The patentability of the native Hawaiian genome

American Journal of Law and Medicine

Volumn 33, Issue 1, 2007, Pages 119-139

  Singeo, Lindsey ^a  

^a BOSTON UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ETHNIC GROUP; GENETIC CODE; GENETIC DATABASE; GENETICS; GENOME; HEALTH CARE; HUMAN; HUMAN RIGHTS; INFORMED CONSENT; NOTE; PATENT; UNITED STATES;

EID: 34249746350     PISSN: 00988588     EISSN: None     Source Type: Journal    
DOI: 10.1177/009885880703300104     Document Type: Note

References (198)

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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. Alice Hsieh, 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).
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.
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10. Id.
11. Mylene Deschenes & Clementine Sallee, Accountability in Population Biobanking: Comparative Approaches, 33 J. L. MED. & ETHICS 40, 41 n.12 (2005).
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.
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27. Id. at 177.
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29. Id. at 749; Paul M. Igasaki, ABA Resolution and Report on the Akaka Bill, 10-JUL HAW. B.J. 80, 82 (2006).
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); Kara H. Ching, Note, Indigenous Self-Determination in an Age of Genetic Patenting: Recognizing an Emerging Human Rights Norm, 66 FORDHAM L. REV. 687, 696 (1997).
48. Chakrabarty, 447 U.S. at 305.
49. Id. at 306 n.3.
50. Id. at 306.
51. Id. at 309.
52. U.S. Patent No. 5,397,696 (filed Aug. 12, 1991), available at http://patft.uspto.gov/ netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d= PALL&p=1&u=%2Fnetahtml%2FPTO% 2Fsrchnum.htm&r=1&f=G&1= 50&s1=5,397,696.PN.&OS=PN/5,397,696&RS=PN/5,397,696; Conley & Makowski, supra note 9, at 301.
53. Conley & Makowski, supra note 9, at 301.
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55. Conley & Makowski, supra note 9, at 302.
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57. Utility Examination Guidelines, 66 Fed. Reg. 1092, 1093 (Jan. 5, 2001).
58. Eileen M. Kane, Splitting the Gene: DNA Patents and the Genetic Code, 71 TENN. L. REV. 707, 727-728 (2004).
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. Alan R. Williamson, Gene Patents: Socially Acceptable Monopolies or an Unnecessary Hindrance to Research?, 17 TRENDS IN GENETICS 670, 670 (Nov. 2001).
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. Christopher P. Austin & Jack L. Tribble, 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).
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 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. Rebecca S. Eisenberg & Robert P. Merges, Opinion Letter as to the Patentability of Certain Inventions Associated with the Identification of Partial cDNA Sequences, 23 AIPLA Q.J. 1, 16-19 (1995).
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. Maureen A. O'Rourke, Toward a Doctrine of Fair Use in Patent Law, 100 COLUM. L. REV. 1177, 1179 (2000).
107. Bradley J. Levang, 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).
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. Robin Feldman, The Open Source Biotechnology Movement: Is it Patent Misuse?, 6 MINN. J.L. SCI. & TECH. 117, 118 (2004).
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 John M. Van Dyke & Melody K. Mackenzie, An Introduction to the Rights of the Native Hawaiian People, 10-JUL HAW. B.J. 63, 63 (2006).
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. Lori Luther & Marie Hirtle, Genetic Diversity - A Clash of Views?, in HUMAN DNA: LAW & POLICY 275, 277 (Bartha Maria Knoppers ed., Kluwer Law Int'l 1997).
150. FURROW ET AL., supra note 127, at 1290.
151. Henry T. Greely, Genes, Patents, and Indigenous People: Biomedical Research and Indigenous Peoples' Rights, 20 CULTURAL SURVIVAL Q. 54 (1996).
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. George J. Annas, Privacy Rules for DNA Databanks Protecting Coded Future Diaries, 270 JAMA 2346 (1993).
161. Standards for Privacy of Individually Identifiable Health Information, 65 Fed. Reg. 82,462, 82,463 (Dec. 28, 2000).
162. Robert A. Curley & Lisa M. Caperna, The Brave New World is Here: Privacy Issues and the Human Genome Project, 70 DEF. COUNS. J. 22, 31 (2003).
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. George J. Annas, Medical Privacy and Medical Research - Judging the New Federal Regulations, 346 NEW ENG. J. MED. 216, 216 (2002).
169. 45 C.F.R. § 164.512(i) (2003); George J. Annas, HIPAA Regulations - A New Era of Medical-Record Privacy?, 348 NEW ENG. J. MED. 1486, 1489 (2003).
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 D ISCRIMINATION & 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. Marina Hadjioannou, The International Human Right to Culture: Reclamation of the Cultural Identities of Indigenous Peoples Under International Law, 8 CHAP. L. REV. 201, 211 (2005).
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.