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HKMUN 2012: Chair Report Forum: General Assembly- Economic and Financial Committee Issue: Policies and restrictions on genetic patents

Student Officer: Sauman Cheng

Position: Committee Chair

Note: This document serves as an introduction to the topic. All delegates are strongly advised to supplement this document with independent research.

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Description of Issue

As the field of biotechnology continues to expand, as it has rapidly for the past two decades, it becomes increasingly important for patent systems across the world to adapt to the influx of patent applications involving genetic materials and technology. Genetic patents present a challenge to patent systems due to the rapid pace of development of genetic technology, the myriad of specialized disciplines within genetic science and thus the overwhelming volume of inventions, as well as the inevitably global nature of the field and its discoveries. The last is of particular significance to the concerns of the United Nations’ Economic and Financial Committee (ECOFIN). Genetic materials and technologies are crucial to the future development of medical methods, healthcare, and agriculture. By extension, the development of global patent systems in the area of genetics concerns the welfare of all peoples and societies, all governments and nations. The aim of the ECOFIN with regards to this issue is to frame a set of policies and restrictions regarding patents involving genetic materials and technologies. Within this question, there are four key areas to address.

First, there currently exists no ‘international patent’ or patent system. Those seeking to procure rights over an invention in more than one area of jurisdiction (whether a nation or a region as applicable) must obtain separate patents for each jurisdiction through the applicable authority. Conditions for patentability are not globally uniform, but usual conditions include novelty (the invention must be new), inventiveness (the invention is not obvious to experts in the field), and utility (usefulness in commercial applications) (Meek). However, patent law still varies widely across jurisdictions in areas such as exceptions to patentability, such as inventions involving human reproductive processes or diagnostic methods and methods of medical treatment (ALRC). There exists, though, previous attempts to globally standardize patent application processes and patent law. The World Intellectual Property Organization (WIPO), a specialized agency of the UN, administers the Patent Cooperation Treaty (1970), providing a single patent filing procedure to all 144 contracting states party to the treaty. The Patent Law Treaty (2000), as of February 2011 with 27 contracting states and 60 signatories, aims to standardize the formal procedures related to obtaining a patent, including requirements to acquire a filing date for an application, as well

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as application format and content. The proposed Substantive Patent Law Treaty, to standardize not just application formalities, but also the requirements involved in granting a patent (World Intellectual). The Trilateral Patent Offices, consisting of the European Patent Office (EPO), the Japan Patent Office (JPO), and the United States Patent and Trademark Office (USPTO), process the majority of the world’s patents, and work in co-operation to construct a common system of patent applications as well as standards of application examination (Trilateral). As such, in formulating new policies on genetic patents, the ECOFIN must consider the pre-existing international and multinational patent law treaties, the progressing movement towards standardization of patent laws and procedures, as well as resistance against such a movement.

Second, there are the social and ethical issues of genetic patents, first and foremost the debate over the patentability of genetic materials and technology. Opposition to granting patents on genetic material and technology questions whether isolated genetic sequences are inventions and thus patentable, or discoveries, which are not. In addition, as the specific functions and role of many genetic sequences are currently unknown, evaluating the utility of genetic patent claims becomes much of a grey area. There are also ethical concerns, such as whether it is ethically acceptable to place human genetic sequences – arguably the common heritage of mankind - under legal monopoly. Other concerns include the varying levels of ease and difficulty to obtain patents over genetic material and technology across different jurisdictions, often due to varying degrees of, or simply the lack of sufficient, knowledge and expertise possessed by patent examiners in the fast evolving and relatively new field of biotechnology, as well as the granting of patents that cover too broad a scope, creating future problems with overlapping patents or unreasonable monopolies.

Third, there is the issue of the exploitation by patent holders of genetic patents in an unethical manner, or a manner otherwise adverse to the further development of biotechnology or the maintenance and improvement of public health. Granting patent rights and connected patent laws governing infringement inherently restricts researchers’ access to genetic material and technology for the purposes of further research and development, thus delaying progress and discoveries, and any related benefits and contributions to the global community. Licensing practices and procedures, due to cost and delay, restrict the access of the medical community to genetic technology and processes for the purposes of experimentation and medical genetic testing. Licensing also places limitations on research due to the cost of procuring licenses, and due to the high number of overlapping or closely related patents already held on the market. Finally, economic-related concerns of fair practice and access to currently patentable technology, as the granting of genetic patents creates monopolies that increase the cost of medical genetic testing as well as other genetic technology applicable in the medical field, and thus reduces availability amongst general public.

Fourth, there are the economic issues stemming from patents involving genetically modified (GM) crops, despite their clear benefits for the improvement of food security. This is an area considerably separate from dominating medical research driven concerns, but has similar social-ethical dimensions. The World Trade Organization (WTO) currently administers the Agreement on Trade Related Aspects of Intellectual Property Rights

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(TRIPS), established in 1994 as a result of a campaign mainly made by developed nations of the WTO. TRIPS connects international trading policies to intellectual property rights by requiring the national laws of all member states to meet prescribed strong standards for such rights (World Trade). In the context of GM crops, the linking of international trade to intellectual property rights has allowed biotechnology companies based in developed nations to acquire indigenous crops from other regions of the world, particularly developing nations in South America and the Indian subcontinent, and use these raw materials to develop patentable, genetically modified crops, which ultimately find their profitable markets in the same developing nations from which the raw materials originated (Pease). Furthermore, the use of GM crops inhibits the traditional practice of saving and distributing seeds from previous harvests. This practice has and will continue to produce an unequal flow of trade from developing countries towards the patent-holding companies based in developed nations.

Timeline of Events

1953: Discovery of the double-helix structure of DNA by James Watson and Francis Crick

1974: Stanford University files a patent claim with the USPTO for a method of creating recombinant (‘chimera’) DNA, developed by Stanley Cohen and Herbert Boyer. Patent granted in 1980 to Stanford University and the University of California, San Francisco, shared with Boyer and Cohen, and expired in 1997. Stanford and UCSF generated USD255 million in licensing revenues from the Cohen-Boyer patent (Case). No patent application could be filed with the EPO in Europe as Boyer and Cohen had published their research before filing an application.

1976: The founding of the first genetic engineering company, Genentech Inc. by Herbert Boyer.

1980: Diamond v Chakrabarty; First patent on a living organism. The US Supreme Court ruled genetically altered microorganisms to be patentable subject matter. Patentability of more complex organisms left to decision by the US Congress, but debate never took place.

1983: Discovery and subsequent patent filed and granted with the USPTO for Polymerase chain reaction (PCR) technology that allows researchers to quickly replicate billions of copies of a segment of DNA by Kary Mullis of Cetus Corporation. Dupont unsuccessfully filed a lawsuit against Cetus in 1989 to invalidate the PCR patents for lack of non-obviousness. Patent has generated licensing revenues of about USD 2 billion over its lifetime, expiring in 2005 in the United States and 2006 in Europe. Despite the strong protective patents and licensing program, PCR technology became very widespread and continues to be used by research labs across the world, partially due to the exercise of “rational forbearance” by the patent holders (i.e. not enforcing intellectual property rights against those only using the patented technology for research purposes) (Case).

1988: Patent issued by the USPTO for the ‘OncoMouse’, a laboratory mouse genetically modified to be more susceptible to cancer. Patents were also filed in Japan,

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Canada, and Europe. Canadian application met with much opposition in the Canadian Supreme Court, but was granted until 2020. Application to the EPO was first rejected, then revised application met with further opposition due to the “odre public” article of the European Patent Convention (EPC); patent granted in 1992 but has since been revoked.

1990-2003: The Human Genome Project (HGP) was an international research project to map the entire ‘human genome’ coordinated by the US Department of Energy and the National Institutes of Health (NIH). Research took place across the United States, United Kingdom, Japan, France, and Germany. Completed in 2003, although further research and analysis continues (About).

2010-present: Association for Molecular Pathology v. U.S. Patent and Trademark Office, known as the Myriad case; lawsuit challenging patents over both isolated DNA sequences and diagnostic methods comparing DNA sequences related to genes affecting cancer. The original US district court decision to invalidate patents on isolated DNA sequences was overturned by a federal appeals court As of December 2011, the ACLU has petitioned the US Supreme Court for further review of the case (Vorhaus). In Canada, the health ministry of Ontario has publicly flouted the corresponding patents, but no lawsuit has been filed by Myriad. In effect, the Canadian patents are currently ineffective (Cook-Deegan).

Main Parties involved and Key Positions

United States – The United States Patent and Trademark Office has to date granted over 3,000 patents on human genes, and 47,000 on inventions involving genetic material. Historically, US courts have supported patent claims over isolated DNA sequences as ‘inventions’ created through human intervention. In recent years, though, there has been a rising movement to reform the patent system in the direction of increasing restrictions on gene patents. In November 2011 the US Department of Justice filed a legal brief asserting that the discovery of an important DNA sequence within a genome is not sufficient grounds for a patent (Ledford). Though this is a landmark statement, it must be noted that the brief does not extend its argument towards manipulated DNA sequences or methods, and the US remains – by the sheer number of genetic patents granted by the USPTO and held by US-based companies – one of the supporters of genetic patenting.

European Patent Organization (including the United Kingdom, France, and Germany) – The EPOrg consists of 38 contracting states and is responsible for granting ‘European patents’ enforceable in any number of the member states. Europe has historically been less protective of intellectual property rights related to genetic patents (for example, only 4% of EU public sector labs have withdrawn genetic tests due to intellectual property claims, versus one-fourth of labs in the US), and the number of genetic patents filed in Europe is only one-seventh the amount of genetic patents filed in the United States (Reardon). This is largely due to stricter requirements on patentability, as Europe places greater emphasis the "ordre public" exception to patentability (no patents on inventions that would interfere with the public order, morality, or the public health), and utility, as the EPO requires patent claims for genetic sequences or fragments to specify the specific function of the

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sequence (Dua). Nevertheless, estimates still number in region of several thousand genetic patents in existence.

Japan – The Japan Patent Office, along with the USPTO and the EPO, currently issues the majority of genetic patents, and has granted over five thousand patents for ‘genetic inventions’ since 1996 (OECD). Unlike the US, however, genetic patents in Japan are less of a controversial issue, as specific guidelines have evolved and been established to govern genetic inventions. Furthermore, unlike in Europe and the United States, questions related to “odre public” exceptions (moral and public order problems) are much less prevalent (Dua).

China – One of the few developing countries with a substantial presence in the field of genetic research and inventions, the PRC patent law – relatively recently amended in 2008 - does allow the granting of genetic patents, despite disallowing patents on life forms (Executive). Unlike the United States, Europe, and Japan, restrictions on genetic patents in the PRC focuses on ensuring the legality of the genetic resources on which the invention was based, rather than the issues of patentability or proof of utility.

India – Also one of the emerging nations in biotechnology, India patent law does allow for the patenting of genetically modified gene sequences that meet the conditions of novelty, inventiveness, and utility, as well as methods of genetic diagnosis. However, isolated naturally occurring gene sequences are explicitly excluded from patenting as they are considered discoveries and not inventions (Sheikh).

Brazil – Brazilian patent law formerly did not consider living beings, in whole or in part, or biological material encountered in nature and isolated from any living being as patentable inventions. However, the patent law was amended in 1997 to allow for genetic patents. It is notable that the number of patent applications doubled from 1996 to 1997 (Chan).

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Works Cited

Chan, H. Phoebe. “International Patent Behavior of Nine Major Agricultural Biotechnology Firms”. AgBioForum. n.p. 2006. Web. 28 Dec. 2011.

Pease, Alison. “Patent Issues in Genetically Modified Crops”. Yale Journal of Medicine and Law. Yale University, 5 Oct. 2010. Web. 28 Dec. 2011.

Trilateral Patent Offices. n.p., n.d. Web. 28 Dec. 2011.

Vorhaus, Dan. “Myriad Gene Patent Litigation”. Genomics Law Report. Robinson Bradshaw & Hinson, 14 Sep. 2011. Web. 28 Dec. 2011.

“ALRC Report 99: Genes and Ingenuity: Gene patenting and human health”. Australian Law Reform Commission. n.p., 24 Aug. 2010. Web. 28 Dec. 2011.

Sheikh, Mita. “Are Gene Patents Possible?”. Managing Intellectual Property: The Global IP Resource. Euromoney Legal Media Group, 1 Sep. 2010. Web. 28 Dec. 2011.

Dua, Kshitij and Aditi Mathur. “A Comparative Study of DNA Sequence Patenting in the USA, Europe & Japan, and Suggestions for the Course of Action for India”. Center for Advanced Study & Research on Intellectual Property. University of Washington School of Law, 2005. Web. 28 Dec. 2011.

“Gene Patents and Global Competition Issues”. Genetic Engineering and Biotechnology News. Mary Ann Liebert, Inc., 1 Jan 2006. Web. 28 Dec 2011.

“Executive Summary: Genetics, genomics and the patenting of DNA”. Genomic Research Center. World Health Organization, n.d. Web. 28 Dec. 2011.

Meek, James. “Special Report: the ethics of genetics”. The Guardian. Guardian News and Media Limited, 15 Nov. 2000. Web. 28 Dec 2011.

Cook-Deegan, Robert. “Gene Patents”. Bioethics Briefing Book. The Hastings Center, 2008. Web. 28 Dec. 2011.

“Case Histories: Seminal Genomic Technologies”. Duke Institute for Genome Sciences & Policy. Duke University, n.d. Web. 28 Dec. 2011.

Ledford, Heidi. “US government wants limits on gene patents”. Nature. Nature Publishing Group, 2 Nov 2010. Web. 28 Dec. 2011

“About the Human Genome Project”. Human Genome Project Information. US Department of Energy Human Genome Program, 19 Sep. 2011. Web. 28 Dec. 2011.

“Genetics and Patenting”. Human Genome Project Information. US Department of Energy Human Genome Program, 7 Jul. 2010. Web. 28 Dec. 2011.