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Governing Control over Human Genetic Resources: Promises and Risks

Published online by Cambridge University Press:  20 January 2017

Nicola Lucchi*
Affiliation:
Jönköping International Business School, Sweden. Contact:

Abstract

The purpose of the paper is to discuss how to regulate the access to and use of biochemical and human genetic material currently considered as part of the market framework. Looking beyond the protection of traditional public goods (such as land or water), the paper emphasizes the debate around the progressive commodification of human genetic resources facilitated by an improper use of intellectual property rights. The discourse around commons is used to evaluate alternative tools and strategies to the issue of private appropriation of human genetic resources and natural compounds

Type
Reports
Copyright
Copyright © Cambridge University Press 2013

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References

1 See Oliver, Deker, Environmental Policy Instruments for Conserving Global Biodiversity, (Berlin: Springer–Verlag 2008), at 57.Google Scholar

2 See James, Boyle, “The Second Enclosure Movement and the Construction of the Public Domain”, 16 Law & Contemporary Problems (2003), pp. 33 et sqq.Google Scholar

3 See Michael A., Heller and Eisenberg, Rebecca S., “Can Patents Deter Innovation? The Anticommons in Biomedical Research”, 280 Science (1998), pp. 698 et sqq., at p. 699;Google Scholar Litman, Jessica, “The Public Domain”, 39 Emory Law Journal (1990), pp. 965 et sqq.;Google Scholar Rai, Arti K. and Eisenberg, Rebecca S., “Bayh–Dole Reform and the Progress of Biomedicine”, 66 Law & Contemporary Problems (2003), pp. 289 et sqq., at p. 295;Google Scholar Samuelson, Pamela, “Mapping the Digital Public Domain: Threats and Opportunities”, 66 Law & Contemporary Problems (2003), pp. 147 et sqq., at p. 155;Google Scholar Reese, Anne and Opeskin, Brian, “Current Issues in Gene Patenting”, in Ian Freckelton and Kerry Petersen (eds.), Disputes and Dilemmas in Health Law (Annandale:N.S.W., Federation Press 2006), pp. 277 et sqq., at 289.Google Scholar

4 On this point, see generally Deibel, Eric, Common Genomes. On open source in biology & critical theory beyond the patent (Amsterdam: Vrije Universiteit, 2009).Google Scholar

5 See Madison, Michael J. et al., “Constructing Commons in the Cultural Environment”, 95 Cornell Law Review (2010), pp. 657 et sqq.;Google Scholar Contreras, Jorge L., “Data Sharing, Latency Variables and the Science Commons”, 25 Berkeley Technology Law Journal (2010), pp. 1601 et sqq. Google Scholar

6 U.S. Congress, Office of Technology Assessment, Biotechnology in a Global Economy, (Washington DC:, U.S. Government Printing Office 1991), at p. 268.Google Scholar

7 See Travis, John, Frontiers in Biotechnology: Biotech Gets a Grip on Cell Adhesion, 260 Science, 906;CrossRefGoogle ScholarPubMed Resnik, David B., Owning the Genome: A Moral Analysis of DNA Patenting. (Albany: Suny Press 2004), at p. 7.Google Scholar

8 See Hess, Charlotte and Ostrom, Elinor, “A Framework for Analysing the Microbiological Commons”, 58 International Social Science Journal (2006), pp. 335 et sqq.CrossRefGoogle Scholar

9 See Adelman, David E., “A Fallacy of the Commons in Biotech Patent Policy”, 20 Berkeley Technology Law Journal (2005), pp. 985 et sqq., at p. 986.Google Scholar

10 See Michael Crichton, “Patenting Life, New York Times, 13 February 2007, at p. A23.

11 Id.

12 Id.

13 See Hamelink, Cees J., 2003, “Human Rights for the Information Society”, in Bruce Girard and Seán Ó Siochrú (eds.), Communicating in the Information Society (Geneva: United Nations Research Institute for Social Development 2003) pp. 121 et sqq., at p. 144.Google Scholar

14 See Murray, Fiona and Stern, Scott, “Do Formal Intellectual Property Rights Hinder the Free Flow of Scientific Knowledge? An Empirical Test of the Anti-Commons Hypothesis”, 63 The Journal of Economic Behavior and Organization (2007) pp. 648 et sqq., at p. 670.CrossRefGoogle Scholar

15 See Hamelink, “Human Rights for the Information Society”, supra note 12, at p. 145.

16 Id.

17 See Sec’y's Advisory Comm. on Genetics, Health, and Soc’y, “Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests, Report of the Secretary's Advisory Committee on Genetics, Health and Society” (2010), at p. 2, available on the Internet at <http://oba.od.nih.gov/oba/sacghs/reports/SACGHSpatents_report_2010.pdf.> (last accessed on 14 May 2013).

18 See Resnik, Owning the Genome: A Moral Analysis of DNA Patenting, supra note 6, at p. 67.

19 Id., at p. 81 See also Arti K. Rai, “Knowledge Commons: The Case of Biopharmaceutical Industry”. First Monday, 4 June 2007, available on the Internet at <http://firstmonday.org/issue12_6/rai/index.html> (last accessed on 25 March 2013).

20 U.S. Department of Justice and Federal Trade Commission, The Evolving IP Marketplace: Aligning Patent Notice and Remedies With Competition (Washington D.C: Federal Trade Commission 2011), at p. 1;Google Scholar Dominique Guellec and Bruno van Pottelsberghe de la Potterie, The Economics of the European Patent System: IP Policy for Innovation and Competition (Oxford: Oxford University Press 2007), at p. 123.Google Scholar

21 Eisemberg, Rebecca, “Patenting the Human Genome”, 39 Emory Law Journal (1990), pp. 721 et sqq., at p. 736.Google Scholar

22 See Hanson, Mark J. 2002. “Patenting Genes and Life: Improper Commodification?”, in David Magnus et al. (eds.), Who Owns Life? (New York: Prometheus Books 2002), pp. 161 et sqq.;Google Scholar Conley, John M. and Makowski, Roberte, “Back to the Future: Rethinking the Product of Nature Doctrine as a Barrier to Biotechnology Patents (Part II)85 Journal of the Patent & Trademark Office Society (2003), pp. 371 et sqq., at p. 393;Google Scholar Resnik, , Owning the Genome: A Moral Analysis of DNA Patenting, supra note 6; Matthew Albright, Profits Pending: How Life Patents Represent the Biggest Swindle of the 21st Century. (Monroe: Common Courage Press 2004);Google Scholar Koepsell, David, Who Owns You? The Corporate Gold–Rush To Patent Your Genes (Malden, Ma: Wiley–Blackwell 2009), at p. 156.Google Scholar

23 See Resnik, Owning the Genome: A Moral Analysis of DNA Patenting, supra note 6, at p. 73; Guellec and van Pottelsberghe de la Potterie, The Economics of the European Patent System: IP Policy for Innovation and Competition, supra note 19, at p. 122.

24 Kathryn Garforth, “Life as Chemistry or Life as Biology? An Ethic of Patents on Genetically Modified Organisms”, in Joanna Gibson (ed.), Patenting Lives: Life Patents, Culture and Development, (Aldershot: Ashgate 2008), pp. 27 et sqq., at p. 46.

25 Id., at p. 42.

26 Howlett, Melanie J. and Christie, Andrew F., “An Analysis of the Approach of the European, Japanese and United States Patent Offices to Patenting Partial DNA Sequences (ESTs)34 International Review of Industrial Property and Copyright (2003), pp. 581 et sqq.;Google Scholar Chambers, Jasemine C., “Patent Eligibility of Biotechnological Inventions in the United States, Europe, and Japan: How Much Patent Policy is Public Policy?”, 34 George Washington International Law Review (2002), pp. 223 et sqq.;Google Scholar Restaino, Leslie G. et al., “Patenting DNA–Related Inventions in the European Union, United States and Japan: A Trilateral Approach or a Study in Contrast?UCLA Journal of Law & Technology(2003), pp. 2 et sqq.;Google Scholar Reese, Anne and Opeskin, Brian, “Current Issues in Gene Patenting” in Ian Freckelton and Kerry Petersen (eds.), Disputes and Dilemmas in Health Law(Annandale, N.S.W.: Federation Press 2006), pp. 227 et sqq., at p. 280.Google Scholar

27 Here the term includes: genetic materials and gene fragments, such as expressed sequence tags (ESTs) and single nucleotide polymorphisms (SNPs).

28 See Diamond v. Chakrabarty 447 US 303 (1980).

29 Decision T 19/90-3.3.2, 1990 O.J. Eur. Pat. Off. 476.

30 Guellec and van Pottelsberghe de la Potterie, The Economics of the European Patent System: IP Policy for Innovation and Competition, supra note 19, at p. 123.

31 Gottschalk v. Benson, 409 U.S. 63, 67 (1972).

32 Conley, John M., “Gene Patents and the Product of Nature Doctrine84 Chicago–Kent Law Review (2009), pp. 109 et sqq., at p. 113;Google Scholar Conley and Makowski, “Back to the Future: Rethinking the Product of Nature Doctrine as a Barrier to Biotechnology Patents (Part II)”, supra note 21 , at p. 303.

33 See Resnik, Owning the Genome: A Moral Analysis of DNA Patenting, supra note 6, at p. 74; Vandana, Shiva, Biopiracy: The Plunder of Nature and Knowledge (Cambridge, Ma: South End Press 1997).Google Scholar

34 Complaint at 19, 22–25, Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010) (No. 09 Civ. 4515).

35 American Civil Liberties Union, “Legal Challenge to Human Gene Patents”, (2009) available on the Internet at <http://www.aclu.org/pdfs/freespeech/brca_qanda.pdf> (last accessed on 25 March 2013).

36 Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office (Myriad I), 702 F. Supp. 2d 181, (S.D.N.Y. 2010), aff’d in part, rev’d in part, 653 F.3d 1329 (Fed. Cir. 2011); Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office (Myriad II), 689 F.3d 1303, (Fed. Cir. 2012), cert. granted sub nom. Myriad Genetics, 133 S. Ct. 694 (2012) (granting certiorari); Petition for Writ of Certiorari at i, Myriad Genetics, 133 S. Ct. 694 (No. 11-725), 2011 WL 6257250. The Court will hear oral argument in the case on April 15, 2013. For a complete analysis and discussion of the case, see Minssen, Timo and Nilson, David, “Standing on shaky ground: US patent–eligibility of isolated DNA and genetic diagnostics after AMP v USPTO – Part I”, 1 Queen Mary J. of Intell. Prop., (2011), pp. 223 et sqq.;CrossRefGoogle Scholar Idd., “Standing on shaky ground: US patent–eligibility of isolated DNA and genetic diagnostics after AMP v. USPTO – Part II”, 1 Queen Mary J. of Intell. Prop, (2012), pp. 136 et sqq.;Google Scholar Idd., “Standing on shaky ground: US patent–eligibility of isolated DNA and genetic diagnostics after AMP v. USPTO – Part III”, 1 Queen Mary J. of Intell. Prop., (2012), pp. 225 et sqq Google ScholarFor the most recent developments, see also Burk, Dan L., “Anticipating Patentable Subject Matter”, 65 Stanford Law Review Online (2013), pp. 109 et sqq. Google Scholar

37 Oliver Brüstle v. Greenpeace eV (C-34/10) [2012] 1 C.M.L.R. 41. For a more detailed analysis, see Enrico Bonadio, “Biotech patents and morality after Brustle”, 34 European Intellectual Property Review (2012), pp. 433 et sqq.; Plomer, Aurora, “After Brüstle: EU accession to the ECHR and the future of European patent law”, 2 Queen Mary J. of Intell. Prop. (2012), pp. 110 et sqq. CrossRefGoogle Scholar

38 See Benkler, Yochai, “Constitutional Bounds of Database Protection: The Role of Judicial Review in the Creation and Definition of Private Rights in Information”, 15 Berkeley Technology Law Journal (2000), pp. 535 et sqq., at p. 557;Google Scholar Resta, Giorgio, “Nuovi Beni Immateriali e Numerus Clausus dei Diritti Esclusivi”, in Giorgio Resta (ed.), Diritti Esclusivi e Nuovi Beni Immateriali (Torino: Utet 2011), pp. 3 et sqq., at p. 68.Google Scholar

39 See generally Boldrin, Michele and Levine, David K., Against Intellectual Monopoly (Cambridge: Cambridge University Press 2008).Google Scholar

40 Bessen, James and Meurer, Michael J., Patent Failure: How Judges, Bureaucrats, and Lawyers Put Innovators at Risk (Princeton: Princeton University Press 2008), at pp. 4671;Google Scholar Boldrin and Levine, Against Intellectual Monopoly, supra note 36; Heller, Michael A., The Gridlock Economy: How Too Much Ownership Wrecks Markets, Stops Innovation, and Costs Lives (New York, NY: Basic Books 2008);Google Scholar Burk, Daniel L. and Lemley, Mark A., The Patent Crisis and How the Courts Can Solve It, (Chicago, IL: University of Chicago Press 2009), at pp. 95100.CrossRefGoogle Scholar

41 Murray and Stern, “Do Formal Intellectual Property Rights Hinder the Free Flow of Scientific Knowledge? An Empirical Test of the Anti–Commons Hypothesis”, supra note 13; Walsh, John P. et al., “Working Through the Patent Problem”, 299 Science (2003), p. 1021CrossRefGoogle ScholarPubMed.

42 Hess and Ostrom, “A Framework for Analysing the Microbiological Commons”, supra note 7, at 335.

43 Liivak, Oskar, “Maintaining Competition in Copying: Narrowing the Scope of Gene Patents41 U.C. Davis Law Review (2007) pp. 177 et sqq., at p. 185.Google Scholar

44 See supra notes 36 and 37.

45 Overwalle, Geertrui Van et al., “Models for Facilitating Access to Patents on Genetic Invention”, 7 Nature Review Genetics (2006), pp. 143 et sqq.;CrossRefGoogle Scholar Id., “Turning Patent Swords into Shares”, 330 Science (2010) pp. 1630–31.Google ScholarPubMed

46 Reichman, Jerome H. and Dreyfuss, Rochelle C., “Harmonization Without Consensus: Critical Reflections on Drafting a Substantive Patent Law Treaty57 Duke Law Journal (2007), pp. 85 et sqq., at p. 105;Google Scholar European Patent Office, Scenarios For The Future – How Might IP Regimes Evolve by 2025? What Global Legitimacy Might Such Regimes Have? (Munich: European Patent Organization 2007), at p. 72.Google Scholar

47 European Patent Office, Scenarios For The Future – How Might IP Regimes Evolve by 2025? What Global Legitimacy Might Such Regimes Have?, supra note 46.

48 WIPO, Substantive Patent Law Harmonization <http://www.wipo.int/patent/law/en/harmonization.htm;> Draft Substantive Patent Law Treaty, WIPO Standing Committee On The Law Of Patents, Tenth Session, Geneva 10–14 May 2004, available on the Internet at <http://www.wipo.int/edocs/mdocs/scp/en/scp_10/scp_10_2.pdf> (last accessed on 25 March 2013).

49 European Patent Office, Scenarios For The Future – How Might IP Regimes Evolve by 2025? What Global Legitimacy Might Such Regimes Have?, supra note 46.

50 See Reichman and Dreyfuss, “Harmonization Without Consensus: Critical Reflections on Drafting a Substantive Patent Law Treaty”, supra note 46.

51 See Hess, Charlotte and Ostrom, Elinor, “Introduction: An overview of the knowledge of commons”, in Charlotte Hess and Elinor Ostrom (eds), Understanding Knowledge as Commons: From Theory to Practice (Cambridge, MA: MIT Press, 2007), pp. 3 et sqq, at p. 6Google Scholar