Implications of Genetic Patents on Human Genetic Resources: Issues of Ownership, Benefit Sharing and Informed Consent

Singh, Kshitij Kumar

doi:10.1007/978-81-322-2059-6_6

Implications of Genetic Patents on Human Genetic Resources: Issues of Ownership, Benefit Sharing and Informed Consent

Kshitij Kumar Singh²

Chapter
First Online: 28 October 2014

1525 Accesses

Abstract

With the increasing commercialization of human genetic research, human genetic material has become a source for patenting. The increased extension of patent rights to human genetic material has serious implications for research subjects and patients whose genetic material is used in the research. The ownership of human genetic material has become a controversial issue as a variety of proprietary rights are claimed over it such as patent rights, personal rights, sovereign rights and academic rights. Among these claims, the ownership rights claims of patients, researchers and research subjects has been contested in courts and started an open debate among legal scholars and policy makers. In genetic research, researchers and sponsors thereof are basically concerned to exploit the human genetic material to earn credit by claiming their exclusive rights. It raises the question, whether may researchers obtain patent rights through observation, isolation and manipulation of the human genetic material, without recognizing and admitting contribution of research subjects and patients who have given their genetic material for the research? The commercial exploitation of human genetic material is not confined to an individual but it also extends to human genetic resources of countries. Trade-Related Aspects of Intellectual Property Rights (TRIPS) does not contain any explicit reference to genetic material, and the laws that restrict access to genetic material to obtain remuneration for the nation such as Convention on Biological Diversity (CBD) exclude human genetic material from their ambit. This has led to a growing exploitation of human genetic resources for scientific or commercial purposes.

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Notes

1.
Bovenberg (2006).
2.
Ibid.
3.
Ibid.
4.
Id. at 3.
5.
Id. at 3–4; (In 1998, the Parliament of Iceland passed the Act on the Centralized Health Sector Database. This Icelandic initiative has been followed by Estonian Gene Bank and the U.K. Gene Bank. The common object of these projects is to compile national or large scale collections of human biological material and to link these with associated clinical and personal health data and genealogical information).
6.
Id. at 4.
7.
Id. at 1.
8.
Id. at 4.
9.
Boyle (2003).
10.
Id. at 102.
11.
Id. at 103.
12.
Id. at 98–99.
13.
Art. 1 of UNESCO’s Universal Declaration on Human Genome and Human Rights 1997.
14.
Id.; Art. 2 of UNESCO’s Universal Declaration on Human Genome and Human Rights 1997.
15.
Bovenberg, supra note 1 at 44.
16.
447 U.S. 303, 309 (1980).
17.
Bovenberg, supra note 1 at 49.
18.
Ibid.
19.
Barnes and Heffernan (2004).
20.
Feldman (2011).
21.
Ibid.
22.
Office of Technology Assessment, New Developments in Biotechnology: Ownership of Human Tissues and Cells (March 1987).
23.
Barnes and Heffernan, supra note 19 at 3.
24.
Feldman, supra note 20, at 1378.
25.
Ibid.
26.
Id. at 1379.
27.
Barnes and Heffernan, supra note 19 at 4.
28.
Moore v. Regents of the University of California, 51 Cal. 3d 120 (1990).
29.
Id. at 126.
30.
Id. at 127.
31.
Ibid
32.
Ibid.
33.
U.S. Patent No. 4,438,032 (Mar. 20, 1984).
34.
Moore, supra note 28 at 128.
35.
Epstein (2011).
36.
Moore, supra note 28 at 137.
37.
Id. at 138.
38.
Ibid.
39.
Id. at 141.
40.
Id. at 142–143.
41.
Id. at 143.
42.
Ibid.
43.
Id., at 143–144.
44.
Id. at 145.
45.
Ibid.
46.
Id. at 132–133.
47.
Moore v. Regents of the University of California—Case Brief Summary, available at http://www.lawnix.com/cases/moore-regents-california.html. (last visited on May 22, 2012).
48.
Moore, supra note 28 at 150 (Arabian J., concurring).
49.
Id. at 152 (Broussard J., dissenting).
50.
Id. at 166 (Mosk J., dissenting) quoting Union Oil Co. v. State Bd. of Equal. (1963) 60 Cal.2d 441, 447 [34 Cal.Rptr. 872, 386 P.2d 496].
51.
Id. at 167 (Mosk J., dissenting); quoting People v. Walker (1939) 33 Cal. App. 2d 18, 20 [90 P.2d 854].
52.
Id. at 167.
53.
Id. at 176, quoting “Toward the Right of Commerciality: Recognizing Property Rights in the Commercial Value of Human Tissue,” 34 UCLA L. Rev. 230 (1986).
54.
N. Narayanan, “Patenting of human genetic material v. bioethics: revisiting the case of John Moore v. Regents of the University of California.” available at http://www.ncbi.nlm.nih.gov/pubmed/20432879 (last visited on may 21, 2012).
55.
World Health Organization (2005).
56.
Ibid.
57.
Greenberg v. Miami Children’s Hospital, 2003 WL 21246347 (S.D. Fla. May 29, 2003); 264 F. Supp. 2d 1064 (S.D. Fla. 2003).
58.
Barnes and Heffernan, supra note 19 at 4.
59.
Greenberg v. Miami Children’s Hospital Research Institute Inc, available at http://indylaw.indiana.edu/instructors/orentlicher/healthlw/Greenberg.htm (visited on May 30, 2012).
60.
Ibid.
61.
Ibid.
62.
Ibid.
63.
Barnes and Heffernan, supra note 19 at 4.
64.
Greenberg, supra note 59.
65.
Barnes and Heffernan, supra note 19 at 4.
66.
Ibid.
67.
Ibid.
68.
Greenberg, supra note 59.
69.
Ibid.
70.
Ibid.
71.
Ibid.
72.
Ibid.
73.
Ibid.
74.
Barnes and Heffernan, supra note 19 at 4.
75.
Ibid.
76.
“Ownership of Biological Sample and Clinical Data II: U.S. Supreme Court denies certiorari in the Catalona decision”, available at www.mwe.com. (visited on May 30, 2012).
77.
Washington University v Catalona 437 F. Supp. 2d 985 (E.D. Mo. 2006), aff’d, 490 F.3d 667 (8th Cir 2007), cert. denied,128 S. Ct. 1122 (2008).
78.
“Patients lose law suit to reclaim their tissues”, available at http://www.whoownsyourbody.org/catalona.html (visited on May 22, 2012).
79.
Ibid.
80.
Ibid.
81.
Barnes and Heffernan, supra note 19 at 4.
82.
Id. at 5.
83.
Ibid.
84.
Ibid.
85.
Supra note 78.
86.
Ibid.
87.
Ibid.
88.
Ibid.
89.
Ibid.
90.
Supra note 76.
91.
Ibid.
92.
Ibid.
93.
Ibid.
94.
Ibid.
95.
Ibid.
96.
“Research without Patient Consent”, available at http://www.whoownsyourbody.org/havasupai.html (visited on May 28, 2012).
97.
Ibid.
98.
Harmon (2010).
99.
Supra note 96.
100.
Barnes and Heffernan, supra note 19 at 5.
101.
Ibid.
102.
Ibid.
103.
Ibid.
104.
Supra note 96.
105.
Ibid.
106.
Harmon, supra note 98.
107.
Ibid.
108.
Ibid.
109.
Barnes and Heffernan, supra note 19 at 4.
110.
Feldman, supra note 20, at 1379.
111.
Id. at 1380.
112.
Ibid.
113.
Id. at 1383.
114.
Ibid.
115.
Id. at 1384.
116.
Ibid
117.
Id. at 1385
118.
Ibid.
119.
Ibid; For example, in India, the Biodiversity Act 2002 recognizes sovereign rights over non-human genetic resources. See the Preamble and Sec. 2(c) of the Biodiversity Act 2002; Further, Department of Biotechnology, Ministry of Science and Technology constituted National Bioethics Committee in 1999 that has formulated Ethical Policies on the Human Genome, Genetic Research & Services. These policies emphasize that “International Law allows for the identification of ownership of sovereign rights over human genetic material (like any other biodiversity plants, animals and microbes) which shall be implemented.” See Department of Biotechnology, Ministry of Science and Technology, Ethical Policies on the Human Genome, Genetic Research & Services 1999, available at http://dbtindia.nic.in/uniquepage.asp?id_pk=113 (last visited on May22, 2012).
120.
Ibid.
121.
Id. at 1402.
122.
Ibid.
123.
Safrin (2004).
124.
Id. at 644.International Undertaking on Plant Genetic Resources for Food and Agriculture, Nov. 23, 1983, Art. 1., available at http:www.fao.org/ag/cgrfa/ia.htm. (visited on May22, 2012).
125.
Ibid.
126.
Ibid.
127.
Id. at 644–645.
128.
Id. at 645.
129.
Ibid.
130.
Ibid.
131.
Id. at 646.
132.
FAO Res.4/89 available at www.upov.int. (Member states are expected to grant and protect these rights at the national level.) Sabrina, Safrin supra note 123 at 646.
133.
Safrin, supra note 123 at 646; International Convention for the Protection of New Variety of Plants Dec 2, 1961, 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.].
134.
UPOV Convention as revised Mar. 19, 1991, Arts. 14(1), 14(5), 15(1)(iii), 15(2), S. TREATY DCC No. 104-17 (1995), available at http:www.upov.int (visited on May25, 2012).
135.
Safrin, supra note 123 at 646.
136.
Ibid.
137.
Id. at 647.
138.
Ibid.
139.
FAO Res. 3/41, available at http://www.fao.org/ag/cgrfa/ia.html.
140.
Safrin supra note 123 at 647.
141.
Ibid.
142.
Convention on Biological Diversity, June 5, 1992, Art. 15(1).
143.
Id. Art. 2.
144.
Id. Art. 15(2).
145.
Safrin supra note 123 at 648.
146.
Ibid.
147.
Andean Common System on Access to Genetic Resources, Decision 391 (July 2, 1996), available at http://www.comunidadandina.org/ingles/treaties/dec/d391e.htm. (hereinafter Common System).
148.
Sabrin, supra note 123 at 650. (See Art. 6 of the Common system which stipulates, “[t]he 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 legislation”).
149.
Ibid.
150.
Ibid.
151.
Ibid. (See Common System; supra note 147, Art. 17).
152.
Ibid.
153.
Id. at 650–651.
154.
Biodiversity Act 2002, No. 18, Feb. 5, 2003.
155.
This refers to any person who is not a resident citizen of India (See supra note 154, Sec. 3(2)).
156.
See supra note 154, Sec. 3(1).
157.
Id. Section 22.
158.
Id. Section 4.
159.
Id. Section 20(1).
160.
Sabrin, supra note 123 at 661.
161.
Ibid.
162.
Id. at 662.
163.
Id. at 662–663.
164.
Id. at 662, (Reports on human genetic research in China trumpet the importance of ethnic diversity as a national resource, describing the distinct characteristics of China’s numerous ethnic groups as a “goldmine” for population geneticists.).
165.
Moore, supra note 28.
166.
Sabrin, supra note 123 at 663.
167.
Id. at 665, Biological Diversity Act, supra note 154, Sec. 6(1).
168.
Biological Diversity Act, supra note 154, Sec. 6(2).
169.
Brazil, Provisional Measure No. 2.186-16 (Aug. 23, 2001), available at http://www.grain.org/brl/brazil-tk-2001-en.cfm [hereinafter Brazil Measure] Arts. 26, 30, 31.
170.
Sabrin, supra note 123 at 666. [For example, in connection with the 2003 meeting of the TRIPS Council, Bolivia, Brazil, Cuba, the Dominican Republic, Ecuador, India, Peru, Thailand, and Venezuela proposed amending the TRIPS Agreement to require, as a condition of patent acquisition, (1) the disclosure of the source and country of origin of genetic resources used in the invention, (2)evidence that the country of origin had consented to its extraction and use, and (3) “evidence of fair and equitable benefit sharing under the relevant national regime.” They further proposed that failure by an applicant to provide this information should render the patent unenforceable.” They argued that these amendments were “imperative to implement the TRIPS Agreement and the CBD in a mutually supportive and complementary. The African Group, which consists of all African nations that belong to the WTO, proposed a similar amendment to the TRIPS Agreement, arguing that the Agreement “has not provided adequate and equitable means to prevent patents mainly in developed Members that have amounted to and resulted in the misappropriation of genetic resources… from developing members.”]
171.
Id. at 670.
172.
Ibid.
173.
Ibid.
174.
Id. at 671.
175.
Id. at 680 (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. See CBD, supra note 142, Art. l3(7).).
176.
Id. at 681–682.
177.
Id. at 682.
178.
Ibid.
179.
Ibid.
180.
Ibid.
181.
Id. at 682–683.
182.
Id. at 684.
183.
Id. at 625.
184.
Ibid.
185.
Ibid.
186.
Ibid.
187.
The Convention on Biological Diversity (CBD) Article 1.
188.
World Health Organization (2002).
189.
Ibid.
190.
Ibid.
191.
Id. at 143–44.
192.
Id. at 144.
193.
Ibid.
194.
Ibid.
195.
Ibid.
196.
Ibid.
197.
Supra note 55 at 32.
198.
Ibid.
199.
Id. at 32–33.
200.
Biodiversity Act supra note 154, Sec. 21(1).
201.
Id. Section 21(3).
202.
Id. Sec. 41(2). India’s law necessitates that every local municipality create a biodiversity management committee. Id. Sections 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. Section 41(3). The National biodiversity Authority must notify the public of any of its approvals. Id. Sections 19(4), 20(4).
203.
Id. Section 6(1).
204.
Supra note 55. at 33.
205.
Ibid.
206.
Id. at 33–34.
207.
Id. at 34.
208.
Ibid.
209.
Ibid.
210.
Ibid.
211.
Id. at 35.
212.
Id. at 241.

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Amity Law School, Noida, Uttar Pradesh, India
Kshitij Kumar Singh

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Singh, K. (2015). Implications of Genetic Patents on Human Genetic Resources: Issues of Ownership, Benefit Sharing and Informed Consent. In: Biotechnology and Intellectual Property Rights. Springer, New Delhi. https://doi.org/10.1007/978-81-322-2059-6_6

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DOI: https://doi.org/10.1007/978-81-322-2059-6_6
Published: 28 October 2014
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