professor margo a. bagley university of virginia school of law

Professor Margo A. Bagley University of Virginia School of Law

Intellectual Property Trade Secrets information that provides economic advantage and is maintained as a secret. Term: perpetual (if secret) Trademarks non-functional word, symbol, color, phrase, etc. that can indicate source/avoid consumer confusion. Term: perpetual (with use) Copyrights protect non-functional original expression of an idea, e.g., musical, sculptural, literary, graphic. Term: life of author + 70 years (95 yrs for work for hire) Patents (Utility)- protects functional embodiments of ideas, e.g. machines, processes, compositions, articles of manufacture. Term: 20 years from application filing date (Design and plant patents also available)

Trademarks Purpose: Identify source of goods or services, protect goodwill of owner Duration: Perpetual, as long as used in commerce Form: Adjective (Coca Cola brand soft drinks, Bayer brand pain reliever)

Examples of Trademarks Word (COKE, YAHOO!, HOME DEPOT) Name (RALPH LAUREN, KATE SPADE) Symbol/Logo Container/product Shape

Examples of Trademarks Packaging Sound Smell Building Design Color

Sound Marks NBC Status: renewed The mark comprises a sequence of chime-like musical notes which are in the key of C and sound the notes G, B, C, the G being the one just below middle C, and the C being middle C...

First FDA-approved DNA-based diagnostic testing kit for cystic fibrosis (Approved May 2005) Greta Burkholder

Gene Trademark Disputes POK family of genes called Pokemon (2001) Fly gene Velcro alternative name required (1993)

Copyright Rights the right to reproduce the copyrighted work; the right to reproduce the right to prepare derivative works based upon the work; the right to prepare derivative works the right to distribute copies of the work to the public; the right to distribute copies the right to perform the copyrighted work publicly; and the right to perform the right to display the copyrighted work publicly. the right to display

Patent Features 1. What is a patent? -paper document -property right granted by federal government (USPTO) 2. Nature of the property right? -Negative right to exclude others from making, using, selling, or offering to sell invention; term of exclusivity limited to 20 years from date of filing; not affirmative right to practice 12

Patent Features Cont. - Some reasons why patent cannot be practiced by owner: Illegality Blocked or dominated Lack FDA approval 13

Patent Features Cont. Nature of the property right Territorial : must obtain patent in every country where protection is desired Personal property : can be bought, sold, licensed, bequeathed, etc. 14

Types of U.S. Patents Utility Patents: for useful, novel, and non- obvious machines, processes, articles of manufacture or compositions >7 million) Design Patents: for a new, original, ornamental, and non-obvious design for an article of manufacture (~400,000) Plant Patents: for new and distinct varieties of asexually reproducing plants (~15,000)

Patent Primer Type (machine, composition of matter, article of manufacture, process) anything under the sun made by man Not patentable: laws of nature, abstract ideas, natural phenomena Utility useful Novelty new Nonobviousness to person of ordinary skill in the art Description, enablement, best mode

Incentives Time limited rights: Art. I, Sec. 8, cl. 8 of the Constitution authorizes Congress to promote the progress of science and useful arts, by securing for limited times... patents added the fuel of interest to the fire of genius Abraham Lincoln

18 Eligibility and Patentability Biotechnology Computer Implemented inventions

Patent Eligibility (35 U.S.C. 101) (Utility Patents): 35 U.S.C. 101 whoever invents... any new and useful process, machine, manufacture, or composition of matter... may obtain a patent therefor. Not patentable: laws of nature, abstract ideas, natural phenomena 19

Sample claim types An isolated DNA comprising... A method for determining a germline alteration in a BRCA1 gene... An apparatus for...

21 Controversial biotech patent subject matter (patents on life) Includes: Transgenic animals (animal suffering, de-valuing life) Genetically modified plants (impact on farmers, the environment, food supply) Genes/DNA (products of nature, building blocks of life/research) Methods of cloning/cloned humans (ownership of humans) Human embryonic stem cells (destroying human embryos, hindering research) Mixed human/animal chimeras (human dignity, species integrity) http://ipgeek.blogspot.com

Patent Subject Matter Diamond v. Chakrabarty (1980): Patentable subject matter includes anything under the sun made by man, living or non-living. A living creature can be a manufacture or composition of matter. 22

DNA/Gene Patents Sample claim: A purified and isolated DNA sequence consisting essentially of a DNA sequence encoding a polypeptide having an amino acid sequence sufficiently duplicative of that of erythropoietin to allow possession of the biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells, and to increase hemoglobin synthesis or iron uptake. (#4,703,008) A patent on a gene covers the isolated and purified gene, but does not cover the gene as it occurs in nature. 23

24 DNA/Gene Patents H.R. 977: bill introduced in Congress 2/9/07 to prohibit patenting of human genetic material no patent may be obtained for a nucleotide sequence, or its functions or correlations, or the naturally occurring products it specifies Concerns: Interference with research on diagnoses and cures (fears of liability) Data withholding and secrecy among researchers Patenting of diseases can impact timeliness of public health testing

Limits on Patent Subject Matter A new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E = mc 2 ; nor could Newton have patented the law of gravity. Such discoveries are manifestations of... Nature, free to all men and reserved exclusively to none. Funk Bros. v. Kalo (USSC 1948)

26 A method of operating a rubber-molding press for precision molded compounds with the aid of a digital computer, comprising: natural logarithm conversion table (ln), the activation energy constant (C) unique to each batch of said compound being molded, a constant (x) dependent upon the geometry of the particular mold of the press, initiating an interval timer in said computer upon the closure of the press for monitoring the elapsed time of said closure, constantly determining the temperature (Z) of the mold at a location closely adjacent to the mold cavity in the press during the molding, constantly providing the computer with the temperature (Z), providing said computer with a data base for said press including at least, repetitively calculating in the computer, at frequent intervals during each cure, the Arrhenius equation for reaction time during the cure, which is ln v = CZ + x where v is the total required cure time, repetitively comparing in the computer at said frequent intervals during the cure each said calculation of the total required cure time calculated with the Arrhenius equation and said elapsed time, and Opening the press automatically when a said comparison indicates equivalence. Diamond v. Diehr, USSC 1981)

27 State Street Bank v. Signature Financial CAFC (1998) Hub and spoke system for administering mutual funds Business methods patentable as long as useful, concrete, tangible result HUB (Pooled fund) Mutual Fund Mutual Fund Mutual Fund Mutual Fund Mutual Fund Mutual Fund Mutual Fund Mutual Fund

28 Amazon.com 1-Click Patent U.S. Patent No. 5,960,411 (issued Sept. 28, 1999). Claim 1 of the 411 patent reads: a method of placing an order for an item comprising: under control of a client system, displaying information identifying the item; and in response to only a single action being performed, sending a request to order the item along with an identifier of a purchaser of the item to a server system; under control of a single-action ordering component of the server system, receiving the request; retrieving additional information previously stored for the purchaser identified by the identifier in the received request; and generating an order to purchase the requested item for the purchaser identified by the identifier in the received request using the retrieved additional information; and fulfilling the generated order to complete purchase of the item whereby the item is ordered without using a shopping cart ordering model. Patent-eligible method or abstract idea?

29 Laboratory Corp. v. Metabolite Claim at issue: 13. A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of: assaying a body fluid for an elevated level of total homocysteine; and correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.

30 Laboratory Corp. v. Metabolite Question Presented: Whether a method patent setting forth an indefinite, undescribed, and non-enabling step directing a party simply to correlate test results can validly claim a monopoly over a basic scientific relationship used in medical treatment such that any doctor necessarily infringes the patent merely by thinking about the relationship after looking at a test result.

31 Laboratory Corp. v. Metabolite Widely expected to limit patent eligibility of business method patents. USSC dismissed cert. as improvidently granted (DIG) June 22, 2006.

32 Laboratory Corp. v. Metabolite From the Breyer Dissent (from dismissal as improvidently granted): Neither does the Federal Circuits decision in State Street Bank help respondents. That case does say that a process is patentable if it produces a "useful, concrete, and tangible result." But this Court has never made such a statement and, if taken literally, the statement would cover instances where this Court has held the contrary. The Court, for example, has invalidated a claim to the use of electromagnetic current for transmitting messages over long distances even though it produces a result that seems "useful, concrete, and tangible." Morse. Similarly the Court has invalidated a patent setting forth a system for triggering alarm limits in connection with catalytic conversion despite a similar utility, concreteness, and tangibility. Flook. And the Court has invalidated a patent setting forth a process that transforms, for computer-programming purposes, decimal figures into binary figureseven though the result would seem useful, concrete, and at least arguably (within the computers wiring system) tangible. Gottschalk.

33 In re Bilski et al. Claim 1: A method for managing the consumption risk of a commodity sold by a commodity provider at a fixed price comprising the steps of: Initiating a series of transactions... Identifying market participants for said commodity Initiating a series of transactions.... Court: not patent eligible under 35 USC 101. Process must be tied to a particular machine or transforms an article.

Analysis 1. Claim to a natural phenomena? If yes, then 2. Preemption test to determine if the claim is only to the natural phenomena Does it substantially/wholly preempt other uses of the natural phenomena? Are there actual limitations on the use of the natural phenomena? 3. Can the process be performed entirely in the human mind? If so, it is obviously not tied to any machine and does not transform any article into a different state or thing. Bilski Greta Burkholder

Prometheus Labs v. Mayo, WL878910 Correlation between drug metabolite levels and therapeutic efficacy/toxicity The claims have three steps: (1) administer the drug to a subject; (2) determine metabolite levels; and (3) be warned that an adjustment in dosage may be required. The claims wholly pre-empt use of the correlation such that the practical effect is a patent on the [correlation] itself. Greta Burkholder

So, What Does this Mean? Are biotechnology process patents patentable or not? Maybe Bilski gets rid of diagnostic patents where the novelty is interpreting a specific concentration as an indication of a disease. Greta Burkholder

Diagnostic Patents After Bilski Method of diagnosing breast cancer and compositions therefor A method of diagnosing breast cancer in an individual aged younger than 41 or older than 54 is provided. The method comprises obtaining a nucleic acid from the individual and determining a nucleotide at a polymorphic site of the nucleic acid Determining that the female has an increased risk of having breast cancer or developing breast cancer when a TT or TO is determined at SMBC.sub.--013; Patent No. 7,517,650 (filed March 3, 2006) Greta Burkholder

Diagnostic Patents After Bilski Diabetes Gene The method of claim 2 useful for determining whether a human subject has or is at risk for developing diabetes mellitus comprising the steps of: a) obtaining a sample from a subject, said sample comprising nucleic acid molecules containing AGT gene; and b) detecting the presence or absence of a genetic polymorphism in the gene of said subject, wherein the presence of said genetic polymorphism identifies a subject that has or is at risk for developing diabetes. Patent No. 7,374,884 (filed May 13, 2004) Greta Burkholder

Potential Fixes for Diagnostic Patents? Look to Diamond v. Diehr Incorporated mathematical formula, but entire process was considered patent-eligible How? Add significant extra solution activity Add limitations, like a treatment or a novel assay to gather the relevant data Tie it to a machine or add transformation (NOT just a mental process) Diamond v. Diehr Greta Burkholder

Utility Normally low threshold, some useful purpose is generally sufficient Applicant must assert a specific, substantial, and credible utility (USPTO Examination Guidelines 2001) 40

41 In re Fisher (CAFC 2005) Claim to A substantially purified nucleic acid molecule that encodes a maize protein or fragment thereof comprising a nucleic acid sequence selected from the group consisting of SEQ ID NO: 1 through SEQ ID NO: 5 rejected for lack of utility Fisher did not know precise structure or function of either the genes or the proteins encoded for by those genes at time of filing

42 In re Fisher (CAFC 2005) Asserted utilities (e.g., serving as a molecular marker for mapping the entire maize genome) were generally applicable to any EST; also, no known use for the proteins produced as a result of ESTs; asserted uses are just a laundry list of research plans

43 In re Fisher (CAFC 2005) Substantial utility requires an invention to have a significant and presently available benefit to the public Specific utility requires a well-defined and particular benefit to the public Credible Utility: whether a person of ordinary skill in the art would accept that the invention is currently available for its purported use

Novelty: Anticipation Every element of claimed invention must be found in a single* prior art reference (Strict Identity/Single Reference Rule) Reference must be enabling to one of ordinary skill in the art (teach how to make) Each claim of the patent is considered separately * Some exceptions apply

Claim Elements 45 Meat Product 2 Slices of Bread Edible Salad Cheese

Prior Art Reference I 46 Hamburger Weekly October 23, 1980 Say Goodbye to Unmanageable Burgers - J. Fadrigo Finally, the scientists at Acme Burger emerged from the depths of their laboratories. With their resurfacing, the scientists brought the latest in burger technology. This revolutionary new burger has an edible salad component, meat product and cheese, all between the two slices of bread. The edible salad component makes for a better handling burger. Look for these new burgers to hit the market early next year.

Anticipation Analysis I 47 October 23, 1980 Hamburger Weekly Say Goodbye to Unmanageable Burgers - J. Fadrigo Finally, the scientists at Acme Burger emerged from the depths of their laboratories. With their resurfacing, the scientists brought the latest in burger technology. This revolutionary new burger has an edible salad Component, meat product and cheese, All between the two slices of bread. The edible salad component makes for a better handling burger. Look for these new burgers to hit the market early next year. ALL ELEMENTS ARE MET. Rejected

Prior Art Reference II 48 October 23, 1980 Hamburger Weekly Say Goodbye to Unmanageable Burgers - J. Fadrigo Finally, the scientists at Acme Burger emerged from the depths of their laboratories. With their resurfacing, the scientists brought the latest in burger technology. This revolutionary new burger has an edible salad component and meat product, both, between the two slices of bread. The edible salad component makes for a better handling burger. Look for these new burgers to hit the market early next year.

Anticipation Analysis II 49 October 23, 1980 Hamburger Weekly Say Goodbye to Unmanageable Burgers - J. Fadrigo Finally, the scientists at Acme Burger emerged from the depths of their laboratories. With their resurfacing, the scientists brought the latest in burger technology. This revolutionary new burger has an edible salad component and meat product, both, between the two slices of bread. The edible salad component makes for a better handling burger. Look for these new burgers to hit the market early next year. ? All elements are NOT met. The publication does NOT anticipate the technology.

Novelty Two Important Dates: Before Applicants invention date More than one year before Applicants filing date 50

Novelty 102(a) 102 (a) A person shall be entitled to a patent unless: - the invention was [publicly] known or [publicly] used by others in this country, or - patented or described in a printed [enabling] publication in this or a foreign country, - before the invention thereof by the applicant for the patent, 51 Application Filed We already knew about that. Date of invention

Novelty 102(b) 102 (b) A person shall be entitled to a patent unless: - the invention was patented or described in a printed publication in this or a foreign country, or - in public use or on sale in this country, - more than one year prior to the date of the application for patent in the United States 52 Application Filed May 7, 1998 May 6, 1997

International Patent Law No global patent Rules vary by country Some treaties aid multi-country filing 53

Paris Convention Oldest IP Treaty, Two Key Provisions: National Treatment: apply domestic law the same way to both foreigners and domestic applicants Right of Priority: applicant has 12 months (6 months for design patents) from filing an application in their home country to file an application on the same invention in another PC country and claim benefit of the earlier date for prior art purposes. 54

PCT (Patent Cooperation Treaty) Allows deferral of national stage examination for up to 30 months from initial filing date Can blanket designate multiple countries for one fee Can obtain preliminary international search report and examination No PCT patent 55

Some Regional Patent Offices EPO: European Patent Office, Grants patents for EU countries plus others EAPO: Eurasian Patent Office, Grants patents for Russia and eight former territories ARIPO: African Regional Industrial Property Organization, grants patents for a group of English speaking African countries (similar to EPO) OAPI: Organisation Africaine de la Propriete Intellectuelle (OAPI), grants patents for group of French-speaking countries (no national offices, still bundle of patents). 57

European Patent Convention Signed in 1973, entered into force 1977 Provides for the grant of European patents using a single application procedure, results in a bundle of national patents European Patent Organization (contracting states, EPO, legislative body) www.epo.org www.epo.org www.espacenet.com (free technology database, may be largest in the world) www.espacenet.com 58

European Patent Office European Patent Office: grants European patents for the contracting states (EU states plus others), based in Munich, offices in the Hague and Berlin as well www.epo.org www.epo.org Received 140,700 patent applications in 2007 (up 3.9%), granted 54,699 patents (down 12%) 34 member states: Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Monaco, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, Norway, Croatia, and the United Kingdom. 59

European Patent Office Problems: Single patent examination, but applicant must still enter national phase Significant costs in national phase (validation-translation only) Patent must be enforced in each jurisdiction 60

European Patent Convention EPC Article 53: European patents shall not be granted in respect of: (a) Inventions the publication or exploitation of which would be contrary to ordre public or morality... Implementing Rule 23(d): explicitly excludes processes for cloning human beings; processes for modifying the germ line genetic identity of human beings; uses of human embryos for industrial or commercial purposes; processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes 61

Thank You!!!!

professor margo a. bagley university of virginia school of law

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