Hyperownership in a Time of Biotechnological Promise: The International Conflict to Control the Building Blocks of Life

Sabrina Safirin

doi:10.2307/3216691

1 Briefly, the cells of all living things contain genes. Genes code for proteins, and proteins determine the structure and characteristics of life forms. Ridley, Matt, Genome 6–9 (1999)Google Scholar PubMed.

2 Chambers, Jasemine, Patent Eligibility of Biotechnological Inventions in the United States, Europe and Japan: How Much Patent Policy is Public Policy ? 34 Geo. Wash. Int’l L. Rev. 223, 237–39 (2002)Google Scholar; Murphy, Sean D.. Biotechnology in International Law, 42 Harv. Int’l L.J. 47, 62–65 (2001)Google Scholar; Fisher, Lawrence, The Race to Cash in on the Genetic Code, N.Y. Times, Aug. 29, 1999 Google Scholar, §3, at 1. While a gene or a genetic sequence in its natural state cannot be patented, a patent may issue if the naturally occurring gene is synthesized from its original state and ascribed a useful function. Demaine, Linda J.. Aaron Xavier Fellmeth, Reinventing the Double Helix: A Novel and Nonobvious Reconceptualization of the Biotechnology Patent, 55 Stan. L. Rev. 303, 359 (2002)Google Scholar. Patenting is discussed more fully in parts I and V infra.

3 Demaine & Fellmeth, supra note 2, at 359. “Over a sixth of these patents cover whole human genes and many of their significant alleles.” Id.

4 Glowka, Lyle, Bioprospecting, Alien Invasive Specks, and Hydrothermal Vents: Three Emerging Legal Issues in the Conservation and Sustainable Use of Biodiversity, 13 Tul. Envtl. L.J. 329, 330–31 (2000)Google Scholar (reporting that ten nations have passed such laws). Since Glowka’s article appeared, at least two other nations, Brazil and India, have put access–restricting regimes into place.

5 Id. at 331.

6 See, e.g., Brown, Michael F.. Who owns Native Culture? 138–39 (2003)Google Scholar (noting that the expansion of patents in the area of biotechnology research eventually made it increasingly difficult for ethnobotanists to collect wild plant specimens). The enclosure systems of developed and developing countries are not identical. Developing nations restrict access to raw or unimproved genetic material existing in the wild. Patents, in contrast, issue for worked or improved genetic material. However, the amount of human improvement involved in a patented gene can be rather small, consisting of isolating the gene and identifying its useful function. In this case, each system encloses material either in or close to its natural state.

7 See, e.g., Heller, Michael A.. Eisenberg, Rebecca S.. Can Patents Deter Innovation? The Anticommons in Biomedical Research, 280 Science 698 (1998)Google Scholar; Rai, Arti K.. The Information Revolution Reaches Pharmaceuticals: Balancing Innovation Incentives, Cost, and Access in the Post–Genomics Era, 2001 U. III. L. Rev. 173, 192–94 Google Scholar; see also Demaine & Fellmeth, supra note 2; Philippe Jacobs & Geertrui van, Overwalle, Gene Patents: A Different Approach, 23 Eur. Intell. Prop. Rev. 505 (2001)Google Scholar (arguing that patents should not be granted for DNA but only for downstream medical goods). But see Eric Mauer, Comment, An Economic Justification for a Broad Interpretation of Patentable Subject Matter, 95 Nw. U. L. Rev. 1057, 1090 (2001)Google Scholar. Others, while accepting the patent eligibility of isolated naturally occurring genes, have proposed a series of mechanisms, such as a broader experimental use exemption and compulsory licensing, to diminish the reach and innovation–inhibiting effects of such patents. Gitter, Donna M.. International Conflicts over Patenting Human DNA Sequences in the United States and the European Union: An Argument for Compulsory Licensing and A Fair– Use Exemption, 76 N.Y.U. L. Rev. 1623 (2001)Google Scholar (suggesting such mechanisms for human DNA sequences); Holman, Molly A.. & Munzer, Stephen R.. Intellectual Property Rights in Genes and Gene Fragments: A Registration Solution for Expressed Sequence Tags, 85 Iowa L. Rev. 735 (2000)Google Scholar (proposing an ASCAP system for genes, whereby all would have access to registered isolated and identified genes upon payment of a fixed fee); Mueller, M. Janice No “Dilettante Affair”: Rethinking the Experimental Use Exception to Patent Infringement for Biomedical Research Tools, 76 Wash. L. Rev. 1 (2001)Google Scholar. In contrast, some maintain that the system by and large is not broken and that the United States should “steady the course.” Epstein, Richard A.. Steady the Course: Property Rights in Genetic Material 22–26 (John M. Olin Law & Econ. Working Paper (2d ser.) No. 152, rev. Mar. 2003), available at <http://www.law.uchicago.edu/Lawecon/index.html" Google Scholar PubMed> (discussing and criticizing “middle of the road” proposals described above and proposing an “all or nothing” approach where some genetic substances, like “express sequence tags,” should be left in the public domain, but everything else should be governed by the usual rules of patent protection). But see Rochelle Cooper Dreyfuss, Varying the Course in Patenting Genetic Material: A Counter–Proposal to Richard Epstein’s Steady Course 1 (NYU Public Law and Legal Theory Research Paper No. 59, Apr. 2003), available at <http://ssrn.com/abstract_id-394000> (disagreeing with Epstein).

8 An anticommons can occur when multiple individuals or entities have rights of exclusion to a given resource. See text at note 84 infra.

9 The rules establishing how much and under what circumstances genetic material may be patented are presently being drawn and refined. Eisenberg, Rebecca S.. How Can You Patent Genes? in Who Owns Life? 117 Google Scholar (David Magnus, Arthur Caplan, & Glenn McGee eds., 2003) (although people have been obtaining patents on genetic sequences for twenty years, the system is still struggling to clarify the ground rules for acquiring them).

10 Genetically rich countries and those engaged in international work under the auspices of the Convention on Biological Diversity are currently determining and refining how much control sovereigns should assert over raw genetic material. See Decision 26, Fifth Meeting of the Conference of the Parties to the Convention on Biological Diversity, Doc. UNEP/CBD/COP/5/26A (2000) (providing for the development of access and benefit–sharing guidelines as a fall–back where countries lack “comprehensive legislation and national strategies for access and benefit–sharing” and establishing two experts panels and one working group to develop such guidelines and other measures to provide for access and benefit sharing). Such guidelines may also assist countries that are developing access legislation. Both the Organization of African States and the Association of South East Asian Nations have drafted model legislation on restricting access to raw genetic material. See part II infra, notes 108–16 and corresponding text.

11 Chambers, supra note 2, at 225 (the United States generates 75% of the world’s agricultural bioengineered products alone). U.S. biotechnology is a $13 billion a year industry, and more than fourteen thousand biotechnology patent applications are filed in the United States each year. Id. at 224.

12 Other developed countries, like the EU membership and Japan, while allowing the patenting of genetic material, allow for the denial of such patents on public policy grounds. Id. at 232, 239; Gitter, supra note 7, at 1644–49. They subject such patents to an experimental use exemption from infringement. Id. at 1689. On the whole, they appear to apply a somewhat stricter standard for nonobviousness than the United States. Chambers, supra note 2, at 241 (worldwide U.S. patent law provides the broadest protection of biotechnological innovations); Correa, Carlos M.. Internationalization of the Patent System and New Technologies, 20 Wis. Int’l L.J. 523, 530 n.40 (2002)Google Scholar; Gitter, supra, at 1677 (noting that European scholars and policymakers emphasize that the European criterion of an inventive step might soon become impossible to meet for any DNA sequence as sequencing becomes increasingly routine and obvious).

13 Agreement on Trade–Related Aspects of Intellectual Property Rights, Art. 27, Annex 1C of Marrakesh Agreement Establishing the World Trade Organization, Apr. 15, 1994 Google Scholar, in World Trade Organization, The Legal Texts: The Results of the Uruguay Round of Multilateral Trade Negotiations 321 (1999)Google Scholar [hereinafter TRIPS]. For the proposition that the United States assumed the leadership role in pressing for the TRIPS Agreement and the obligations that TRIPS places on countries to patent biotechnological inventions, see Abbott, Frederick M.. TRIPS in Seattle: The Not–So–Surprising Failure and the Future of the TRIPS Agenda, 18 Berk. J. Int’l L. 165, 168 (2000)Google Scholar; Murphy, supra note 2, at 68–69, 99; Raustiala, Kal & Victor, David G.. The Regime Complex for Plant Genetic Resources, 58 Int’l Org. 277, 284 (2004)Google Scholar.

14 There is an expansive body of literature exploring the moral issues raised by the patenting of genetic material. See, e.g., Kass, Leon R.. Toward A More Natural Science: Biology and Human Affairs 149–50 (1985)Google Scholar; Gitter, supra note 7, at 1649–50 (summarizing moral objections to the patenting of genes); Hanson, Mark J.. Patenting Genes and life: Improper Commodification? in Who Owns Life? Google Scholar supra note 9, at 161.

15 International Undertaking on Plant Genetic Resources for Food and Agriculture, Nov. 23, 1983, Art. 1, available at <http://www.fao.org/ag/cgrfa/iu.htm>>Google Scholar [hereinafter Undertaking]. Eight developed countries, including the United States, expressed reservation to this language out of concern that it might conflict with intellectual property protections that they were extending to plant breeders under the UPOV Convention, infra note 29. See Raustiala & Victor, supra note 13, at 288; note 27 infra and corresponding text.

16 Asebey, Edgar J.. & Kempenaar, Jill D.. Biodiversity Prospecting: Fulfilling the Mandate of the Biodiversity Convention, 28 Vand. J. Transnat’l L. 703, 718 (1995)Google Scholar; Jeffrey, Michael I.. Bioprospecting: Access to Genetic Resources and Benefit– Sharing Under the Convention on Biological Diversity and the Bonn Guidelines, 6 Singapore J. Int’l & Comp. L. 747, 758 (2002)Google Scholar; Adair, John R.. The Bioprospecting Question: Should the United States Charge Biotechnology Companies for the Commercial Use of Public Wild Genetic Resources f 24 Ecology L.Q. 131, 141 (1997)Google Scholar (noting that access to wild genetic resources had traditionally been open); Fowler, Cary, Protecting Farmer Innovation: The Convention on Biological Diversity and the Question of Origin, 41 Jurimetrics 477, 480 (2001)Google Scholar; Raustiala & Victor, supra note 13, at 284 (“For most of human history, the rule of common heritage governed [plant genetic resources].”).

17 Birnie, Patricia W.. & Boyle, Alan E.. International Law and the Environment 141 (2d ed. 2002)Google Scholar (qualifying that under international law, the use of global common property must be legitimate and reasonable).

18 Id. The concept of common property or a global commons in international law is similar to the concept of a commons or public good in traditional property law. As Jeremy Waldron explains, a commons is an area or a resource whose organizing premise is that it is available in principle for the use of every person. Waldron, Jeremy, The Right to Private Property 32 (1988)Google Scholar. Typical examples include air, rainwater, public parks, and the intangible resource of information in the public domain.

19 Birnie & Boyle, supra note 17, at 141. Although the terms are often used interchangeably, the concept of common property in international law should not be confused with the international law concept of the common heritage of mankind. Id. at 143; Baslar, Kemal, The Concept of the Common Heritage of Mankind in International Law (1998)Google Scholar. The “common heritage of mankind” is expressed in certain post–World War II international treaties. These include the Agreement Governing the Activities of States on the Moon and Other Celestial Bodies of 1979 and, most important, the United Nations Convention on the Law of the Sea of 1982. Scholars, drawing on these two treaties, have identified five elements of the international common heritage of mankind: (1) exemption of the common area, such as the moon or the deep seabed and its resources, from appropriation by national governments; (2) international management of the area or resource through an international authority; (3) the sharing of benefits derived from the use of the area and its resources; (4) use of the area or resource solely for peaceful purposes; and (5) an obligation to protect the area or resource for future generations. Baslar, supra, at 209; Birnie & Boyle, supra, at 143–44. The international concept of common property and the concept of international common heritage of mankind share the principle of nonsovereignty over the resource in question. They differ, however, in that the concept of the common heritage of mankind envisions a strong international authority to govern the resource. It also involves the sharing of the benefits of the property concerned by all states, even if they are unable to participate in the actual extraction. Id. Despite sporadic use of the term “common heritage of mankind” in FAO documents and other references related to the Undertaking, most scholars have concluded or assumed that genetic resources were treated as international common property rather than common heritage of mankind property. See, e.g., Baslar, supra, at 307–10; see also note 16 supra. Genetic resources were not subject to control by an international body or to international benefit–sharing arrangements.

20 Asebey & Kempenaar, supra note 16, at 719.

21 Id.; Jeffrey, supra note 16, at 758.

22 Birnie & Boyle, supra note 17, at 141 (speaking about international common property in general and not genetic material in particular). Once reduced to possession by taking, however, individual resources, such as a fish caught on the high seas, could become property. Id.

23 Diamond v. Chakrabarty, 447 U.S. 303 (1980) (allowing a patent on a genetically engineered bacterium and holding that patents could issue on living things). In 1985 the grant of a utility patent to genetically modified seed was upheld. Ex parte Hibbard, 227 U.S.P.Q. (BNA) 443 (Bd. Pat. App. & Interferences 1985); see also Pioneer, Hi– Bred Int’l, Inc. v. J.E.M. Agric. Supply, Inc., 200 F.3d 1274 (Fed. Cir. 2000)Google Scholar (patents may be granted to seeds and seed–grown plants). In 1988 the first patent for a genetically modified animal was issued to Harvard University for a mouse engineered for susceptibility to cancer, U.S. Patent No. 4,736,866.

24 Murphy, supra note 2. Under TRIPS, countries must extend patent protection for microorganisms. Parties have discretion whether to grant patents to plants and animals. Most developed countries have extended patents for plants and animals. Countries that have refused to extend patent protection to plants and animals include Brazil, India, and Norway. See Correa, supra note 12, at 548; Marden, Emily, The Neem Tree Patent: International Conflict over the Commodification of Life, 22 B.C. Int’l & Comp. L. Rev. 279, 293 (1999)Google Scholar; The Complex Realities of Sharing Genetic Assets, 392 Nature 525 (1998)Google Scholar; Macilwain, Colin, When Rhetoric Hits Reality in Debate on Bioprospecting, 392 Nature 535 (1998)Google Scholar.

25 Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200 (Fed. Cir.), cert, denied sub nom. Genetics Inst. v. Amgen, Inc., 502 U.S. 856 (1991); Eisenberg, Rebecca S.. Re–examining the Role of Patents in Appropriating the Value of DNA Sequences, 49 Emory L.J. 783, 785–86 (2000)Google Scholar; Murphy, supra note 2, at 64; Thompson, Nicholas, Gene Blues, Wash. Monthly, Apr. 2001 Google Scholar, at 9.

26 Eisenberg, supra note 25; Thompson, supra note 25.

27 The rise of intellectual property rights over plants evolved over time. For a thorough discussion of the rise and expansion of these rights, see Helfer, Laurence R.. Intellectual Property Rights in Plant Varieties: International Legal Regimes and Policy Options for National Governments 14–21 Google Scholar (UN Food and Agriculture Organization, 2004); Raustiala & Victor, supra note 13, at 286–93.

28 FAO Res. 4/89, available at <http://www.fao.org/ag/cgrfa/iu.htm>>Google Scholar .

29 International Convention for the Protection of New Varieties of Plants, Dec. 2, 1961 Google Scholar, as revised Oct. 23, 1978, Arts. 5(1), 6(1), 33 UST 2703, available at <http://www.upov.int> . Member states are expected to grant and protect these rights at the national level.

30 UPOV Convention, supra note 29, as revised Mar. 19, 1991, Arts. 14(1), 14(5), 15(1)(iii), 15(2), S. Treaty Doc. No. 104–17 (1995), available at <http://www.upov.int> . Under the UPOV Convention, as revised in 1978, a farmer could replant seeds from the crop produced by protected seeds for his own subsequent use, as well as exchange seeds with other fanners without paying additional royalties to the breeder. The 1991 revisions no longer allowed for the free exchange of seeds and imposed limitations on their replanting. HELFER, supra note 27, at 19. The UPOV Convention, as revised in 1978, also allowed breeders to use a protected variety to create new varieties without the prior authorization of the original breeder. The 1991 revisions, while recognizing this right, limited it to new varieties that are not “essentially derived” from protected varieties. While this limitation was intended to prevent second–generation breeders from making mere cosmetic changes in a protected variety, controversy exists over the amount of genetic distance required before a second–generation variety does not “essentially derive” from the first. The overall effect of the amendment has been to narrow the exemption and expand the rights of first–generation breeders. Id. at 19.

31 Raustiala & Victor, supra note 13, at 287, 290. The Trips Agreement, supra note 13, negotiated in the early 1990s and adopted in 1994, requires that biotechnological innovations, with certain exceptions, and plants receive intellectual property protection.

32 Columbia University, School of International and Public Affairs, Access to Genetic Resources: An Evaluation of the Development and Implementation of Recent Regulation and Access Agreements 3 (Environmental Policy Studies Working Paper No. 4, 1999) (unpublished manuscript), available at <http://www.bionet–us.org> [hereinafter Columbia Access Paper]. Developed countries also destroyed much of their genetic diversity when they destroyed natural habitats, such as forests, to make room for factories, homes, etc.

33 Lily la Torre López, All We Want Is To Live In Peace 208 (Int’l Union for the Conservation of Nature [IUCN], 1999) (90% of the world’s biodiversity is found in the tropical and subtropical regions of developing countries); Macilwain, supra note 24; see also]. Spectar, M. , Patent Necessity: Intellectual Property Dilemmas in the Biotech Domain & Treatment Equity for Developing Countries, 24 Hous. J. Int’l L. 227, 231 (2002)Google Scholar (stating that major centers of genetic diversity or centers of origin of the world’s economically important crops are located in the tropics or subtropics); Hunter, Christopher,Comment, Sustainable Bioprospecting: Using Private Contracts and International Legal Principles to Conserve Raw Medicinal Materials, 25 B.C Envtl. Aff. L. Rev. 129, 131, 136 (1998)Google Scholar (approximately 50% of all species reside in the tropical forests, including nearly half of the 250,000 species of the world’s higher plants).

34 Biodiversity Prospecting 23 (Walter V. Reid et al. eds., 1993). See generally Aoki, Keith, Neocolonialism, Anticommons Property, and Biopiracy in the (Not–So–Brave) New World Order of International Intellectual Property Protection, 6 Ind. J. Global Legal Stud. 11, 47 (1998)Google Scholar (summarizing the objections of Vandana Shiva, Ruth Gana [Okediji], Rosemary Coombe, James Boyle, Jack Kloppenberg, and others who have written about the “Great Seed Ripoff” made possible by international conventions that allowed plant breeders to use traditional indigenous varieties of seeds and “improve them” via minor genetic alterations without compensating the countries where those seeds originated); Odek, James O.. Bio–piracy: Creating Proprietary Rights in Plant Genetic Resources, 2 J. Intell. Prop. L. 141, 141 (1994)Google Scholar (explaining that developing countries now “passionately” protest the prospecting for plant species in their tropical forests by scientists from multinational corporations who are “protecting their discoveries” through intellectual property rights. “To developing countries, these practices constitute uncompensated exploitation of their ‘plant genetic resources’ in the name of intellectual property rights.”).

35 Biodiversity Prospecting, supra note 34, at 23.

36 Statement of President Ali Hassan Mwinyi of Tanzania, UN Doc. A/CONF. 151/26/Rev. 1, at 36 (1993)Google Scholar, quoted in Jacoby, Craig D.. & Weiss, Charles, Recognizing Property Rights in Traditional Biocultural Contribution, 16 Stan. Envtl. L.J. 74, 89(1997)Google Scholar.

37 FAO Res. 3/91, available at <http://www.fao.org/ag/cgrfa/iu.htm> .

38 See Raustiala & Victor, supra note 13, at 288, 290 (core notion of the 1983 Undertaking was that no nation owned plant genetic material).

39 Convention on Biological Diversity, June 5, 1992, Art. 15(1), 31 ILM 818, 823 (1992)Google Scholar PubMed [hereinafter CBD]. As of October 2004, 188 states had ratified or acceded to the Convention. The United States has signed but not joined the Convention. Parties to the Convention on Biological Diversity, at <http://www.biodiv.org> (last modified Oct. 12, 2004).

40 CBD, supra note 39, Art. 2.

41 Shine, Clare & Palitha, T.. Kohona, B. , The Convention on Biological Diversity: Bridging the Gap Between Conservation and Development, 1 Reciel 278, 282 (1992)Google Scholar.

42 CBD, supra note 39, pmbl.

43 The existence of sovereign rights over a nation’s territory, including its natural resources, is a fairly well established principle in international law. Correa, Carlos M.. Sovereign and Property Rights over Plant Genetic Resources 2 (Background Study Paper, Comm’n on Plant Genetic Resources) (1994)Google Scholar (citing Resolution 1803 of the UN General Assembly, UN GAOR, 17th Sess., Supp. No. 17, at 15, UN Doc. A/5217 (1962), which provides in paragraph 3 that due care should be taken “to ensure that there is no impairment, for any reason, of the State’s sovereignty over its natural wealth and resources”). Each nation has the authority to regulate extraction of its natural resources. Stone, Christopher D.. What to Do About Biodiversity: Property Rights, Public Goods, and the Earth’s Biological Riches, 68 S. Cal. L. Rev. 577, 602 n.63 (1995)Google Scholar (citing GA Res. 3281, UN GAOR, 29th Sess., Supp. No. 31, at 50, UN Doc. A/9631 (1974); GA Res. 3171, UN GAOR, 28th Sess., Supp. No. 30, at 52, UN Doc. A/9030 (1973); GA Res. 1803, supra).

44 CBD,supra note 39, Art. 15(2).

45 See generally Aoki, supra note 34, at 49.

46 See generally Correa, supra note 12 (many developing countries, like Brazil, have explicitly excluded existing biological materials from patentability unless they are genetically altered). The furor over a patent application on a cell line cultivated from a Guayami woman’s blood illustrates this objection. In the early 1990s, U.S. researchers took blood samples from members of the Guayami tribe to check for a propensity for hairy–cell leukemia. In 1991 researchers applied for a patent on a cultivated cell line, identifying Dr. Jonathan Kaplan as the “inventor” of the cell line. When news of the application reached the press, indigenous communities were outraged. Aoki, supra note 34, at 53.

47 Assurances by some that the patenting of genes isolated from an individual or a plant or animal does not preclude those donors from using their own genes provide little comfort. See, e.g., Eisenberg, supra note 9. If anything, these assurances appear to highlight the breadth of the taking as the patent holder apparently enjoys the right to exclude uses of the patented gene, with the exception of its biological action in the host’s body.

48 Shiva, Vandana, Biopiracy: The Plunder of Nature and Knowledge 2 (1997)Google Scholar. Although made in the context of objecting to the TRIPS Agreement, these statements reflect the general views of activists and many developing countries on the relationship between intellectual property rights and raw materials taken from those countries.

49 Id. at 3.

50 For a general discussion, see Pollack, Andrew, Patenting Life: A Special Report: Biological Products Raise Genetic Ownership Issues, N.Y. Times, Nov. 26, 1999 Google Scholar, at A1. See also Drahos, Peter, Biotech Patents, Markets and Morality, 21 Eur. Intell. Prop. Rev. 441, 442–43 (1999)Google Scholar. The expansion of patent protection to an increasing array of genetic material and biotechnological innovations has resulted not only from the acceleration of such activity in the United States, but also from the internationalization of some of these protections through the TRIPS Agreement. Under Article 27 of the TRIPS Agreement, supra note 13, member states of the World Trade Organization must extend patent protection to biotechnological innovations. While countries need not extend patent protection to plants, they must provide for a sui generis system that offers some intellectual property protection for plants. Raustiala & Victor, supra note 13, at 292, note that throughout the TRIPS review process, “developing countries, sometimes joined by the EU, sought to limit the scope of protection for improved plant genetic resources but the United States generally sought the widest possible ambit for intellectual property protection.”

51 See generally Raustiala & Victor, supra note 13, at 289; Stone, Christopher D.. New Issues for a New Century: Land Use, Biodiversity, and Ecosystem Integrity, 27 Ecology L.Q. 967, 991–92 (2001)Google Scholar (describing approach aimed at achieving conservation by solidifying the property interests of the nation in which the resource originated).

52 See Raustiala & Victor, supra note 13, at 293; see also Naomi, Roht–Arriaza,Of Seeds and Shamans: The Appropriation of the Scientific and Technical Knowledge of Indigenous and Local Communities, 17 Mich. J. Int’l L. 919, 927 (1996)Google Scholar (to achieve fair and equitable benefit sharing for the use of biological resources and the conservation of biological diversity, the CBD “vests sovereign rights” to genetic resources in the state). The CBD represents the principal international forum for the definition of rules pertaining to access to and benefit sharing of genetic resources. The Food and Agriculture Organization (FAO), by Resolution 7/93, renegotiated the International Undertaking on Plant Genetic Resources to “harmonize” it with the CBD. See the home page of the Undertaking, <http://www.fao.org/ag/cgrfa/iu.htm> .

53 Raustiala & Victor, supra note 13, at 290. The International Union for the Conservation of Nature, for example, prepared a guide outlining basic elements for a draft access and benefit–sharing system for use by governments in drafting access and benefit–sharing legislation. Lyle Glowka, A Guide To Designing Legal Frameworks To Determine Access To Genetic Resources (IUCN Envt’l Pol’y & Law Paper No. 34, 1998). This guide was used by the Andean Pact nations of Bolivia, Colombia, Ecuador, Peru, and Venezuela in developing their common access regime. Achim Seiler & Graham Dutfield, Regulating Access and Benefit Sharing: Basic Issues, Legal Instruments, Policy Proposals, Doc. UNEP/CBD/WG–ABS/1/INF/4, at 69 (2001), available at <http://www.biodiv.org/doc/meetings/abs/abswg–01/information/abswg–01–inf–04–en.pdf> .

54 See supra notes 4, 5 and corresponding text.

55 Andean Pact, Common System on Access to Genetic Resources, Decision 391 (July 2, 1996), available at <http://www.comunidadandina.org/ingles/treaties/dec/d391e.htm>>Google Scholar [hereinafter Common System],

56 Columbia Access Paper, supra note 32, at 34. Colombia, in particular, is said to account for 10% of the world’s terrestrial species of plants and animals.

57 For example, Peru served as cochair of one of the CBD sub–working groups of the Access and Benefit Sharing Working Group. Venezuela served as chair of the negotiating group for the International Treaty on Plant Genetic Resources for Food and Agriculture, Nov. 3,2001, available at <http://www.fao.org/ag/cgrfa/itpgr.htm> [hereinafter PGR Treaty].

58 For example, Colombia insisted for many years that the PGR Treaty govern access not only to genetic resources, but also, as does the Common System, supra note 55, Arts. 1, 2, access to derivatives of such resources (i.e., the molecular products of gene expression). The CBD’s access and benefit–sharing provisions do not extend to units as small as a molecule, which does not contain “functional units of heredity.” Including such derivatives would substantially increase restrictions on access to genetic material. See Seiler & Dutfield, supra note 53, at 70.

59 The Andean Pact adopted the Common System in 1996, a mere three years after the entry into force of the CBD. For the influence of the Common System, see for example, Uganda Wildlife Society And Environmental Law Institute, Legal and Institutional Options For Governing Access To Genetic Resources In Uganda 10–11, 29 (Environmental Law Institute, 1999) (citing the Andean Pact regime as a potential model in certain respects for Uganda’s regulations on access and benefit sharing). The Andean model has also been included in virtually all case studies on access and benefit–sharing legislation.

60 Columbia Access Paper, supra note 32, at 39 (the Common System “grants ownership of genetic resources and derivatives to the member nation or state”). Common System, supra note 55, Art. 6 (“The genetic resources and their byproducts which originated in the Member Countries are goods belonging to or the heritage of the Nation . . . as stipulated in their respective national legislation.”). The Colombian legislature declared that “genetic resources . . . belong to the nation, as they are part of the natural resources or riches.” Columbia Access Paper, supra, at 40.

61 Columbia Access Paper, supra note 32, at 40; see infra note 65.

62 See Common System, supra note 55, Arts. 3, 6.

63 Id.

64 Common System, supra note 55, Arts. 1, 3, 6. Article 2 of the CBD, supra note 39, defines “in–situ conditions” as “conditions where genetic resources exist within ecosystems and natural habitats, and in the case of domesticated or cultivated species, in the surroundings where they have developed their distinctive properties.” Article 1 of the Common System largely mimics this definition.

65 Common System, supra note 55, Art. 6; Seiler & Dutfield, supra note 53, at 74. The Common System distinguishes between biological resources, which contain genetic resources, and genetic resources. Consistently with this approach, Article 14 of the Common System provides that the system shall not impede die use and free movement of biological resources, such as fish, plants, or fauna, within the Andean area, “provided that there is no access to the genetic resources contained in the biological resources.” Similarly, the fourth complementary provision, adopted by the Andean Pact, requires that certain exports of biological resources bear the inscription “Use of this product as a genetic resource is not authorized.” Kerry Ten, Kate & Laird, Sarah A.. The Commercial Use Of Biodiversity 33 n. 1 (1999)Google Scholar. Moreover, the State does not claim ownership to the knowledge of indigenous communities associated with genetic resources, such as knowledge relating to the healing property of plants. Common System, supra, Art. 7.

66 Common System, supra note 55, Art. 7; Columbia Access Paper, supra note 32, at 39–40.

67 Common System, supra note 55, Art. 17; Seiler & Dutfield, supra note 53, at 70–71, 73.

68 Columbia Access Paper, supra note 32, at 39; Seiler & Dutfield, supra note 53, at 71.

69 Seiler & Dutfield, supra note 53, at 70–71. To obtain this consent, the researcher must provide the national government with all information concerning the genetic resource at issue, including its actual and potential uses, its derivatives, and the risks that could arise from accessing it. Id. at 70. The applicant need not provide this information to any other stakeholder. Id. The Common System does provide for “accessory” contracts between researchers and the owners or administrators of the property on which the bioprospecting is to take place. Id. at 71. These contracts, however, are subject to the agreement between the State and the researcher. Id.

70 Columbia Access Paper, supra note 32, at 43.

71 Biological Diversity Act, 2002, No. 18, Feb. 5, 2003, available at <http://envfor.nic.in/divisions/biodiv/act/bio_div_act.htm>>Google Scholar .

72 This refers to any person who is not a resident citizen of India. Id. §3(2).

73 Foreign corporation refers to any “body corporate, association or organization . . . not incorporated or registered in India” or “which has any non–Indian participation in its share capital or management.” Id.

74 “Biological resource” broadly encompasses “plants, animals and micro–organisms or parts thereof, their genetic material and by–products . . . with actual or potential use or value.” Id. §2(c). Biological resources do not include “products which may contain portions or extracts of plants and animals in unrecognizable and physically inseparable form.” Id. §2(c), (p).

75 Id. §3(1). “Commercial utilization” refers to end uses of biological resources for commercial purposes, such as for drugs, food flavors, cosmetics, colors, and “genes used for improving crops and livestock through genetic intervention.” Id. §2(f).

76 Id. §3. The National Biodiversity Authority is a national interagency body. Id. §8.

77 The Biological Diversity Act, supra note 71, §22, authorizes states within India to create state biodiversity boards. These boards may regulate, prohibit, and restrict the “commercial utilization,” “bio–survey,” and “bioutilization” of any biological resource by Indians, but not by foreigners. The Biological Diversity Act, §§7, 24, requires Indian resident citizens and Indian corporations to give “prior intimation” (undefined but seems to mean prior notification) to the state biodiversity board before engaging in such activities. They need not, however, obtain the approval of the National Biodiversity Authority before engaging in such activities.

78 Id. §§4, 19(1).

79 Id. §20(1).

80 Id. §21. The law refrains from requiring the payment of royalties or fees in all cases. It does, however, consistently mention such royalties and fees in connection with bioprospecting approval, ostensibly assuming that die National Biodiversity Authority will usually require such payments. Id. §§6(2), 19(1), 19(3), 20(3).

81 Id. §21(3).

82 Id. §41(2). India’s law requires that every local municipality create a biodiversity management committee. Id. §§41(1), 2(h). These local committees may levy collection fees from any person accessing or collecting biological resources from areas within their territorial jurisdiction. Id. §41 (3). The National Biodiversity Authority must notify the public of any of its approvals. Id. §§19(4), 20(4).

83 Id. §6(1).

84 Heller, Michael A.. The Tragedy of the Anticommons: Property in the Transition from Marx to Markets, 111 Harv. L. Rev. 621, 622 (1998)Google Scholar.

85 Hardin, Garrett, The Tragedy of the Commons, 162 Science 1243, 1244–45 (1968)Google Scholar. In addition to depleted fisheries, traditional examples of this tragedy include air pollution, overgrazed fields, the extinction of species, and marine pollution.

86 Heller, supra note 84, at 622, 677.

87 Id. at 677.

88 Id. at 622–23.

89 Id. at 623.

90 Id.

91 Id. at 625.

92 Heller & Eisenberg, supra note 7 (pointing to anticommons problems in basic medical research); Rai, supra note 7, at 192–94 (upstream patents in biotechnology can deter innovation).

93 Heller & Eisenberg, supra note 7, at 698; Rai, supra note 7, at 192–94.

94 Ostensibly to spur and support the biotechnology industry, the U.S. Patent and Trademark Office has adopted a fairly generous approach to granting patents in the biotechnology area. It has granted patents for gene discoveries that border new useful technologies, traditionally eligible for the patent grant, and basic research results, traditionally precluded from the patent grant. Id.

95 See generally Burk, Dan L.. , & Lemley, Mark A.. Policy Levers in Patent Law, 89 Va. L. Rev. 1575, 1611 (2003)Google Scholar (summarizing effects of an anticommons).

96 Id.

97 Doll, John, 280 Science 700 (1998)Google Scholar; Walsh, John P.. Arora, Ashish, & Cohen, Wesley M.. Work Through the Patent Problem, 299 Science 1021 (2003)Google Scholar (concluding that strong patent protection in the area of research tools has rarely thwarted innovation); see also Rai, Arti K.. & Eisenberg, Rebecca S.. The Public Domain: Bayh–Dole Reform and the Progress of Biomedicine, 66 Law & Contemp. Probs. 289, 297 n.47 (2003)Google Scholar (discussing patent thicket but that companies’ response has been to put things into the public domain); Epstein, supra note 7, at 20. But see Burk & Lemley, supra note 95 (concluding that the biotech industry is particularly susceptible to anticommons problems).

98 Ten Kate & Laird, supra note 65, at 19; see Philippines Exec. Order No. 247 (May 18, 1995), available at <http://law.nus.edu.sg/apcel/dbase/filipino/primary.html> .

99 The bioprospecting applicant must first submit a letter of intent along with a research proposal and a filing fee to the national Inter–Agency Committee on Biological and Genetic Resources (IACBGR). The IACBGR is a national regulatory body established under section 6 of the executive order to enforce and implement its provisions. If the research proposal passes an initial screening by the committee’s Technical Secretariat, the applicant submits, inter alia, a formal application, an institutional profile, an environmental impact assessment, and a processing fee. After the IACBGR considers the project and the benefit–sharing agreement, it submits its recommendation to yet another government agency for approval or disapproval. Upon approval of the application, the applicant pays a bioprospecting fee as determined by the IACBGR. Ten Kate & Laird, supra note 65, at 30.

100 Id. at 28 (citing Exec. Order No. 247, supra note 98, §2); Columbia Access Paper, supra note 32, at 57. Section 2.1(w) of the Philippine Implementing Rules and Regulations defines prior informed consent as

the consent obtained by the applicant from the Local Community, IP [Indigenous Cultural Communities or Indigenous Peoples], PAMB [Protected Area Management Board] or Private Land Owner concerned, after disclosing fully the intent and scope of the bioprospecting activity, in a language and process understandable to the community, and before any bioprospecting activity is undertaken.

Philippines Dep’t of Env’t & Nat. Res., Admin. Order No. 20 (July 9, 1996), available at <http://law.nus.edu.sg/apcel/dbase/filipino/regs/phrbio.html>>Google Scholar [hereinafter Phil. Regulations].

101 Phil. Regulations, supra note 100, §§6.1.3, 7.1. Appropriate local authority refers to “Indigenous Cultural Communities or Indigenous Peoples,” municipal or city mayor of the local government unit, or Protected Area Management Board. Id. §2.1(w).

102 Id. §§2.1(w), 6.1.3, 7.1.

103 Id. §7.2.1.

104 Id. §7.2.2. The applicant then submits the signed prior informed consent certificate(s) and proof of public notification and sector consultation to the Technical Secretariat. Id. §7.3. The Technical Secretariat evaluates the application and documents and submits its evaluation to the full IACBGR. Id.

105 Exec. Order No. 247, supra note 98, §5(e); Lesser, William, Sustainable Use of Genetic Resources Under the Convention on Biological Diversity: Exploring Access and Benefit Sharing Issues 57 (1998)Google Scholar.

106 Foreign applicants must agree to conduct research in collaboration with Philippine scientists from Philippine institutions, Phil. Regulations, supra note 100, §8.1.12. Applicants must also make technologies developed from research on Philippine endemic species available royalty–free for commercial and local uses to the national government, id. §8.1.9, and make available commercial products derived from Philippine resources to the national government and local communities concerned, id. §8.1.13.

107 Columbia Access Paper, supra note 32, at 55.

108 OAU, African Model Legislation for the Protection of the Rights of Local Communities, Farmers and Breeders, and for die Regulation of Access to Biological Materials (2000), available at <http://www.grain.org>>Google Scholar [hereinafter OAU Model Legislation]; Seiler & Dutfield, supra note 54, at 88. This regional model will become or influence the law of some, if not many, of the OAU member states.

109 OAU Model Legislation, supra note 108, Art. 5(1).

110 Id.

111 Id., Art. 8 (1)(iv). Other requirements include, inter alia, depositing duplicates of biological specimens along with complete field information with designated governmental agencies, and immediately informing the national competent authority and the concerned local community or communities of all findings from the research and development pertaining to the resource. Id., Art. 8 (1)(ii), (iii).

112 ASEAN, Framework Agreement on Access to Biological and Genetic Resources (draft text Feb. 24, 2000), available at <http://www.grain.org>>Google Scholar [hereinafter ASEAN Agreement]. The Framework Agreement aims at “ensur[ing] that access regulations within the ASEAN region are uniform and consistent in accordance with identified minimum requirements as set out in this Framework Agreement.” Id., Art. 2.

113 ASEAN is composed of Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam.

114 ASEAN Agreement, supra note 112, Art. 10. The agreement directs member states to establish legally binding procedures to require such consent.

115 Id.

116 Id., Art. 11. The agreement stipulates a minimum set of benefit–sharing requirements. These include “ [t]he participation of nationals in research activities; [t]he sharing of research results, including all discoveries; . . . [f]ees, royalties and financial benefits.” Required benefit sharing also includes die deposit of a complete set of all voucher specimens in national institutions, “access by nationals to all national specimens deposited in international ex–situ collections,” and the “donation to national institutions of equipment used as part of research.” Id.

117 Brazil, Provisional Measure No. 2.186-16 (Aug. 23, 2001), available at <http://www.grain.org/brl/brazil-tk-2001-en.cfm>>Google Scholar [hereinafter Brazil Measure].

118 Id., Arts. 2, 16. The Measure broadly defines genetic heritage as “information of genetic origin contained in samples ... of plant, fungal, microbial or animal specimens,” whether living or dead, encountered in situ in Brazil or maintained in ex situ collections after in situ collection within Brazil. Id., Art. 7(1). “Within Brazil” includes collections done within Brazil’s national territory, on its continental shelf, or in its oceanic exclusive economic zone. Id. A nation’s exclusive economic zone extends 200 miles off its coast.

119 Id., Art. 3. The Measure requires national government authorization where access is sought for scientific research, technological development, or exploratory activity to identify components of the genetic heritage with potential commercial uses. Id., Art. 7(IV), (VII). The Measure creates a national Council for the Management of Genetic Resources to authorize access to genetic material within Brazil and associated traditional knowledge. Id., Arts. 10, 11(IV), 15(III). The national council is within the Ministry of Environment.

120 Id., Arts. 16, §9, 11(IV)(b).

121 Id., Art. 16, §9. Where access occurs in a protected area, such as a park, authorization requires the prior consent of the relevant competent body. Id.

122 Id., Art. 11(IV)(a).

123 Id., Art. 16, §4. Where the “potential for economic use ... in either a product or process” based on accessed genetic heritage or derived from traditional knowledge is identified after the collection was authorized and for which a contract was never signed, “the benefiting institution” must contact the management council to execute such a contract. Id. §5.

124 Id., Art. 29.

125 Id., Art. 24. Benefits may include division of profits, royalties, technology transfer, unrestricted licensing of products or services, and training of persons. Id., Art. 25.

126 Locke, Christopher, Forest Pharmers Go Bioprospecting, Red Herring, Apr. 1, 2001, at 84, 86, available at <http://www.redherring.com>Google Scholar Joshua Rosenthal, Politics, Culture and Governance in the Development of Prior Informed Consent and Negotiated Agreements with Indigenous Communities 12 (Sept. 4, 2003) (final draft of paper prepared by deputy director, Fogarty International Center, Nat’l Insts. of Health).

127 Locke, supra note 126, at 86.

128 Rosenthal, supra note 126, at 12–13.

129 Id. at 14.

130 Id. at 15.

131 Id.

132 Id. The ICBG would perform the play in a given community only if invited by a municipal president or community representative.

133 Id.

134 Id.

135 Id. at 18–19.

136 Id. at 15.

137 Id. at 16; Locke, supra note 126, at 86.

138 Locke, supra note 126, at 86.

139 Rosenthal, supra note 126, at 16. No other researchers, however, had expressed interest in such a project. Id. The opportunity cost was a phantom or, at best, uncertain. Moreover, it is hard to see how the Mayan ICBG experience would entice others to venture into its failed wake.

140 Locke, supra note 126, at 86.

141 Id.; Rosenthal, supra note 126, at 17–18.

142 Rosenthal, supra note 126, at 17–18.

143 See infra note 146.

144 Rosenthal, supra note 126, at 21–22.

145 Id.

146 Labrador, David, Refining Green Gold, Sci. Am., Dec. 2003 CrossRef Google Scholar, at 38; Macilwain, supra note 24 (reporting how the anticipated post–CBD “gold rush” of scientists hurrying to developing countries to bioprospect has failed to materialize); see Ten Kate & Laird, supra note 65, at 300–01. As of 1999, not a single access agreement had been negotiated with any Andean Pact nation. Columbia Access Paper, supra note 32, at 35–43. Since then, a small handful have been concluded. Telephone interview with Joshua Rosenthal, deputy director, Fogarty Institute, NIH (July 7, 2003).

147 Locke, supra note 126, at 84.

148 Columbia Access Paper, supra note 32.

149 Id. A three–hundred–page book by Kerry ten Kate and Sarah Laird, supra note 65, on the commercial use of biological diversity discusses surprisingly few nongovernment bioprospecting projects involving access to specimens of genetic material for potential application in a commercial good, since the adoption of the CBD. A large percentage, if not the majority, of the “benefit–sharing” cases discussed occurred earlier and involved U.S. government subsidies or traditional payment for the extraction of bulk raw materials that are used as inputs for end products rather than genetic sampling. An example of bulk raw material is the bulk cultivation of Kava for export.

150 Bioprospecting projects are taking place, see Brown, supra note 6, at 139–40; Ten Kate & Laird, supra note 65, but at relatively low levels, see notes 146 and 147 supra, and note 153 infra and corresponding text.

151 See Rai, supra note 7, at 192–93.

152 See note 146 supra; see generally Ten Kate & Laird, supra note 65, at 32 (noting that access regimes are elaborate and that many domestic and foreign scientists and companies report finding them cumbersome, time–consuming, and costly to follow).

153 Columbia Access Paper, supra note 32, at 35–43. In addition, a Colombian national abandoned a bioprospecting project altogether after realizing the ramifications of the application process. Id. at 43.

154 Benefit–Sharing Case Studies: Aristocladus korupensis and Prunus africana, Doc. UNEP/CBD/COP/4/Inf.25, at 6, 7, 10–14 (1998)Google Scholar, available at <http://www.biodiv.org/doc/case–studies/abs/cs–abs–aristo–pdf> .

156 Heller, supra note 84, at 622, 677, 688.

156 See notes 71–83 supra and corresponding text.

157 Convention Concerning Indigenous and Tribal Peoples in Independent Countries, No. 169, June 27, 1989, Art. 15(2), 28 ILM 1382 (1989)Google Scholar, reprinted in ILO, International Labour Conventions and Recommendations 1919–1991, at 1436(1992)Google Scholar PubMed.

158 Indeed, human rights scholarship is replete with examples of sovereign abuse of individuals and indigenous communities to further national government political and economic objectives. See, e.g., Mayotte, Judy, Civil War in Sudan: The Paradox of Human Rights and National Sovereignty, 47 J. Int’l Aff. 497 (1994)Google Scholar.

159 Brazil Measure, supra note 117, Art. 17.

160 Brown, supra note 6, at 160. See generally L, Trad. McClellan, Note and Comment, The Role of International Law in Protecting the Traditional Knowledge and Plant Life of Indigenous Peoples, 19 Wis. Int’l L.J. 249 (2001)Google Scholar (discussing struggle of indigenous people to obtain the right to control resources).

161 Cyranoski, David, Microbe Hunt Raises Doubts over Local Benefits of Bioprospecting, 420 Nature 109 ( 2002)Google Scholar.

162 Id.

163 Id.

164 Indigenous communities have been relocated and their lands expropriated, and governments have used force to suppress their objections to oil exploration. See Kimerling, Judith, ‘The Human Face of Petroleum’: Sustainable Development in Amazonia, 10 RECIEL 65, 73 (2001)Google Scholar; Watch Amazon, Burlington’s Oil Projects vs. Indigenous Communities and Rainforest Protection (2003)Google Scholar, at <http://www.amazonwatch.org/amazon/EC/burling/> ; Udomittipong, Pipob & R, Tyler. Giannini, Expanding Oil in Collapsing Markets? South East Asia, at <http://www.ran.org/oilreport/seasia.html>>Google Scholar (visited Sept. 24, 2004); Udomittipong, Pipob & R, Tyler. Giannini, Offshore Boom, Onshore Impact: Central Africa, at <http://www.ran.org/oilreport/africa.html>>Google Scholar (visited Sept. 24, 2004).

165 In the case of oil, the government of Nigeria suppressed those who opposed oil drilling on indigenous lands even to the point of executing noted activist Kenneth Saro Wiwa. See, e.g., Logan Michael Breed, Note, Regulating Our 21st–century Ambassadors: A New Approach to Corporate Liability for Human Rights Violations Abroad, 42 Va. J. Int’l L. 1005, 1010(2002)Google Scholar.

166 In both India’s and Brazil’s access legislation, the government grants consent for the bioprospecting project, and it is the job of the government to obtain any necessary consent from local communities or engage in the watered–down obligation of “consultation” with them.

167 Roht-Arriaza, supra note 53, at 955 (“The goal is not simply to receive money in exchange for access to knowledge and resources, but to control whether, and how, such knowledge is commercialized, while also leaving it available for noncommercial uses.”). See generally Coombe, Rosemary J.. Intellectual Property, Human Rights & Sovereignty: New Dilemmas in International Law Posed by the Recognition of Indigenous Knowledge and the Conservation of Biodiversity, 6 Ind. J. Global Legal Stud. 59,100–03 (1999)Google Scholar (emphasizing the need for indigenous communities to be able to say no to die use of their resources); Sarma, Lakshmi, Note, Biopiracy: Twentieth Century Imperialism in the Form of International Agreements, 13 Temp. Int’l & Comp. L.J. 107 (1999)Google Scholar (stressing the importance to indigenous people of controlling their resources).

168 Brazil’s Measure, supra note 117, provides in Article 8(II) that traditional knowledge associated with Brazil’s genetic heritage forms part of Brazil’s “cultural heritage.”

169 See Roht–Arriaza, supra note 53, at 928 (noting that “by consulting indigenous peoples, bioprospectors can increase the success ratio in trials for useful substances from one in 10,000 samples to one in two”). While estimates like this may be too optimistic, government agencies and the private sector have used indigenous knowledge of the applications of plants and other organisms to lead them to raw material helpful for drug development. See Brown, supra note 6, at 104, 125–32, 140–41; Ten Kate & Laird, supra note 65, at 61; 7 Pharmaceutical, Biology 5 (Joshua Rosenthal ed., 1999).

170 Biological Diversity Act, supra note 71, §§3(1), 4; Brazil Measure, supra note 117, Arts. 8, 11(IV)(b), 12, 16.

171 Canada, for example, recently vested indigenous communities with a range of natural resources.

172 Roht-Arriaza, supra note 53, at 948.

173 See BROWN, supra note 6, at 99 (reporting that Peru threatened to take away land given to indigenous communities if those communities did not commercially develop the lands but, rather, continued to use them for subsistence agriculture).

174 Hamilton, Cindy, The Human Genome Diversity Project and the New Biological Imperialism, 41 Santa Clara L. Rev. 619, 621–22 (2001)Google Scholar; see, e.g., Ten Kate & Laird, supra note 65, at 45 (global net sales of human proteins developed by rDNA techniques reached $7.7 billion in 1993 alone); Fisher, supra note 2.

175 Hamilton, supra note 174, at 621– 22.

176 Annas, George J.. Rules for Research on Human Genetic Variation—Lessons from Iceland, 342 Neweng. J. Med. 1830 (2000)Google Scholar PubMed; Gene Prospecting in Remote Populations, Science, Oct. 24,1997, at 565; Hamilton, supra note 174, at 623; Dickson, David, Back on Track: The Rebirth of Human Genetics in China, 396 Nature 303, 304 (1998)Google Scholar; Pomfret, John & Nelson, Deborah, In Rural China, a Genetic Mother Lode, Wash. Post, Dec. 20, 2000 Google Scholar, at A1.

177 Annas, supra note 176, at 1830.

178 See, e.g., id.; Dickson, supra note 176; Greely, Henry T.. Iceland’s Plan for Genomics Research: Facts and Implications, 40 Jurimetrics, Winter 2000 Google Scholar, at 153; Mining a Rich Seam of Genetic Diversity, supra note 176; Specter, Michael, Decoding Iceland, New Yorker, Feb. 18, 1999 Google Scholar, at 40; Weber, Wim, Tonga Sells Genetic Heritage to Australian Firm, Lancet, Dec. 2, 2000 CrossRef Google Scholar, at 1910, available in 2000 WL 9007333.

179 Charles, James, Lost Village Could Hold Key to Cures, Daily Express, Jan. 3, 2001 Google Scholar, at 1, available in 2001 WL 13273533; Hundley, Tom, Remote Italian Town on the Map for Geneticists: Clues to Disease Are Sought, Chi. Trib., Dec. 31, 2000 Google Scholar, at 1.

180 Greely, supra note 178, at 164; Rural Advancement Foundation International [RAFI, now ETC Group] Communiqué, Companies Step up Efforts to Sample Remote Populations (Nov. 12, 1997), available at <http://www.etcgroup.org> ; RAFI Communiqué, Gene Hunters in Search of “Disease Genes” Collect Human DNA from Remote Island Populations (May 30, 1995), available at http://www.etcgroup.org/article.asp?newsid-207>. The populations of the Pacific islands of Pingelap and Norfolk are also targets for genetic research. Barkham, Patrick, Faraway Tonga Cashes in on Its Gene Pool Secrets, Guardian, Nov. 23, 2000 Google Scholar, available in 2000 WL 29681585.

181 Telephone conversation with Mervyn Tano, executive director, International Institute for Indigenous Resource Management (June 2001). Mr. Tano estimated that the Cherokee Nation had already received some thirty applications for studies on the genetic makeup of its population and that the Navajo Nation had received numerous such requests.

182 GLOWKA, supra note 54, at 33; Ten Kate & Laird, supra note 65, at 17. India’s national law excludes human genetic material, see Biological Diversity Act, supra note 71, Art. 1 (c), as does the Asean Agreement, supra note 112, Art. 4. Access to human genetic material for research or commercialization, with several exceptions, remains largely unregulated. Ten Kate & Laird, supra, at 17.

183 See, e.g., Who, Genomics and World Health: Report of the Advisory Committee on Health Research §§7.1–7.6 (2002)Google Scholar [hereinafter Who Report], available at <http://www3.who.intAvhois/genomics/genomics_report.cfm> ; Hamilton, supra note 174; RAFI Communiqué, Phase II for Human Genome Research: Human Genetic Diversity Enters the Commercial Mainstream (Jan. 21, 2000), available at http://www.etcgroup.org/article.asppnewsid-230 [hereinafter RAFI, Phase II]; RAFI Communiqué, The Human Tissue Trade; The Global Traffic and Market in Human Biomaterials (Jan. 30, 1997), available at <http://www.etcgroup.org/search.asp?page-3&type-communique> ; RAFI, Gene Hunters, supra note 180; Pomfret & Nelson, supra note 176; Human Rights Movement Condemns Gene Research in Tonga, Pac Islands Broadcasting Ass’n News Serv., Nov. 28, 2000, available in 2000 WL 18811901.

184 See Who Report, supra note 183, §§7.5, 7.4.4 (indicating that patenting of genetic material of indigenous people is increasing opposition to population genetic studies and including suggestions for increased attention to benefit sharing). Article 4 of the Universal Declaration on the Human Genome and Human Rights, which was adopted by the UNESCO General Conference in 1998, states that “ the human genome in its natural state shall not give rise to financial gains.” 29 C/Res. 16, UNESCO Gen. Conf, 1 Res., at 41 (1998)Google Scholar. However, it is argued that where genomics research gives rise, for example, to profitable drugs, “it is not unreasonable for individuals who allow access to their DNA to consider themselves as owners of a resource and to demand fair compensation, which is considered to be in the region of 50% of net profits and royalties.” WHO Report, supra, §7.5; see also v, Moore. Regents of Univ. of Cal., 793 P.2d 479 (Cal. 1990)Google Scholar (patenting of cell line obtained from a patient); F, Jon. Merz, , Discoveries: Are There Limits on What May Be Patented? in Google Scholar Who Owns Life? supra note 9, at 99 (describing furor over patenting of die gene responsible for Canavans disease, where members of the affected Jewish community donated tissue samples used to identify the patented gene). See generally Mahoney, Julia D.. The Market for Human Tissue, 86 U. Va. L. Rev. 163 (2000)Google Scholar.

185 Who Report, supra note 183, §§7.4.4, 7.5.

186 Id. §7.4.4, Box 7.2.

187 The Second Meeting of the Parties to the CBD “reaffirmed that human genetic resources are not included within the framework of the Convention.” Decision 11/11, para. 2, Doc. UNEP/CBD/COP/2/19, at 22 (1996)Google Scholar.

188 Dickson, supra note 176, at 305.

189 Id. at 304; see also Belkin, Lisa, Chasing Bad Genes to the Ends of the Earth: The High–Tech Future of Medicine Is in the Blood of Remote Peoples, N.Y. Times, Apr. 26, 1998 Google Scholar, §6 (Magazine), at 46, 52.

190 Sugimoto, Dawn, Isolated Tonga Sells Its DNA Info to Science, Lethbridge Herald, Nov. 25, 2000 Google Scholar, available in 2000 WL 27467389.

191 Barkham, supra note 180.

192 China, , General Office of the State Council, Interim Measures for the Administration of Human Genetic Resources (June 10, 1998)Google Scholar, in U.S. Embassy Beijing, New PRC Human Gene IPR Rules (Sept. 1998), at <http://www.usembassy–china.org.cn/sandt/geneipr.htm> .

193 Id., Art.4.

194 Id. For an international collaborative project involving the human genetic resources of China, the application documents must include an “[i]nformed consent form of the donor of the human genetic material and/or his (her) legal representatives.” Id., Art. 12. The rules’ consent requirements, however, do not appear to apply to genetic material secured by the Chinese government. For a discussion of international rules for the protection of individuals, see note 204 infra.

195 Transfert.net, La Chine passera àla carte d’identité électronique à partir de janvier 2004 (Sept. 1, 2003), at <http://www.transfert.net>>Google Scholar . The card, which is required for all citizens over sixteen, also includes the person’s nationality, address, and place of birth.

196 Id.

197 The proviso in the Universal Declaration on the Human Genome and Human Rights, supra note 184, that “the human genome in its natural state shall not give rise to financial benefits” does not appear to restrict such alienation. Presumably a gene, once removed, is no longer in its natural state. Also, the declaration refers to the entire human genome rather than individual genes. For potential limitations on government actions, see infra note 204.

198 The ASEAN Agreement, supra note 12, Art. 4, prohibits the prospecting of genetic material of human origin and urges “the establishment of a multilateral process to effectively regulate die access, use, and commercialization of human genetic materials.” See also WHO Report, supra note 183 (discussing potential need for international guidelines to help national governments negotiate with multilateral corporations for the sharing of benefits arising out of the use of human genetic material).

199 See, e.g., Hamilton, supra note 174, at 636–39; see also RAFI, Phase II, supra note 183, at 15 (asserting that the CBD Conference of Parties should seek an advisory opinion from the International Court of Justice clarifying its responsibility with respect to human genetic diversity); RAFI News Release, US Funding of Human Biodiversity Collections Carries on Despite Contrary Scientific Advice 3 (Nov. 14, 1997)Google Scholar (stating that the CBD parties have been inadvertently ceded a role in addressing issues concerning human biodiversity and should bring the issue of collection of human genetic material before the UN human rights commissioner and the ICJ). The Convention on Biological Diversity does not necessarily distinguish between human and other genetic resources. Ten Kate & Laird, supra note 65, at 17, 45. Articles 1, 2, and 15 of the Convention, supra note 39, which set forth its objectives, definitions, and provisions on access to genetic resources, respectively, do not exclude human genetic resources from their terms. Article 2 of the Convention broadly defines “genetic material” as “any material of plant, animal, microbial or other origin containing functional units of heredity” (emphasis added). The term “or other origin” could be understood to include genetic material of human origin. Articles 15(1) and 15(5) of the Convention, which recognize the right of national governments to control genetic resources, could apply to human genetic resources as well. Although the Second Meeting of the Parties to the Convention “[r]eaffirmed that human genetic resources were not included within the framework of the Convention,” the parties can revisit the issue. Decision II/11, supra note 187, para. 2. The Conference of die Parties has at times shown little regard for the jurisdictional limits of the Convention. For example, the CBD does not retroactively apply to genetic resources collected prior to its entry into force. CBD, supra, Art. 15, para. 3. This did not stop the Fourth Meeting of the Conference of the Parties from embarking on a work program that encompassed collections of material acquired prior to the CBD’s entry into force. Decision IV/8, para. 2, Doc. UNEP/CBD/COP/4/27, at 109 (1998).

200 Who Report, supra note 183.

201 See, e.g., U.S. Patent No. 4,370,417,1026 (issued Jan. 25, 1983) (patent for DNA sequence for plasminogen activator protein); U.S. Patent No. 4,703,008,1083 (issued Oct. 27, 1987) (patent for DNA sequence for erythropoietin). For the Supreme Court’s decision, see Diamond v. Chakrabarty, 447 U.S. 303 (1980).

202 Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200 (Fed. Cir. 1991).

203 Moore v. Regents of Univ. of Cal., 793 P.2d 479 (Cal. 1990).

204 The nonbinding UNESCO Declaration on the Human Genome and Human Rights of 1998, supra note 184, and the nonbinding International Declaration on Human Genetic Data, Oct. 16, 2003, available at <http://www.unesco.org>>Google Scholar , provide some protections for individuals. Article 5 of the 1998 declaration requires researchers to obtain the free and informed consent of participants in genetic research. The 2003 declaration stipulates that genetic material should be extracted from humans only with their prior informed consent and that such material should not be used for an incompatible different purpose without their consent. The State, however, may decide to do away with this requirement for “compelling reasons by domestic law consistent with the international law of human rights.” 2003 declaration, supra, Art. 8(a). In addition, material given for one reason may be used for another without the person’s consent if the “use proposed is in the public interest” or where data are unlinked to any particular person. Id., Art. 16(a). For a discussion of controls and the limits of such controls on the conduct of human genetic research, see Greely, Henry T.. The Control of Genetic Research: Involving the “Groups Between,” 33 Hous. L. Rev. 1397, 1406 (1997)Google Scholar; Shira, Prada–Frank, Human Genomics: A Challenge to the Rules of the Game of International Law, 40 Colum. J. Transnat’l L. 613 (2002)Google Scholar.

205 CBD, supra note 39, Art. 15(1). But see note 212 infra,

206 See generally Stone, supra note 44, at 597.

207 Id.

208 Id.

209 Id.

210 Id.

211 Id.

212 Some commentators argue that the Convention distinguishes genetic resources from other natural resources because it stipulates that national governments should facilitate access to genetic resources. See, e.g., Downes, David, New Diplomacy for the Biodiversity Trade: Biodiversity, Biotechnology, and Intellectual Property in the Convention on Biological Diversity, 4 Touro J. Transnat’l L. 1, 8–9 (1993)Google Scholar. This position is largely undercut by the language of Article 15(1) of the Convention, which plainly likens genetic material to other natural resources. Moreover, the Convention’s requirement that countries facilitate access to genetic material is weak, requiring them solely to “endeavour” to create conditions to facilitate access. CBD, supra note 39, Art. 15(2). This weak obligation is further eroded by other provisions, which encourage countries to obtain “benefit sharing” for the use of genetic resources (Art. 1) and specify that access to genetic material normally requires the prior informed consent of the national government (Art. 15(5)). Such controls are not normally prescribed by treaty for other natural resources. Not surprisingly, nations in the aftermath of the CBD have not promulgated laws to enable and facilitate access to genetic material but, rather, to curtail access to such material to obtain monetary and other benefits.

213 CBD, supra note 39, Arts. 15(5) (“Access to genetic resources shall be subject to prior informed consent of the Contracting Party providing such resources, unless otherwise determined by that Party.”), 15(3) (“For the purpose of this Convention, the genetic resources being provided by a Contracting Party, as referred to in this Article . . . , are only those that are provided by Contracting Parties that are countries of origin of such resources or by the Parties that have acquired the genetic resources in accordance with this Convention.”). I note that, as is often the case, the CBD’s provisions are somewhat confusing and not entirely consistent with each other. Article 2 appears to define the “country providing genetic resources” more broadly than solely the country of origin as stipulated in Article 15(3). Under Article 2, the “country providing genetic resources” is the one “supplying genetic resources collected from in–situ sources... or taken from ex–situ sources, which may or may not have originated in that country.”

214 Id., Art. 2.

215 See generally Fowler, supra note 16, at 484–86 (generally discussing this problem for purposes of benefit sharing under the CBD). While Dr. Fowler limits his discussion to plant genetic resources, I believe that the problems that he has identified will arise with respect to Other genetic resources as well.

216 Without providing guidance, the CBD defines “habitat” as “the place or type of site where an organism or population naturally occurs.” What does it mean for something to occur naturally in a place? For example, do species that have been transported by human beings from one country to another “naturally occur” in the new country?

217 Stone, supra note 52, at 984.

218 Id.

219 Id.; Jacoby & Weiss, supra note 36, at 93 (predicting that policing and patrolling borders to control the flow of genetic resources would be difficult and expensive).

220 See Stone, supra note 44, at 605.

221 Coombe, Rosemary J.. The Recognition of Indigenous People’s and Community and Traditional Knowledge in International Law, 14 ST. Thomas L. Rev. 275 (2001)Google Scholar (discussing proposals to disclose origin of genetic resources in patent application); Glowka, supra note 4, at 332 (calling for shifting enforcement burdens from source countries to user countries); Nuno Pires de, Carvalho, Requiring Disclosure of the Origin of Plant Genetic Resources and Prior Informed Consent in Patent Applications Without Infringing the TRIPS Agreement: The Problem and the Solution, 2 Wash. U.J.L. & Pol’Y 371 (2000)Google Scholar.

222 Biological Diversity Act, supra note 71, §6(1).

223 Id. §6(2).

224 Brazil Measure, supra note 117, Art. 31.

225 Id., Art. 31. Violation of the Measure triggers a menu of potential penalties. These include confiscation of products derived from samples of the genetic heritage or associated traditional knowledge, suspension of the sales of such products, and suspension or cancellation of any patent related to such samples or associated traditional knowledge. Id., Art. 30. In addition, a person or a corporation that economically exploits a product or process developed from samples of components of Brazil’s genetic heritage or associated traditional knowledge accessed in violation of the Measure is subject to a penalty of 20% of the gross amount obtained from selling or licensing the product or process. Id., Art. 26.

226 Jeffrey, supra note 16; Pires de Carvalho, supra note 221.

227 Seiler & Dutfield, supra note 54, at 90.

228 Id.

229 See, e.g., World Trade Organization, TRIPS: Reviews, Article 27.3(B) and Related Issues, Background and the Current Situation, ai<http://www.wto.org/english/tratop_e/trips_e/art27_3b_background_e.htm> (last modified June 24, 2004)+(last+modified+June+24,+2004)>Google Scholar.

230 World Trade Organization, Council for Trade–Related Aspects of Intellectual Property Rights, The Relationship Between the TRIPS Agreement and the Convention on Biological Diversity and the Protection of Traditional Knowledge, WTO Doc. IP/C/W/403, paras. 1, 9 (June 24, 2003). In addition, China, Pakistan, Zambia, and Zimbabwe had made a similar proposal to the TRIPS Council in 2001. Id., para. 1 & n.2. The WTO documents cited here and below are available online at <http://www.wto.org> .

231 WTO Doc. IP/C/W/403, supra note 230, para. 14.

232 Id., para. 21.

233 World Trade Organization, Council for Trade–Related Aspects of Intellectual Property Rights, Taking Forward the Review of Article 27.3(b) of the TRIPS Agreement, WTO Doc. IP/C/W/404 §III(D) (June 26, 2003). The African Group proposed that Article 29 of the TRIPS Agreement be amended as follows: “Members shall require an applicant for a patent to disclose the country and area of origin of any biological resources and traditional knowledge used or involved in the invention, and to provide confirmation of compliance with all access regulations in the country of origin.”

234 Id. §I.

235 Heifer, Laurence R.. Regime Shifting: The TRIPs Agreement and New Dynamics of International Intellectual Property Lawmaking, 29 Yale J. Int’l L. 1, 68 (2004)Google Scholar; see, e.g., World Trade Organization, Council for Trade–Related Aspects of Intellectual Property Rights, Communication from the European Communities and Their Member States, WTO Doc. IP/C/W/383, para. 54 (Oct. 17, 2002) (expressing the Communities’ general objections to such requirements as part of the patent process); Hunter, David, Salzman, James, & Zaelke, Durwood, International Environmental Law and Policy 967–68 (1998)Google Scholar (reciting U.S. objections that such requirements would be a legal and administrative “nightmare”); Jeffrey, supra note 16, at 773 (discussing U.S. opposition to such demands).

236 The European Communities and Switzerland offered a compromise in response to developing country demands for additional disclosure rules. This compromise fell far short of meeting those demands and developing countries rejected it. The EC compromise called for the negotiation of “a self–standing disclosure requirement.” This requirement would not function as a new eligibility criterion for patent eligibility or the enforcement of patents but, in the words of the proposal, “would allow WTO Members to keep track . . . of all patent applications with regard to genetic resources for which they have granted access.” Heifer, supra note 235, at 68–69. Switzerland indicated its receptivity to allowing nations to require disclosure of the source of genetic material in patent applications but refused to require such disclosure as a matter of international law or condition the patent grant on such disclosure. World Trade Organization, Council for Trade–Related Aspects of Intellectual Property Rights, Communication from Switzerland, WTO Doc. IP/C/W/400/Rev. 1 (June 18, 2003).

237 These are that the invention be new, nonobvious, and useful and be disclosed to the public in the patent application.

238 See, e.g., Whip, Juicy, Inc. v. Orange Bang, Inc., 185 F.3d 1364 (Fed. Cir. 1999)Google Scholar (noting that it is not the task of the Patent and Trademark Office to serve as arbiters of deceptive trade practices or to determine whether drugs are safe, or otherwise to exercise the police powers of the states); Pires de Carvalho, supra note 221, at 372; see also TRIPS, supra note 13, Art. 27.2 (although members may exclude certain inventions from patentability to protect ordre public or morality, “such exclusion [shall not be] made merely because the exploitation is prohibited by their law”).

239 Pires de Carvalho, supra note 221, at 372, 379–89.

240 Id. Indeed, some developed countries are aware of the apparent conflicts between access–restricting legislation and the TRIPS Agreement. See, e.g., World Trade Organization, Council for Trade–Related Aspects of Intellectual Property Rights, Communication from Brazil, WTO Doc. IP/C/W/228, para. 24 (Nov. 24, 2000)Google Scholar (pointing to conflicts between the CBD and TRIPS “at the implementation level”). Pires de Carvalho suggests that, while a refusal to grant a patent under such circumstances would violate the TRIPS Agreement, a country’s refusal to enforce a patent for failure to disclose that genetic material was acquired without the country of origin’s consent would not. Analysis of this untested approach is the topic of a separate article.

241 See Adelman, Martin J.. Et Al., Cases and Materials on Patent Law, 2d at 60 (2003)Google Scholar (highlighting the importance of TRIPS for the pharmaceutical industry); Martin J. Adelman & Badia, Sonia, Prospects and Limits of the Patent Provision in the TRIPS Agreement: The Case of India, 29 Vand. J. Transnat’l L. 507, 524, 532 (1996)Google Scholar (Prior to TRIPS, countries like India widely manufactured drugs that were patented in developed countries. TRIPS prevents this practice and therefore is extremely important to the pharmaceutical industry.).

242 See generally ADELMAN ET AL., supra note 241, at 60.

243 The 1996 TRIPS dispute between the United States and the European Union against India illustrates how quickly a country’s failure to protect pharmaceutical products properly can create a trade dispute. India failed to comply with the TRIPS requirement that it provide a “mailbox mechanism” through which patent applicants could deposit their claims during the transitional period that applies to developing countries. In less than two years, the United States filed claims against India before the WTO and the European Union joined as a third participant. India—Patent Protection for Pharmaceutical and Agricultural Chemical Products, Doc. WT/DS50/AB/R (adopted Jan. 16, 1998).

244 See Stone, supra note 52, at 1000 (admitting that the prospective use values for biodiversity, particularly the pharmaceutical potential, have been “conveniently exaggerated” by well–intentioned academics).

245 Labrador, supra note 146; accord Stone, supra note 52, at 991 (pointing to “evidence that as national efforts become more stringent, the interest of bioprospecting firms may wane, resulting in fewer prospecting agreements”).

246 See note 219 supra and corresponding text.

247 See notes 92–97 supra and corresponding text.

248 Burk & Lemley, supra note 95, at 1625–26 (footnote omitted). Proceeding with a particular gene therapy or downstream bioengineered good involves high costs in locating and bargaining with the holders of patents on these various genes and gene fragments. See generally id. at 1611 (summarizing effects of an anticommons). Any one patent holder can thwart a project by refusing to license its individual genetic component unless paid a “bribe” to do so. Id. The problem is exacerbated even further by “reach–through” licenses, whereby the owners of upstream patents seek control of and royalties on the downstream uses of their patented genes. Id. at 1626. But see note 97 supra for those who disagree that an anticommons is emerging.

249 Peter Pringle, Food, Inc. 20, 33 (2003).

250 Id. (quoting the developer of the golden rice as saying he had to ignore the patents while experimenting with the rice “or I couldn’t move at all”).

251 Rai, Arti K.. Fostering Cumulative Innovation in the Biopharmaceutical Industry: The Role of Patents and Antitrust, 16 Berkeley Tech. L.J. 813, 842 (2001)Google Scholar.

252 Burk & Lemley, supra note 95, at 1627.

253 Id.

254 Epstein, supra note 7; see also Mauer, supra note 7, at 1090 (favoring a broad interpretation of patentable subject matter).

255 Dreyfuss, supra note 7, at 1; see supra note 7.

256 See generally Burk & Lemley, supra note 95, at 1678.

257 Gitter, supra note 7, at 1677 (discussing how easy it is to isolate genes with computer–assisted high–throughput sequencing); Walter V. Reid, Technology and Access to Genetic Resources, in Access To Genetic Resources 53 (Mugabe et al. eds., 1997); see Thompson, supra note 25 (describing race to isolate and discover functions of genes).

258 See notes 146, 152, & 153 supra and corresponding text.

259 See notes 221–28 supra and corresponding text.

260 Ten Kate & Laird, supra note 65, at 302.

261 Macilwain, supra note 24; Stone, supra note 52, at 974 (“reliance on laboratory–concocted ‘designer genes’ is reducing the need to scout up natural samples”).

262 Conversation between author and deputy director of the Genomics Institute, University of Illinois, Champagne–Urbana (Nov. 2001); Gewin, Virginia, While Industrial Agrobiotech R&D Falters, Opportunities in Plant Biology in the Public Sector Are Growing, 419 Nature Jobs 4, 5 (Oct. 10, 2002), at <http://www.naturejobs.com>Google Scholar .

263 Harte, John, Land Use, Biodiversity, and Ecosystem Integrity: The Challenge of Preserving Earth’s Life Support System, 27 Ecology L.Q. 929,959 (2001)Google Scholar.

264 Id.

265 Pharmaceutical Biology, supra note 169, at 19–20.

266 See generally Baslar, supra note 19, at 40–41 (citing Roman belief that sharing certain basic resources would further the common interest); Boyle, James, Shamans, Software, and Spleens 9–10, 119 (1996)Google Scholar (arguing that intellectual property regimes “can actually slow down scientific progress, diminish the opportunities for creativity, and curtail the availability of new products”); Lawrence Lessig, The Future of Ideas (Vintage Books 2002) (2001).

267 See generally Rose, Carol M.. The Several Futures of Property: Of Cyberspace and Folk Tales, Emission Trades and Ecosystems, 83 Minn. L. Rev. 129, 181–82 (1998)Google Scholar.

268 See Stone, supra note 44, at 597–98.

269 Brush, Stephen B.. Genetically Modified Organisms in Peasant Farming: Social Impact and Equity, 9 Ind. J. Global Legal Stud. 135, 157 (2001)Google Scholar (“Genetic resources retain their viability partly because they are shared so widely . . .”). An open system for genetic material does not harm the resource itself or appear to pose a great risk of overutilization. Genetic resources are renewable, largely abundant, and access to a limited sample of the resource generally satisfies research objectives.

270 Id.

271 See generally Ordish, George, The Great Wine Blight (1972)Google Scholar.

272 Id.

273 Hawtin, Geoffrey & Reeves, Timothy, Intellectual Property Rights and Access to Genetic Resources in the Consultative Group on International Agricultural Research, in Intellectual Property Rights III: Global Genetic Resources: Access and Property Rights 41 (Steve A. Eberhart et al. eds., 1998)Google Scholar. These centers are located in Colombia, Indonesia, Mexico, Peru, Syria, the Philippines, Kenya, India, the United States, Sri Lanka, Nigeria, Italy, the Netherlands, and C6te d’lvoire. Id. at 53–54.

274 Id. at 41; People, Plants, and Patents 92–93 (Crucible Group, 1994) (noting that the CGIAR holds the “world’s largest international collection of crop and forest germplasm—more than 500,000 accessions.... The CGIAR has trained more than 50,000 agricultural researchers and has worked with national agricultural research services to feed at least 500 million people in the South who would not otherwise be fed.”)

275 People, Plants, and Patents, supra note 274, at 92 (the CGIAR centers make about “600,000 accessions and breeding lines . . . available free of charge to researchers every year, mostly in developing countries”).

276 See generally Hawtin & Reeves, supra note 273, at 41–42 (describing creation of CGIAR system in 1971 as outgrowth of the common heritage environment that allowed for the free collection and sharing of samples of genetic material, and challenge to CGIAR system of increased intellectual property rights and assertion of sovereign rights that marked the 1980s and 1990s). The renegotiation of die Undertaking, supra note 15, sought in part to preserve the international germ plasm system. The new PGR Treaty, supra note 57, that emerged from these negotiations succeeds in protecting the international germ plasm collections to a large extent. It also creates a limited open system for sharing a select group of plant genetic resources of core staple crops for food and agriculture. Such collections, however, no longer operate as openly as they once did. They are required to create detailed records on the source of new materials contributed, subject provided materials to certain conditions, and make their collections available only for certain purposes. The new PGR Treaty entered into force on June 29, 2004. As of that date, fifty–five nations had ratified the Treaty and fifty more had signed it. For a discussion of the Treaty, see Heifer, Laurence R.. Using Intellectual Property Rights to Preserve the Global Genetic Commons: The International Treaty on Plant Genetic Resources for Food and Agriculture, in International Public Goods and Transfer of Technology Under a Globalized Intellectual Property Regime (J. H. Reichman & Keith Maskus eds., forthcoming 2005)Google Scholar.

277 Pringle, supra note 249, at 32, 40.

278 Brush, supra note 269.

279 The difficulty of empirically proving the benefits of open systems over closed ones is a classic problem. Despite the existence of patent laws for centuries, their comparative efficacy over public domain systems in promoting innovation has yet to be empirically proven. See World Bank, Knowledge for Development—World Development Report 1998/1999, at 34–35 (1999)Google Scholar (no systematic empirical evidence confirms the positive impact of intellectual property rights on increasing research and development; and while tighter intellectual property rights “may actually slow the overall pace of innovation,” systematic empirical evidence proving this is similarly lacking); Boyle, supra note 266 (pointing to lack of empirical proof that intellectual property rights in aggregate increase the overall amount of innovation); Letter from Thomas Jefferson to Isaac McPherson (Aug. 13, 1813), Jefferson, Thomas, Writings 1286 (Merrill D. Peterson ed., 1984), available at <http://www.temple.edu/lawschool/dpost/mcphersonletter.html>>Google Scholar (noting that the lack of patent laws in other countries did not appear to reduce their comparative ability to innovate).

280 Heller & Eisenberg, supra note 7; see Stone, supra note 52 (noting the general overvaluation of genetic resources).

281 See notes 34–36, 45 supra and corresponding text.

282 See People, Plants, and Patents, supra note 274, at 93–94 (noting position that raw material provided under the CGIAR system should be freely available only if improved varieties are made freely available); Odek, supra note 34. This position was repeatedly taken by many developing countries during the renegotiation of the International Undertaking on Plant Genetic Resources that took place between 1996 and 2001. (I participated in the negotiations as legal counsel to the U.S. delegation and personally heard such proposals.)

283 See Burk & Lemley, supra note 95, at 1597; Gitter, supra note 7, at 1624–25; Eisenberg, Rebecca S.. Analyze This: A Law and Economics Agenda for the Patent System, 53 Vand. L. Rev. 2081, 2083–84 (2000)Google Scholar; Dreyfuss, supra note 7, at 1; Epstein, supra note 7.

284 See Burk & Lemley, supra note 95, at 1597; Eisenberg, supra note 283, at 2085–98; Gitter, supra note 7, at 1625; Merges, Robert P.. & Nelson, Richard R.. On the Complex Economics of Patent Scope, 90 Colum. L. Rev. 839 (1990)Google Scholar.

285 See Eisenberg, supra note 283; Gitter, supra note 7; Dreyfuss, supra note 7; Epstein, supra note 7.

286 See supra notes 7, 9.

287 Burk & Lemley, supra note 95, at 1668–96.

288 See note 320 infra; see, e.g., Brenner v. Manson, 383 U.S. 519 (1966) (majority and dissenting opinion each focus on the effect that setting the utility bar would have on innovation and disclosure of innovation, the majority holding that scientific development would be better served with a utility rule that did not allow the issuance of patents to processes that produced chemical compounds whose usefulness had not been shown and the dissent reaching the opposite conclusion).

289 Burk & Lemley, supra note 95, at 1599; Lemley, Mark A.. Romantic Authorship and the Rhetoric of Property, 75 Tex. L. Rev. 873,888–90 (1997)Google Scholar (pointing to innumerable court decisions, statutory provisions, and commentators for this proposition).

290 See generally Burk & Lemley, supra note 95, at 1581–95.

291 The international regarding calculus that I propose has application beyond the patenting of genetic material. A broader discussion of this issue is the subject of a separate law review article.

292 The international regarding calculus that I propose should not be confused with the usual determinations of whether actions contemplated by the United States violate U.S. obligations under international law. See, e.g., Dinwoodie, Graeme B. & Dreyfuss, Rochelle Cooper, Preserving the Public Domain of Science Under International Law, in International Public Goods and Transfer of Technology Under a Globalized Intellectual Property Regime (J. H. Reichman & Keith Maskus eds., forthcoming 2005)CrossRef Google Scholar (discussing whether proposed cures to overpatenting in the genomics area would violate provisions of the TRIPS Agreement), available at <http://ssrn.com/abstract_id–478961> .

293 See K, Arti. Rai, , Engaging Facts and Policy: A Multi–institutional Approach to the Patent System Reform, 103 Colum. L. Rev. 1035 (2003)Google Scholar.

294 Burk & Lemley, supra note 95; Rai, supra note 293.

295 Rai, supra note 293.

296 See supra note 13.

297 Id.

298 Notable exceptions include Demaine & Fellmeth, supra note 2 (considering international resolutions on genetic patents in die human genome area), and, although not specifically in the genetics area, Boyle, supra note 266; Bagley, Margo A.. Patently Unconstitutional: The Geographical Limitation on Prior Art in a Small World, 87 Minn. L. Rev. 679, 688–90 (2003)Google Scholar (arguing that U.S. should include foreign prior uses as patent–defeating prior art and asserting that the “[§]102 geographical limitation facilitates the ‘pirating’ of... genetic resources from developing countries, exacerbating feelings of ill will toward the United States for its hypocritical stance in this area”).

299 See, e.g., Burk & Lemley, supra note 95; Eisenberg, Rebecca S.. Intellectual Property at the Public–Private Divide: The Case of Large–Scale cDNA Sequencing, 3 U. Chi. L. Sch. Roundtable 557 (1996)Google Scholar; Holman & Munzer, supra note 7, at 774; Dreyfuss, supra note 7; Epstein, supra note 7.

300 See, e.g., Gitter, supra note 7 (considering the patenting of human genetic material in the United States and the European Union); Dinwoodie & Dreyfuss, supra note 292.

301 See, for example, the laws of India, Brazil, and the Andean Pact discussed supra in parts I and II.

302 See note 282 supra,

303 Indeed, one of the last terms of the renegotiated Undertaking that nations agreed upon was a provision limiting the ability of a breeder who obtained genetic material from the international system to patent such genetic material “in the form received.” PGR Treaty, supra note 57, Art. 12.3(d). This term reflects the core concern of developing countries that freely given genetic material should not be enclosed. I believe the debate on this issue will continue as nations will likely disagree as to the meaning of “in the form received.” Developed countries will understand this term to encompass genes isolated from germ plasm samples. Consistently with its practice of allowing the patenting of isolated genetic material, the United States will likely interpret this term as not encompassing genetic material isolated from received germ plasm since the material was not received in its isolated form. If genes isolated from germ plasm obtained from the international system are patented, one can expect less sharing of germ plasm and a retreat to enclosure.

304 Burk & Lemley, supra note 95, at 1597 (citing, inter alia, Wiley, John Shepard Jr., Copyright at the School of Patent, 58 U. Chi. L. Rev. 119 (1991)Google Scholar; S, Rebecca. Eisenberg, , Patents and the Progress of Science: Exclusive Rights and Experimental Use, 56 U. Chi. L. Rev. 1017, 1024–30 (1989)Google Scholar; and a slew of Supreme Court cases).

305 See, e.g., Prada–Frank, supra note 204, at 654–55 (supporting patent protection for human genes as an incentive to improve health care).

306 A detailed discussion and analysis of the precise way that an international regarding calculus would operate is the subject of a separate law review article. The discussion that follows provides an entry point into the concept and its implications.

307 See generally Rai, supra note 293, at 1131–32 (pointing out the line–drawing function exercised by the U.S. PTO when it sets its guidelines, as well as the limits of its power).

308 See Eisenberg, Rebecca S.. & Merges, Robert P.. 1995 Opinion Letter as to the Patentability of Certain Inventions Associated with the Identification of Partial cDNA Sequences, 23 Am. Intell. Prop. L. Ass’n Q.J. 1 (1996)Google Scholar; Eisenberg, supra note 299; Epstein, Richard A.. Property Rights in cDNA Sequences: A New Resident for the Public Domain, 3 U. Chi. L. Sch. Roundtable 575 (1996)Google Scholar (arguing against the patenting of ESTs); Enserink, Martin, Patent Office May Raise the Bar on Gene Claims, 287 Science 1196, 1197 (2000)Google Scholar; Marshall, Elliot, Patent Office Faces 90–Year Backlog, 272 Science 643 (1996)Google Scholar. For an in–depth discussion of ESTs and the controversy surrounding them, see Holman & Munzer, supra note 7.

309 See sources cited supra note 308; see also Rai, Arti K.. Regulating Scientific Research: Intellectual Property Rights and the Norms of Science, 94 Nw. U. L. Rev. 77 (1999)Google Scholar.

310 See sources cited supra notes 308, 309.

311 See sources cited supra notes 308, 309.

312 See sources cited supra notes 308, 309.

313 U.S. Patent and Trademark Office, Examination Guidelines for the Utility Requirement, 66 Fed. Reg. 1092, 1098 (Jan. 5, 2001); Enserink, supra note 308.

314 See 66 Fed. Reg. 1092 (Jan. 5, 2001).

315 Several commentators urged that genes should not be patentable because they are discoveries, not inventions, or because they are products of nature or define something as basic as what it means to be a human being. Id. at 1092–93.

316 Comment (6), id. at 1094.

317 Response to comment (6), id.

318 Comment (2), id. at 1093. For developing country concerns, see infra note 339.

319 Burk & Lemley, supra note 95, at 1575, 1644–46, 1696; Merges & Nelson, supra note 284, at 840–41.

320 See, e.g., Burk & Lemley, supra note 95 (generally pointing to courts’ discretion in implementing and interpreting patent law, specifically taking line drawing for the nonobviousness standard as an example); Holman & Munzer, supra note 7, at 774–814 (analyzing innovation–inhibiting or –promoting effects of granting or refusing patents to ESTs); Jacobs & van Overwalle, supra note 7; Merges & Nelson, supra note 284, at 840–68, 884–916 (PTO’s discretion in determining patent scope and even broader discretion of courts in determining patent scope, and innovation–inhibiting or –promoting impacts of such determinations); Epstein, supra note 7, at 37–40, 51–57 (economic consequences of allowing patents on ESTs and genetic materials in general).

321 Its aggressive approach to patenting isolated the United States at the renegotiation of the International Undertaking for Plant Genetic Resources, as well as contributed to U.S. isolation at international discussions under the rubric of the Convention on Biological Diversity.

322 Burk & Lemley, supra note 95, at 1631.

323 Id. at 1632–33.

324 Id at 1633.

325 35 U.S.C. § 103(b) (2000).

326 Burk & Lemley, supra note 95, at 1634–38; Dinwoodie & Dreyfuss, supra note 292.

327 See, e.g., Diamond v. Diehr, 445 U.S. 926 (1980) (determining that a computer algorithm could be patented); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948) (deciding that a collection of seeds was a product of nature).

328 While not speaking to patent law in particular, Justice Antonin Scalia points to the dangers of using other countries’ approaches to guide the decisions of U.S. courts. Scalia, Antonin, Keynote Address: Foreign Legal Authority in the Federal Courts, 98 ASIL Proc. 305 (2004)Google Scholar.

329 See, e.g., Sandra, Day O’Connor, Broadening Our Horizons: Why American Judges and Lawyers Must Learn About Foreign Law, Int’l Jud. Observer, June 1997 Google Scholar, at 2 (stating that “American judges and lawyers can benefit from broadening our horizons” and explaining how her own experience on the Court has suggested that “we often have a lot to learn from other jurisdictions”); Sandra, Day O’Connor, Keynote Address, 96 ASIL Proc. 348, 350 (2002)Google Scholar (suggesting that “conclusions reached by other countries and by the international community should at times constitute persuasive authority”); Breyer, Stephen, Keynote Address, 97 ASIL Proc. 265 (2003)Google Scholar (expressing his own view of the relevance of other countries’ approaches and citing Justices Ruth Bader Ginsburg, David Souter, and John Paul Stevens, who have also at times referred to comparative foreign experience). But see Scalia, supra note 328 (criticizing, with several exceptions, the use of foreign materials in U.S. judicial decision making). See also Agora: The United States Constitution and International Law, 98 AJIL 42 (2004)Google Scholar.

330 Breyer, supra note 329, at 266.

331 The import into the United States of a product that has been patented in the United States but not overseas constitutes infringement of the U.S. patent. 35 U.S.C. §271(a) (2000)Google Scholar PubMed.

332 See generally ADELMAN ET AL., supra note 241, at 148; Rai, supra note 309, at 77.

333 Demaine & Fellmeth, supra note 2.

334 Id.

335 See Eisenberg, supra note 9, at 119–20; Epstein, supra note 7, at 44–51.

336 Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200 (Fed. Cir. 1991) (allowing patents over naturally occurring, yet isolated genes as akin to chemical compounds); Eisenberg, supra note 9, at 119–20; Epstein, supra note 7, at 44–51.

337 See, e.g., Burk & Lemley, supra note 95, at 1644–45, 1681–82; Eisenberg, supra note 299; Enserink, supra note 308; Epstein, supra note 7, at 51–57.

338 See, e.g., supra note 326.

339 Tansey, Geoff, Trade, Intellectual Property, Food and Biodiversity 8 (1999)Google Scholar (noting that many developing countries oppose the patenting of genetic material; examples include Argentina, Brazil, and the Andean Pact countries); Murphy, supra note 2 (making same point).

340 See supra note 12.

341 See notes 247–55 supra and corresponding text; see also Jacobs & van Overwalle, supra note 7 (arguing that patents should not be granted for DNA but only for downstream medical goods); Matthew Erramouspe, Comment, Staking Patent Claims on the Human Blueprint: Rewards and Rent–Dissipating Races, 43 Ucla L. Rev. 961, 998 (1996)Google Scholar (arguing for stricter limits on gene patentability).

342 See Dinwoodie & Dreyfuss, supra note 292, at 12–20; Gitter, supra note 7, at 1684–92 (in the context of human DNA sequences); Mueller, supra note 7. On experimental use or fair use generally, see Eisenberg, supra note 304; A, Maureen. O’Rourke, , Toward a Doctrine of Fair Use in Patent Law, 100 Colum. L. Rev. 1177, 1205 (2000)Google Scholar.

343 For a discussion of whether research exemptions comply with die TRIPS Agreement, see Dinwoodie & Dreyfuss, supra note 292, at 12–20.

344 Eldred v. Ashcroft, 537 U.S. 186, 188, 206 (2003). According to the official summary:

A key factor in the [expansion of the copyright term] was a 1993 European Union (EU) directive instructing EU members to establish a baseline copyright term of life plus 70 years and to deny this longer term to the works of any non–EU country whose laws did not secure the same extended term. By extending the baseline United States copyright term, Congress sought to ensure that American authors would receive the same copyright protection in Europe as their European counterparts.

345 See the Web site of the CBD, <http://www.biodiv.org> , for a list of the various working groups and expert panels on access to genetic resources and benefit sharing. See also Report of the Sixth Meeting of the Conference of the Parties to the Convention on Biological Diversity, Doc. UNEP/CBD/COP/6/20, at 254 (2002)Google Scholar (setting up international guidelines for access and benefit sharing).

346 See Jeffrey, supra note 16 (the meaning of the CBD’s terms will evolve over time). See generally Chandler, Melinda, The Biodiversity Convention: Selected Issues of Interest to the International Lawyer, 4 Colo. J. Int’l Envtl. L. & Pol’y 141 (1993)Google Scholar (noting the general ambiguity of the CBD’s terms and provisions).

347 Raustiala & Victor, supra note 13, at 295.

348 PGR Treaty, supra note 57, Art. 10 (which begins by proclaiming sovereign rights over plant genetic resources and then tries to create a more open system).

349 Id., Arts. 10–13, 15, 16; see also A Treaty on Plant Genetic Resources, Agriculture 21 (Dec. 2001), available at <http://www.fao.org/ag/magazine/0112sp3.htm>>Google Scholar (discussing the seven years of difficult negotiations).

350 Such a change in international assumption would not necessarily require an amendment to the CBD because the Convention allows countries to refrain from asserting sovereign rights. CBD, supra note 39, Art. 15(7).

351 35 U.S.C. §§101–103 (2000); TRIPS, supra note 13, Art. 27(1).

352 35 U.S.C. §112; TRIPS, supra note 13, Art. 29.

353 The usual term for a patent is twenty years from the time of application. 35 U.S.C. § 154(a)(2); TRIPS, supra note 13, Art. 33.

354 See supra notes 7, 308, 309.

355 In the United States, the conception of the patent as an exception to the general concept that ideas form part of the public domain finds vivid expression in the writings of Thomas Jefferson, who characterized patents as an “embarrassment.” Letter from Thomas Jefferson, supra note 279. The Supreme Court, in Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141 (1989), reiterated that patents are an exception to the general rule that information should form part of the public domain.

356 See supra note 167.

357 See supra note 171.

358 See Odek, supra note 34, at 175–76 (citing Kloppenburg, Jack R.. & Kleinman, Daniel L.. The Use and Control of Plant Genetic Resources 171, 194, 199 (1988)Google Scholar).

359 Raustiala & Victor, supra note 13, at 289.

360 Odek, supra note 34, at 175–76.

361 Raustiala & Victor, supra note 13.

362 For a discussion of this discovery, see Adair, supra note 16.

363 Were indigenous communities living in such parks, the situation would be more complex.

364 Sums received from bioprospecting in national parks in both Costa Rica and the United States have been used to promote conservation activities.

360 Columbia Access Paper, supra note 32, at 61.

366 Correspondence between Sabrina Safrin and legal counsel of the Instituto Nacional de Biodiversidad (INBIO) (Feb. 2004) (on file with author); see, e.g., Ten Kate & Laird, supra note 65, at 253–57 (describing Diversa-INBIO agreement); Columbia Access Paper, supra note 32, at 18 (describing Merck-INBIO agreement).

367 Brush, supra note 269, at 135 (agricultural bioengineered products are less profitable than bioengineered organisms in the pharmaceutical and chemical industries); Fowler, supra note 16, at 487.

368 See, e.g., Fowler, supra note 16, at 487.

369 The PGR Treaty, supra note 57, creates a more open system for plant genetic resources for core staple crops for food and agriculture. This model may warrant repetition in other areas, such as some human genetic resources.

370 Malaysia has a strong federal system comprising thirteen states, each with its own legislature and extensive powers over natural resources. Kate, Kerryten & Wells, Adrian, Benefit–Sharing Case Study: The Access and Benefit–Sharing Policies of the United States National Cancer Institute: A Comparative Account of the Discovery and Development of the Drugs Calanolide and Topotecan 18 (1998)Google Scholar. Access to genetic resources within Malaysia is regulated as much by the states as by the federal government. Bioprospecting activities in Malaysia will often require both federal and state approval. See generally id. at 18–20.

371 Forests Ordinance of Apr. 1994, §65A(b), reprinted in Ten Kate & Wells, supra note 370, at 19 n.50.

372 Ten Kate & Wells, supra note 370, at 20; Stone, supra note 51, at 992 (discussing uncertainty of determining which gene will prove valuable). He does riot propose a comprehensive approach.

373 Ten Kate & Wells, supra note 370, at 20 (suggesting that observers have made such criticism).

374 Id. at 19–20 (quoting the proposed amendment). The proposal under consideration remains somewhat tailored in that it excludes plants and microbial genetic resources from its scope. Id. It also applies only to foreigners.

375 See BIODIVERSITY PROSPECTING, supra note 34; Reid, supra note 257, at 62; Seiler & Dutfield, supra note 54, at 110.

376 Reid, supra note 257, at 62–63; Seiler & Dutfield, supra note 54, at 110.

377 Costa Rica’s agreement with Merck is mentioned in most articles or books that deal with access and benefit sharing regarding genetic resources. See, e.g., Biodiversity Prospecting, supra note 34; Ten Kate & Laird, supra note 65; Adair, supra note 16; Asebey & Kempenaar, supra note 16; Kadidal, Shayana, Note, Plants, Poverty and Pharmaceutkal Patents, 103 Yale L.J. 223 (1993)Google Scholar; Locke, supra note 126, at 84; Columbia Access Paper, supra note 32, at 18 (Merck–INBIO is probably the most famous of access and benefit–sharing arrangements); Seiler & Dutfield, supra note 54.

378 Correspondence between Sabrina Safrin and INBIO legal counsel, supra note 366.

379 See INBIO Web site, <http://www.inbio.ac.cr/>>Google Scholar .

380 See supra note 375.

381 Id.; see also Raustiala & Victor, supra note 13, at 289.

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