* Managing Editor, Boston College Third World Law Journal (2000–2001).
1 See Glenn M. Wiser, PTO Rejection of the “Ayahuasca” Patent Claim: Background and Analysis  2, at http://ciel.org/ptorejection.html (Nov. 1999).
2 Id.  1.
3 Id.
4 Id.
5 Id.  2.
6 See Wiser, supra note 1,  2; Ctr. for Int’l Envtl. Law (CIEL), Comments on Improving Identification of Prior Art: Recommendations on Traditional Knowledge Relating to Biological Diversity Submitted to the United States Patent and Trademark Office  IV(D), at http://ciel.org/bwp.html (Aug. 1999) [hereinafter CIEL]. Under the U.S. Patent Act, applicants cannot patent medicinal plants in their natural state. See Alan L. Durham, Patent Law Essentials: A Concise Guide 80 (1999). However, if a Western researcher separates the plant’s chemical compounds in a fashion that is not naturally occurring, it becomes eligible for patent protection. See 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, 938 (1996).
7 See Bill Lambrecht, Amazon Tribal Leaders Challenge U.S. Patent: They Say American Has No Right to Plant Used in Healing, St. Louis Post-Dispatch, Mar. 31, 1999, at A5 (quoting Antonio Jacanamijoy).
8 See Wiser, supra note 1,  3, 5.
9 See CIEL, supra note 6,  IV(D).
10 See, e.g., James O. Odek, Bio-Piracy: Creating Proprietary Rights in Plant Genetic Resources, 2 J. Intell. Prop. L. 141, 145–49 (1994); Valentina Tejera, Note, Tripping over Property Rights: Is It Possible to Reconcile the Convention on Biological Diversity with Article 27 of the TRIPS Agreement?, 33 New Eng. L. Rev. 967, 972 (1999); Craig Benjamin, Biopiracy and Native Knowledge: Indigenous Rights on the Last Frontier, Native Americas, June 30, 1997, available at 1997 WL 15895006; Vandana Shiva, The U.S. Patent System Legalizes Theft and Biopiracy, The Hindu, at http://www.purefood.org/Patent/USpatsys.cfr (July 28, 1999). In 1997, corporations and government agencies were researching 1000 traditional plants and their uses. Benjamin, supra. For instance, in a period of five years the National Cancer Institute collected 10,000 plant specimens from six countries. Id. Although it is a publicly funded organization, the Institute obtains patents on discoveries that have potential commercial value. Id.
11 See Emily Marden, The Neem Tree Patent: International Conflict over the Commodification of Life, 22 B.C. Int’l & Comp. L. Rev. 279, 279 (1999); Tejera, supra note 10, at 971; see also Lakshmi Sarma, Note, Biopiracy: Twentieth Century Imperialism in the Form of International Agreements, 13 Temp. Int’l & Comp. L.J. 107, 108 (1999).
12 See Marden, supra note 11, at 279; Roht-Arriaza, supra note 6, at 938.
13 See Scott Holwick, Note, Developing Nations and the Agreement on Trade-Related Aspects of Intellectual Property Rights, 1999 Y.B. Colo. J. Int’l Envtl. L. & Pol’y 49, 57–58 (2000); Sarma, supra note 11, at 108; see also Roht-Arriaza, supra note 6, at 938. See generally Odek, supra note 10, at 145–49 (discussing examples of uncompensated appropriation of plant genetic resources).
14 See David R. Downes, How Intellectual Property Could Be a Tool to Protect Traditional Knowledge, 25 Colum. J. Envtl. L. 253, 263 (2000); Odek, supra note 10, at 145; Sarma, supra note 11, at 117; Tejera, supra note 10, at 971; Shiva, supra note 10; see also Marden, supra note 11, at 280.
15 See Diamond v. Chakrobarty, 447 U.S. 303, 309 (1980); Andrew J. Pollack, Biological Products Raise Genetic Ownership Issues: Governments Are Demanding Share of Profits, N.Y. Times, Nov. 26, 1999, at C4.
16 See Pollack, supra note 15, at C4. For instance, Brazilian environmentalists sued a non-governmental organization alleging that it stole traditional knowledge from indigenous peoples. See Mario Osava, Brazil-Biodiversity: Crackdown on Eco-Pirates, Inter. Press Service, Aug. 14, 1997, available at 1997 WL 13256081. Since the suit, legislative proposals have been put forth in an attempt to protect Brazil’s biodiversity by imposing harsh penalties on biopirates claiming rights to biological materials taken from the rain forests. See id.
17 See 35 U.S.C.  102 (1994).
18 See id.
19 See Shayana Kadidal, Subject-Matter Imperialism? Biodiversity, Foreign Prior Art and the Neem Patent Controversy, 37 IDEA 371, 386 (1997) (citing Donald S. Chisum, Foreign Activity: Its Effect on Patentability under United States Patent Law, 11 Int’l Rev. Indus. Prop. & Copyright L. 26, 36 (1980)).
20 See Marden, supra note 11, at 289; see also Roht-Arriaza, supra note 6, at 936. See generally Kadidal, supra note 19.
21 See Kadidal, supra note 19, at 397.
22 See Roht-Arriaza, supra note 6, at 926–27; Pollack, supra note 15, at A1. A large amount of the Earth’s genetic diversity has already disappeared. See Roht-Arriaza, supra note 6, at 926–27. For example, ninety percent of all the vegetable types distributed by seed houses in the United States early in the twentieth century are extinct today. Id. In the past 100 years, half of Europe’s domestic animal species became extinct. Id.
23 See, e.g., Roht-Arriaza, supra note 6, at 927; Pollack, supra note 15, at A1.
24 See 35 U.S.C.  101–103 (1994).
25 See Sarma, supra note 11, at 130; CIEL, supra note 6,  II; see also Roht-Arriaza, supra note 6, at 936–40.
26 See 35 U.S.C.  102(a); Durham, supra note 6, at 80.
27 35 U.S.C.  102(a). In addition to  102(a)’s prior art categories that preclude issuance of a patent,  102(b) states that a person shall be entitled to a patent unless “the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States . . . .” Id.  102(a)–(b).
28 See Durham, supra note 6, at 80.
29 See id. at 80–81.
30 See id.
31 35 U.S.C.  102(a).
32 Id.
33 See id.; Kadidal, supra note 19, at 380, 385. To prove prior use one must show that the prior user had a physical embodiment of the claimed invention, used the invention as the current applicant intends, and did not conceal his use of the invention. See id. at 381–82. Prior knowledge requires that there was a model or written procedure that if reduced to practice would have worked in the way that the current applicant intends. Id. at 381.
34 See Durham, supra note 6, at 82.
35 See id. at 83.
36 See 35 U.S.C.  102(a).
37 See Sarma, supra note 11, at 130; see also Downes, supra note 14, at 277–78.
38 See Roht-Arriaza, supra note 6, at 926, 928; Sarma, supra note 11, at 116–17. Bioprospectors who inquire from indigenous people about useful plants can increase the success ratio of their trials for useful substances from 1 in 10,000 to 1 in 2. See Roht-Arriaza, supra note 6, at 928.
39 See 35 U.S.C.  102(a); Durham, supra note 6, at 82; Roht-Arriaza, supra note 6, at 921, 926, 928.
40 35 U.S.C.  103.
41 See id. 35 U.S.C.  103(a) reads:
A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.
Id.  103(a). For a helpful case, see Graham v. John Deere Co., which holds that obviousness or non-obviousness of subject matter is to be determined by looking to the scope and content of prior art, the differences between prior art and claims at issue, and the level of ordinary skill in the pertinent art. See 383 U.S. 1, 17 (1966); see also Roht-Arriaza, supra note 6, at 937. An inventor who simply examines prior knowledge and follows the next logical step to solve a problem, has not met the nonobviousness requirement of the Patent Act. See Graham, 383 U.S. at 17; see also Roht-Arriaza, supra note 6, at 937.
42 See 35 U.S.C.  102(a), 103.
43 See id.; Sarma, supra note 11, at 130.
44 See Sarma, supra note 11, at 129–30.
45 See Roht-Arriaza, supra note 6, at 937.
46 See In re Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990); Roht-Arriaza, supra note 6, at 937.
47 See Dillon, 919 F.2d at 692–93; see also Roht-Arriaza, supra note 6, at 937.
48 See Ex parte Gray, 10 U.S.P.Q.2d (BNA) 1922, 1924 (Bd. Pat. App. & Interf. 1989); Roht-Arriaza, supra note 6, at 937.
49 See Roht-Arriaza, supra note 6, at 937.
50 See id.
51 See id. at 938, 940.
52 See 35 U.S.C.  101 (1994).
53 See id.
54 See U.S. Const. art. I,  8; 35 U.S.C.  101 (emphasis mine).
55 See Durham, supra note 6, at 64.
56 See id.
57 See id.
58 See id.
59 See Roht-Arriaza, supra note 6, at 936; Holwick, supra note 13, at 52–53; Sarma, supra note 11, at 107, 124; see also Vandana Shiva, Biopiracy: The Plunder of Nature and Knowledge 81 (1997). Shiva notes that TRIPS was conceived and shaped by coalitions of U.S., Japanese and European corporations. See generally id.
60 See generally Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, Legal Instruments—Results of the Uruguay Round vol. 31, 33 I.L.M. 81 (1994) [hereinafter TRIPS Agreement].
61 See Charles R. McManis, The Interface Between International Intellectual Property and Environmental Protection: Biodiversity and Biotechnology, 76 Wash. U. L.Q. 255, 255–56 (1998); TRIPS Agreement, supra note 60; Convention on Biological Diversity, June 5, 1992, 31 I.L.M. 818, 837 (1992) [hereinafter Biodiversity Convention]; Convention on Biological Diversity, 3 Dep’t St. Dispatch 423 (June 1, 1992) [hereinafter Dep’t State Dispatch]; John Passacantando, Commentary, U.S. Insists on Loopholes for Toxics, L.A. Times, Dec. 8, 2000, at B9.
62 TRIPS Agreement, supra note 60, pmbl.
63 See generally TRIPS Agreement, supra note 60. Prior to TRIPS, international treaties, such as the Paris Convention, Berne Convention, and Washington Treaty, did not set requirements for minimum levels of domestic intellectual property protection. See John E. Giust, Noncompliance with TRIPS by Developed and Developing Countries: Is TRIPS Working?, 8 Ind. Int’l & Comp. L. Rev. 69, 71 (1997). In contrast, TRIPS is replete with requirements for minimum levels of protection, thereby directly regulating intellectual property protection in each Member State. See id.
64 See TRIPS Agreement, supra note 60, art. 27(1); Roht-Arriaza, supra note 6, at 953. Article 27(1) states: “patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. . . .” TRIPS Agreement, supra note 60, art. 27(1). Some scholars have argued that the phrase “capable of industrial application” includes only innovations meant to be used in the industrial sector. See Roht-Arriaza, supra note 6, at 939. Equating the phrase to the U.S. requirement of “useful” allows for a broader interpretation. See id. However, as Roht-Arriaza points out, the very name of TRIPS—Trade-Related Intellectual Property Rights—illustrates the treaty’s application to goods subject to international trade, excluding goods that are primarily used locally. See id.
65 See Office of the U.S. Trade Representative, Executive Office of the President, The Uruguay Round Agreements Act, Statement of Administrative Action, Agreement on Trade-Related Aspects of Intellectual Property Rights,  A.15, Sept. 27, 1994, available at 1994 WL 761796 [hereinafter Administrative Action].
66 See Violations of Intellectual Property Rights: How Do We Protect American Ingenuity?: Hearings Before the House Subcomm. on Int’l Econ. Pol’y and Trade of House Comm. on Int’l Relations, 106th Cong. (1999) (statement of Ambassador Richard W. Fisher, Deputy U.S. Trade Representative), available at 1999 WL 27595601 [hereinafter Fisher]; see, e.g., World Trade Organization, Pakistan-Patent Protection for Pharmaceutical and Agricultural Chemical Products, Mar. 7, 1997, available at 1997 WL 371039 [hereinafter WTO].
67 See Fisher, supra note 66; see also Sarma, supra note 11, at 133.
68 See TRIPS Agreement, supra note 60, art. 65(4); Giust, supra note 63, at 91. Under article 65, a developing country has five years from the date that TRIPS went into effect (Jan. 1, 1995) to apply its provisions. TRIPS Agreement, supra note 60, art. 65(2). Additionally, to the extent that a developing country Member is obliged by the Agreement to extend product patent protection to areas of technology that were not formerly covered, it may delay the application of the provisions on product patents to such areas of technology for another five years. Id. art. 65(4).
69 See id. art. 70(8)(a); Giust, supra note 63, at 91. Article 70(8)(a) of TRIPS reads:
Where a Member does not make available as of the date of entry into force of the WTO Agreement patent protection for pharmaceutical and agricultural chemical products commensurate with its obligation under Article 27, that Member shall: (a) . . . provide as from the date of entry into force of the WTO Agreement a means by which applications for patents for such inventions can be filed. . . .
TRIPS Agreement, supra note 60, art. 70(8)(a).
70 See id. art. 70(8)(b).
71 See Fisher, supra note 66.
72 See WTO, supra note 66.
73 See id.
74 See Fisher, supra note 66.
75 See id.; World Trade Organization, Communication from the Permanent Mission of India, India-Patent Protection for Pharmaceutical and Agricultural Chemical Products, Apr. 16, 1999, available at 1999 WL 231665.
76 See Fisher, supra note 66. Prior to 1999, India’s patent law did not protect agricultural, horticultural or medical products or processes. See Martin J. Adelman & Sonia Baldia, Prospects and Limits of the Patent Provision in the TRIPS Agreement: The Case of India, 29 Vand. J. Transnat’l L. 507, 519–20, 524–25 (1996). India’s weak patent protection and protectionist laws favored domestic manufacturers of pharmaceuticals. See id. at 519–20. For instance, Indian producers could copy the latest drugs from throughout the world and sell them in the domestic market. See id. These companies quickly gained in efficiency and became very competitive in the world market. See id.
The drawback to India’s patent system was that Indian companies had no incentive to invest in research and development. See J.H. Reichman, Compliance with the TRIPS Agreement: Introduction to a Scholarly Debate, 29 Vand. J. Transnat’l L. 363, 379 (1996). Proponents of TRIPS argue that expansion of India’s patent system to cover pharmaceuticals will encourage domestic companies to invest in the research and development of drugs to combat diseases of local importance. See id. However, opponents of TRIPS point to the experience of Italy, since its introduction of strong patent protection for pharmaceutical products in 1978. See F.M. Scherer & Sandy Weisburst, Economic Effects of Strengthening Pharmaceutical Patent Protection in Italy, 26 IIC 1009, 1023 (1995). Scherer and Weisburst concluded that “the legitimization of drug product patents in Italy did not induce a marked shift in Italian pharmaceutical manufacturers’ strategic emphasis from emulating drugs developed elsewhere to developing innovative drugs.” Id. Furthermore, research and development “expenditure growth . . . did not accelerate after the patent regime transition” and “the number and character of new product launches did not change significantly.” Id. Given the results in Italy, Scherer and Weisburst doubt that “significantly increased new drug development efforts are likely in the nations required under the . . . [TRIPS Agreement] to offer drug product patents for the first time.” Id. at 1024.
77 See TRIPS Agreement, supra note 60, art. 27(3)(b).
78 Id. Art. 27(3)(b) reads:
Members may also exclude from patentability . . . plants and animals other than microorganisms, and essentially biological processes for the production of plants or animals other than non-biological and micro-biological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof.
Id. The TRIPS Agreement does not define what is meant by an “effective sui generis system.” See id. Yet, some commentators believe that this reference is intended to refer to a system modeled after the International Convention for the Protection of New Varieties of Plants (UPOV). See International Convention for the Protection of New Varieties of Plants, Dec. 2, 1961, 33 U.S.T. 2703 [hereinafter UPOV]; Klaus Bosselmann, Plants and Politics: The International Legal Regime Concerning Biotechnology and Biodiversity, 7 Colo. J. Int’l Envtl. L. & Pol’y 111, 124 (1996) (stating that European nations adopted sui generis plant protection under UPOV rather than patent-based protection); J. Benjamin Bai, Comment, Protecting Plant Varieties under TRIPS and NAFTA: Should Utility Patents be Available for Plants?, 32 Texas Int’l L.J. 139, 140 (1997) (suggesting that the UPOV is a suitable system of protection on the international level). The UPOV sets minimum standards and assigns rights for both the finding and breeding of new plant species. Roht-Arriaza, supra note 6, at 941. Unlike patents, plant breeder rights allow the free use of a protected variety in order to breed and commercialize other new varieties. Id. Originally, the UPOV let farmers save seeds from season to season without paying royalties to the seed companies. Id. However, since its inception, the UPOV has been altered to give more protection to plant breeders and less to farmers. Id. In addition, like under a patent system, traditional farmers are not allowed protection for their innovative breeding work under UPOV. Id. To obtain UPOV protection, a plant must be: differentiated from existing plants through “precise recognition and description”; uniform or “sufficiently homogeneous”; and “stable in its essential characteristics.” Id. (quoting UPOV, art. 4). While most developed states are parties to UPOV, practically no developing states have signed. Id.
79 See Sarma, supra note 11, at 113; Indigenous Peoples’ Seattle Declaration on the Occasion of the Third Ministerial Meeting of the World Trade Organization,  3(a), at http://www.nativeweb. org/manifestos/seattle_wto.html (Nov. 30-Dec. 3, 1999) [hereinafter Seattle Declaration].
80 See Alan S. Gutterman, The North-South Debate Regarding the Protection of Intellectual Property Rights, 28 Wake Forest L. Rev. 89, 122–23 (1993); Sarma, supra note 11, at 113.
81 See Roht-Arriaza, supra note 6, at 936; Sarma, supra note 11, at 113; see also Downes, supra note 14, at 277–78.
82 See Odek, supra note 10, at 168.
83 See Sarma, supra note 11, at 109. TRIPS has been criticized for requiring developing countries to pass strong patent laws. See Kevin W. McCabe, The January 1999 Review of Article 27 of the TRIPS Agreement: Diverging Views of Developed and Developing Countries Toward the Patentability of Biotechnology, 6 J. Intell. Prop. L. 41, 52 (1998). Developing countries tend to regard patents as a means for developed countries “to maintain their head start in technology and deny a transfer of technology so that [the developing countries] can begin their own research and development industries.” Bosselmann, supra note 78, at 127.
84 See Sarma, supra note 11, at 109.
85 See id. at 111–12, 118, 125.
86 See, e.g., Shiva, supra note 59; Marci A. Hamilton, The TRIPS Agreement: Imperialistic, Outdated, and Overprotective, 29 Vand. J. Transnat’l L. 613, 613 (1996).
87 See Biodiversity Convention, supra note 61, pmbl., art. 8(j); TRIPS Agreement, supra note 60, art. 27; Sarma, supra note 11, at 121.
88 See Biodiversity Convention, supra note 61, art. 1; McManis, supra note 61, at 255.
89 See Biodiversity Convention, supra note 61, pmbl.
90 Id. art. 8(j).
91 See id. art. 9. The Biodiversity Convention seeks to help indigenous people in lesser developed countries by recognizing their governments’ sovereign rights over indigenous knowledge within their borders. See Steven M. Rubin & Stanwood W. Fish, Biodiversity Prospecting: Using Innovative Contractual Provisions to Foster Ethnobiological Knowledge, Technology, and Conservation, 5 Colo. J. Int’l Envtl. L. & Pol’y 23, 34–36 (1994)(discussing Biodiversity Convention, articles 11, 15, 16 and 18 regarding importance of proper compensation to local people).
92 Roht-Arriaza, supra note 6, at 949.
93 See id.
94 See Rubin & Fish, supra note 91, at 35; Sarma, supra note 11, at 122.
95 Rubin & Fish, supra note 91, at 32.
96 See id. at 35.
97 See Biodiversity Convention, supra note 61, art. 8(j); Sarma, supra note 11, at 122–23.
98 See Sarma, supra note 11, at 123.
99 See McManis, supra note 61, at 257.
100 See id. at 256. Shortly before the “Earth Summit” in Rio, President Bush expressed U.S. opposition to the Biodiversity Convention. See id. The United States interpreted the Biodiversity Convention as allowing countries to require technology transfer in exchange for access to genetic resources, and, therefore, found it unacceptable. See Amy E. Carroll, Comment, Not Always the Best Medicine: Biotechnology and the Global Impact of U.S. Patent Law, 44 Am. U. L. Rev. 2433, 2477–78 (1995).
101 Dep’t St. Dispatch, supra note 61.
102 See McManis, supra note 61, at 256.
103 See id.
104 See id. at 257.
105 See id.
106 See Roht-Arriaza, supra note 6, at 949.
107 See Wiser, supra note 1,  2.
108 See id.  5.
109 See Pollack, supra note 15, at C4.
110 See id.
111 See id.
112 See id. Mr. Miller has said that the effort to find a distributable medicinal use for ayahuasca was unsuccessful and he has no plans to study it further. See id.
113 See U.S. Plant Patent No. 5751 (issued June 17, 1986); Wiser, supra note 1,  2.
114 U.S. Plant Patent No. 5751 (issued June 17, 1986); see Wiser, supra note 1,  2.
115 See U.S. Plant Patent No. 5751 (issued June 17, 1986).
116 See Wiser, supra note 1,  2.
117 See Lambrecht, supra note 7, at A5.
118 See id. The indigenous tribes declared Mr. Miller an “enemy of indigenous peoples” and stated that if Miller or his associates returned to the Amazon, tribes “will not be responsible for the consequences to their physical safety.” See id. (quoting COICA).
119 See id. The U.S.-based Inter-American Foundation stopped all aid to COICA in 1998, after allotting more than $500,000 in recent years. See id.
120 See Wiser, supra note 1,  2.
121 See id. To the tribes, the ayahuasca vine has a similar religious significance to the Christian cross. See id.  1.
122 See id.  3.
123 See id.
124 See id.
125 See Wiser, supra note 1,  3; see also Durham, supra note 6, at 38 (explaining that reexamination allows the Patent Office to reconsider and reject previously issued patents in light of newly uncovered prior art). While the public is normally barred from patent prosecutions, anyone can request a reexamination, “ . . . including a licensee, an accused infringer, a government agency or someone who simply likes to meddle. All that is necessary to begin is knowledge of a prior patent or printed publication that casts doubt on the validity of some or all of the patent claims.” Durham, supra note 6, at 38–39 (footnotes omitted).
126 See Wiser, supra note 1,  3; see also 35 U.S.C.  102 (1994).
127 See Wiser, supra note 1,  3.
128 See 35 U.S.C.  161; Wiser, supra note 1,  3; see also Durham, supra note 6, at 177 (explaining that a patent cannot issue for the discovery of a plant in the wild).
129 See Wiser, supra note 1,  3.
130 See id.  4.
131 See Ctr. for Int’l Envtl. Law & Coalition for Amazonian Peoples & Their Env’t, U.S. Patent Office Admits Error, Rejects Patent Claim on Sacred “Ayahuasca” Plant 2, at http://ciel.org/Ayahuasca RejectionPR.html (Nov. 4, 1999). This is the first time that herbarium sheets have been used to bar someone from obtaining a plant patent. See Wiser, supra note 1,  5(B).
132 See Shiva, supra note 10; Wiser, supra note 1,  5(A).
133 See Pollack, supra note 15, at A1, C4.
134 See CIEL, supra note 6,  IV(D).
135 See id.
136 See id.
137 See id.
138 See Kadidal, supra note 19, at 402–03.
139 CIEL, supra note 6,  III; see also Kadidal, supra note 19, at 396–97, 400–01.
140 See CIEL, supra note 6,  III. Although adding foreign prior use as prior art reference would reduce the number of biotechnology patents issued, this decrease in the available monetary compensation for developers could be offset by setting up licensing agreements with indigenous communities wherein the corporate developer shares with the community that supplied the traditional knowledge any royalties from successful drugs or agricultural products. See Laurie Goering, Brazil Wants Cut of Biotech Firms’ Jungle Plunder, Chi. Trib., Apr. 6, 1999, at 1.
141 See Item 8: The Relationship Between the TRIPS Agreement and the Convention on Biodiversity,  13–18, WTO Doc. WT/CTE/W/65 (Sept. 29, 1997) (communication from India) [hereinafter India Paper]; Shiva, supra note 10.
142 See India Paper, supra note 141,  13–18; Seattle Declaration, supra note 79,  3(d); Shiva, supra note 10; see also CUTS Ctr. for Int’l Trade Econ. & Env’t, Briefing Paper, Trips and Biodiversity, at http://Cuts-India.org/trade-susdevl.htm (1999) [hereinafter CUTS].
143 See Wiser, supra note 1,  3; CIEL, supra note 6,  IV(D). See generally Tol-O-Matic, Inc. v. Proma Produkt-Und Marketing Gesellschaft, m.b.H., 945 F.2d 1546 (Fed. Cir. 1991); Lowell v. Lewis, 15 F. Cas. 1018 (C.C.D. Mass. 1817) (No. 8568); U.S. Patent and Trademark Office, Facts on Patenting Life Forms Having a Relationship to Humans, Media Advisory 98–6, at http://www.uspto.gov/web/offices/com/speeches/98–06.htm (Apr. 1, 1998) [hereinafter PTO, Media Advisory].
144 See Lowell, 15 F. Cas. at 1019.
145 See id.
146 Id.
147 See id.
148 See Robert Patrick Merges, Intellectual Property in Higher Life Forms: The Patent System & Controversial Technologies, 47 Md. L. Rev. 1051, 1062–66 (1988); Brett G. Alten, Note, Left to One’s Devices: Congress Limits Patents on Medical Procedures, 8 Fordham Intell. Prop. Media & Ent. L.J. 837, 845–46 (1998); Thomas A. Magnani, Note, The Patentability of Human-Animal Chimeras, 14 Berkeley Tech. L.J. 443, 451 (1999).
149 See, e.g., Rickard v. Du Bon, 103 F. 868, 868, 873 (2d Cir. 1900) (holding that process for artificially producing spots on tobacco leaves used to wrap cigars, such that leaves resembled those used to wrap high-quality cigars, was unpatentable for lack of utility); see Merges, supra note 148, at 1062; Magnani, supra note 148, at 451.
150 See Alten, supra note 148, at 845; Magnani, supra note 148, at 451.
151 See Donald Chisum, Patents: A Treatise on the Law of Patentability, Validity and Infringement  4.03, at 4–17 to 4–24.1 (1999) (reviewing relevant case law); Alten, supra note 148, at 846.
152 See Chisum, supra note 151, at 4–17; Merges, supra note 148, at 1062–66.
153 See Carrie F. Walter, Note, Beyond the Harvard Mouse: Current Patent Practice and the Necessity of Clear Guidelines in Biotechnology Patent Law, 73 Ind. L.J. 1025, 1026 (1998); see also Chisum, supra note 151, at 4–17; Merges, supra note 148, at 1062, 1067–68, 1075.
154 See, e.g., Chicago Patent v. Genco, 124 F.2d 725, 726, 728 (7th Cir. 1941) (holding that pinball is different from gambling in order to uphold a patent on pinball machine); Whistler Corp. v. Autotronics, Inc., 14 U.S.P.Q.2d 1885, 1886 (N.D. Tex. 1988) (upholding patent on radar detector despite claims that its sole purpose was to circumvent police attempts to enforce speed limit); Ex parte Murphy, 200 U.S.P.Q. 801, 802, 803 (P.T.O. Bd. App. 1977) (upholding patent on slot machine); see Alten, supra note 148, at 846–47.
155 See Magnani, supra note 148, at 453.
156 See Rick Weiss, US Ruling Aids Opponent of Patents for Life Forms, Wash. Post, June 17, 1999, at A2 [hereinafter Weiss, US Ruling]. See generally Tol-O-Matic, Inc. v. Proma Produkt-Und Marketing Gesellschaft, m.b.H., 945 F.2d 1546, 1552–53 (Fed. Cir. 1991); PTO, Media Advisory, supra note 143.
157 See Council Directive 98/44/EC, art. 6, 1998 O.J. (L 213) 13 [hereinafter Council Directive]; Magnani, supra note 148, at 453.
158 See TRIPS Agreement, supra note 60, art. 27(2).
159 See generally Magnani, supra note 148; Weiss, US Ruling, supra note 156, at A2; PTO, Media Advisory, supra note 143.
160 See Magnani, supra note 148, at 445. In ancient Greek mythology, a chimera was a fire-spewing monster with the head of a lion, body of a goat, and tail of a snake. See Webster’s Third New International Dictionary 389 (ed. 1986). Recently, advances in biotechnology have resulted in permutations of species called chimera. See Magnani, supra note 148, at 443. Some suggested future uses for such inventions are using them as subjects of research and as organ donors. See id. at 456. It is theorized that humans would be less likely to reject organs from an animal with some human characteristics. See id.
161 See Magnani, supra note 148, at 443; Rick Weiss, Patent Sought on Making of Part-Human Creatures, Wash. Post, Apr. 2, 1998, at A12 [hereinafter Weiss, Patent Sought].
162 See Magnani, supra note 148, at 443; Weiss, Patent Sought, supra note 161, at A12.
163 See PTO, Media Advisory, supra note 143.
164 Id.
165 Id. (quoting Judge Story as quoted in Tol-O-Matic, Inc. v. Proma Produkt-und Marketing Gesellschaft m.b.H., 945 F.2d at 1546, 1552–53 (Fed. Cir. 1991)).
166 See Lowell v. Lewis, 15 F. Cas. 1018, 1019 (C.C.D. Mass. 1817) (No. 8568); PTO, Media Advisory, supra note 143.
167 See PTO, Media Advisory, supra note 143.
168 See id. See generally Ex parte Allen, 2 U.S.P.Q.2d 1425, 1427 (Bd. Pat. App. & Interferences 1987) (rejecting claim that genetically engineered oysters were naturally occurring subject matter but rejecting the patent on obviousness); Transgenic Non-Human Mammals, U.S. Patent. No. 4,736,866 (issued Apr. 12, 1988) (patent for mouse injected with human hormones) [hereinafter Harvard Mouse Patent].
169 See Tol-O-Matic, 945 F.2d at 1552–53; PTO, Media Advisory, supra note 143.
170 Tol-O-Matic, 945 F.2d at 1547.
171 See id. at 1552.
172 See id. at 1552–53; Lowell v. Lewis, 15 F. Cas. 1018 (C.C.D. Mass. 1817) (No. 8568); Magnani, supra note 148, at 453.
173 See Magnani, supra note 148, at 453 (new type of cylinder would not be considered immoral, so there was no reason to bring in the moral utility argument). But see Juicy Whip, Inc. v. Orange Ban, Inc., 185 F.3d 1364, 1365–66 (Fed. Cir. 1999) (stating moral utility doctrine has not been broadly applied by courts in recent years and upholding patent depite fact that invention was designed to deceive customers by imitating another product).
174 See Weiss, US Ruling, supra note 156, at A2 (quoting PTO opinion); PTO, Media Advisory, supra note 143.
175 See Weiss, US Ruling, supra note 156, at A2.
176 See id.; PTO, Media Advisory, supra note 143.
177 See Diamond v. Chakrobarty, 447 U.S. 303, 309 (1980); Weiss, US Ruling, supra note 156, at A2.
178 See Diamond, 447 U.S. at 309; Ex parte Allen, 2 U.S.P.Q.2d 1425, 1428 (Bd. Pat. App. & Interf. 1987); Harvard Mouse Patent, supra note 168.
179 See Tol-O-Matic, Inc. v. Proma Produkt-Und Marketing Gesellschaft m.b.H., 945 F.2d at 1546, 1552–53 (Fed. Cir. 1991); PTO, Media Advisory, supra note 143.
180 See CIEL, supra note 6,  IV(D). The attorneys at CIEL argue that a case by case analysis of the morality of patent applications is not feasible. See id. Rather, they suggest that the PTO should develop new procedures and principles that would aid it in setting guidelines for the patenting of living things. See id.
181 See Council Directive, supra note 157, art. 6; see also Magnani, supra note 148, at 453.
182 See Council Directive, supra note 157, arts. 3, 6.
183 Timothy G. Ackerman, Comment, Dis’ordre’ly Loopholes: TRIPS Patent Protection, GATT and the ECJ, 32 Tex. Int’l L.J. 489, 495 (1997).
184 See id.
185 See Civil Code [C. civ], arts. 1131, 1133 (Fr.); Dennis Lloyd, Public Policy 6 (1953); Ackerman, supra note 183, at 495.
186 See Civil Code [C. civ], art. 6 (Fr.); Ackerman, supra note 183, at 495. Article 6 of the Civil Code reads, “One may not derogate by private agreements from laws which involve public policy and morality.” Civil Code [C. civ], art. 6 (Fr.).
187 See Ackerman, supra note 183, at 495 (quoting M. Forde, The “Ordre Public” Exception and Adjudicative Jurisdiction Conventions, 29 Int’l & Comp. L.Q. 259, 259–60 (1981)).
188 See generally Council Directive, supra note 157.
189 See id. art. 6.
190 See id.
191 See Magnani, supra note 148, at 454.
192 See id.
193 See id.; see also Walter, supra note 153, at 1045. The NBAC was formed on October 3, 1995 by executive order of President Clinton. See Walter, supra note 153, at 1026, 1045. Up to that point, the U.S. was one of few industrialized nations without a commission to examine bioethics. See id. at 1045. President Clinton stated that one of the primary tasks of the NBAC was to review the propriety and social effects of issuing patents on genes. See id.
194 See TRIPS Agreement, supra note 60, art. 27(2).
195 See id.
196 Id.
197 See Ackerman, supra note 183, at 496.
198 See Forde, supra note 187, at 261 (discussing treaties that help determine what law will be used in a transnational dispute and the exceptions provided in that law); Ackerman, supra note 183, at 496.
199 See Ackerman, supra note 183, at 496–97.
200 See id.
201 See TRIPS Agreement, supra note 60, art. 27(2); Ackerman, supra note 183, at 492. It is useful to look to prior GATT decisions concerning the definition of the word necessary in order to appreciate the limited scope of this exception. See Ackerman, supra note 183, at 506–07.
202 See 35 U.S.C.  101 (1994); TRIPS Agreement, supra note 60, art. 27(2); Tol-O-Matic, Inc. v. Proma Produkt-Und Marketing Gesellschaft m.b.H., 945 F.2d 1546, 1552–53; Lowell v. Lewis, 15 F. Cas. 1018, 1019 (C.C.D. Mass. 1817) (No. 8568).
203 See TRIPS Agreement, supra note 60, art. 27(2); Tol-O-Matic, 945 F.2d at 1552–53; Lowell, 15 F.Cas. at 1019.
204 See TRIPS Agreement, supra note 60, art. 27(2); Tol-O-Matic, 945 F.2d at 1553; Lowell, 15 F. Cas. at 1019.
205 See Chisum, supra note 19, at 37; Kadidal, supra note 19, at 371, 396–97; see also Shiva, supra note 10.
206 Kadidal, supra note 19, at 371, 396–97; Shiva, supra note 10.
207 See Kadidal, supra note 19, at 371, 396–97; CIEL, supra note 6, intro.
208 U.S. Const., art. 1  8, cl. 8.
209 See CIEL, supra note 6,  I.
210 See id.
211 See id.
212 See id.
213 See id.
214 See Roht-Arriaza, supra note 6, at 926–28; Sarma, supra note 11, at 113.
215 See CIEL, supra note 6,  I.
216 See id.
217 See id.
218 See id.
219 See Chisum, supra note 19, at 37; Kadidal, supra note 19, at 387, 397; see also Shiva, supra note 10.
220 See Act of July 4, 1836, ch. 357, 5 Stat. 117, 119 (current version at 35 U.S.C.  102(b) (1994)) [hereinafter 1836 Act]; Chisum, supra note 19, at 36; Kadidal, supra note 19, at 385.
221 1836 Act, ch. 357, supra note 220,  7, 15. Congressional rationale of the exclusion did not appear “in the report accompanying the 1836 Act or in the subsequent codifications.” Chisum, supra note 19, at 36. Chisum speculates that the change may have been in response to a contemporaneous Supreme Court decision which “invalidated a patent because of use of the invention in England and France with the inventor’s consent prior to his filing an application in the United States.” Id. (citing Shaw v. Cooper, 32 U.S. (7 Pet.) 292 (1833)). Chisum further speculates that the evidentiary difficulties in proving foreign use were influential to Congress’s decision. See id. In addition, in 1836, one major goal of the patent system was to disclose foreign inventions to the American public which would probably have remained secret absent granting of a U.S. patent. See Kadidal, supra note 19, at 386.
222 See 35 U.S.C.  102(a), 102(g).
223 See id.
224 See Kadidal, supra note 19, at 387. “Biodiversity often leaves little in the way of a patent record because it tends to occur in countries where its products, or improvements thereon, are unpatentable.” Id.
225 See id. at 395.
226 See Chisum, supra note 19, at 37; Kadidal, supra note 19, at 395–96 (both citing President’s Commission on the Patent System, To Promote the Progress of the . . . Useful Arts in an Age of Exploding Technology 6 (1966)) [hereinafter President’s Commission]. Chisum notes that the Commission’s report “failed to induce any legislative action,” despite its strong advocacy of a universal conception of prior art. Chisum, supra note 19, at 37.
227 See Chisum, supra note 19, at 37; Kadidal, supra note 19, at 395–96 (both citing President’s Commission, supra note 226, at 6).
228 See Chisum, supra note 19, at 37; Kadidal, supra note 19, at 395–96 (both citing President’s Commission, supra note 226, at 6).
229 See Chisum, supra note 19, at 37; Kadidal, supra note 19, at 395–96 (both citing President’s Commission, supra note 226, at 6).
230 See Chisum, supra note 19, at 37; Kadidal, supra note 19, at 395–96 (both citing President’s Commission, supra note 226, at 6).
231 See Kadidal, supra note 19, at 397 (citing President’s Commission, supra note 226, at 6).
232 See id. (citing Chisum, supra note 152,  3.05(5) n.13).
233 See Pollack, supra note 15, at C4; Wiser, supra note 1,  1.
234 See 35 U.S.C.  102 (1994); Wiser, supra note 1,  2.
235 See Kadidal, supra note 19, at 397; Shiva, supra note 10.
236 See Roht-Arriaza, supra note 6, at 936–37, 948–49, 965; Sarma, supra note 11, at 135–36; see also Shiva, supra note 10.
237 TRIPS Agreement, supra note 60, art. 27(3)(b).
238 Biodiversity Convention, supra note 61, art. 3.
239 See India Paper, supra note 141,  5; Tejera, supra note 10, at 983; see also Shiva, supra note 10.
240 See TRIPS Agreement, supra note 60, pmbl.
241 See Biodiversity Convention, supra note 61, arts. 1, 8(j).
242 See id. art. 3.
243 See id. arts. 8(c), 8(j).
244 See id. art. 8(j); Shiva, supra note 59, at 122; Tejera, supra note 10, at 984. Article 8(j) states that application and promotion of the knowledge should be made “with the approval and involvement of the holders of such knowledge.” Biodiversity Convention, supra note 61, art. 8(j).
245 See India Paper, supra note 141,  13–18; Tejera, supra note 10, at 984; see also CUTS, supra note 142; Shiva, supra note 10.
246 See India Paper, supra note 141,  13; Downes, supra note 14, at 274–75.
247 See India Paper, supra note 141,  13; TRIPS Agreement, supra note 60, art. 29(1).
248 See India Paper, supra note 141,  13.
249 See id.
250 See Biodiversity Convention, supra note 61, art. 15; India Paper, supra note 141,  13; see also Downes, supra note 14, at 274–75.
251 See India Paper, supra note 141,  13.
252 See Tejera, supra note 10, at 985; see also Seattle Declaration, supra note 142,  3(f).
253 See India Paper, supra note 141,  15.
254 See id.
255 See India Paper, supra note 141,  15; Tejera, supra note 10, at 985.
256 See Tejera, supra note 10, at 985; Shiva, supra note 10.
257 See India Paper, supra note 141,  16.
258 See Biodiversity Convention, supra note 61, art. 1; India Paper, supra note 141,  16.
259 See Downes, supra note 14, at 268–69.
260 See id.
261 See TRIPS Agreement, supra note 60, art. 22. The most well-known example of a system of geographic indications is France’s system of protecting its locally produced food and wine. See Downes, supra note 14, at 269–70. Such products are considered valuable because of a combination of environmental factors and cultural factors, including the “traditional, collectively maintained techniques for production.” Id.
262 See Downes, supra note 14, at 271.
263 See id.
264 See id. at 272.
265 See id. at 269.
266 See TRIPS Agreement, supra note 60, arts. 15, 24, 27.
267 See Shiva, supra note 10.
268 See Biodiversity Convention, supra note 61, art. 1; Shiva, supra note 10.
269 Brenda Salburg, Farmers, Indigenous Folk Fight Patenting of Plants: An Ecuadorian Vine Is a Symbol for What Critics Call Theft of Culture, Nat’l L.J., Dec. 13, 1999, at col. 4.
270 See id.
271 Id. (quoting Loren Miller).
272 Id. (quoting Loren Miller).
273 See Alten, supra note 148, at 846–47.
274 See Alten, supra note 148, at 846–47; Magnani, supra note 148, at 451.
275 See Tol-O-Matic, Inc. v. Proma Produkt-Und Gesellschaft m.b.H., 945 F.2d 1546, 1552–53 (Fed. Cir. 1991); PTO, Media Advisory, supra note 143.
276 See Tol-O-Matic, 945 F.2d at 1552–53; Council Directive, supra note 157, art. 6; PTO, Media Advisory, supra note 142.
277 35 U.S.C.  102 (1994).
278 35 U.S.C.  101–103.
279 See id.; Sarma, supra note 11, at 129–30.
280 See 35 U.S.C.  101–103; Roht-Arriaza, supra note 6, at 936–37, 938–39.
281 See Chisum, supra note 19, at 37; Kadidal, supra note 19, at 397; Shiva, supra note 10.
282 See Pollack, supra note 15, at C4.
283 See TRIPS Agreement, supra note 60, art. 27.
284 See id.; Membership of the World Trade Organization, Revision, WTO Doc. WT/INF/6/Rev.7, available at http://www.wto.org (Mar. 21, 2000).
285 See TRIPS Agreement, supra note 60, pmbl; see also Shiva, supra note 59, at 122.
286 See Shiva, supra note 59, at 120–21.
287 See id. at 66, 123–24.
288 See id. at 68.
289 See Biodiversity Convention, supra note 61, pmbl., art. 8(j).
290 See, e.g., Lambrecht, supra note 7, at A5.
291 See, e.g., Shiva, supra note 59, at 125–26 (discussing the anti-GATT movement led by Indian farmers); Valerie Taliman, Native Peoples Protest WTO: Activists Fear Threats to Sovereignty, Indian Country Today, at http://www.alphacdc.com/ien/intellectualproperty. html (Dec. 1999) (discussing indigenous groups’ involvement in the protests at the WTO meeting in Seattle); India: An Anti-National, Anti-People Law, The Hindu, Jan. 19, 1998, available at 1998 WL 7698418.