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The Patentability of the Native Hawaiian Genome

Published online by Cambridge University Press:  06 January 2021

Lindsey Singeo*
Affiliation:
Boston University School of Law, Chemistry, Washington University in St. Louis

Extract

In 2003, the University of Hawaii proposed patenting the Native Hawaiian genome with the purpose of generating both economic- and healthrelated benefits for the Native Hawaiian people. This proposal, however, was strongly opposed by the Native Hawaiian community, which viewed it as an unwelcome imposition of Western property concepts upon their traditional ideology. Population-based genetic databases are not an entirely new concept. The governments of Iceland and Estonia have created national genetic databases and assumed authority over their ownership and operation. Iceland has even licensed its genome to a private company. Furthermore, the United States has previously been involved in patenting the genetic code of other indigenous groups, such as the Hagahai tribe in Papua New Guinea and the native inhabitants of the Solomon Islands. A patent on the Native Hawaiian genome, however, would be unique because it would concern the rights of American citizens.

Type
Article
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2007

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References

1 Cheryl Ernst, Licensing Hawaiian Genes for Medical Research, Malamalama: The Magazine of the Univ. of Haw., July-Oct. 2003, at 16, available at http://www.hawaii.edu/malamalama/archive/downloads/0307_all.pdf.

2 See, e.g., Association of Hawaiian Civic Clubs Resolutions 2004, Urging the Association of Hawaiian Civic Clubs to Support Education in Genetics and the Ethical Issues Surrounding Genetic Studies that Impact on Native Hawaiians (2004), http://www.aohcc.org/conv2004/AoHCC_Resolutions_2004.htm (last visited Mar. 11, 2007).

3 Hsieh, Alice, A Nation's Genes for a Cure to Cancer: Evolving Ethical, Social and Legal Issues Regarding Population Genetic Databases, 37 Colum. J. L. & Soc. Probs. 359, 370 (2004)Google Scholar.

4 Ernst, supra note 1.

5 Earth Island Institute, US Patents Human Beings, Earth Island J., Winter 1995-96, available at http://www.earthisland.org/eijournal/new_articles.cfm?articleID=417&journalID=61.

6 Id.

7 The Native Hawaiian Government Reorganization Act of 2007, S. 310, 110th Cong. (2007).

8 Hsieh, supra note 3, at 363-4.

9 Conley, John M. & Makowski, Roberte, Back to the Future: Rethinking the Product of Nature Doctrine as a Barrier to Biotechnology Patents, 85 J. Pat. & Trademark Off. Soc’y 301, 301 (2003)Google Scholar.

10 Id.

11 Deschenes, Mylene & Sallee, Clementine, Accountability in Population Biobanking: Comparative Approaches, 33 J. L. Med. & Ethics 40, 41 n.12 (2005)Google Scholar.

12 Hsieh, supra note 3, at 360.

13 Deschenes & Sallee, supra note 11, at 41.

14 Id.

15 Ernst, supra note 1.

16 Eleanor C. Nordyke, The Peopling of Hawaii 22 (2d ed., Univ. of Haw. Press 1989) (1977).

17 Id. at 22-23.

18 Id. at 25.

19 Ernst, supra note 1.

20 Id.

21 See, e.g., Association of Hawaiian Civic Clubs, supra note 2.

22 Conway-Jones, Danielle, Safeguarding Traditional Hawaiian Knowledge and Cultural Heritage: Supporting the Right to Self-Determination and Preventing the Co- Modification of Culture, 48 How. L.J. 737, 747748 (2005)Google Scholar.

23 Hokulei Lindsey, R., Responsibility with Accountability: The Birth of a Strategy to Protect Kanaka Maoli Traditional Knowledge, 48 How. L.J. 763, 763 (2005)Google Scholar.

24 Conway-Jones, supra note 22, at 747.

25 The Paoakalani Declaration ¶ (Oct. 2003), available at http://www.papaolalokahi.org/coconut/resources/pdf/PaoakalaniDeclaration05.pdf.

26 Mueller, Daniel G., Comment, The Reassertion of Native Hawaiian Gathering Rights Within the Context of Hawaii's Western System of Land Tenure, 17 U. Haw. L. Rev. 165, 166 (1995)Google Scholar.

27 Id. at 177.

28 Conway-Jones, supra note 22, at 748-749.

29 Id. at 749; Igasaki, Paul M., ABA Resolution and Report on the Akaka Bill, 10-JUL Haw. B.J. 80, 82 (2006)Google Scholar.

30 The Paoakalani Declaration, supra note 25, at ¶ 5.

31 Lindsey, supra note 23, at 763-764.

32 Id. at 764.

33 The Paoakalani Declaration, supra note 25, at ¶ 3.

34 Conway-Jones, supra note 22, at 751-752.

35 Press Release, Indigenous Peoples Council on Biocolonialism, Univ. of Haw. Research on Genetically Engineered Taro Breaches Native Hawaiian Rights (Feb. 5, 2005), available at http://www.ipcb.org/issues/agriculture/htmls/2005/hawaiipr.html.

36 Hsieh, supra note 3, at 365.

37 Press Release, Nat’l Insts. of Health: Nat’l Human Genome Research Inst., The Human Genome Project Completion: Frequently Asked Questions (2002), available at http://www.genome.gov/11006943.

38 Hsieh, supra note 3, at 365.

39 Press Release, Nat’l Insts. of Health: Nat’l Human Genome Research Inst., Int’l Consortium Launches Genetic Variation Mapping Project (Oct. 2002), available at http://www.genome.gov/10005336.

40 Id.

41 Id.

42 Hsieh, supra note 3, at 370.

43 Alan Boyle & The Associated Press, Databank to Catalog African DNA, MSNBC, May 27, 2003, http://msnbc.msn.com/id/3077166/.

44 U.S. Const. art. I, § 8, cl. 8.

45 35 U.S.C. § 101 (2006).

46 Conley & Makowski, supra note 9, at 302-303.

47 447 U.S. 303 (1980); Ching, Kara H., Note, Indigenous Self-Determination in an Age of Genetic Patenting: Recognizing an Emerging Human Rights Norm, 66 Fordham L. Rev. 687, 696 (1997)Google Scholar.

48 Chakrabarty, 447 U.S. at 305.

49 Id. at 306 n.3.

50 Id. at 306.

51 Id. at 309.

53 Conley & Makowski, supra note 9, at 301.

54 Taubes, Gary, Scientists Attacked for ‘Patenting’ Pacific Tribe, 270 Sci. 1112, 1112 (1995)Google Scholar.

55 Conley & Makowski, supra note 9, at 302.

56 Friedlaender, Jonathan, Genes, People, and Property: Furor Erupts Over Genetic Research on Indigenous Groups, 20 Cultural Survival Q. 22, 22 (1996)Google Scholar, available at http://www.culturalsurvival.org/publications/csq/csq-article.cfm?id=1579.

57 Utility Examination Guidelines, 66 Fed. Reg. 1092, 1093 (Jan. 5, 2001).

58 Kane, Eileen M., Splitting the Gene: DNA Patents and the Genetic Code, 71 Tenn. L. Rev. 707, 727728 (2004)Google Scholar.

59 E.g. Conley & Makowski, supra note 9.

60 Id. at 303.

61 35 U.S.C. § 101 (2006).

62 General Electric Co. v. De Forest Radio Co., 28 F.2d 641 (3d Cir. 1928).

63 Id. at 642-643.

64 Id.

65 Id.

66 189 F. 95 (S.D.N.Y. 1911), rev’d in part on other grounds, 196 F. 496 (2d Cir. 1912).

67 Id.

68 Id. at 103.

69 Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).

70 Conley & Makowski, supra note 9, at 305.

71 Parke-Davis & Co., 189 F. at 103.

72 Taubes, supra note 54, at 1112.

73 Diamond v. Diehr, 450 U.S. 175, 185 (1981).

74 E.g. In re Alappat, 33 F.3d 1526 (Fed. Cir. 1994).

75 Kane, supra note 58, at 752.

76 35 U.S.C. § 101 (2006).

77 35 U.S.C. § 102(a) (2006).

78 Williamson, Alan R., Gene Patents: Socially Acceptable Monopolies or an Unnecessary Hindrance to Research?, 17 TRENDS in Genetics 670, 670 (Nov. 2001)Google Scholar.

79 Press Release, Nat’l Insts. of Health, Int’l Human Genome Sequencing Consortium Describes Finishing Human Genome Sequence (Oct. 20, 2004), available at http://www.genome.gov/12513430.

80 See Robert Patrick Merges & John Fitzgerald Duffy, Patent Law and Policy: Cases and Materials 229 (3d. ed. 2002).

81 Utility Examination Guidelines, 66 Fed. Reg. 1092, 1098 (Jan. 5, 2001).

82 See Merges & Duffy, supra note 80, at 229.

83 Id.

84 Id.

85 383 U.S. 519, 534 (1966).

86 Austin, Christopher P. & Tribble, Jack L., Gene Patents and Drug Development: The Perspective from Merck, in Human DNA: Law & Policy 379, 382 (Bartha Maria Knoppers ed., Kluwer Law Int’l 1997)Google Scholar.

87 Kane, supra note 58, at 720.

88 Utility Examination Guidelines, 66 Fed. Reg. 1092 (Jan. 5, 2001).

89 Revised Interim Utility Guidelines Training Materials at 5-7, available at http://www.uspto.gov/web/menu/utility.pdf.

90 Id.

91 Id.

92 Id.

93 Id.

94 383 U.S. 519 (1966).

95 Id. at 535.

96 Merges & Duffy, supra note 81, at 250.

97 Id.

98 Id. at 251.

99 Eisenberg, Rebecca S. & Merges, Robert P., Opinion Letter as to the Patentability of Certain Inventions Associated with the Identification of Partial cDNA Sequences, 23 AIPLA Q.J. 1, 1619 (1995)Google Scholar.

100 See Ernst, supra note 1, at 16.

101 Utility Examination Guidelines, 66 Fed. Reg. 1092, 1094 (Jan. 5, 2001).

102 Id.; International HapMap Project, About the International HapMap Project, http://www.hapmap.org/abaouthapmap.html (last visited Dec. 4, 2005).

103 17 U.S.C. § 107 (2006).

104 17 U.S.C. § 107(1)-(4) (2006).

105 Kane, supra note 58, at 730.

106 O’Rourke, Maureen A., Toward a Doctrine of Fair Use in Patent Law, 100 Colum. L. Rev. 1177, 1179 (2000)Google Scholar.

107 Levang, Bradley J., Comment, Evaluating the Use of Patent Tools for Technology: A Refutation to the USPTO White Paper Concerning Biotechnology Patent Pools, 19 Santa Clara Computer & High Tech. L. J. 229, 234 (2002)Google Scholar.

108 Merges & Duffy, supra note 80, at 257.

109 Id. at 257.

110 O’Rourke, supra note 106, at 1179.

111 See id. at 1180.

112 Julie E. Cohen et al., Copyright in a Global Information Economy 205 (2002).

113 Id.

114 Id.

115 Feldman, Robin, The Open Source Biotechnology Movement: Is it Patent Misuse?, 6 Minn. J.L. Sci. & Tech. 117, 118 (2004)Google Scholar.

116 17 U.S.C. § 106(2) (2006).

117 Cohen, supra note 112, at 117.

118 Feldman, supra note 115, at 118.

119 Id. at 119.

120 Carpet Seaming Tape Licensing Corp. v. Best Seam Inc., 616 F.2d 1133, 1141 (9th Cir. 1980).

121 Id. at 1142.

122 See Feldman, supra note 115, at 117-118.

123 Transparent-Wrap Machine Corp. v. Stokes & Smith Co., 329 U.S. 637, 648 (1947).

124 E.g., id. at 638-639.

125 Id. at 643-644.

126 See Van Dyke, John M. & Mackenzie, Melody K., An Introduction to the Rights of the Native Hawaiian People, 10-JUL Haw. B.J. 63, 63 (2006)Google Scholar.

127 Barry R. Furrow et al., Health Law: Cases, Materials, and Problems 356 (5th ed. 2004).

128 Id. at 356 (quoting Schloendorff v. Society of New York Hospital, 105 N.E. 92 (1914)).

129 Johnson v. Kokemoor, 545 N.W.2d 495, 501 (Wis. 1996).

130 793 P.2d 479 (Cal. 1990).

131 Id. at 481.

132 Id.

133 Id.

134 Id. at 481-482.

135 Id. at 482.

136 Id. at 483.

137 Id.

138 See Ching, supra note 47, at 705-706.

139 264 F. Supp. 2d 1064 (S.D. Fla. 2003).

140 Id. at 1067.

141 Id. at 1068.

142 Id. at 1070.

143 See id. at 1072.

144 International HapMap Project, Ethical Concerns, http://www.hapmap.org/ethicalconcerns.html.en (last visited Dec. 4, 2005).

145 Id.

146 Id.

147 Id.

148 Id.

149 Luther, Lori & Hirtle, Marie, Genetic Diversity – A Clash of Views?, in Human DNA: Law & Policy 275, 277 (Knoppers, Bartha Maria ed., Kluwer Law Int’l 1997)Google Scholar.

150 Furrow et al., supra note 127, at 1290.

151 Greely, Henry T., Genes, Patents, and Indigenous People: Biomedical Research and Indigenous Peoples’ Rights, 20 Cultural Survival Q. 54 (1996)Google Scholar.

152 Luther & Hirtle, supra note 149, at 277.

153 Office of Hawaiian Affairs, Native Hawaiian Databook 9 (2002).

154 See Rice v. Cayetano, 528 U.S. 495, 518-519 (2000).

155 See Van Dyke & Mackenzie, supra note 126, at 63.

156 Office of Hawaiian Affairs, http://www.oha.org/ (last visited Dec. 4, 2005).

157 Office of Hawaiian Affairs, OHA Mission, http://www.oha.org/cat_content.asp?contentid=20&catid=22 (last visited Dec. 4, 2005).

158 Rice, 528 U.S. at 498-499.

159 Arakaki v. Hawaii, 314 F.3d 1091 (9th Cir. 2002).

160 Annas, George J., Privacy Rules for DNA Databanks Protecting Coded Future Diaries, 270 JAMA 2346 (1993)Google Scholar.

161 Standards for Privacy of Individually Identifiable Health Information, 65 Fed. Reg. 82,462, 82,463 (Dec. 28, 2000).

162 Curley, Robert A. & Caperna, Lisa M., The Brave New World is Here: Privacy Issues and the Human Genome Project, 70 Def. Couns. J. 22, 31 (2003)Google Scholar.

163 45 C.F.R. § 164.104 (2003).

164 Id.; Press Release, U.S. Dept. of Health & Human Servs., Protecting the Privacy of Patients’ Health Info. (Apr. 14, 2003).

165 Furrow et al., supra note 127, at 1300.

166 45 C.F.R. § 164.502 (2003).

167 45 C.F.R. § 164.508 (2003).

168 Annas, George J., Medical Privacy and Medical Research – Judging the New Federal Regulations, 346 New Eng. J. Med. 216, 216 (2002)Google Scholar.

169 45 C.F.R. § 164.512(i) (2003); Annas, George J., HIPAA Regulations – A New Era of Medical-Record Privacy?, 348 New Eng. J. Med. 1486, 1489 (2003)Google Scholar.

170 Annas, HIPAA Regulations, supra note 169, at 1489.

171 Annas, Medical Privacy, supra note 168, at 216.

172 Ga. Code Ann. § 33-54-3 (2005).

173 Ga. Code Ann. § 33-54-6 (2005).

174 Haw. Rev. Stat. § 671-3(b) (2003).

175 E.g., Arakaki v. State of Hawaii, 314 F.3d 1091 (9th Cir. 2002) (holding that the OHA Board of Trustees cannot be limited to persons of Native Hawaiian ancestry).

176 Rice v. Cayetano, 528 U.S. 495, 519-520 (2000).

177 U.N. Econ. & Soc. Council, Sub-Comm. on Prevention of Discrimination & Prot. of Minorities, Report of the Sub-Commission on Prevention of Discrimination & Protection of Minorities on its Forty-Sixth Session 103, U.N. Doc. E/CN.4/Sub.2/1004/56 (Oct. 28, 1994) (prepared by Osman El-Hajje) [hereinafter UN Draft Declaration].

178 Hadjioannou, Marina, The International Human Right to Culture: Reclamation of the Cultural Identities of Indigenous Peoples Under International Law, 8 Chap. L. Rev. 201, 211 (2005)Google Scholar.

179 UN Draft Declaration, supra note 177, at 106.

180 Id. at 107-115.

181 Id. at 112.

182 Id. at 108.

183 Id. at 107.

184 See Arakaki v. Lingle, 477 F.3d 1048 (9th Cir. 2007).

185 The Native Hawaiian Government Reorganization Act of 2005, S. 147, 109th Cong. (2005). This bill is also known as the “Akaka bill,” in reference to the Native Hawaiian senator who introduced it. Vicki Viotti, The Akaka Bill – What Would it Mean for Hawaii?, The Honolulu Advertiser, Apr. 10, 2005, available at http://the.honoluluadvertiser.com/article/2005/Apr/10/op/op05p.html.

186 Senator Daniel Akaka, Democrat from Hawaii, Akaka Bill, http://akaka.senate.gov/akakabill-b.html (last visited Mar. 9, 2006).

187 Gene Park, Majority Power Gives New Hope for Akaka Bill, The Honolulu Star-Bulletin (Nov. 10, 2006), available at http://starbulletin.com/2006/11/10/news/story04.html.

188 S. Rep. No. 109-68, at 9 (2005) (Conf. Rep.).

189 Sally Apgar, ABA Throws Its Support Behind Akaka Bill, The Honolulu Star- Bulletin (Feb. 14, 2006), available at http://starbulletin.com/2006/02/14/news/story10.html.

190 Id.

191 S. Rep. No. 109-68, at 12 (2005) (Conf. Rep.).

192 S. 147, 109th Cong. § 4(4)(A)-(B) (2005).

193 See S. Rep. No. 109-68, at 12 (2005) (Conf. Rep.).

194 Sterling Kini Wong, Akaka Confident that Recognition Bill is Constitutional, Ka Wai Ola OHA, Sept. 26, 2005, available at http://www.oha.org/content.asp?contentid=432.

195 Id.

196 E.g., Press Release, Council for Native Hawaiian Advancement, 1,000 Letters Delivered to Governor Linda Lingle (Oct. 26, 2005), available at http://hawaiiancouncil.org/docs/newsroom/download/CNHA1000Letters.pdf.

197 Gordon Y.K. Pang, Hawaiian Independence Groups Send ‘No’ Message, The Honolulu Advertiser, Jul. 1, 2005, available at http://the.honoluluadvertiser.com/article/2005/Jul/01/ln/ln15p.html.

198 Id.