and administrative pow-ers over the patent process. But only two of the seven recommendations apply to patent litigation: the strengthening of the experimental use defense and the removal of the doctrine of willful infringement. If all seven recommen-dations were fully implemented, patent prosecution – and hence the role of the PTO – would gain greater importance in the patent process and litiga-tion would be more streamlined. The NAS report does not justify or even address its implicit, and seemingly extreme, assumption about the relative importance of the USPTO and the courts. The report’s implicit assumption is consistent with that of a patent system and its history of an open grant by creating a more open, multilateral process through reforming administration rather than litigation.

As is the case with many areas of the law, one principal goal of patent law is to ensure reciprocity and trust in the rules that regulate the innovation process. Administrative review has a greater potential for creating such reci-procity and trust than judicial review of patents. Through properly defined and administered rules, the USPTO can resolve ex ante uncertainty over rights and produce a record of the prior art and inventiveness that is pub-licly open and reviewable. Judicial review, by contrast, resolves rights only after protracted litigation between two parties. Whereas judicial review is a public process, litigation resolves uncertainty ex post, after the parties have presented the facts and an arbiter has determined the applicable law and


applied it. For the kind of assurances needed in the innovation process, it makes sense to strengthen the prosecution process relative to the litigation process.

Furthermore, prosecution is potentially more open than litigation. The lat-ter typically involves two parties and is only triggered when there is a dispute. The former is triggered upon application of a patent and involves the appli-cant and the agency. Under current rules, the patent prosecution process is not open. However, the presence of a government agent reviewing the process offers some basis for public review and oversight of the application. The public oversight offered by the government agent should not, of course, be exagger-ated, but the final product of review is an open record that can be reviewed and that can serve as a basis for information available to all members of the public who are interested in a particular industry or technology. This public oversight of the prosecution process can be strengthened by implementing opposition and other review proceedings that allow interested parties to par-ticipate in the process. Needless to say, the administrative proceedings would increase the costs of patent prosecution, but these added up-front costs may prevent protracted infringement litigation. Administrative processes have the potential of being more open and inclusive than litigation, so the preference for administrative review is justified within the broad goals assuring reciproc-ity and trust in the patent system.

But once reciprocity and trust are seen as the motivations for patents as a regulatory system, two problems become apparent in the NAS report. The first is the amount of deference granted to the findings of the PTO, specif-ically the question of the presumption of patent validity. The second is the relationship between patent law and competition policy. The report pays very little or no attention to each of these points, even though they are crucial to how we should understand patent reform.

The question of proper deference to the USPTO is an ongoing controversy. In 1999, the Supreme Court held in Dickinson v. Zurko that the standards of the Administrative Procedure Act (APA) are applicable to judicial review of factual findings by the PTO.49 Contrary to some perceptions, the Court did not hold that the USPTO was an agency under the APA, but assumed it, fol-lowing the stipulation of the parties. Nonetheless, the application of the APA meant that at some level the courts had to accord the USPTO some defer-ence. Subsequent rulings by the Federal Circuit weakened this deference in two ways. The first was through judicial determination of what constituted an agency finding of fact, which requires deference, and an agency finding

49 527 U.S. 150, 152 (1999).


of law, which does not.50 In the remand from Zurko, for example, the Federal Circuit found that what was purported to be an agency finding of fact was really “official notice,” the administrative equivalent of judicial notice, and therefore could be reviewed de novo in the nonobviousness determination.51 The second way that subsequent rulings weakened Zurko was by distinguish-ing between levels of deference. The Supreme Court rejected the clearly erroneous standard of review in Zurko, but was unclear as to whether the sub-stantial evidence standard or the arbitrary and capricious standard, both rec-ognized under the APA, was the appropriate alternative.52 The Federal Circuit ruled, after Zurko, that the less deferential substantial evidence standard was applicable.53 The Zurko decision demonstrates that without proper consider-ation of the deference question, judicial review can undo a simple shift of authority from the courts to the PTO. The failure of the NAS report to address the issue, regardless of the resolution, is a major weakness.

The problem of deference is exacerbated by the problem of expertise. The presumption of deference for fact-finding in the APA rests on the assumption of agency expertise in the field of regulation. At the same time, the estab-lishment of the Federal Circuit – an appellate court charged with reviewing appeals in patent cases – was based on the need for judicial expertise in the area of patents. Clearly, agency deference in the field of patents cannot be based solely on expertise, unless there is some basis for assuming that agencies are more expert than courts. Orin Kerr finessed this question by arguing that the USPTO is a different administrative agency from the public law agencies (such as the FTC or OSHA) to whom the APA was meant to apply.54 Patent law is about private rights, so no deference is mandated, he concludes. But the matter is not so simple. Patent law is regulatory in the sense that its goal is to regulate primary conduct. The regulatory goal is implemented through an agency, the PTO. Admittedly, the USPTO has a different mission from other agencies, but as a functional matter, it carries out similar administrative tasks in reviewing applications and making decisions about grants and denials. If these ministerial tasks have any meaning, and are not meant to be simply undone or duplicated by courts, some degree of deference is due. The ques-tion is, how much?

50 Arti Rai, “Engaging Facts and Policy: A Multi-Institutional Approach to Patent System Reform,” 103 Colum. L. Rev. 1035, 1056 (2003)

51 In re Zurko, 258 F.3d 1379, 1384–1385 (Fed. Cir. 2001).52 258 F.3d at 1381.53 In re Gartside, 203 F.3d 1305 (Fed. Cir. 2000).54 Orin Kerr, “Rethinking Patent Law in the Administrative State,” 42 Wm. & Mary L. Rev. 127,

129 (2000).


The answer may rest on one specific area of deference that has been the focus of debate, and a specific focus of reform for the FTC: the presumption of validity of a patent.55 The current Patent Act expressly grants a presumption of validity to a granted patent in any judicial proceeding. This presumption, as the FTC report demonstrates, has been criticized for allowing invalid patents to survive judicial scrutiny and serve as the basis for anticompetitive patent litigation. As I discuss later, the presumption of validity is perhaps not the source of the problem. For addressing the problem of adequate deference, however, the presumption of patent validity provides a useful model. I propose that the USPTO be granted deference but only for ministerial acts such as determining that an application is novel and nonobvious, given the prior art disclosed during patent prosecution. However, the court should give no defer-ence to the scope of the prior art and should be allowed to review de novo the relevant prior art and the patentability of the invention given the expanded prior art. This proposed standard of deference differs from existing law in two ways. First, it is narrow, applying only to ministerial acts by the PTO. Second, it would apply to determinations of validity and invalidity equally.

My proposed standard of deference would, if adopted in conjunction with the other proposals to make the prosecution process more open, aid to ensure the needed sense of reciprocity and trust necessary for patent reform. The proposed standard would also address the problems of anticompetitive patent litigation. While the NAS report does not directly address this issue, the 2003 FTC report does. In fact, the anticompetitive use of patents works to under-mine the integrity of innovation markets as well as reciprocity and trust in the patent system. For these reasons, the FTC recommendations should be understood as complementary to those of the NAS.

The FTC recommendations relate to two central arguments in my over-view of patent policy. First, my regulatory theory of patent law would sup-port a broad scope of patentable subject matter as well as a separation of the patentability decision from exercises of state police power for the purposes of improving public health, safety, and welfare. Second, patent reform, such as the recommendations from the NAS, should be guided by the need to support reciprocity and to generate trust both in the innovation process and the pat-ent system. In this section, I turn to the controversial question of the proper relationship between patent law and competition policy. I argue that the administration of patents should be guided by the goals of competition policy. This point is consistent with the argument of separation between patentability and the exercise of the police power because it applies to patent infringement

55 FTC Report, supra note 48, Executive Summary; 35 U.S.C. §282 (2000).


and antitrust litigation. The point is also consistent with my emphasis on the values of reciprocity and trust, a critical aspect of patent policy. Promoting reciprocity and trust and creating market integrity require a recognition of the intimate relationship between patent law and competition policy.

In 2003, the FTC released a report entitled To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy.56 The recommen-dations of the report overlap with and are complementary to those of the NAS report. Whereas the NAS report presents seven insights into evaluating patent reform, the FTC report essentially has one: competitive markets are a key to innovation. To address this insight, the FTC presents ten recommendations for patent reform designed to better align patent policy and competition law. The recommendations, briefly, are:

1) Create post-grant review of and opposition to patents within the PTO;2) Lower the standard for challenging patent validity by replacing a clear

and convincing evidence standard with a preponderance of the evi-dence standard;

3) Raise the standards for nonobviousness by (1) tightening the commer-cial success test and (2) evaluating inventions that are a combination of or modification to the prior art from the standards of creativity and problem-solving skills that are representative of those having ordinary skill in the art;

4) Adequately fund the PTO;5) Implement internal reforms to the USPTO that permit a more rigorous

collection and review of prior art references;6) Consider possible harm to competition before extending the proper

scope of subject matter;7) Require publication of all patent applications eighteen months after

filing;8) Create intervening or prior user rights;9) Require either actual written notice or actual knowledge for a claim of

willful infringement;10) Encourage the USPTO and the Federal Circuit to consider economic

learning and competition policy in patent law decision making.57

Although I agree with the FTC report in spirit, I am skeptical of some of the specific recommendations. Expanding the funding of the PTO, chang-ing the standard of review for challenging validity, and limiting the scope of

56 See note 48 to this chapter.57 See note 48 to this chapter at 10–17.


patentable subject matter each seem questionable. Given that the USPTO is one of the few government agencies to show a surplus through its activities and that the legislative impetus to appropriate this surplus keeps reappear-ing in each Congressional session, the funding of the USPTO is arguably a compelling issue, particularly for addressing competition issues. The shift in the standard of review is a potential invitation for protracted and unnecessary litigation, whereas the narrowing of patentable subject matter is questionable. However, the calls for an opposition proceeding, for intervening and prior user rights, and for reform of willful infringement are each promising. My goal here is not to critique each of the recommendations. Instead, the FTC’s focus on the relationship between patent law and competition policy is impor-tant for developing a regulatory theory of patent law and complementary to the goals of strengthening the role of the PTO, as the NAS recommends. Many of the recommendations in the FTC report have been implemented in the America Invents Act, the 2011 patent reforms to the U.S. Patent Act.

This section has presented an extensive summary of the major issues that inform patent policy. While three functions typically explain patents, incen-tives, tool for commercialization, and disclosure, the policies underlying pat-ent law are deep and controversial. With this background, I now present three larger theories of patents, which will be important in understanding policies toward personalized medicine patenting.

Incentive Theory

Patents are typically understood as providing an incentive for potential inven-tors and innovators to develop a useful, novel, and nonobvious process or product.58 Put most starkly, the promise of market exclusivity, and the result-ing economic rents, provided by the patent grant attracts individuals to allo-cate resources to the process of invention.59 With this goal in mind, congress calibrates the patent grant through the terms of patent so as to structure incen-tives to “promote progress in the useful arts,” following the constitutional mandate.60

58 See Mark A. Lemley, “Ex Ante and Ex Post Justifications for Intellectual Property,” 71 U. Chi. L. Rev. 129, 134–137 (2004) (comparing justifications for intellectual property based on incen-tives for creation with justifications based on incentives for marketing); Robert P. Merges, “Commercial Success and Patent Standards: Economic Perspectives on Innovation,” 76 Cal. L. Rev. 803, 805 (1988).

59 See, e.g., Henry E. Smith, “Intellectual Property as Property: Delineating Entitlements in Information,” 116 Yale L. J. 1742 (2007); Mark F. Grady & Jay I. Alexander, “Patent Law and Rent Dissipation,” 78 Va. L. Rev. 305 (1992).

60 U.S. Const. Art. I, Section I, Cl. 8.


According to the incentive theory, whether racial categories in patent law are desirable depends on the meaning of progress.61 If progress means pure economic returns to the total wealth in society, then racial categories arguably should be largely irrelevant to the grant of a patent.62 The scope of a patent should rest on the economic benefits of an invention, which need not be cor-related with any racial dimensions or uses. This last point implicitly assumes a liberal economic view of racial categories, which, as I discuss later, assumes that race is a veil masking meritorious factors that support economic develop-ment and progress.63 Under this liberal economic assumption, the use of racial categories is either an unfortunate use of language or a distraction from the goals of economic growth.

Progress, however, may also be consistent with the use of racial categories. If the goal of maximizing economic wealth is distorted through racial dis-crimination, then the patent grant could arguably be used to target inventive activity aimed at correcting racial discrimination.64 For example, if medical research has historically ignored the study of diseases prevalent among certain minority groups with the result that aggregate economic wealth is less than it could be, then the patent grant can be structured with the use of racial cat-egories to correct this incorrect allocation of resources.65 A similar argument

61 See Dotan Oliar, “Making Sense of the Intellectual Property Clause: Promotion of Progress as a Limitation on Congress’ Intellectual Property Power,” 94 Geo. L. J. 1771 (2006); Adam D. Moore, “Intellectual Property, Innovation, and Social Progress: The Case Against Incentive Based Arguments,” 26 Hamline L. Rev. 601 (2003).

62 This statement follows from the argument that race is irrelevant to productivity and racial discrimination will be rooted out through competitive markets without the intervention of the state. For the classic statement of this argument in the economics literature, see Gary S. Becker, The Economics of Discrimination (Chicago: University of Chicago Press, 1971). For a popular version of this argument that parallels the classic economic argument, see Joseph L. Graves, Jr., The Race Myth: Why We Pretend Race Exists in America (New York: Penguin, 2004) 203–207. For a response by economists to these arguments, see William A. Darity, Jr. & Patrick L. Mason, “Racial Discrimination in the Labor Market,” in David Colander et al., eds., Race, Liberalism, and Economics (Ann Arbor: University of Michigan Press, 2007) 194–200.

63 The liberal theory of race is delineated later in the chapter. The view that race is a veil is an example of color-blindness. For an analysis of this position, see Glenn C. Loury, The Anatomy of Racial Inequality (Cambridge, MA: Harvard University Press, 2002) 112–113 (con-trasting what he calls race blindness with race egalitarianism).

64 See Loury, idem., for a discussion of this position, which he calls race egalitarianism. For the classic, economic statement that some government intervention may be needed to cor-rect racial discrimination, see Kenneth J. Arrow, “The Theory of Discrimination,” in Orly Ashenfelter & Albert Rees, eds., Discrimination in Labor Markets (Princeton: Princeton University Press, 1973) 3–33.

65 For this history of racial bias in scientific research and experimentation, see Harriet A. Washington, Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present (New York: Doubleday, 2006); John P. Jackson,


could be made for the race-friendly toys and racially targeted hair and skin products discussed in the previous chapter. According to this argument, racial categories in patent law are a corrective measure to redress discrimination in the choice of inventive activities. Whereas this argument has been couched in terms of wealth maximization, a similar argument would follow if progress were understood in terms of equity as well as wealth maximization.66 Under this broader criterion for progress, racial categories in patent law serve a redis-tributive function to promote inventions to meet underserved and unrepre-sented needs.

Simplistic in its terms, the incentive theory provides the most straightfor-ward understanding of racial categories: they are desirable if consistent with progress in the useful arts. The difficult normative work arises in how progress is understood, particularly in racial terms. According to the incentive theory, the assessment of racial categories in patent law depends on the connection between racial categories and the appropriate measure of progress, which reflects the normative view of race more broadly.

Market Theory

As a subset of incentive theory, the market theory of patents views the patent grant as an instrument to create incentives for the commercialization of inven-tion, a tool not solely for invention but also for innovation.67 However, market theory is not simply an explanation based on incentives. Under the terms of market theory, the patent grant should be designed to reflect market needs and the ability of the patent owner to shape the commercial path of innovation. While the incentive theory assesses patent law solely in terms of the returns to invention as a lure for inventive activity, the focus of market theory is on how patent law reflects the forces of demand and supply in the marketplace.

Jr., Science for Segregation: Race, Law, and the Case against Brown v. Board of Education (New York: NYU Press, 2005) 19–42; Charles Weijer & Robert A. Crouch, “Why Should We Include Women and Minorities in Randomized Control Trials?,” in Ezekiel J. Emanuel et al., eds., Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary (Baltimore: Johns Hopkins University Press, 2003) 171–172; Edward J. Larson, Sex, Race, and Science: Eugenics in the Deep South (Baltimore: Johns Hopkins University Press,1995); Bonnie P. Spanier, Im/Partial Science: Gender Ideology in Molecular Biology (Bloomington: Indiana University Press, 1995); William H. Tucker, The Science and Politics of Racial Research (Urbana-Champaign: University of Illinois Press, 1994).

66 See Loury, supra note 63 to this chapter at 115–117 (discussing egalitarian arguments against color-blindness).

67 See Edmund W. Kitch, “The Nature and Function of the Patent System,” 20 J. L. & Econ. 265, 271 (1977); F. Scott Kieff, “IP Transactions: On The Theory and Practice of Commercializing Innovation,” 42 Hous. L. Rev. 727, 743 (2005).


The incentive theory is sometimes referred to as an ex ante theory of intellec-tual property because of the theory’s focus on activities prior to the making of the invention. By contrast, the market theory is referred to as an ex post theory because of the emphasis on how the invention is disseminated after it is made.68

Assessing racial categories under the market theory requires more than establishing a connection between patents and progress. Initially, the mar-ket theory assumes that connection through the link between patents and commercialization. But the normative implications arise from how the details of patent law are driven largely by considerations of commercialization. For example, the market theory would imply that secondary considerations should play a greater role in the nonobviousness determination than considerations of technical novelty.69 Furthermore, the market theory would place greater emphasis on licensing practice as the means to disseminate inventions, imply-ing, for example, a narrower role for defenses to infringement, such as exper-imental use or repair.70 As applied to racial categories, the critical question is the role of race in defining markets. To the extent that the use of race is anti-thetical to the goals of commercialization, racial categories should be avoided in the patent grant.

The connection between race and markets is largely a question of the nor-mative framework for racial categories, to be discussed in more detail later under liberal and critical perspectives on race.71 In terms of the normative foundations of patents, the appropriateness of racially defined markets is par-allel to the issue of how broadly or narrowly commercialization should be understood. If one accepts the view that patent law requires the commercial-ization of every possible variation of an invention, then defining markets in terms of race would be as appropriate as defining markets in terms of any other possible use of the invention.72 However, if one accepts the view that patent

68 See Lemley, note 58 to this chapter.69 See Merges, note 58 to this chapter.70 See F. Scott Kieff, “Facilitating Scientific Research: Intellectual Property Rights and the

Norms of Science – A Response to Rai and Eisenberg,” 95 Northwestern University L. Rev. 691, 693 (2001).

71 For an analysis of the racially defined markets and commercialization based on racial target-ing, see Emma Coleman Jordan & Angela P. Harris, When Markets Fail: Race And Economics (St. Paul: Foundation Press, 2006) 444–485 (describing the market for counterculture). For a striking example of race-conscious commercialization, see Felecia R. Lee, “Network for Blacks Broadens Its Schedule,” The New York Times, July 9, 2007, B1, B7 (describing program-ming on Black Entertainment Television).

72 See, e.g., David Dante Troutt, “A Portrait of the Trademark as Black Man: Intellectual Property, Commodification, and Redescription,” 38 U.C. Davis L. Rev. 1141 (2005) (provid-ing an example of how a human person can become commodified through intellectual


law mandates non-commercialized spaces, sometimes referred to as the pub-lic domain, then the question becomes whether commercialization based on race goes too far.73

Scholars have debated the scope of commercialization in patent law in terms of cumulative innovation, sometimes referred to as the “shoulders of giants effect.”74 According to this view, innovators need to borrow from prede-cessors in order to perfect inventions and promote progress. If the scope of pat-ent commercialization is too broad, current patent owners may be hesitant in licensing future innovators for fear of obsolescence or competition. Therefore, the argument goes, the scope of commercialization needs to be narrowed – for example, through such doctrines as experimental use.75 The implications of this argument for racial categories are not immediately clear. There is no reason to think that cumulative innovation would be directly impeded by racially tailoring an invention. But there is the risk, however, that racial cat-egories may lead to segregation of research efforts along racial lines.76 To the extent that allowing racial categories leads to divisions of research based on white populations and research based on black populations, as may perhaps happen in the fields of biomedical or pharmacogenetic research, the use of racial categories may inhibit cross-fertilization and synergies among research-ers and innovators.77 In other words, race-specific patents may lead to the anti-commons problems reported by policy makers and scholars, with too many patents too narrowly drawn being issued to too many disparate players.78

To summarize, to the extent the market theory is viewed as a subset of the incentive theory, the analysis of the previous subsection applies. However, the market theory introduces unique problems of its own, such as the problems created by allowing patents to be commercialized too broadly. Finally, just as the assessment of racial categories under the incentive theory rests on the

property law). For an exegesis of the trend toward commodification, see Margaret Jane Radin, Contested Commodities (Cambridge, MA: Harvard University Press, 1996).

73 See David Lange, “Reimagining the Public Domain,” 2003 Law & Contemp. Problems 463 (2003); Pamela Samuelson, “Enriching Discourse on Public Domains,” 55 Duke L. J. 783 (2006).

74 See Suzanne Scotchmer, “Standing on the Shoulders of Giants: Cumulative Research and the Patent Law,” 5 J. Econ. Persp. 29, 31 (1991).

75 See, e.g., Tom Saunders, “Comment: Renting Space on the Shoulders of Giants: Madey and the Future of the Experimental Use Doctrine,” 113 Yale L. J. 261 (2003).

76 See Mark Rothstein, “Legal Conceptions of Equality in the Genomic Age,” 25 Law & Ineq. 429 (2007).

77 See Dorothy E. Roberts, “Legal Constraints on the Use of Race in Biomedical Research: Towards a Social Justice Framework,” 34 J. L. Med. & Ethics 526 (2006).

78 Michael Heller & Rebecca S. Eisenberg, “Can Patents Stifle Innovation? The Anticommons in Biomedical Research,” 280 Science 698 (1998).


connection between race and progress, so the assessment under the market theory rests on the connection between race and commercialization efforts.

Cultural Theories

Patent law in particular, and intellectual property more broadly, have been justified as an instrument to promote civil society by creating a system of economic and property rights that allow for civic participation and market engagement.79 The emphasis from this perspective is not on the financial incentives to create and to commercialize inventions, but on the development of and access to knowledge. Yochai Benkler, for example, speaks about social production and the role of intellectual property laws in promoting collabora-tion among creative peoples, both makers and users.80 The rules of patent law should be designed to facilitate such collaboration and the social accumula-tion of knowledge. Madhavi Sunder, to provide another example, has written on the parallels in intellectual property and identity politics and highlighted how the confluence of economic, political, and civil rights shape the contem-porary debate over the structure of legal systems.81 These two scholars, and several others,82 have broadened the stakes for intellectual property, and their ideas demonstrate how patents are instrumental in the formation of civil soci-ety grounded in a knowledge-based economy.

As a normative framework, cultural theories would assess patent laws in terms of the promotion of the values of openness, political freedom, and eco-nomic justice. Promoting progress, under the cultural theories of patents, implies not the maximization of wealth or the commercialization of inven-tions, but assuring access to knowledge and resources necessary for human flourishing and community development. With respect to the racialized pat-ents, cultural theories would suggest that the use of racial categories would be justified if they served these humanistic goals. In this regard, Holbrook’s

79 See Peter K. Yu, “The International Enclosure Movement,” 82 Ind. L. J. 827 (207); Neil Weinstock Netanel, “Copyright and a Democratic Civil Society,” 106 Yale L. J. 283 (1996); Shubha Ghosh, “Globalization, Patents, and Traditional Knowledge,” 17 Colum. J. Asian L. 73 (2003).

80 Yochai Benkler, The Wealth of Networks: How Social Production Transforms Markets and Freedom (New Haven: Yale University Press, 2006) 91–130.

81 See Madhavi Sunder, “IP3,” 59 Stan. L. Rev. 257, 272–274 (2006).82 See Keith Aoki, “Distributive and Syncretic Motives in Intellectual Property Law (With

Special Reference to Coercion, Agency, and Development),” 40 U.C. Davis L. Rev. 717, 742 (2007); Margaret Chon, “Intellectual Property and the Development Divide,” 27 Cardozo L. Rev. 2821, 2830 (2006).


notion of the expressive impact of patents resonates. The presence of racial categories in patents – documents issued by the federal government – demonstrates an endorsement for a particular view of race. If the use of race is disparaging or stereotypical, such as with the reference to Negroes stealing chickens, or through the more than occasional reference to a racial epithet, then the government is acknowledging the background racism and stereo-types that would otherwise by voiced privately. If the patent document, on the other hand, evokes positive views of African Americans, affirming certain cultural tropes and artifacts from a racially defined community, then the gov-ernment endorsement serves a positive goal that promotes the inclusion of diverse groups. Assessing racial categories in patent law requires distilling the message being sent by the patent. If the message is one of openness, political freedom, and economic justice, then cultural theories would endorse the use of racial categories in patent law.

This analysis, however, assumes that patents serve largely a symbolic func-tion as a signal of specific positions that the state should or should not endorse.83 But the patent instrument is inherently a tool for openness. Protection through a patent substitutes for protection through secrecy.84 If patents sending nega-tive signals about race should be suppressed or denied, then the government would be encouraging secrecy. Holbrook’s notion of the expressive impact implicitly assumes that denying a patent means that the troubling invention, attitude, or signal will disappear from the public realm. This is true in the trivial sense that the expression will not be publicized, but it is not true that it will be converted into a more positive signal. If Holbrook is correct that pat-ents have an expressive impact, then what the government should do in some instances is publicize the negative message and counter it. Just as the answer to negative speech is more positive speech, so the answer to bad patent signals is positive patent signals and not the relegation of improper uses of racial cat-egories to the domain of secrecy.85

What this suggests is that assessing the use of racial categories rest on more than the mere suppression of bad signals. Instead, patent law needs to pro-mote openness, freedom, and justice through greater access to the process of how patents are assessed and to greater dialogue about the meaning of race. Here, we move beyond the scope of this book to the larger questions of how

83 See Holbrook, supra note 4 at 583.84 See Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470 (1974).85 See Robert Post, “Reconciling Theory and Doctrine in First Amendment Jurisprudence,”

88 Cal. L. Rev. 2353, 2363 (2000) (construing the marketplace of ideas for the First Amendment).


to structure the system of patent prosecution and review.86 For the narrower purposes of this book, the argument I am making here is that cultural theories of patent need to consider institutions other than the patent system to assess patent law.87 If patents are a form of expression and state endorsement, then the meaning of racial categories in patents depends on the meaning of race within other institutions, such as the gaming establishments or the schools or the health care facilities or the shopping centers in which the patented inven-tions will be practiced. Racial categories in patents need to be assessed, there-fore, against the broader culture within which the inventions are made and used. Therefore, even more than under the incentive and market theories of patents, the assessment of racial categories in patent law depends on address-ing contested theories of race within culture more broadly.

To summarize: the incentive theory, the market theory, and cultural theo-ries would assess the use of racial categories in patent law in terms of wealth maximization, the benefits of commercialization, and the creation of open civil society, respectively. But understanding the propriety of using racial cat-egories under each of these theories requires understanding, in turn, the con-nection between race and wealth creation, race and markets, and race and culture. To complete this part of the puzzle, I turn next to the issue of liberal and critical theories of race.

The Perspective of Liberal and Critical Race Theories

Both liberal and critical theories of race demonstrate a commitment to prin-ciples of nondiscrimination, democracy, and equal treatment. The two theo-ries differ, however, in the ability of the institutions of market and democracy to correct for historically rooted and long-standing fears and animus defined in racial terms. In this section, I present liberal and critical theories of race that will provide the basis for assessing the use of racial categories in pat-ent law. In the immediately following section, I synthesize these theories of race with the theories of patents discussed in the previous section to develop an analytical taxonomy of approaches for assessing the patents described in Chapter 3.

86 For an exploration of these issues, see Adam Jaffe & Josh Lerner, Innovation and Its Discontents: How Our Broken Patent System Is Endangering Innovation and Progress, and What to Do About It (Princeton: Princeton University Press, 2004).

87 This point is an illustration of the embeddedness of economic, and legal, institutions within culture. See Mark Granovetter, “Economic Action and Social Structure: The Problem of Embeddedness,” 91 American Journal of Sociology 481–510 (1985).


Liberal Theories of Race

Color-blindness is the hallmark of liberal theories of race.88 There are, how-ever, various shades of color-blindness. At the ideal level, proponents of liberal theories aspire to a world in which decisions about the allocation of market resources and the distribution of political power are made without any consid-eration of race. What this means in practice is that such decisions are made on the merits of the situation and the character of the individual participants. A less idealistic view would recognize that power often, perhaps always, plays some role in the functioning of markets and of politics, but the exercise of eco-nomic and political power needs to be absent of racial considerations. Color-blindness does not, however, mean social homogenization of either skin tones or culture. Most liberal theorists of race would celebrate a healthy pluralism, the clichéd melting pot.89 But such diversity in the public realm is a reflec-tion of individual group identity rather than subordination of or discrimina-tion against groups. There is, however, a sense that once racial difference is understood as irrelevant to individual decision making in any context, racial difference will go away to be replaced with a mutual respect for individual autonomy and self-creation.

Liberal theories of race retreat from the principle of color-blindness in many instances. In defining the cultural sphere, race can arise as a healthy and much needed ingredient to the promotion of a vibrant and healthy work-force and marketplace.90 Race may also be an element in remedies for past discrimination and continuing obstacles that are historical relics from less lib-eral times.91 Therefore, in the affirmative action debate, race can be a factor to

88 See Andrew Kull, The Color-Blind Constitution (Cambridge, MA: Harvard University Press, 1992) (exploring the implications of Justice Harlan’s dissent in Plessy v. Ferguson); John A. Powell, “The Colorblind Multiracial Dilemma: Racial Categories Reconsidered,” 31 U.S.F. L. Rev. 789 (1997); Jerry Kang, “Cyber-Race,” 113 Harv. L. Rev. 1130, 1154–1160 (1999).

89 See Peter H. Schuck, “The Perceived Values of Diversity, Then and Now,” 22 Cardozo L. Rev. 1915, 1927–1928 (2001).

90 Judge Alex Kozinski illustrated this point vividly when he described an affirmative action plan in Seattle designed to racially integrate elementary schools as giving “the American melting pot a healthy stir without benefiting or burdening any particular group.” Parents Involved in Community v. Seattle School, 426 F.3d 11162, 1196 (9th Cir. 2005) (Judge Kozinski’s concurrence to majority opinion upholding the plan). The U.S. Supreme Court reversed the decision, with Chief Justice Roberts asserting the color-blind position: “The way to stop discrimination on the basis of race is to stop discriminating on the basis of race.” Parents Involved in Community, supra note 14 at 82.

91 See Adarand Constructors, Inc. v. Pena, 515 U.S. 200, 253–255 (1995) (adopting strict scrutiny for use of racial classifications by federal government and remedying past discrimination may serve as a compelling interest if narrowly tailored).


be considered in some public decision making but only in a narrowly tailored remedial fashion to correct for specifically identified instances of past group discrimination.92 Furthermore, race can be used sometimes in the university admissions context to promote the goals of diversity, specifically in public ser-vice professions such as law.93 Race, however, is a constitutional suspect class and only very narrow policy justifications can support its use.94

Economist Glenn Loury has written about the complexities posed for lib-eral theories of race by the principle of color-blindness.95 In the 1980s, Loury was a staunch conservative with respect to race, advocating a strict color-blind position that mandated self-help and the avoidance of the culture of victim-hood.96 Recently, Loury has made an about-face for pragmatic reasons and has espoused a critique of strict color-blindness. In his The Anatomy of Racial Inequality (2002), given as the W.E.B. DuBois Lecture at Harvard in 2000, Loury posits three axioms: (1) race is socially constructed; (2) race is not an essentialist category, but a social artifact; and (3) as a socially constructed cat-egory, race has result in the creation of stigma and prejudicial attitudes harm-ful to racialized groups.97 In addition to these axioms, Loury identifies three contexts in which racial categories are used: (a) policy implementation; (b) policy evaluation; and (c) civic construction of a nation’s shared purpose and common fate.98 He argues that color-blindness is appropriate only for public decision making in the third for a, but not in the first two. He argues that color blindness is appropriate for the civic construction of a nation’s shared pur-pose and common fate, but not for policy implementation and evaluation.99 Specifically, racial categories should not be considered in the broad mandate of an open and inclusive society, but should be considered in the areas of policy implementation and policy evaluation in order to reach the goal of an open and inclusive society.100

Loury presents a pragmatic approach to color-blindness, one that acknowledges the failure of a strict color-blind position to combat continuing

92 See Grutter, note 8 to this chapter at 328–332; Gratz v. Bollinger, 539 U.S. 244 (2003).93 See Grutter, note 8 to this chapter.94 See Johnson, note 5 to this chapter.95 Loury, note 63 to this chapter at 8–11.96 Professor Loury’s early conservative position was stated in Glenn C. Loury, “A New American

Dilemma,” December 31, 1984. An about-face can be seen in the article, Glenn C. Loury, “How to Mend Affirmative Action,” 127 The Public Interest 33–43 (1997).

97 Loury, note 63 to this chapter at 5.98 Idem. at 148–149.99 Idem. at 150–152.

100 Idem. at 153.


stereotypes and animus based on race. The approach almost, but not quite, echoes the critical theory position presented later: almost, because of the emphasis on the recognition that race continues to be debilitating; not quite, because of the appeal to assimilation. Liberal theories of race falter around the principle of assimilation.101 On the one hand, assimilation supports the goal of inclusion and leads to fairness and equality of opportunity. On the other hand, assimilation can deny difference by mandating that individuals comport their distinctiveness and cultural affiliations to the will of the majority. Pragmatic turns appeal to concepts like diversity or pluralism or phrases like “rainbow republicanism” to accommodate difference to the color-blind principle.102 Such accommodation leads to charges of balkanization and fragmentation of public spaces and the call for a return to strict color-blindness.103 Loury’s approach attempts to recognize the use of racial categories as an instrument to reach certain policy goals while retaining an open, inclusive civic sphere demarcated along assimilationist lines.

The connections between race and wealth maximization, between race and markets, and between race and culture can be understood against the liberal goal of assimilationism. Under the color-blind principle, in both the strict and pragmatic forms, race should be irrelevant to the goals of wealth maximization and therefore needs to be expunged as a category. More prag-matic forms, however, would recognize that racial animus and the persistence of past discrimination requires consideration of race in the implementation of particular policies, such as admissions or the award of other public benefits. Therefore, the intersection of wealth maximization and color-blindness would support the use of racial categories to reach the goals of corrective justice to remedy past harms.

Liberal theories of race would find little room for racial categories in the market sphere. In such an arena, willing buyers and willing sellers should coor-dinate solely in order to engage in voluntary, mutual enhancing transactions. While liberal theorists would not deny that the specter of race can appear in the market sphere, the animus arising from race can be cured through proper implementation of race-conscious policies in the public sphere through anti-discrimination laws or through race-conscious policies in providing benefits,

101 See, e.g., Ian F. Haney Lopez, “‘A Nation of Minorities’: Race, Ethnicity, and Reactionary Colorblindness,” 59 Stan. L. Rev. 985, 993 (2007).

102 See Kathleen Sullivan, “Comment: Rainbow Republicanism,” 97 Yale L. J. 1713, 1716 (1988) (arguing against a civic republican view of social pluralism in favor of a structure of private voluntary associations that are independent from the purview of the state).

103 See Lopez, supra note 101 at 996.


such as education. When racial pluralism arises in the market arena, for example, through the development of enclave or ethnic markets, within which members of certain racially or ethnically defined groups trade with each other, racial categories are a useful tool to promote diversity and cultural pluralism in the marketplace.104 Such appeal to “rainbow commercialism” would support the use of racial categories as brands, or trademarks, much like the use of colors as a trademark upon the showing of secondary meaning, through which sellers and buyers can signal to each other their willingness to engage in beneficial trades.105 Racial signals of this sort serve to invite inclu-sion rather than impose exclusion. As a result, the civic sphere, which includes the market, is enriched.

Finally, when liberal theories of race connect racial categories with culture, the result is the promotion of diversity.106 The appeal to diversity does not arise from a rejection of the color-blindness principle, but as a necessary comple-ment to the goal of assimilationism. If the difficult truth is that it is illiberal to abolish difference, whether racial or otherwise, while moving toward the goal of assimilation and inclusiveness, then difference is accommodated by creating a zone within the civic sphere in which difference can flourish but not intrude into the workings of politics or the market. This sphere of cultural diversity is one in which racial categories can be tolerated, even encouraged, as individuals can play out their racial or ethnic identities through celebra-tion of festivals and displays of costumes and customs. The cultural sphere provides an escape hatch from the color-blind realm that allows markets and politics to function in a seemingly neutral manner. Differences are recog-nized with the understanding that they will be put aside in the boardroom and the political arena.

These positions are summarized in Table 4.1. However, a complete under-standing of how racial categories function within patent law requires con-sidering critical theories of race as well, which is the subject of the next section.

104 See, e.g., Lan Cao, “The Diaspora of Ethnic Economies: Beyond the Pale?,” 44 Wm. & Mary L. Rev. 1521, 1530 (2003) (although not using the term “rainbow commercialism,” illustrating the point through an analysis of ethnic enclaves and markets in major global cities). For a striking example of this phenomenon, see American Multicultural Marketing, http://ameri-canmulticultural.com

105 See Susan Scafidi, Who Owns Culture?: Appropriation and Authenticity in American Law (New Brunswick: Rutgers University Press, 2005) 151 (proposing trademark-like protection for culture identities in commodified public spaces).

106 See Will Kymlicka, Multicultural Citizenship: A Liberal Theory of Minority Rights (Oxford: Oxford University Press, 1995) 23–31; Amartya Sen, Identity and Violence: The Illusion of Destiny (New York: W.W. Norton, 2006) 149–152.


Critical Theories of Race

As a general proposition, critical theories of race express skepticism of the overly optimistic goal of assimilationism that is the hallmark of liberal theories.107 The criticism is aimed in part at the assumption within liberal theories of the neutrality of assimilation, which serves to mask the way in which economic and political power continues to be distributed on racial lines even after the remedies provided by civil rights laws.108 Many scholars emphasize how such remedies have failed to provide genuine economic and political power to those who have been subordinated by racial animus and stereotypes.109 The goal of critical scholarship is to transform legal institutions in a way that implements the principle of anti-subordination and engenders genuine empowerment rather than assimilation within an economic and political structure that is majoritarian and exclusive while purporting to be assimilationist and inclusive.110

Critical theorists contrasts with liberal theorists on two counts. First, liberal theories demonstrate a commitment to liberty, particularly freedom from dis-criminatory conduct based on racial identity.111 However, such freedom may not translate into actual opportunity and a more equal division of resources as antidiscrimination norms become construed and applied narrowly to per-mit the efficient functioning of markets and governments. The liberal ideal of assimiliation assumes that once formerly subordinated groups are free to participate in markets and politics, the forces of competition will allow the groups and individuals within them to flourish. But this vision assumes that

107 See Kenji Yoshino, “Covering,” 111 Yale L. J. 769, 772 (2002).108 See Alan Freeman, “Legitimizing Racial Discrimination Through Antidiscrimination Law:

A Critical Review of Supreme Court Doctrine,” 62 Minn. L. Rev. 1049 (1978); Lani Guinier, “The Triumph of Tokenism: The Voting Rights Act and the Theory of Black Electoral Success,” 89 Mich. L. Rev. 1077 (1991); Reva Siegal, “Why Equal Protection No Longer Protects: The Evolving Forms of Status-Enforcing State Action,” 49 Stan. L. Rev. 1111 (1997).

109 See, e.g., Derrick Bell, “Brown v Board of Education and the Interest Convergence Dilemma,” 93 Harv. L. Rev. 518 (1980); Derrick Bell, “Racial Realism,” 24 Conn. L. Rev. 363 (1992); Kimberle Crenshaw, “Demarginalization and the Intersection of Race and Sex: A Black Feminist Critique of Antidiscrimination Doctrine, Feminist Theory, and Antiracist Politics,” 1989 University of Chicago Legal Forum 139 (1989); Neil Gotanda, “A Critique of ‘Our Constitution is Color-Blind,’” 44 Stan. L. Rev. 1 (1991).

110 See Patricia Williams, The Alchemy of Race and Rights (Cambridge, MA: Harvard University Press, 1991) 5–7; Gerald Torres, “Critical Race Theory: The Decline of the Universalist Ideal and the Hope of Plural Justice-Some Observations and Questions on an Emerging Phenomenon,” 75 Minn. L. Rev. 993 (1991).

111 See Mark Kelman, “Market Discrimination and Groups,” 53 Stan. L. Rev. 833, 835 (2001) (describing “simple discrimination” as ground in an individual right to be free from discrimi-natory conduct).


competition will function in a neutral, equalizing manner when in fact the forces of competition may lead to stratification.112 Second, liberal theories espouse a commitment to equality between the races, but critical theories demonstrate that the liberal notion of equality is formalistic, ignoring how his-torical and social context can create disparities among individuals that other-wise appear equal before the law.113 Critical theorists seek substantive equality and a distribution of economic and political power to previously subordinated groups.114

The push of critical theories to substantive equality and freedom can sup-port many possible avenues for legal reform. For example, Derrick Bell has argued that Brown v. Board of Education should have upheld the “separate but equal” doctrine of Plessy v. Ferguson and upheld substantive equality of educational resources between the races.115 Patricia Williams, to take another example, has demonstrated that informal law – the law in action as often attributed to the legal realists – can in practice lead to unequal access to economic power among the races through the creation of a double standard between blacks and whites.116 Formal rules, appropriately enforced, can ben-efit subordinated groups, but the devil is in the details that liberal theorists often ignore. Contrary to the view traced to the legal realist tradition that law is a veil that masks the real workings of power, some critical theorists espouse a more careful calibration of law and its relationship to power, sug-gesting that either the law’s absence or the law’s presence can hurt racially subordinated groups.117 The hard question is how legal, social, and economic institutions are shaped and the role of individual and group voice in shaping those institutions.118

112 See Amy Chua, World on Fire: How Exporting Free Market Democracy Breeds Ethnic Hatred and Global Instability (New York: Anchor Books, 2003) 11–12 (describing ethnic tensions in Phillippines exacerbated by markets).

113 See, e.g., Siegel, note 108 to this chapter at 1120; Linda Greene, “Race in the 21st Century: Equality Through Law?” 64 Tulane L. Rev. 1515 (1990); Charles Lawrence, “The Id, The Ego, and Equal Protection: Reckoning with Unconscious Racism,” 39 Stan. L. Rev. 317 (1987); Mari Matsuda, “Looking to the Bottom: Critical Legal Studies and Reparation,” 22 Harvard Civil Rights – Civil Liberties L. Rev. 323 (1987).

114 For a discussion of the principle of substantive equality, see Chon, note 82 to this chapter at 2834; Margaret Chon, “Intellectual Property ‘From Below’: Copyright and Capability for Education,” 40 U.C. Davis L. Rev. 803 (2007).

115 See Derrick Bell, Silent Covenants: Brown v. Board of Education and the Unfulfilled Hope for Racial Reform (Oxford: Oxford University Press, 2004).

116 See Patricia Williams, “Alchemical Note: Reconstructing Ideals from Deconstructed Rights,” 22 Harv. C.R.-C.L. L. Rev. 401, 408 (1987).

117 See Giradeau Spann, “Pure Politics,” 88 Mich. L. Rev. 1971 (1990).118 See Lani Guinier & Gerald Torres, The Miner’s Canary: Enlisting Race, Resisting Power,

Transforming Democracy (Cambridge, MA: Harvard University Press, 2003).


What critical theories tell us about race is that assimilation is not only a difficult and turbulent process, but also a misguided one. At the heart of assimilation is an essentializing of racial identity that requires its dissolution. But the racial bonds are complex ones, with many nodes and bases. As Neil Gotanda has noted, race and racial categories arise in many stripes.119 There are, to cite his typology, formal-race, status-race, and culture-race, and each of these mandates a different approach to curing the ills of subordination.120 Formal-race entails categories of race that are applied rule-like to establish difference. It is exemplified by the reference to “black patients” in the BiDil patent or the “WHITES ONLY” signs of the Jim Crow era. The law creates a category that has to be applied as tightly as possible. Status-race is sociologi-cal, attributing race based on social markers, like residential neighborhoods or where one buys one’s clothing. Status-race arises in how goods might be marketed along ethnic lines, but may also arise without reference to a racial category. Finally, culture-race is an anthropological category, marking distinc-tions based on practices and artifacts. This type of race arises in the patent for skin color or hair and reflects race as a dimension of culture. Given that race is multidimensional and is used in many different ways, it is not surprising that the goal of assimilation is a contested and perhaps fruitless one, absent, in the extreme, the elimination of different races altogether.

This latter point permeates the work of Kenji Yoshino, whose writings on queer theory have implications for the analysis of racial categories in this book.121 Professor Yoshino identifies three critical moves in the goal of assimi-lation, moves that illustrate the futility of assimilationism (and, by implica-tion, color-blindness).122 The first move is that of conversion whereby the different other (defined either in terms of race or sexual orientation or gender) is absorbed into majority culture through attempts to eradicate difference.123 Integration is one part of this move, but at the extremes may include expung-ing physical differences such as hair texture or skin color. The second move is one of passing, whereby difference is allowed but placed behind a veil of sameness; the different other attempts to adopt attributes of the majority with the aim of acceptance.124 The final move is that of covering, whereby differ-ence is allowed but silenced; the different other is able to maintain difference but only in a closeted realm that is acknowledged but not integrated into the

119 See Gotanda, note 109 to this chapter at 37–40.120 Idem. at 37.121 See Yoshino, note 107 to this chapter.122 Idem. at 783.123 Idem. at 784.124 Idem. at 785.


realm of the majority in civil society.125 Each of these moves, according to Yoshino, belie the myth of assimilation and serve to further subordinate the other into the cultural, political, and economic majority.

The mosaic of critical theories aid in defining the connections between race and wealth maximization, race and markets, and finally race and cul-ture. These positions are summarized in Table 4.1 and are discussed in detail here. Critical theories would be highly skeptical of the norm of wealth max-imization and would suggest that norms of justice and equity should at least supplement, if not trump, considerations of wealth. Within this modified view of wealth maximization, critical theories would advocate for the principle of anti-subordination as a counter to the tendencies of color-blindness perco-lating up from liberal theories. While on the surface the anti-subordination principle may seem similar to that of corrective justice, critical theories seek more than the remedial measures espoused by liberal theories. The anti-subordination norm entails eradicating all vestiges of racial subjugation and differentiation beyond remedying discrete incidents of discrimination. In the realm of the market, critical theories would endorse pluralism, recognizing the place of ethnic enclaves in shaping markets and countering subordination and discrimination of the past. Under this view, race is more than a brand, a cosmetic label attached to products. Race can serve to invigorate markets by creating connections among groups through economic empowerment and the distribution of real resources to previously marginalized groups. Finally, in the domain of culture, critical theories would advocate affirmative empower-ment, allowing badges of racial distinction to flourish and enrich the domains of civic society in addition to the market.

When Patent Law and Race Intersect: Summarizing the Positions

As Table 4.1 demonstrates, liberal theories and critical theories complement each other in some ways but offer distinct normative positions on the connec-tions between race and wealth maximization, race and markets, and race and culture, respectively. When juxtaposed with the three theories of intellectual property, the theories of race provide normative frameworks within which to assess the use of racial categories in patent law. The table summarizes the principal normative points developed in this chapter and will serve as the guide for the policy analysis in Chapter 5.

125 Idem. at 879 (analyzing racial covering through such practices as grooming).


Before proceeding to the policy discussion, let me summarize the norma-tive analysis. The challenge in this book is to integrate the normative goals of patent law and the normative treatment of identity, specifically theories of race, which is the most controversial dimension of identity. To integrate these two divergent normative analyses, I started with the proposition that patent law and policy needs to recognize conceptions of personhood. In the context of personalized medicine, patents touch intimately on social and individual conceptions of personhood. The work of Margaret Radin, who makes the case for treating personhood as separate from – and a constraint on – property, guides in answering the question of how patent law and policy can incorpo-rate the normative values of personhood. Derek Parfit makes the case that personal identity is not an absolute, but instead is contingent on brain, body, and experiences. Finally, Hannah Arendt provides the argument that a per-son’s experiences reflect the human condition that flows from the vita activa, consisting of labor, work, and action.

This framework for understanding personhood maps onto patent law and policy. At the heart of patenting is invention, a mix of labor and work among researchers, lab assistants, scientists, and entrepreneurs. Patenting also is a political act, implicating governmental bodies and adversarial processes as well as markets and commercialization. These activities take place in conjunc-tion with the activities of the medical profession, the mix of medical practitio-ners and patients who are often the subject of the patented inventions. Patent policy can be understood in terms of the activities of these various actors and through the normative lens of distributive justice. In the case of personalized medicine that is expressly race-based, one critical dimension of distributive justice is the treatment of persons in racial terms. The normative theories of race, divided here into liberal and critical theories, when juxtaposed with the theories of patent law, create a patchwork of positions that provide a frame-work for policy analysis.

This framework comes into play in Chapter 5 where I distill the norma-tive theory into some policy proposals on how to sensibly develop personal-ized medicine patents. I present these proposals as bases for discussion as the

Table 4.1. Intersecting theories of patent and of race

Liberal Theories Critical Theories

Incentive Theory Corrective Justice Anti-subordinationMarket Theory Race as Trademark PluralismCultural Theory Diversity Affirmative Empowerment


debate over personalized medicine patents continue. Although connected to the normative theory presented in this chapter, the proposals are at the same time pragmatic and intuitive in their appeal. These proposals offer a glimpse into one possible future of personalized medicine. They offer a basis for comparison with some of the realities of personalized medicine that we see emerging. These new empirical dimensions of personalized medicine are the subject of Chapter 6, which concludes this book by presenting two other case studies that take the ones of Myriad and Nitromed a few steps further.

179

Identifying racial categories in patent law present an opportunity to revisit fundamental questions about the normative bases for the structure of patent law and the treatment of race. Table 4.1 summarizes the various normative positions that one can take toward the use of racial categories in patents. In this chapter, I analyze several recommendations that have been offered by advocacy groups and scholars about the proper treatment of racial categories. Although these recommendations have been made in response to the BiDil controversy, understanding them requires appreciating the broader context of race and patent law. Placing these recommendations in the context of the six positions identified in Table 4.1, I then present my own viewpoint, namely that racial categories in patent law should be understood through the lens of cultural theory, with several specific recommendations about the proper place for racial categories in patent claims and patent specifications.

The debate over the racialized patents, and racialized medicine more broadly, has yielded three identifiable positions. First, the National Association for the Advancement of Colored Persons (NAACP) and other advocacy groups have come out in favor of BiDil and race-focused medical research and pharmaceuticals.1 Targeting resources toward racialized medi-cine, according to this view, corrects for the lack of organized and cumulative attention by the medical community to the needs of minority groups. The second position, advocated by Sullivan and Lillquist, would find state support

5

Persons, Patents, and Policy

1 See Keith J. Wiinstein, “NAACP Presses US on Heart Drug,” The Wall Street Journal A20 (January 25, 2007) (reporting advocacy by NAACP to obtain Medicare coverage for BiDil). For academic commentary advocating BiDil and race-specific therapies more broadly, see Gary Puckrein, “BiDil From Another Vantage Point, Health Affairs – Web Exclusive,” W368 (August 15, 2006); Michael D. Ruel, “Using Race in Clinical Research to Develop Tailored Medications: Is the FDA Encouraging Discrimination or Eliminating Traditional Disparities in Health Care for African Americans?” 27 J. Legal Medicine 225–241 (2006).


of racialized medicine as violating the Equal Protection Clause of the U.S. Constitution.2 Sullivan and Lillquist would permit the use of race in private epidemiological studies in order to identify and target underserved needs, but argue that FDA approval of pharmaceuticals along racial lines does not meet the standard of strict scrutiny under the Fourteenth Amendment.3 Although these scholars do not directly address the issue of patents, their argument would have some clear implications, which are discussed later. Finally, Kahn addresses the issue of racialized patents directly in his scholar-ship and expresses skepticism of racialized pharmaceutical patents.4 While acknowledging the NAACP position, his view is that drug companies have used the opportunity to narrowly categorize their patents along racial lines to expand their commercial interests rather than to meet the needs of the public, especially underserved groups. His criticism is in line with broader scholarly prognoses of the current patent system, which sacrifices the public interest, whether gauged by the community of scientific researchers or con-sumers, to commercial aggrandizement.5

These three positions on racialized pharmaceutical patents map onto Table 4.1 fairly readily. The NAACP position follows from an incentive the-ory of patents combined with a perspective somewhere between the liberal and critical theory of race. While the NAACP position is not articulated solely in terms of corrective justice, the position does not fully adopt the anti-subordination position of critical theory, although it is probably closer to this side of the spectrum. Allowing race as a consideration in the granting of a patent, or FDA approval, would create incentives to develop diagnostic and pharmaceutical tools to treat previously ignored diseases and to study neglected populations. However, understanding patents solely as an instru-ment to create incentives ignores the expressive impact of patents and the possible effects of the patents on the markets for pharmaceutical products

2 See Erik Lillquist & Charles A. Sullivan, “The Law and Genetics of Racial Profiling in Medicine,” 39 Harv. C.R.–C.L. L. Rev. 391, 392 (2004); Erik Lillquist & Charles Sullivan, “Legal Regulation on the Use of Race in Medical Research,” 34(3) J. L., Medicine, & Ethics 535, 538 (2006).

3 See Jonathan Kahn, “Race-ing Patents/Patenting Race: An Emerging Political Geography of Intellectual Property in Biotechnology,” 92 Iowa L. Rev. 353, 361 (2007); Jonathan Kahn & Pamela Sankar, “Being Specific About Race-Specific Medicine, Health Affairs Web Exclusive,” W375 (2006) (“Physicians should be able to prescribe BiDil, if it is appropriate, to any patient regardless of race”). For a similar position, focusing on the FDA approval pro-cess, see Sharona Hoffman, “’Racially-Tailored’ Medicine Unraveled,” 55 Am. U. L. Rev. 395 (2005).

4 See Kahn, note 3 to this chapter at 355.5 See Kahn, note 3 to this chapter at 381. For a discussion of the current patent systems and

commercialization, see discussion in Chapter 4.

Persons, Patents, and Policy 181

and health care. Nonetheless, the position would find a critical need to cre-ate these incentives, which would trump some of the adverse consequences of racialized patents.

Professor Sullivan and Lillquist’s appeal to the Equal Protection Clause echoes liberal theories of race with the normative goal of color-blindness. Their work does not directly address racialized patents, but we can distill their argument from what they say about the Equal Protection Clause and FDA approval. The professors are highly critical of the government’s use of racial categories in its decision marking, particularly in the awarding of benefits.6 Consistent with the color-blind principle, they would conclude that the use of racial categories in patent claims would violate the Equal Protection Clause. The more difficult question is how they would treat the use of racial catego-ries in the patent specifications. In the context of the specifications, racial categories do not serve to define who obtains the state benefit and who does not. Instead, racial categories serve a descriptive function to provide context for the invention, serving as an interpretative tool to understand the meaning of the patent and its claims. Given that Sullivan and Lillquist do not condemn the use of racial categories in epidemiological studies, because this represents private decision making not based on animus, the inference is that they would not condemn racial categories in patent specifications. Putting these pieces together, the position would be that the state cannot consider race in making decisions, but individual inventors can take race into account as background context to their inventions. Note that this position would be consistent with any of the three theories of patents, and given that Sullivan and Lillquist do not directly address patents in their work, it would be speculative to determine which theory they would endorse. What is clear, however, is that their position flows from a strongly liberal theory of race, one that endorses the color-blind principle.

Similarly, Kahn’s position also flows from a liberal theory of race, one that would endorse color-blindness and assimilation. In contrast with Sullivan and Lillquist, however, Kahn does have an explicit theory of patents, one that com-bines the incentive and market theories.7 His concern is that using patents to promote race-specific inventions will both create the wrong set of incen-tives, by diverting research efforts into tailoring existing drugs along racial lines, and transform the noble goals of serving the unmet health care needs of African-American communities into crass commercial ones. It is important to note that Kahn does support the ambitions of the NAACP in correcting

6 See Lillquist & Sullivan, “Racial Profiling,” supra note 2 at 393.7 See Kahn, supra note 3 at 391.


the deficiencies of medical research and health care.8 But his criticisms echo many of the criticisms of the patent system for creating strong private property rights that benefit established business interests at the expense of innovation and meeting the needs of the public.9

Kahn’s position also echoes traditional color-blind norms.10 For example, he questions whether an existing chemical composition, such as BiDil, should be granted a patent simply because an inventor discovers a modification that meets the needs of a specific racially defined group. To say that such a modifi-cation satisfies the nonobviousness requirement assumes that the baseline for determining obviousness is what works for a white patient.11 Racially defined patents reinforce existing stereotypes and further segregate medical research along racial lines. In contrast to the NAACP position, Kahn notes that the use of racialized patents may have unintended consequences and actually result in medical research becoming focused on modifying existing drugs along racial lines instead of innovating new drugs or therapies or studying orphan diseases.12 Although Kahn’s argument is grounded in a liberal tradition, there is a critical slant to his position. Racialized patents benefit the well-to-do clas-ses who can afford the new patented therapies, at the expense of the needy and continually neglected segments of racially defined communities. In short, granting patents along racial lines is a misguided policy, noble in motives but counterproductive in practice. Disallowing such patents consistent with the color-blind principle is necessary to avoid this path.

All of these positions raise compelling insights about patent law and the use of racial categories. But each considers only the case of racially defined phar-maceutical patents. My research shows that racial categories, at least those of African-American and Negro, have been pervasive in the patent system. One needs to develop an approach to racialized patents that takes into consider-ation the full range of inventions where race has emerged as a consideration. I contribute to this debate in light of the patents identified in this book by endorsing a cultural theory of patent law to assess the use of racial categories in patent law. I also contend that the cultural theory needs to be understood in conjunction with a liberal theory of race that adopts some of the more salient features of the critical theories of race.

As compared to the incentive and market theories, a cultural theory is best suited to address the issue of race in patent law, for two reasons. First,

8 Idem.9 Idem. at 393.

10 See Kahn & Sankar, note 3 to this chapter at W376.11 See Kahn, note 3 to this chapter at 394.12 Idem. at 395.


cultural theory subsumes the other two. Because cultural theories aim to understand patent’s role in structuring civil society, and market institutions are a part of civil society, cultural theories of patent highlight how commer-cialization occurs within the context of market and non-market institutions. Furthermore, the incentive theory assumes that patents provide incentives by allowing inventors to capture value. As value is determined through forces of consumer need and wants as well as productive technologies, so the sources of value include cultural factors as well as traditional market factors. Therefore, cultural theory also informs the incentive theory of patent.

The argument that cultural theory subsumes the other two theories per-haps proves too much. But there are many instances in which market the-ory and incentive theory may be perfectly adequate without considerations of culture. For example, understanding how a patent may affect the ability of an inventor to commercialize a new type of chemical process can be sat-isfactorily addressed through consideration of market factors alone. But the racial dimension of the patents described in the second section of this chapter necessitates understanding of both the commercial and cultural contexts of these inventions. Therefore, the fact that we are dealing with race supports turning to the cultural theory of patents to assess the inventions described in this book normatively.

Under the terms of cultural theories of patent, racial categories should be analyzed in terms of their effects on promoting diversity (under a liberal the-ory of race) or promoting affirmative empowerment (under a critical theory of race). At this point, the analysis can take a number of possible turns depend-ing on whether one is aligned closer with the liberal or the critical theory. Kenji Yoshino, for example, has advocated for rigorous protection of cultural attributes, whether within queer or racial communities, as a counterforce to assimilationism.13 Richard Ford has advocated for a more pragmatic posi-tion, one that supports pluralism but does not lead to antagonism between groups.14 To call Ford’s position a Catholic one would be ironic, given the battles over doctrine and rituals that has marked Western Christianity, but Ford is concerned that the types of cultural claims endorsed by Yoshino are unsettling and potentially destructive.15 A more general point along these lines is made by Madhavi Sunder, who identifies parallels between these debates over cultural markers in the arena of identity politics and those over the ubiq-uity of privatization of information and knowledge in the arena of intellectual

13 See Kenji Yoshino, “Covering,” 111 Yale L. J. 769, 892 (200214 See Richard Ford, Racial Culture: A Critique (Princeton: Princeton University Press, 2005)

211–214 (urging to look “beyond difference”).15 Idem. at 97–124 (arguing against “racial characteristics” and the politics of difference).


property.16 Her solution is to turn to the normative goals of distributive jus-tice to resolve these oppositions and as a means to mediate competing claims through the goal of protecting groups that lack political and economic power.17 Following her solution, rights claims, whether over culture or over informa-tion, would be secured for those who have the least access to political and market institutions.18

In the context of racialized patents, whether covering pharmaceutical inventions, hair care products, or toys, the use of racial categories should be assessed under a more nuanced application of the anti-subordination prin-ciple. The appropriateness of using these categories rests on their effect on perpetuating the subordination of groups by imposing limits on access to crit-ical resources or by perpetuating stereotypes. A nuanced application of this principle would also recognize the principle that civil society mandates some degree of cooperation and harmony among various groups.19 Therefore, this principle should be applied to avoid claims that would put different groups in opposition and further fragment the public arena. I am proposing a prag-matic application of the principle of affirmative empowerment in the context of patent (and implicitly in intellectual property more broadly). Three con-crete propositions arise from this argument: (1) the proper treatment of race in claims and specifications; (2) the proper role of race in the nonobviousness analysis; and (3) the proper role of race in the utility analysis. I conclude this section by discussing each in turn.

A racial category should not be an element of a patent claim, but may be used in the patent specifications

Patent claims define the legal rights enforced by the state in an action for infringement. Patent specifications, by contrast, act as an interpretative tool, providing the background context of an invention against which to fix the legal meaning of the claims. The use of a racial category in a patent claim requires the court to define the meaning of that category when a particular invention is used. For example, the claims in the BiDil patent refer to a “black patient.” If a claim for infringement arises with respect to this patent, the court would have to determine if in fact the invention was used on a black patient.

16 See Madhavi Sunder, “IP3,” 59 Stan. L. Rev. 257, 274 (2006).17 Idem. at 273.18 Idem. at 274.19 See Francis Fukuyama, “Trust: The Social Virtues and the Creation of Prosperity,” in Don

E. Eberly, ed., The Essential Civil Society Reader: The Classic Essays (New York: Rowman & Littlefield, 2000) 257.


To do this, the court would have to fix the meaning of “black” as applied to the racial identity of an individual.

Two problems arise from the interpretation of “black patient.” First, as a matter of patent doctrine, this claim may fail for lack of definiteness. The Patent Act requires “one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.”20 This contemporary requirement is explained by the need “to inform the pub-lic during the life of the patent of the limits of the monopoly asserted, so that it may be known which features may be safely used or manufactured without a license and which may not.”21 A claim is definite if “those skilled in the art would understand what is claimed when the claim is read in light of the specification.”22 The use of a racial category in a patent claim requires that the meaning of that contour be understood. If there is ambiguity as to what makes a patient “black” – or Asian, or Hispanic, for that matter – the claim containing a racial category would very likely be invalid.

Second, as a matter of policy, a court will have to worry about interpreting the phrase “black patient” in a way that effectively essentializes an aspect of individual identity, concluding that one individual is black and another one is not.23 This essentialization could occur whenever a racial category is used in a patent claim and can be avoided only by preventing racial categories in claim language. Effectively, the patent owner of a patent limited to African Americans would be the exclusive supplier of that invention to the African-American community, while others are free to provide the same invention to non-African-American communities. Race-specific patent claims create exclusivity over a particular racially defined market.

The issue is different when racial categories are used in patent specifications because the language of specifications is more fluid and does not become fixed through legal interpretation. Racial categories in specifications do not create the risk of essentializing identities. Instead, the specifications provide the context against which the claims and the invention can be understood.24 The presence of a racial category in the specification does not limit the scope of the invention or its application. Most importantly, it does not exclude access to an invention based on the race of the user. For example, if the specification states that an invention was used on a particular racial group in experimental

20 35 U.S.C. § 112 ¶ 2.21 Permutit v. Graver Corp., 284 U.S.. 52, 60 (1931).22 Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565, 1568 (Fed. Cir. 1986).23 See, e.g., Angela P. Harris, “Race and Essentialism in Feminist Legal Theory,” 42 Stan. L.

Rev. 581, 592 (1990).24 See Orthokinetics, note 22 above; Phillips v. AWH Corp., 415 F.3d 1305, 1321 (Fed. Cir. 2005).


trials or was motivated by practices within racially defined communities, these factors disclose the background to the development of the invention but do not impose limitations on how the invention can be practiced for infringe-ment purposes. Such disclosure is important for assessing the relevance of the invention and for informing future inventors about the background and context of the invention without excluding access based on race.25

My proposal that racial categories should not be allowed in claims but should be allowed in specifications parallels my earlier analysis of Sullivan and Lillquist, but for very different reasons. Lillquist and Sullivan follow the strict color-blind principle as applied to state action.26 My proposal follows from the anti-subordination principle in critical theory when understood within the cultural theory of patents. Within this normative framework, race is an acceptable factor for states to consider as long as it counters historical practices of subordination and does not impose stereotypical or disempower-ing conceptions of racial identity. Because claim interpretation in patent law fixes the meanings of words for infringement analysis, racial categories in pat-ent claims should be avoided in order to prevent the essentialization of racial identities. However, race can be used as a background factor in order to com-bat and cure practices of subordination, and therefore would be acceptable in patent specifications.

Proponents of the incentive or market theory of patents, however, would find my proposal to work against the promotion of racially-tailored or targeted research and development initiatives. Because inventors who pursue these initiatives could not capture the benefits of race-specific inventions through claim language, these initiative would be undermined by my proposal. But this objection reflects the critical differences between the cultural theories of patent law and the other two. Incentive and market theories focus on patents as legal instruments to promote the creation and commercialization of inven-tions, respectively. The focus is exclusively on the generation of profits from

25 The use of disclosure as described here is referred to as the possession requirement. The excerpt from the Permutit decision, excerpted earlier, illustrates one of the values underlying the possession requirement: informing the public of the contours of the patent owner’s prop-erty right. See Permutit, note 21 to this chapter. The possession requirement also prevents the inventor from “pretending that his inventions is more than what it really is, or different from its ostensible objects.” Evans v. Eaton, 20 U.S. (7 Wheat.) 356, 433–434 (1822). See, also, University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916 (Fed. Cir. 2003); Lizardtech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336 (Fed. Cir. 2005); Ariad Pharms, Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010). For a discussion of the implications of the posses-sion requirement for patent policy, see Timothy R. Holbrook, “Possession in Patent Law,” 59 SMU L. Rev. 123, 129 (2006).

26 Se Lillquist & Sullivan, Racial Profiling, supra note 2 at 394.


innovation. The cultural theory of patents emphasizes that the goal of patent law is to promote knowledge and access within civil society, of which the market is only one institution. To the extent race-specific patent claims serve to essentialize identities and deny access based on race, the benefits of incen-tivizing and commercializing race-specific innovation need to be balanced against the subordinating use of racial categories. My proposal strikes the cor-rect balance by allowing racial categories to be considered in the specification in order to have adequate disclosure of the racial benefits of invention without the fears of stigmatization and essentialilizing.

Given that racial claims in patenting are quite infrequent, this proposal may have little bite. But to the extent that the claims in the BiDil patent are the wave of the future, as scholars like Kahn suggest,27 the arguments against race-specific claiming should be kept in mind. This proposal can be implemented in a number of ways. First, Congress could amend the Patent Act or the com-missioner could amend the Manual for Patent Examination and Procedure to prevent such claiming.28 Second, courts should look on race- specific claims as they arise in litigation with suspicion, holding that such claims are not enforce-able without violating the Equal Protection Clause of the U.S. Constitution.29 However, the basis for this violation should be grounded not in the color-blind principle, but in the principle that enforcing such claims requires the state to construe the meaning of racial terms in ways that essentialize the meaning of racial identity and potentially stigmatize individuals based on their racial affil-iation. Put another way, the use of the racial category in patent claims is not justified by a compelling state interest in either promoting diversity or curing past discrimination, as required under current law.

In the context of BiDil and other pharmaceutical patents, race is often defined in terms of self-identification. But even if the meaning of “black patient” in the BiDil patent claim, or the similar use of racial identifiers in other claims, is fixed through the decision of the user of the invention, the problem discussed here is not resolved, for two reasons. First, self-identifica-tion is not a basis for claim interpretation.30 Even though the Federal Circuit has recognized that a patent owner can be one’s own lexicographer,31 there is no precedent for interpreting a patent claim through the meaning given

27 See Lillquist & Sullivan, Racial Profiling, supra note 2 at 394.28 See Kahn, supra note 3 at 398.29 See Lillquist & Sullivan, Racial Profiling, supra note 2 at 391 for a similar proposal based on

the principle of color-blindness.30 See Phillips, supra note 24 at 1320 (identifying two sources for patent claim interpretation:

intrinsic and extrinsic evidence, and not including interpretations by an individual user as an interpretative source).

31 See Vitronics, Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).


by a specific user of a patent. To the contrary, the Federal Circuit has stated that a patent claim should be given its ordinary meaning, and the current methodology for interpreting claims seems to eschew idiosyncratic readings.32 Second, even with self-identification, the problem remains that the patent owner becomes the exclusive provider of the invention to a racially defined group, while other groups are given a wider range of choices. This disparate impact based on race still remains problematic even if individuals are allowed to self-identify as “black.” Self-identification may actually lead to a perverse result as individuals may seek to not self-identify as “black” in order to avoid being captured by a monopolist vendor of the invention.

A racial category should be not a consideration in the nonobviousness of an invention

Racial categories are sometimes used to distinguish an existing invention in order to obtain a new patent on the underlying invention. Professor Kahn documents that Nitromed pursued precisely this strategy in obtaining a patent for BiDil.33 Many of the patents for toys, specifically for board games, seem-ingly take traditional games and tailor them to African-American heritage. Such racial tailoring is desirable in order to promote diversity and pluralism within the marketplace and civil society more broadly. But such racial tai-loring should not be basis to determine that the invention is nonobvious, for two reasons. To understand these reasons, let me first explain the doctrine of nonobviousness.

To obtain a patent, an inventor must show that the invention was useful, novel, nonobvious, and enabled. Novelty means that the invention has not been disclosed in all its elements in the prior art. However, even if an inven-tion is novel, a patent may be denied if the differences between the invention and the prior art are obvious to someone who has ordinary skill in the art.34 For example, I could not obtain a patent on a standard deck of cards because it is already known in the prior art. If I tried to patent a deck of cards that used the likenesses of presidents rather than kings and queens, such a patent would be denied because I have just made a trivial change to a known invention. The nonobviousness standard is designed to be an objective inquiry that filters out trivial inventions from the field of patenting.35

32 See Phillips, supra note 24 at 1309 (claims given their ordinary and customary meaning).33 See Kahn, supra note 3 at 403–405.34 See Graham v. John Deere, Inc., 383 U.S. 1 (1966).35 See Comm. On Intellectual Prop. Rights in the Knowledge-Based Econ., Nat’l Research

Council, A Patent System for the 21st Century (Stephen A. Merrill et al. eds., 2004); Fed.


One objection to racial tailoring is the frequent objection that patents recently have been granted to trivial variations on known products.36 This objection stems from a concern with the integrity of the patent system and the need to promote innovation in the marketplace. Although these criticisms have been made from the perspective of incentive or market theories of pat-ent law, the cultural theory of patents would also provide a basis for trivial patents. If inventors were allowed to take known inventions, whether in the field of biotechnology, pharmaceutical, or entertainment, and simply place a racial spin on them, then the market could be flooded with products and ser-vices that have a veneer of cultural diversity without necessarily affirmatively empowering traditionally subordinated groups. The objection is not based on lack of cultural or racial authenticity, but the fear of racial pandering that would be promoted by allowing race alone to be a factor in the nonobvious-ness inquiry.

Allowing race alone to be a factor in the nonobviousness inquiry raises the possibility of “double patenting.” Section 101 of the U.S. Patent Act states that “a” patent shall be granted to an invention that meets the standards of pat-entability.37 The singular article has been construed to mean that an inven-tion can be patented only once. This restriction applies to obvious changes to an invention as well as literal replications of a previously patented invention. As the Federal Circuit has stated, “double patenting is a judicially created doctrine adopted to prevent claims in separate applications or patents that do not recite the ‘same’ invention, but nonetheless claim inventions so alike that granting both exclusive rights would effectively extend the life of patent protection.”38 In the case of race-specific patents, the concern is that an inven-tor may take a known invention and seek to obtain a second patent by tailoring it to a racially or ethnically defined market. This practice seems to be the case with BiDil, which Nitromed patented as a race-specific variant on a chemi-cal compound whose patent had expired. The rule against double patenting should be applied to prevent this result.

A third objection is the essentializing effect of the use of race in the non-obviousness inquiry itself. To say that adding race alone to a known invention

Trade Comm’n, To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy (2003), available at http://www.ftc.gov/os/2003/10/innovationrpt.pdf; Cotropia, supra note 75 at 113

36 See Adam Jaffe And Josh Lerner, Innovation and Its Discontents: How Our Broken Patent System Is Endangering Innovation and Progress, and What to Do About It (Princeton: Princeton University Press, 2004) 34–35.

37 35 USC § 101. See See Miller v. Eagle Manufacturing Co., 151 U.S. 186 (1894) (establishing rule against double-patenting).

38 Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1373 (2005).


makes the invention nonobvious assumes that the underlying baseline is that of the white majority. As a practical matter, the nonobviousness inquiry is based on the policy of encouraging certain directions of inventive activity. For example, it has been noted that the nonobviousness standard is lower for biotechnology inventions with the result of promoting faster innovation in that industry.39 Analogously, the case has been made that considering race as a factor for nonobviousness would spur greater innovation in neglected areas of research and medicine.40 But applying the nonobviousness standard in this way would tend to define what constitutes normal invention and innovation in terms of majoritarian terms. The risk is that companies will use a race-based nonobviousness standard to create trivial variations of existing inventions rather than develop inventions that target the substantive needs of previously neglected populations.41

A racial category can be used in consideration of the utility of an invention

To obtain a patent, the inventor must demonstrate some application, or util-ity, for the invention. This utility must be substantial and specific. The utility requirement serves two purposes. First, it ensures that patents are granted to inventions that do have some application and are not merely theoretical or abstract creations. Second, it ensures that the inventor has sufficiently worked on his or her invention to discover its applications in a substantive and well-defined way.

Racial categories can be used in determining the utility of an invention, particularly in promoting the affirmative empowerment of racially defined groups. While racial categories in patent claims and in the nonobviousness inquiry may serve to reify stereotypes or essentialize elements of identity, racial categories in the context of utility can serve to identify beneficial applications of inventions that can target inventive activity toward previously ignored or neglected groups without essentializing them.42 For example, in the context

39 See Dan L. Burk & Mark A. Lemley, “Policy Levers in Patent Law,” 89 Va. L. Rev. 1575, 1634 (2003).

40 See Kahn, note 3 to this chapter at 403 (stating the argument).41 Idem. at 405 (challenging the argument). The history of the BiDil patent is a concrete

example of this theoretical possibility. Nitromed pursued the race-specific patent claims in the shadow of the expiration of its earlier patent that was not racially tailored in 2003. The business plan seems to be one of expanding the patent life of the invention through racial tailoring.

42 The beneficial utility requirement can be traced to Justice Story’s opinion in Lowell v. Lewis, 15 Fed. Cas. (C.C.D.. Mass. 1817), holding that an invention that is “frivolous or injurious


of racialized medicine, the utility requirement can identify how particular treatments or innovations address orphan diseases. The utility requirement can also identify niche markets, such as for the hair and skin-related products described in Chapter 3. Therefore, utility can be used to promote racial plu-ralism in inventorship without the problem of essentializing racial categories by using these categories to provide the context for inventions. Furthermore, allowing race to be a factor in the utility analysis would benefit inventors that target some beneficial applications to subordinated communities without imposing the negative implications that would arise from the use of race in the claims or in the nonobviousness inquiry.

There are three caveats to this proposal. First, the utility requirement is just one of five requirements for patentability. Therefore, just because race is an accepted factor for utility does not mean that identifying a racial appli-cation will be sufficient for the award of a patent. Having used race to satisfy the utility requirement, the inventor would in addition have to show how the novelty, nonobviousness, enablement, and subject matter criteria are met with non-race-based factors. My proposal allows for the consideration of race to promote affirmative empowerment in the civic sphere while avoiding some of the damaging uses of race. I pursue this goal by allowing considerations of race for the purposes of utility, but limiting the use of race in claims and for nonobviousness.

Second, even with the utility requirement there is the risk that race will be used to essentialize groups, particularly through assumptions about race as a genetic marker in the context of pharmaceutical inventions. This danger can be avoided by having a high standard for substantial utility when race is being considered.43 Epidemiological information on the incidence of disease

to the well-being, good policy, or sound morals of society” could not be granted a patent. Courts and the USPTO have retreated from this morality limitation on patentability. See Juicy Whip, Inc. v. Orange Bang, Inc., 185 F.3d 1364, 1376 (Fed. Cir. 1999) (“the principle that inventions are invalid if they are principally designed to serve immoral or illegal purposes has been applied broadly in recent years”). Commentary on beneficial utility has been mixed among the academic community. See Robert Merges, “Intellectual Property in Higher Life Forms: The Patent System and controversial Technologies,” 47 Md. L. Rev. 1051, 1062–1068 (1988) (expressing skepticism toward the beneficial utility requirement as applied to technol-ogy regulation). But see Margo A. Bagley, “Patent First, Ask Questions Later: Morality and Biotechnology in Patent Law,” 45 Wm. & Mary L. Rev. 469, 472 (2003) (advocating a revival of the morality limitation on patenting for biotechnology).

43 See Utility Examination Guidelines, 66 Fed. Reg. 1092 (Jan. 5, 2001) (requiring specific and substantial utility that affects a “real world” use, as opposed to an abstract or throwaway util-ity). See In re Fisher, 421 F.3d 1365, 1368 (Fed. Cir. 2005) (imposing a high standard of specific and substantial utility to deny the patenting of “express sequence tags” as being too general and speculative to constitute real-world utility). Cf. Fujikawa v. Wattanasian, 93 F.3d 1559


and success of treatment can be data in establishing utility, but, as has been pointed out, it would be dangerous to make any inferences from such data that there is a genetic component of race. Such epidemiological data would be consistent with the view that race is purely socially constructed.44

Third, racial categories can arise in a way that perpetuates stereotypes, as evidenced by the various patents on toys from the nineteenth century. The utility requirement should be applied to distinguish between beneficial and subordinating uses of racial categories.45 Once again, substantial utility can serve as a filter between these two competing types of uses. If the applica-tion of the invention serves to benefit racial groups by including previously excluded groups within civil society, such as through recognizing market niches or products targeted toward emerging segments of the economy, then beneficial utility would be established. Similar targeting of orphan diseases would also meet the beneficial utility requirement.46

A difficult question is raised by patents that might have both beneficial and subordinating uses. For example, the skin depigmentation patent can be used to correct for skin diseases but can also be used to serve a market that facilitates passing or legitimizes negative stereotypes about nonwhite skin. Within the cultural theory of patent, such mixed-use inventions pose a deep dilemma and reflect schisms within communities about individual auton-omy in how an individual shapes and defines one’s identity.47 In this case, my

(Fed. Cir. 1996) (“In the pharmaceutical arts, our court has long held that practical utility may be shown by adequate evidence of any pharmacological activity”). For race-specific pharmaceuticals, a higher standard for utility is mandated.

44 See Morris W. Foster, “Analyzing the Use of Race and Ethnicity in Biomedical Research From a Local Community Perspective,” 34 J. L. Med. & Ethics 508, 510 (2006); Raj Bhopal, “Race and Ethnicity: Responsible Use From Epidemiological and Public Health Perspectives,” 34 J. L. Med. & Ethics 500, 502 (2006); Margaret A. Winker, “Race and Ethnicity in Medical Research: Requirements Meet Reality,” 34 J. L. Med. & Ethics 520, 522 (2006).

45 I have been critical of morality limitations on patentability in earlier writings. See Shubha Ghosh, “Patents and the Regulatory State: Rethinking the Patent Bargain Metaphor After Eldred,” 19 Berkeley Tech. L. J. 1315, 1362 (2004). I still stand by my earlier position that the goal of patent law is not to police troubling technologies. I am, however, acknowledging here that in the construction of race, morality does play some role in not extending patent protec-tion to racialized patents that may subordinated racial groups.

46 See, e.g., Douglas Loughnot, “Potential Interactions of the Orphan Drug Act and Pharmacogenomics: A Flood of Orphan Drugs and Abuses?,” 31 Am. J. L. & Med. 365, 368 (2005).

47 See Amartya Sen, Reason Before Identity: The Romanes Lecture for 1998 (Oxford: Oxford University Press, 1999) 1–31. For a concrete example, consider the recent and ongoing debate over the identity of Barack Obama. See, e.g., Amos N. Jones, “Black Like Obama: What the Junior Illinois Senator’s Appearance on the National Scene Reveals about Race in America, and Where We Should Go from Here,” 31 T. Marshall L. Rev. 79, 79 (2005) (asking the ques-tion “When, how, and why did Barack Obama become black?”).


proposal is to look skeptically on inventions that have some subordinating uses and carefully balance the beneficial uses with the potentially subordinating uses. In the case of the depigmentation patent, the therapeutic benefits of the invention would need to be shown to be substantial to counter the potential subordinating uses.

Racial categories should be generally discouraged as indicators of identity and should be kept separate from genetic markers of identity

The policy recommendations aim to move away from the use of racial cate-gories in claiming inventions. Such categories are archaic and impossible to enforce under patent law. Furthermore, they tend to narrow and misdirect the incentives for research and inventive activity. At the same time, racial categories are still in use in epidemiological studies, and research finding encourages drug development and disease treatment in previously ignored population. Without more refined and more specifically targeted categories, racial ones tend to be used in practice. Hence, the policy recommendations seek to balance this practice with the broader goal of removing racial catego-ries from the patent claim. Persons cannot be subject to a state-recognized property right, especially persons defined in racial categories.

The even broader goal is to have categories that respect individual auton-omy but also recognize relevant differences for the purpose of diagnosing and treating diseases. What these categories will be is yet to be determined. One dimension of personalized medicine is to identify genetic sequences that are specific to individuals but also demonstrate characteristics that may be com-mon to a group, the product of shared ancestry and history. Such genetic markers may be useful for biomedical purposes and may serve as substitutes for antiquated racial categories. The vocabulary for these identifiers has yet to be created, and patent law through the claiming process may provide some guidance in formulating such terminology.

As mentioned in a number of places in this book, it is very important to separate the language based on genetics from traditional racial categories. Sociological and cultural categories may have correlates with genetic typolo-gies, but the former does not reduce to the latter. Therefore, it is important not only to limit the use of traditional racial categories in the patenting and commercialization processes, but also to create a wholly new vocabulary that recognizes the source and meaning of genetic identifiers, as reflecting ances-try and history and not socially and legally constructed categories like black, white, Asian, Latino, and so forth. This move is difficult as these traditional categories are ready-to-use signifiers. But their ease of use belies their troubled


history and can readily blur (dare I say whitewash?) their troubled legal, politi-cal, and social uses.

One example of how this alternative usage can arise is provided by the patent at issue in Mayo v. Prometheus, a 2012 patent case in which the U.S. Supreme Court invalidated a personalized medicine patent. I discuss the implications of this case for the future of personalized medicine in the concluding chapter. The patent, however, is illustrative of how the drafting of personalized medi-cine patents can avoid race-specific (or in this case, culture-specific language). At issue is an invention for determining the dosage of a drug to treat Crohn’s Disease based on the level of a blood metabolite in the patient. Developed by researchers at Hospital-Saint-Justine in Montreal, Canada, the invented process allows a health care provider to calibrate the dosage to the needs of an individual patient based on the measured level of the metabolite. While the Supreme Court is addressing the specific question of whether such an inven-tion, which seems to require an abstract mental step, is patentable, the draft-ing of the claim indicates how personalized medicine patents can avoid racial categories. Crohn’s Disease is prevalent among the Jewish population, but the patent makes no mention of this demographic information in either the specification or the claim. Instead, the invention is specified and claimed in terms of biochemical characteristics of the patient. These characteristics can be independent of race, ethnic, or cultural characteristics of the patient. The invention most likely benefits a particular group as well as members outside that group, but the patenting was obtained without limitations based on trou-bling and archaic categories. Groups benefit but are not singled out in ways that continue the usage of categories that have been suspect under the law.

Summary

I have made the case for assessing race-based patents through a cultural the-ory of patents that incorporates a norm of anti-subordination from critical theories of race. My goal is to use the patent system to promote pluralism and affirmative empowerment within civil society. The approach I propose is designed to coordinate the tensions between commercialization and race in the development of race-specific patents and race-specific markets. The patents documented in Chapter 3 show that racial categories have been and continue to be present in the patent system. What we make of this history and the continuing presence of racial categories in patenting rests on the norma-tive underpinning of patent law and of our use of race. The proposals I make here provide a path to the beneficial promotion of race in contemporary civil society based on the commercialization of innovation.

195

The examples of Myriad and Nitromed were the basis for starting this book’s narrative. Case studies on the Marshfield Clinic’s Personalized Medicine Research Project and the litigation between Prometheus and the Mayo Clinic serve as this book’s coda. The cases of Myriad and Nitromed highlight some of the central issues raised by personalized medicine, whether based on genetic or sociological characterizations of the person. The two concluding examples illustrate ongoing legal and policy issues in personalized medicine and per-haps hint at its future.

Creating a Biobank

The Marshfield Clinic was formed by a group of six physicians in 1916.1 Headquartered in Marshfield, a town in central Wisconsin, the clinic serves much of central, western, and northern Wisconsin with outreach to the Upper Peninsula of Michigan. It is a primary source of medical care for much of rural Wisconsin and, through collaborations with the University of Wisconsin-Madison Medical School, engages in extensive biomedical research. The Marshfield Clinic owns 416 patents issued from 1991 to 2007 and has several pending patent applications, filed as recently as 2011.2 The Clinic’s patent port-folio covers a wide-ranging set of inventions from medical devices to methods for identifying genetic markers associated with diseases such as prostate can-cer. Some of its patented inventions are in the field of personalized medicine, although its strategy has not been to describe the inventions in racial or eth-nic terms. Instead, the focus is on genetic sequences that indicate proclivity

6

A Business, a Litigant, a Metaphor: The Future of Personalized Medicine Patents

1 http://www.marshfieldclinic.org/patients/?page=about_legacy2 Based on a search of the USPTO database using “Marshfield Clinic” as a search term in

assignee field, conducted in January 2012.


toward certain diseases. Some recently filed patent applications, discussed later in the chapter, provide some example of associating these sequences with racial or ethnic groupings.

The Clinic’s biobank project, started in 2003, is its major foray into per-sonalized medicine. As described by several researchers associated with the project:

It has been suggested that common gene variants are responsible for the majority of common diseases, and population-based study designs may be useful to help identity these common variants and their relative importance in the population. Some scientists have advocated for larger sample sizes to increase statistical power to detect disease genes and some have argued for a larger number of SNPs (single nucleotide polymorphisms), especially for people of African descent.3

The Personalized Medicine Research Project (PMRP) collects samples of DNA, serum, and plasma from self-selected members of the Wisconsin popu-lation. The database of samples is stored in electronic records, which will allow research scientists to study the genetic basis of disease, the effects of pharmaceuticals at the genetic level (pharmacogenomics), and population genetics – the incidence of genetic markers for disease among ethnic popula-tions. As the Clinic describes it, “the purpose of the PMRP is to establish a resource that will facilitate research in pharmacogenetics, genetic epidemiol-ogy and population genetics, with the ultimate goal of improving health and medical treatment.”4

The PMRP was implemented subject to the procedures of the Clinic’s Internal Review Board with respect for the privacy and consent of the par-ticipants, who were patients from the Clinic’s service area. The study design considers a homogeneous ethnic population in order to implement controls for future research. Although this emphasis on homogeneity reduces the gen-eralizability of any findings, the study was designed for an ethnically homo-geneous population to aid in the reproducibility of the genetic associations and to prevent population stratification of the genetic data. In 2005, after the first two years of the study with a cohort size of 18,000 adults, researchers reported that “the PMRP will allow researchers to study the genetic basis of disease and drug response in a way that can be generalized to adults of central

3 Catherine A. McCarty et al., “Marshfield Clinic Personalized Medicine Research Project (PMRP): Design, Methods and Recruitment for a Large Population-Based Biobank,” Personalized Medicine (2005) 2(1): 49–79.

4 Idem. at 50.

A Business, a Litigant, a Metaphor 197

and northern European descent.”5 Based on this preliminary work, the Clinic planned to expand its biobank to include other racial and ethnic groups.6

Some of the fruits of the Clinic’s research are six identified patent applica-tions relating to personalized medicine filed from 2006 to 2011. These patent applications cover inventions relating to genetic sequences and markers asso-ciated with diseases prevalent in certain racial and ethnic groups and spe-cialized treatment targeted toward these groups. The Clinic’s patenting of these personalized medicine inventions for diagnosis and treatment reflects the poor sampling of traditionally underrepresented populations in the epide-miological study. As stated in a 2008 application for a diagnostic kit for mea-suring drug-metabolizing enzymes, assigned to Third Wave Technologies, a Madison, WI company making reference to Marshfield’s research:

In the Human Genome Project (HGP), researchers collected blood (female) or sperm (male) samples from a large number of donors. However, only a few samples were processed as DNA resources, and the source names are pro-tected so neither donors nor scientists know whose DNA is being sequenced. The human genome sequence generated by the private genomics company Celera was based on DNA samples collected from five donors who identified themselves as Hispanic, Asian, Caucasian, or African-American. The small number of human samples used to generate the reference sequences does not reflect the genetic diversity among population groups and individuals. Attempts to analyze individuals based on the genome sequence information will often fail.7

The applications filed by the Marshfield Clinic are responses to this sampling and underrepresentation problem. Although the inventions covered by the application are not always limited to particular groups, they do respond to this undersampling of neglected populations. For example, in the 2007 applica-tion for a “Susceptibility Gene For Myocardial Infarction, Stroke, and PAOD: Methods Of Treatment,” which was filed by researchers making use of data from the Marshfield clinic study, the applicants refer to the BiDil patent:

Cardiovascular disease is one of the primary causes of death among African Americans and over 4 in every 10 non-Hispanic black adults have CVD, including myocardial infarction, stroke and congestive heart failure

5 Idem. at 59.6 Idem.7 “Methods and Compositions for Analysis of Ugt1a1 Alleles,” U.S. Patent App. 2008/0032305

(published February 7, 2008). The USPTO deemed this application abandoned on October 20, 2010 for failure to respond to office requests. A review of the prosecution history suggests that the applicant abandoned the application after it was denied status as a small entity, which would have qualified the applicant for reduced fees.


(American Heart Association, 2005 statistics). Race-based therapeutics are emerging to treat populations of human patients that are at a high risk based on their race. For example, BiDil (isosorbide dinitrate hydralazine hydro-chloride) is currently approved for treatment of heart failure in self- identified black patients to improve survival, to prolong time to hospitalization for heart failure, and to improve patient-reported functional status. In addition, U.S. Pat. No. 6,465,463 purports to describe methods of reducing mortality asso-ciated with heart failure in black patients comprising administering to these patients hydralazine compounds in combination with isosorbide dinitrate or isosorbide mononitrate.8

The invention at issue in this application is not limited to the African-American, or any other, population. Instead, the invention is for a method that takes account of these observed differences among groups. Similarly, in a 2011 application for a “Methods for Administering Anticoagulant Therapy,” assigned to the Marshfield Clinic, the applicants state:

Because of differences in the frequency of the underlying genetic variants among major racial groups, the potential clinical benefit from prospective CYP4F2 genotyping varies by race. In Caucasians and Asians, the minor allele frequency for CYP4F2 is ˜30% compared to ˜7% in African-Americans. Accordingly, from a population perspective, the expected contribution of this polymorphism to stable warfarin dose in African-Americans is likely to be less than in Caucasians and Asians.9

As with the other pending applications, the 2011 application includes an acknowledgment of observed differences and an invention designed to take account of them in medical diagnosis and treatment (see Figure 6.1).

The Marshfield Clinic seemingly adopts a patenting strategy that takes into account differences among racial and ethnic groups in terms of diagnosis and treatment, but does not incorporate them expressly in the patent claims, as Nitromed did. This strategy serves one purpose of broadening the applicability of the invention, as opposed to limiting it to one dimension defined by race or ethnicity. In general, patent owners prefer to have a patent with broad scope so that it can cover more markets and applications. The Clinic’s strategy is consis-tent with this goal. However, the strategy also reflects an acknowledgment that

8 U.S. Patent App. 2007/0280917 (published December 6, 2007). The USPTO granted a patent on this application on December 21, 2011.

9 U.S. Patent App. 2011/0189675 (filed April 13, 2011). The USPTO issued a nonfinal rejection on this application on December 21, 2011, on the grounds that the invention involved mental steps and constituted a law of nature and therefore was not patentable subject matter. The office action is available at http://portal.uspto.gov/external/PA_PeaiPair/view/BrowsePdfServlet?objectId=GWFKWT7MPXXIFW4&lang=DINO (last viewed on January 20, 2012).


Figure 6.1. Claims from a 2011 application filed by the Marshfield Clinic.


personalized medicine needs to take account of racial and ethnic differences as defined sociologically. Unlike the patent for obfuscating identity discussed in Chapter 3, the Clinic’s pending patents do not conflate the genetic and the sociological. Instead, the pending patents reflect a research design that uses homogeneous populations to identify genetic sequences and particular forms of pharmacogenetic therapies. The disclosures acknowledge this meth-odology and also potential differences that may arise across groups defined in sociological terms.

The Marshfield Clinic reflects one possible path for personalized medi-cine. As of this date, there has not been a legal challenge to this methodology. The applications are still under review with the USPTO, which seems to be seeking more evidence of nonobviousness and novelty of the pertinent inven-tions. The case of Prometheus Laboratories illustrates another possible path, involving a patent that is being reviewed by the U.S. Supreme Court. This case serves as the final item for discussion in this book, an illustration of a business, a legal dispute, and a metaphor for personalized medicine patents.

The Business

Prometheus Laboratories is a San Diego, CA company that develops and mar-kets diagnostic tests and therapies for a range of diseases, including Crohn’s disease and lactose intolerance. Their Web site includes a picture of a patient with the caption: “I am unique. So are my medical needs” and a slogan that captures their mission: “For the person in every patient.”10 The advertising blurb summarizes well the philosophy underlying personalized medicine. The blurb also illustrates the issues raised by invention and patenting in the field of personalized medicine, both of which conceptualizes persons as mem-bers of groups. Group categories guides research; group categories insinuate into the language of patents. How to reconcile individualized medicine with group categories is the challenge this book has addressed.

To respond to this challenge is to recognize that patents have expanded into realms beyond that of the mechanical, the chemical, and the biological into the personal. By this statement, I mean that the concept of what is an invention has expanded to include aspects of a human identity. Through this expansion, the neat boundary between the human subject acting on materi-als in the word and the objects that are shaped from these materials, such as machines, physical objects, chemical compositions, has blurred. With expan-sions in biotechnology, the human person is both the subject and object of

10 http://www.prometheuslabs.com/About.asp (last viewed January 19, 2012).


invention. As a matter of policy, of morality, and of ethics, I have raised the claim that to avoid reducing a human being to an object of invention, patent law needs more carefully to acknowledge the person and the limitations that respect for the person places on patenting. The point is not to impede progress in medical diagnosis and treatment that without question benefits persons. Rather, the goal is to realize these benefits without losing sight that a person is not a mere object of invention, but a communicative being with wants and needs. This book is an attempt to make these dimensions of the person con-crete within patent law and policy.

The legal argument I presented does not rest on some fixed, unchanging notion of personhood as a constraint on patenting. Developing a humanist approach to patent law cannot ignore the malleability and diversity of what it means to be a person. The strategy I have adopted starts from the observation that invention and identity depend on categories used to describe and define persons. These categories guide research; they guide the drafting of patents. The case studies of Myriad and Nitromed that began this book demonstrate how companies seeking commercial channels construct individual identity to define market opportunities. These choices in turn shape the identity of inventions. That inventions themselves have an identity reflecting catego-ries of race, ethnicity, and gender show the reach of categorization of persons to the conception of products and markets. Identity is invented and in turn inventions are given identities.

The previous two chapters of the book turned toward the implications for policy and practice in patent law for placing limits on inventions in the field of personalized medicine. The turn in these chapters was to the practical, to reconciling the benefits of the fruits of personalized medicine with the dangers to persons from the institutional design for promoting and pursuing personalized medicine inventions. The strategy in these two chapters is to pro-vide a normative theory of categorizing persons and to identify mechanisms within existing patent law to pursue a normatively sound set of practices for promoting personalized medicine. Racial categories were the specific focus because they are the most controversial ones that arise in the field of person-alized medicine. But future work can turn to other categories and the broader question of whether persons can be categorized so as to retain respect for per-sonal autonomy and identity. Can personalized medicine be pursued without reducing persons to objects? This question remains the ongoing challenge, and this book has presented an approach to answering these questions.

One danger is the conflating of genetic notions of identity with sociological notions. The Myriad and Nitromed examples treat the genetic and sociologi-cal as separate. But one patent from 2011 shows how genetic categories and


sociological ones may merge. The patent discussed in Chapter 3 for obfuscat-ing identities refers to genetic markers that may correlate with sociological categories of race and ethnicity. This patent ostensibly supports a color-blind treatment of genetic information, but the invention itself is based on the assumption that there is a correlation between sociological categories and genetic traits. Although a causal linkage is not implied, the identification of a correlation readily supports biological theories of race and ethnicity, theories that have been pernicious in the past and are suspect in the present. A cleaner approach I have suggested is to focus on the biological and ignore altogether suspect sociological categories when pursuing personalized medicine. By doing so, researchers can focus on promoting progress in the genetic informa-tion and avoid the sociological categories altogether.

Prometheus Laboratories promotes diagnosis and treatments illustrative of personalized medicine. Its advertising blurb emphasizes the uniqueness of personal medical needs. The company uses and enforces patents to pursue these personal needs. Two patents that Prometheus lab licenses exclusively, and enforces, were the subject of a dispute before the U.S. Supreme Court during the 2011–2012 term.11 The alleged infringers, which lost at the appellate level, are the Mayo Clinic of Rochester, Minnesota, and the affiliated Mayo Medical Laboratory. The patents cover the identification of metabolites in human blood to aid in calibrating the treatment of gastrointestinal disorders associated with Crohn’s disease. To put it simply, the invention entails admin-istering the treatment to a patient, reading the level of metabolites in the specific patient post-treatment, and calibrating the treatment based on mea-sured metabolite level. The district court found that patents invalid because they entailed an abstract idea, or mental step, that is not patentable.12 The Federal Circuit reversed this decision, finding that the patents were valid.13 The U.S. Supreme Court first asked the Federal Circuit to reconsider the case in light of the 2010 Supreme Court decision, Bilski v. Kappos.14 The Federal Circuit upheld its earlier decision,15 and the Supreme Court reversed the Federal Circuit decision. This ongoing litigation and the business model of Prometheus provide a coda to my argument and a glimpse into the possible future of personalized medicine and patenting.

11 Mayo Collaborative Services v. Prometheus Laboratories, Inc., 131 S.Ct. 3027 (June 20, 2011).12 Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 2008 WL 878910 (S.D.Cal.

2008).13 Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 581 F.3d 1336 (Fed.Cir.(Cal.)

2009)14 130 S. Ct. 3218 (2010).15 Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628 F.3d 1347 (Fed.Cir. 2010).


The Litigant

Prometheus Laboratories licenses and practices the patents at issue, but the inventors were research scientists associated with Hospital-Sainte-Justine, a nonprofit hospital in Montreal, Canada. The hospital is the owner of the pat-ent. As with Myriad and Nitromed, the inventions are the product of a non-profit research laboratory that in turn licenses or transfers patent rights to a for-profit entity. The alleged infringer is also a nonprofit entity that is challeng-ing the validity of the patent. This dynamic is no different than that of a for-profit entity suing another for-profit entity for patent infringement. Inventors and licensees are attempting to carve out market niches, and competing com-panies are testing the boundaries of patent rights, contending often that the patent encompasses knowledge and practices that should not be proprietary. How these boundaries are drawn is a matter to be determined.

In the Prometheus case, these boundaries explicitly and implicitly corre-spond to dimensions of personhood and identity. The central issue in the dispute is whether the invention is an unpatentable abstract idea, or men-tal step. A mental step, or process, is excluded from patent protection.16 It is deemed too abstract for legal protection and hence too ephemeral and ethe-real for legal institutions to effectively and predictably police. Furthermore, mental steps are deemed essential to pursuing certain activities. If a patent were recognized, everyone would be an infringer. The exception for men-tal steps expressly recognizes that there are aspects of a person that cannot be patented. Thoughts, ways of processing information, thinking through a problem – these are operations of the human mind. One could even say that they are necessary for invention to occur. No one entity or person can claim ownership in such essential processes.

The Federal Circuit, however, held that the diagnostic and treatment meth-ods were not unpatentable mental steps. The methods did not exist purely in the mind but had concrete application to the human body and to the treat-ment of a disease. Framing the legal issues in terms of whether the process resulted in some type of physical transformation, the Federal Circuit found the requisite transformation in terms of modification of the pharmaceutical treatment based on the metabolite levels in the patient’s body.17

The Supreme Court reviewed the Federal Circuit’s decision in 2011 and held that the patent was invalid. The Court reasoned that the Prometheus pat-ent was simply reciting a law of nature without identifying a novel application.

16 Le Roy v. Tatham, 55 U.S. 156 (1852).17 See note 15 to this chapter at 1357–1358.


A law of nature is not patentable, but a specific application of the law can be.18 During oral argument in December 2011, the Mayo Clinic contended that the process is fundamentally mental, requiring a mental process to calibrate the dosage level.19 At the heart of the invention, the Clinic argued, is a mathemat-ical correlation that is purely mental. The Federal Circuit, however, framed the invention in terms of the effects on the patient’s body rather than in terms of what was being executed in the medical service provider’s head. The Supreme Court disagreed with the Federal Ciruit’s analysis, ruling that the patent covered only a statistical correlation without providing specific appli-cation of the correlation to medical diagnosis or treatment. Allowing such a patent, the Court held would have inhibit the ability of medical practitioners to freely diagnose and treat patients.

Not at issue in the case, but central to the path of personalized medicine, is the way in which the inventors characterized persons in drafting the patent. As mentioned in Chapter 5, the inventor did not rely on racial or ethnic cat-egories. Nor did the inventor draft the patent in terms of identifiable genetic markers. Instead, the patent speaks to a particular chemical composition of the human patient, the metabolites, as measured by the medical service provider. Through this construction, the invention is tailored to individual characteris-tics of the patient without appeal to a group category. The patent avoids many of the problems identified in Chapters 4 and 5. The inventors have found a characteristic that can be measured and calibrated for personalized treatment. Personalized medicine is implemented without categorization.

Although the patent claims in Prometheus were found to be invalid because they only recited a law of nature, perhaps they indicate one possible path for personalized medicine. By not categorizing on racial or other personal terms, the claims avoid the tensions between individualized treatment and group identification. The tension, as the legal controversy over the patents shows, is that this path focusing on individualized data from a patient may conflict the mental processes of medical practitioners. The Federal Circuit resolves this tension by framing the invention in terms of what happens in the body of the patient, reducing the mental elements of the invention to trivial intermedi-ate steps. But all medical treatment or diagnostic will have an effect on the human body. The question is whether the invention is too broad and inter-feres in medical treatment and diagnosis too broadly. To emphasize the policy behind the exception for mental steps: if the patent is allowed to stand, would

18 Mayo v. Prometheus, 132 S. Ct. 1289 (2012).19 Transcript of Oral Argument at 24, available at http://www.supremecourt.gov/oral_argu-

ments/argument_transcripts/10–1150.pdf (last viewed January 19, 2012).


every medical practitioner potentially be an infringer? Some of the Supreme Court’s questioning during oral argument seemed to point toward this funda-mental issue. Whether the Court pursues this inquiry and incorporates these policies in the disposition will be seen.

The Culture of Personalized Medicine Markets

Ultimately, patent policy toward personalized medicine requires a fuller understanding of persons, not just the person being treated and the way the patient is categorized, but also the medical provider and the institutions within which they operate. Although a patent is seen as a commercial instrument, patents on methods of personalized medicine have effects beyond the com-mercial sphere. They can affect the culture for professional medical service and society conceptualizes the person. They can affect the culture for profes-sional medical service in the treatment of the patient. They can also affect how society conceptualizes and values the patient as person. The cultural theory of patents, presented in Chapter 5, speaks to these broader influences of patenting. If patents do serve as legal tools for incentivizing inventions, for marketing new products and processes, and for disclosure of new forms of knowledge, their influence goes beyond a narrow technical sphere of research and commercial development. A patented invention reflects and shapes the culture within which it arises.

Within the practice of medicine, a patent on a method of diagnosing and treating diseases using personalized medicine would affect how practitioners deal with patients and colleagues. Intellectual property is described as having a chilling effect on users. Such effects are often traced to creators of copy-rightable works, for example, documentary filmmakers, song writers, and per-formers. With the expansion of personalized medicine patents, such chilling effects may extend to those treating patients with implications for the identi-fication of a disease and for the prescription of medicines. A medical practi-tioner would be concerned that a particular diagnostic tool might be subject to patent law and potentially expose the practitioner and his employer to lia-bility. Congress has excluded some medical practitioners from liability for sur-gical method patents. Such immunity may be extended to other treatment methods. It should also be expanded to diagnostic methods.

One motivation behind the lawsuit against Myriad was the potential effects of diagnostic method patents on the ability of a medical practitioner to speak with other colleagues or with a patient about a particular diagnostic tech-nique. To be sure, patent law prohibits only the use of a patented invention. In the case of a diagnostic method patent, this use would entail the practice


of the diagnosis. Users can talk about a patented invention. However, with respect to diagnostic method, the line between talking about an invention and using it may be blurry. Talking may include communicating with a patient to obtain information about symptoms relevant to a diagnosis. Talking may also include communicating with a colleague to aid in interpreting or assess-ing the symptoms to continue the diagnosis. The proverbial second opinion, which seemingly includes only talking about a diagnosis, may inadvertently stray into aspects of a patented diagnosis itself. Even if professional conversa-tion and interaction may not lead to a finding of infringement, the specter of a patent may have chilling effects on practice. The opinions in Myriad did not address these consequences of the diagnostic patent at issue because the facts of the case did not directly raise these issues. But an assessment of the poli-cies underlying these patents should include a consideration of these potential consequences.

As described in Chapter 1, much ink has been spilled over how personal-ized medicine and genetic patents may lead to ownership of a person’s gene or even a whole person. Such concerns are overstated. As the opinions in Myriad indicate, courts distinguish between the genetic sequence in its natural state and the sequence as identified and isolated in the laboratory. Only the latter is covered by the patent. If the two cannot be distinguished, then there is no pat-ent protection. A more real concern is how patenting can affect the practice of medicine. The effects can include those of chilling discussion and treatment for fear of infringement of an unlicensed patent. The effects can also include research energy and money shifted to patenting and commercialization rather than on treatment and diagnosis. How patents affect culture in subtle ways are more of a concern than the alarmist outcries against ownership of people and new forms of genetic enslavement.

The cultural effects go to practices in the medical community, the organi-zation of basic research and medical treatment, and the implications of these changes in reshaping the market for health care. A simple story is that a patent creates a monopoly, or a market with one seller of a product or service. This artificial monopoly, the simple account goes, can gouge consumers, reduce quality, and impede innovation. The patent-as-monopoly story is a simple one. Often patented inventions can be designed around, with different companies owning patents on variations over inventions. As in the case of Myriad and Nitromed, these “design-arounds” may not necessarily result in different pat-ents, but in low-cost alternatives to patented technologies. The market effects of patents are not in the creation of a single seller, but in the increase in costs that arise from research and development for the purpose of competing in obtaining patents and in design-arounds. These costs may yield benefits in


the form of new products or new ways of administering well-known and estab-lished technologies. To the extent that the additional costs yield additional benefits, they are hard to fault.

The problem is when the costs are incurred as defensive measures. One policy concern in the area of medical malpractice has been, and to a certain extent continues to be, defensive medicine, or the pursuit of excessive treat-ment in order to avoid a medical malpractice claim.20 Similarly, the patent system can lead to overinvestment in research and development when com-panies seek patents in order to maintain a competitive position in an existing marketplace rather than improve existing inventions or enter new markets.21 It seems odd to fault research and development. They are, of course, the path-way to creating new technologies. At some point, however, the health care sys-tem might be improved by reducing expenses on research and development and investing more on the treatment of patients and the delivery of products and services. Where that point lies is difficult to determine. Any additional expenditure on research and development can be justified by noting that the extra dollar spent on it may result in a life-saving measure. Sometimes such justification may be speculative. But even if the justification is not purely spec-ulative, the question has to be asked whether the expense is worth making. That is a difficult question to answer. Whether to save a hypothetical life is a question analogous to whether to sustain life through life-extending tech-nologies. But the latter is more difficult and is left to the person whose life is at stake and the family with consultation from health care providers. The former is a question that is often too tempting to answer in the positive, espe-cially given that the answer is left to decision makers in business entities were profits may also be at stake or to policy makers who would be hard-pressed to justify why additional expenses were not spent to yield the miracle cure. Nonetheless, at some point, additional research dollars would be better allo-cated toward health care delivery rather than health care innovation.

The parade of horribles associated with personalized medicine patents is not lead by the corporate slave owner of genetic sequences. Rather in the lead is the self-described innovator or entrepreneur incentivized by the mar-ket profits made possible by patents. The solution is to create safeguards that patents are granted to inventions of sufficiently high quality to promote the investment of research and development in the most socially valuable medical treatments and diagnostic methods. The reforms suggested in Chapter 5 are

20 Daniel P. Kessler, William M. Sage & David J. Becker, “Impact of Malpractice Reforms on the Supply of Physician Services,” 293 JAMA 2618 (2005).

21 Mark A. Lemley, “Property, Intellectual Property, and Free Riding,” 83 Texas L. Rev., 1031 at 1059 (2004–5)


directed toward improving patent quality. If patents are granted to genuinely breakthrough inventions, research and development dollars would go toward the most socially beneficial projects. Furthermore, if patents were difficult to obtain, the incentives to move in the market from delivery of services to research and development would be mitigated. The implication would be that only a few firms would engage in research and development whereas others would focus on treatment. Consequently, patents may be concentrated only among a few companies that engage in research and development. Although this concentration may produce the concerns about market power discussed earlier, effective enforcement of licensing rules and judicious application of antitrust law may mitigate these concerns. Furthermore, the health care mar-ket may be more effectively divided among innovators and providers. There can be overlap between the two, but such a division, even if not strict, may promote high-quality patenting and effective delivery of innovation.

Whatever the actual market for personalized medicine might look like – and there are many forms such a market can take – the point of the preceding discussion is that patenting can affect the culture of innovation. Personalized medicine patenting can have other, more salient cultural effects in terms of how we understand the person and ourselves. These effects are more amor-phous and arguably speculative. But they are worth exploring. At a broad level, the shift to a heliocentric view of the solar system changed the humans’ con-ception of cosmos and their place in it. Understanding of evolution changed the way human beings viewed their relationship to the natural world. These epistemic shifts are not as simple as I describe them here; rather they are complex, touching on questions of scientific method, morality, and the abil-ity to alter one’s environment through technological, ethical, and cultural advancements.

Patents affect the cultural landscape in many ways. Patented inventions support marketed products and commodities, as described in Chapter 3. These marketed products are part of a constructed social and cultural space that reflects and shapes attitudes toward other people and conceptions of one-self. The famous doll experiment by the psychologist Kenneth Clark was criti-cal to the Supreme Court’s overturning, in Brown v. Board of Education,22 of separate-but-equal as a correct interpretation of the Equal Protection Clause. Dr. Clark’s experiments showed that children of all races viewed black dolls as inferior to white dolls.23 The marketed toy became a cultural artifact reflecting

22 347 U.S. 483 (1954).23 Idem. at 494 & n.11; Richard Kluger, Simple Justice: The History of Brown v. Board of

Education and Black America’s Struggle for Equality (New York: Knopf, 1975) 706–707.


social values. While the particular dolls at issue in Dr. Clark’s experiment may not have been patented, the point is that patents on other race-specific toys show how incentives for invention and marketing reflect the cultural mores of the marketplace.

Personalized Medicine, the Body, and the Self

There should be nothing surprising in the statement that patents reflect society. What is more challenging is the implication of this observation. One view is that the connection between patents and culture are so tenuous that patent law offers little redress for social and cultural reform. It would be incredibly naïve and foolish to view patent law itself as harboring a solution to society’s injustices. The problem revealed in Dr. Clark’s experiments is not the patent on the dolls, if there were any. The problem was the interpretation of the Equal Protection Clause that supported and validated pernicious legal and social practices. At the same time, it would be equally naïve to view patent law as a purely techni-cal doctrine dealing with inventiveness without recognizing that inventions have a social and cultural dimension. The implications for patent law may be modest, but if one accepts that the patent system is one of private incentives, policy makers should be aware of the results of these incentives. Contrary to Werner von Braun’s treatment of his rockets, we should be concerned with not only how inventions are patented but also where they end up.

Personalized medicine, ideally, provides more effectively tailored treat-ments to individuals. Patents on personalized medicine create incentives for developing and commercializing inventions that aid in more effective diagno-sis and treatment. Such inventions can have benefits not only for the specific patient being treated, but also for health care delivery and society as a whole in promoting better knowledge of disease proclivities and an earlier and better delivery of medical services. However, personalized medicine and the patents that support it can alter how we conceive of personhood. There may be a tendency to reductionism; a person is only a sequence of genes or a particular characteristic like skin color. There is a tendency to turn a person into a com-modity, an object to be studied and a source of patentable inventions. This book has examined these possibilities and proposed ways to militate against them. Patents rest on the language used to describe an invention, and that lan-guage influences how inventions are marketed by patent owners and licensees as well as how they are viewed by the public, by the patent office, and by the courts.

Personalized medicine will shape conceptions of personhood through the marketing and use of its technologies. Advertising can make consumers more


aware of how genetic history and makeup can shape health care choices.24 To some, such knowledge may bring a sense of fatalism. To others, the knowl-edge of disease proclivities may be liberating and support better planning and health care choices. Health care itself can develop on different dimensions of the person, with medical practitioners identifying specific genetic and chem-ical compositions within a person as the key identifiers for disease and key targets for disease treatment. In short, personalized medicine can provide more refined technical information about one’s self. Such refined knowledge can improve outcomes, provide benefits for patients, and improve medical delivery.

These benefits from improved knowledge will come about if the knowledge is used appropriately. At a number of points in this book, I have suggested the possibility of personalized medicine reducing persons to certain dimensions, whether it be genetic sequencing or physical characteristics. Such possibilities arise from the use of outdated categories to describe and differentiate persons and the lack of a new syntax with which to articulate the genetic and biologi-cal dimensions of a person. The chemicals that comprise a person are treated as objects, and oftentimes a person does not view these objects in personal or subjective terms. One’s blood, one’s waste products, one’s bodily fluids are distinct from one’s self, which is greater than the sum of the physical parts of one’s body. At the same time, personalized medicine forces us to pay greater attention to these physical objects that constitute our body to obtain a bet-ter handle on the shell that houses what we call the self. Such a distancing between the physical and the mental dimensions of the self may be difficult to maintain.

To echo the thought experiment of philosopher Derek Parfit, discussed in Chapter 1, at what point does the physical intrude on what is my person? If I cut my nails, I am not a different person. If I cut off all the hair on my head, I may be perceived as a different person, but I may feel that I am the same. What if I cut off a limb? Or to ask a different question, what if a technique allows me to splice my DNA and combine it with some new sequence? We view our selves as distinct from physical characteristics. People are derided if they view other people only in terms of physical features. To reduce a person to their physical characteristics is referred to as objectification, implying that the person is separate from the physical dimensions of the body. Personalized medicine, with the full force of marketing and commercialization, has the potential to reduce the person to the physical and turn the contingent into fixed, immutable markers of identity.

24 “Ethnic Advertising: One Message, or Many?” The Economist, December 31, 2011, at 48–49.


Personalized medicine, however, can also objectify the person through reducing mental steps to a commodified invention. As previously discussed, the patent at issue in the Prometheus dispute covers a diagnostic method of adjusting treatment of a gastrointestinal disease based on the measure level of a metabolite in the human body. This “adjusting,” challengers to the pat-ent argue, is a mental step, which is excluded from patentable subject matter. Patent law in many jurisdictions excludes mental steps for reasons described in more detail previously. Patents on mental steps are impractical to enforce and may have too broad and unidentifiable scope. From the perspective of person-hood, patents on mental steps may impinge on the very subjectivity of a person that is seen as distinguishable from the objective and physical dimensions of the body. To allow patents on mental steps is to allow private rights to intrude into the subjective workings of a person, the basis for personal introspection as well as the source for communication between persons. Such impingement and intrusion is particularly disfavored within a legal regime that is devoted to promoting invention and innovation, like patent law. Invention rests on con-ception, but of course must go beyond the mere conceiving of ideas. To allow a proprietary right over mental processes is potentially to make exclusionary the very source of invention. Almost by definition, mental steps as the fount of invention cannot itself be the invention’s object.

To summarize, personalized medicine and its patents confront directly the core of personhood. Whether as patient under treatment or as consumer of diagnostic methods, the person is affected by how personalized medicine shapes the markets for its patented inventions and the cultural context that the markets shape and to which they respond. Furthermore, personalized medi-cine can alter how we conceive of our own personhood, whether as a patient or as a thinking, inventing person. To what extent personalized medicine has these effects depends on the form that patenting and commercialization take. The goal of a book like this is to make readers, who in part may by policy mak-ers, attuned to the potential paths of personalized medicine patents.

The Metaphor

Prometheus Laboratories is a business. Prometheus Laboratories is a litigant. But as its mythic name indicates, Prometheus Laboratories is also a metaphor, its name an appropriate and resonant one for a business and litigant in a suit about personalized medicine. Prometheus, the myth has it, was a Titan, a cross-breed of the divine and the human, who stole fire from the gods and gave it to human beings. Because of this transgression, Zeus, the king of the gods, tied Prometheus to a rock where every day an eagle would feast on his


liver, which would in turn grow back during the night to repeat the cycle the next day.

The beauty of a metaphor is that it can be read in many ways. Prometheus’ punishment, the repetitive and never-ending acts of consumption and restora-tion, is in some ways like patent law itself, with the issues of patentability being eaten away in one era only to be revived in subsequent ones. The policy issues raised by personalized medicine are no different from those raised by chemi-cal patents in the nineteenth century and by pharmaceuticals, biotechnology, and software in the twentieth. As with so many areas of the law, policy makers and legal scholars relive the same issues with different economic and social contexts. Unlike Prometheus, we do, however, get some change of scenery.

Prometheus as metaphor also stands for the reduction of the self to pure object, feed for carnivorous birds. The word “prometheus” means “fore-thought” in ancient Greek, and we can imagine his thoughts serving as a dis-traction from the savagery suffered by his body. But Prometheus the thinker was punished for his good intentions, his foresight, in bringing knowledge to human beings. His crime was invading the proprietary space of the gods. Although Aristotle wrote of a legal system that some analogize to patents,25 there is no mention in Greek mythology of a patent office on Mount Olympus. The gods maintained proprietary rights in fire through might rather than through law. The Prometheus story is not one that maps so neatly onto patent law, under which process, rules, and advocates replace rocks, chains, and rap-tors. Nonetheless, the story does remind us of an instinct to guard knowledge, especially of items fundamental and life-altering, and make it proprietary.

Like the Old Testament tale of forbidden fruit, a tale of carnality, curiosity, and consumption, the Prometheus myth is an admonition against the quest for knowledge without the boundaries on how knowledge is to be gleaned and used. The antidote for excessive and unbounded knowledge is not ignorance, of course. Instead, knowledge is more than the accumulation of technique and technology. Such accumulation must come with an awareness of the lim-its of knowledge and its consequences. The anxiety over the unleashing of the energies in the atom and the nucleus that hung over society after World War II has solely been morphed into the anxieties unleashed by the unlocking of the gene. Prometheus’ punishment is not simply the ravishment of his body, but also the mental anxiety of witnessing the feast. At least he can, after a few iterations, experience some quietude in knowing what is going to happen and separating his mind from the bodily pain. With the knowledge that comes

25 Aristotle, The Politics (Stephen Everson ed., Cambridge: Cambridge University Press, 1988) 36–39.


from unlocking the nucleus or the gene, however, comes the anxiety of uncer-tainty, of not knowing where the new paths will lead.

Anxiety may be an overstatement. While knowledge also introduces uncertainty, it is tempered by caution and gauging of the consequences. The freedom that makes technological breakthroughs possible also supports thought and planning on how to make proper use of these breakthroughs. The thought and planning become reflected in law. This pronouncement should not be taken as sanguine or overly optimistic. Instead, it is a reminder of why books like this one are written and why law serves not only to promote innovation and progress, but also to guide its course. To recognize the per-sons that underlie patents is to underscore the persons that create and must take on the charge to transform the law, the inventors, the patent owners, the medical providers, the patients, the legislators, the judges, the readers of this book.

Final Thoughts

Personalized medicine patenting raises many issues of theory, practice, and policy. But should anyone other than an academic audience care? This book presents some detailed examples and perhaps overly detailed analyses of what is at stake when companies pursue a strategy of research and innovation in developing and patenting diagnostic and therapeutic methods for personal-ized medicine. The analyses have looked to the meaning of personhood, its relevance to patents, and its implications for policy with respect to biomedi-cal innovation. The book presents some policy recommendations and, more importantly, a framework that will, I hope, inform future discussion. But with all the self-promotion that comes with writing a book, an author should step back and ask why it all matters.

Whatever one’s perspective on patenting, personalized medicine, or inno-vation, one has to recognize that we are at a watershed in how medical treat-ment and diagnosis will be delivered and structured. Medical practitioners will be able to agglomerate information about a person’s genetic and biomedi-cal history in order to tailor diagnoses and therapies that can cure or at least curb diseases. Medical information is as much a part of the information age as the Internet, software, and social networking. Because such information collection is so specialized, the ordinary citizen may not be as attuned to it unless a disease manifests itself and encounters with the medical establish-ment become necessary. Just as one worries about a social security number or a credit card receipt, one needs to be aware of developments in biomedical information collection and processing.


As the many patents and inventions discussed show, trends in innovation in the area of personalized medicine will increase. These inventions will allow for more sophisticated identification of disease and tailoring of treatment as well as methods for managing and obfuscating this information. The patent system plays a role in these paths of innovation. Reform of patent law, and of intellectual property law more generally, is no longer a specialized interest. Intellectual property affects what products and services we have access to and on what terms. In no area is this point more salient than in the area of patents that affect heath care. I hope this book provides some guidance in under-standing the emerging and ongoing legal, economic, and political issues.

Most importantly, personalized medicine implicates how we think of our-selves. Genetic research has opened up frontiers previously unexplored, which provide opportunities for medical breakthroughs, commercialization, and personal understanding. Knowledge, once witnessed, cannot be and should not be contained. What paths knowledge creates cannot be predicted. With knowledge, however, comes the ability to shape and direct the paths. How the paths should be formed is open to debate even if the need to shape them is not. Will personalized medicine reduce a person to one’s genes? Will the identification of genetic markers for disease lead to fatalism and inaction? Personalized medicine patents are part of our shared experiences as persons. How we respond to these experiences will reflect not only the persons we are now, but the persons we can become.

215

Index

Arendt, Hannah, 11, 21, 22, 23, 24, 25, 177

Baker v. Selden, 147, 148BiDil, 2, 3, 6, 54, 55, 56, 63, 65, 102, 104, 105,

179, 180, 182, 184, 187, 188, 189, 190, 197, 198Bilski v. Kappos, 202biotechnology, 1, 2, 20, 46, 47, 130, 189, 190,

191, 200, 212black patient, 2, 6, 19, 36, 56, 100, 101, 126, 127,

130, 131, 184, 185, 187breast cancer, 1, 3, 6, 27, 33, 41, 42, 43, 44, 48,

63, 66, 99, 100

categories, 18, 19, 22, 27, 29, 54, 57, 63, 65, 66, 67, 69, 71, 72, 73, 74, 79, 81, 87, 89, 93, 94, 95, 97, 98, 100, 102, 106, 126, 127, 129, 131, 132, 133, 144, 151, 162, 163, 164, 165, 166, 167, 168, 170, 171, 172, 175, 176, 179, 181, 182, 183, 184, 185, 186, 187, 188, 190, 192, 193, 194, 200, 201, 204, 210

Civil Rights, 28, 69, 74, 174claims, 30, 34, 35, 49, 56, 59, 65, 69, 71, 73, 87,

89, 100, 101, 104, 106, 130, 131, 132, 134, 136, 138, 139, 145, 179, 181, 183, 184, 185, 186, 187, 188, 189, 190, 191, 198

copyright, 20, 52, 137, 140, 146, 147, 148, 149, 150, 151

critical theories of race, 133, 168, 172, 173, 182, 194

Diamond v. Chakrabarty, 27, 141dilator, 2, 54discrimination, 74, 129, 130, 162, 169, 171, 173,

176, 187distributive justice, 133, 134, 135, 136, 137,

177, 184

embryo, 36, 37entrepreneur, 207epidemiology, 4, 65, 66, 73, 97, 98, 100, 106,

127, 180, 181, 192, 193, 197equal protection, 28, 128European Court of Justice, 34European Patent Office, 24, 44, 151European Union, 6, 37

FDA, 2, 3, 54, 55, 58, 103, 179, 180, 181Food and Drug Administration, 2, 54

gender, 17, 28, 29, 55, 64, 66, 93, 102, 175, 201

genetics, 50, 63, 127, 193, 196

hypertension, 2, 4, 27, 33, 54, 55, 56, 60, 61, 93, 100, 129

identity, 7, 15, 18, 27, 63, 65, 79, 80, 87, 88, 89, 91, 93, 94, 98, 106, 127, 128, 129, 130, 132, 166, 169, 173, 175, 177, 183, 185, 186, 187, 190, 192, 193, 196, 200, 201, 203, 210

intellectual property, 19, 20, 23, 24, 29, 30, 48, 52, 54, 64, 129, 133, 134, 136, 138, 139, 140, 150, 161, 164, 165, 166, 176, 184, 214

Intergenerational justice, 140

KSR v. Teleflex, 60, 105

Liberal Theories of Race, 169

Marshfield Clinic, 195, 196, 197, 198, 199, 200

Mayo Clinic, 195, 202, 204Myriad Genetics, 1, 24, 41, 42, 44, 47, 50

Index216

Nitromed, 2, 3, 4, 6, 7, 15, 19, 22, 27, 29, 31, 33, 36, 38, 39, 41, 43, 53, 54, 55, 60, 61, 63, 64, 94, 100, 126, 127, 128, 130, 178, 188, 189, 190, 195, 198, 201, 203, 206

nitrous oxide, 54, 55nonobviousness, 8, 46, 49, 58, 59, 61, 71, 73,

99, 100, 103, 104, 105, 106, 141, 142, 153, 154, 156, 158, 160, 164, 182, 184, 188, 189, 190, 191, 200

Parfit, Derek, 11, 16, 17, 18, 19, 21, 177, 210patent, 2, 3, 4, 6, 7, 8, 9, 10, 11, 12, 16, 19, 22, 23,

24, 27, 28, 29, 30, 31, 32, 33, 34, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 127, 128, 129, 130, 131, 132, 133, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 172, 175, 176, 177, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 197, 198, 200, 201, 203, 204, 205, 206, 207, 208, 209, 211, 212, 213, 214

patent prosecution, 31, 56, 155, 156, 157, 159, 168

patentability, 1, 3, 34, 36, 53, 56, 58, 59, 60, 70, 71, 73, 99, 100, 103, 104, 105, 106, 141, 144, 145, 152, 156, 159, 189, 191, 192, 212

patentable subject matter, 8, 36, 37, 49, 51, 52, 53, 141, 142, 143, 144, 145, 146, 147, 149, 150, 151, 152, 153, 159, 161, 198, 211

personalized medicine, 3, 10, 11, 12, 13, 15, 16, 19, 22, 23, 24, 25, 38, 39, 41, 46, 53, 55, 61, 62, 63, 64, 66, 67, 94, 102, 126, 127, 128, 129, 130, 153, 161, 177, 193, 194, 195, 196, 197, 200, 201, 202, 204, 205, 206, 207, 208, 209, 210, 211, 212, 213, 214

personhood, 12, 13, 14, 15, 16, 17, 19, 21, 22, 25, 27, 28, 34, 37, 38, 177, 201, 203, 209, 211, 213

policy, 1, 3, 10, 11, 12, 13, 14, 15, 19, 20, 21, 25, 27, 28, 29, 31, 33, 34, 35, 36, 38, 39, 44, 46,

47, 49, 52, 60, 61, 62, 65, 67, 95, 126, 128, 129, 133, 142, 143, 152, 153, 157, 159, 160, 161, 165, 170, 171, 176, 177, 182, 185, 186, 190, 191, 193, 195, 201, 204, 205, 207, 209, 211, 212, 213

Prometheus Laboratories, 144, 200, 202, 203, 211

property, 8, 10, 12, 13, 14, 15, 20, 23, 24, 25, 26, 28, 33, 35, 37, 39, 49, 62, 64, 79, 129, 131, 132, 133, 134, 135, 138, 139, 140, 142, 150, 166, 177, 182, 186, 193, 205, 214

race specific patent, 55, 187, 190Radin, Margaret, 11, 13, 14, 15, 165, 177

specifications, 49, 65, 69, 71, 98, 100, 179, 181, 184, 185, 186

start-up, 2, 41, 90Stem cells, 37stem cells, human embryonic, 40surveillance, 94

teach, suggest, motivate, 59, 105trade secrets, 21trademark, 54, 78, 79, 172TSM, 59, 60, 105, 106

U.S. Constitution, 28, 35, 140, 151U.S. Court of Appeals for the Federal

Circuit, 1, 4, 10, 49, 53, 61, 71, 144, 145, 146, 147, 150, 151, 157, 158, 160, 187, 189, 202, 203, 204

U.S. Supreme Court, 1, 35, 37, 38, 46, 60, 99, 105, 140, 141, 142, 144, 145, 146, 147, 149, 151, 152, 157, 158, 169, 173, 194, 200, 202, 203, 205, 208

United States Patent and Trademark Office, 41, 56, 65, 66, 89, 101, 104, 145, 197, 198, 200

USPTO. See United States Patent and Trademark Office

written description, 56, 58, 69, 70, 72, 74, 76, 78, 80, 81, 84, 88, 89, 91, 93, 97, 98, 99, 101, 102

identity-_invention-_and_the_culture_of_personalized_medicine_patenting_ebook3000.pdf

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