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<meta content="This paper briefly considers some of the perceived problems associated with the exclusive rights model of patent management in biotechnology. It then goes on to explore the range of legal options for dealing with some of these perceived problems, together with alternative co-operative approaches that are currently under discussion in various forums, including open access models. This review shows that there are many parallels in the issues currently being debated in the information technology and biotechnology industries in relation to the copyright and patent regimes of intellectual property." name="eprints.abstract" />
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<meta content="There is a vast body of literature on this debate, far too extensive to list fully here. A useful starting point is a special issue of the journal Academic Medicine: D Korn and SJ Heinig (guest eds) “Public Versus Private Ownership of Scientific Discovery: Legal and Economic Analyses of the Implications Human Gene Patents” (2002) 11(12) Academic Medicine pp1301-1399. Many of the leading academic commentators on this topic in the US have papers in this issue of the journal.
2 It should be noted that this paper does not aim to enter into the debate about the translation of open source principles into biotechnology. This issue has been canvassed extensively elsewhere. See particularly J Hope, Open Source Biotechnology (Canberra: Australian National University PhD Thesis, 2004) @ http://rsss.anu.edu.au/~janeth.
3 Nuffield Council on Bioethics, The Ethics of Patenting DNA: A Discussion Paper (London: Nuffield Council; 2002) at 56 (the Nuffield Discussion Paper).
4 Nuffield Discussion Paper, ibid at 47-64.
5 K Jensen and F Murray, “Intellectual Property Landscape of the Human Genome” (2005) 310 Science 239.
6 See, for example, National Research Council, Intellectual Property Rights and Research Tools in Molecular Biology (Washington DC: National Academy of Sciences, 1997).
7 H Pearson, “What Is a Gene?” (2006) 441 Nature 399.
8 See, for example O Vukmirovic and S Tighman, “Exploring Genome Space” (1999) 405 Nature 820
9 See, for example, JP Walsh, A Arora and W Cohen “Effects of Research Tool Patenting and Licensing on Biomedical Innovation” in W Cohen and St Merrill (eds.), Patents in the Knowledge-Based Economy (Washington: National Academies Press, 2003) at 286-287, @ http://books.nap.edu/books/0309086361/html/285.html#pagetop (Walsh et al: Patenting).
10 RS Eisenberg, “How Can You Patent Genes?” (2002) 2 The American Journal of Bioethics 3.
11 See generally P Kanavos, “Determinants of Market Structure in the International Biopharmaceutical Industry”, in OECD, Economic Aspects of Biotechnologies Related to Human Health: Part II: Biotechnology, Medical Innovation and the Economy: The Key Relationships (Paris: OECD, 1998). For an example of country-specific strategies, see Biotechnology Australia, Australian Biotechnology: A National Strategy (Canberra: AGPS, 2000).
12 Rebecca Eisenberg, in particular, frequently refers to this issue in her work. See, for example, RS Eisenberg, “Bargaining Over the Transfer of Proprietary Research Tools: Is This Market Failing or Emerging?” in RC Dreyfuss, DL Zimmerman and H First (eds.), Expanding the Boundaries of Intellectual Property: Innovation Policy for the Knowledge Society, (Oxford: Oxford University Press, 2001).
13 On the broad problem of blocking patents in areas of cumulative innovation see: R Merges and R Nelson, “On the Complex Economics of Patent Scope (1990) 90 Columbia Law Review 839; S Scotchmer, “Standing on the Shoulders of Giants: Cumulative Research and the Patent Law” (1991) 5 Journal of Economic Perspectives 29.
14 M Heller and RS Eisenberg, “Can Patents Deter Innovation? The Anticommons in Biomedical Research” (1998) 280 Science 698.
15 Ibid.
16 T Caulfield, RM Cook-Deegan, FS Keiff and JP Walsh, “Evidence and Anecdotes: an Analysis of Human Gene Patenting Controversies” (2006) 24 Nature Biotechnology 1091 (Caulfield et al: Evidence).
17 Walsh et al: Patenting, above note 9 at 287 (also see JP Walsh, A Arora and W Cohen, “Working Through the Patent Problem” (2003) 299 Science 1021); J Straus, H Holzapfel and M Lindenmeir, Empirical Survey on Genetic Invention and Patent Law, (Munich: 2002) (copy on file with the authors); D Nicol and J Nielsen Patents and Medical Biotechnology: An Empirical Analysis of Issues Facing the Australian Industry (Centre for Law and Genetics Occasional Paper No. 6; 2003) @ http://www.ipria.org/publications/reports.html (also see D Nicol and J Nielsen, “Australian Medical Biotechnology: Navigating a Complex Patent Landscape” (2005) European Intellectual Property Review 313); Intellectual Property Institute on behalf of the Department of Trade and Industry, Patents for Genetic Sequences: The Competitiveness of Current UK Law and Practice (2004) @ http://www.dti.gov.uk/5397_DTi_Patent_Study.pdf; N Thumm, Research and Patenting in Biotechnology: A Survey in Switzerland (Swiss Federal Institute of Intellectual Property; 2003) @ http://www.ige.ch/E/jurinfo/j100.htm#2; Committee on Intellectual Property Rights in Genomic and Patent Research and Innovation, National Research Council of the National Academies, Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation and Public Health (National Academies Press; 2005).
18 See particularly JP Walsh, C Cho and W Cohen, “View from the Bench: Patents and Material Transfers” (2005) 309 Science 2002 (Walsh et al: Material Transfers).
19 Madey v Duke University 307 F 3d 1351, 1360–1 (Fed. Cir. 2002).
20 Walsh et al: Patenting, above note 9.
21 See particularly M Cho, S Illangasekare, M Weaver, D Leonard and J Merz, “Effect of Patents and Licenses on the Provision of Clinical Genetic Testing Services” (2003) 5 Journal of Molecular Diagnostics 3; J Merz, A Kriss, D Leonard and M Cho, “Diagnostic Testing Fails the Test” (2002) 415 Nature 577.
22 R Atkinson et al, “Public Sector Collaboration for Agricultural IP Management” (2003) 301 Science 174-5.
23 Caulfield et al: Evidence, above note 16.
24 Nicol and Nielsen, above note 16 at 190-191. See also Caulfield et al: Evidence, above note 16; ER Gold et al, “Continuing the Debate on Existing Evidence about Gene Patents” Nature Biotechnology in press.
25 See generally Nicol and Nielsen, above note 17 at 93-123.
26 There has been little public engagement on this topic and evidence about what the public thinks about gene patents is exceedingly limited. See T Caulfield, E Eisiendel, J Merz and D Nicol “Trust, Patents, and Public Perceptions: The Governance of Controversial Biotechnology Research” (2006) 24 Nature Biotechnology 1352.
27 For example: Australian Law Reform Commission, Genes and Ingenuity: Gene Patenting and Human Health Report 99 (2004); SA Merrill, RC Levin and MB Myers (eds), A Patent System for the 21st Century (2004); Canadian Biotechnology Advisory Council, Report: Human Genetic Materials, Intellectual Property and the Health Sector (2006).
28 On this point, see particularly Caulfield et al: Evidence, above note 16.
29 Note to editor: include reference to Melissa de Zwart’s article.
30 As discussed in detail from the perspective of US patent and copyright law in M O’Rourke, “Towards a Doctrine of Fair Use in Patent Law” (2000) 100 Columbia Law Review 1177.
31 Australian Law Reform Commission, above note 27 at 336-343; Advisory Council on Intellectual Property Patents and Experimental Use (Canberra: Australian Government; 2004) at 19; Canadian Biotechnology Advisory Committee, above note 27 at 25-26.
32 J Barton, “Patents, Genomics, Research and Diagnostics” (2002) 77 Academic Medicine 1339 at 1342; Australian Law Reform Commission, above note 25 at 342-343.
33 K Strandburg, “What Does the Public Get? Experimental Use and the Patent Bargain” (2004) Wisconsin Law Review 81.
34 Nicol and Nielsen, above note 16 at 239-241.
35 Australian Law Reform Commission, above note 27 at 552.
36 However, developing countries are starting to use these mechanisms for manufacturing generic versions of patented pharmaceuticals. See, for example, Ministry of Public Health and National Health Security Office Thailand, Facts and Evidences on the 10 Burning Issues Related to the Government Use of Patents on Three Patented Essential Drugs in Thailand (2007) @ http://www.moph.go.th/hot/White%20Paper%20CL-EN.pdf
37 OECD, Guidelines for the Licensing of Genetic Inventions (2006) OECD, Paris.
38 NIH, “Principles and Guidelines for Recipients of NIH Research grants and Contracts on Obtaining and Disseminating Biomedical research Resources: Final Notice” (1999) 64 Federal Register 72090. See also National Research Council, above note 6.
39 NIH, “Best Practices for the Licensing of Genomic Inventions: Final Notice” (2005) 70 Federal Register 18413.
40 L Pressman et al, “The Licensing of DNA Patents by US Academic Institutions: an Empirical Study” (2006) 24 Nature Biotechnology 31.
41 Nicol and Nielsen, above note 17 at 105-110. See also Productivity Commission, Public Support for Science and Innovation, Research Report (Canberra: Productivity Commission; 2007) pp284-293 @ http://www.pc.gov.au/study/science/finalreport/index.html
42 Nicol and Nielsen, above note 17 at 110-122.
43 Nicol and Nielsen, above note 17 at 132-134.
44 Y Benkler, “Commons-based Strategies and the Problem of Patents” (2004) 305 Science 1110 at 1110-1111.
45 J Clark et al, Patent Pools: A Solution to the Problem of Access in Biotechnology Patents? (United States Patent and Trademark Office; 2000) at 9-10.
46 See particularly R Merges, “Contracting into Liability Rules: Intellectual Property Rights and Collective Rights Organizations” (1996) 84 California Law Review 1293. See also Clark et al, ibid at 8.
47 See particularly Heller and Eisenberg, above note 14.
48 S Carlson, “Patent Pools and the Antitrust Dilemma “ (1999) 16 Yale Journal on Regulation 359.
49 For example, US Department of Justice and Federal Trade Commission, Antitrust Guidelines for the Licensing of Intellectual Property (US Department of Justice; 1995).
50 G Graff and D Zilberman “Towards an Intellectual Property Clearinghouse for Agricultural Biotechnology (2001) 3 Intellectual Property Strategy Today 1; G Graff, A Bennett, B Wright, and D Zilberman “Intellectual Property Clearinghouse Mechanisms for Agriculture: Summary of an Industry, Academia, and International Development Round Table” (2001) 3 Intellectual Property Strategy Today 15 @ http://www.biodevelopments.org/ip/ (accessed 20 September 2003).
51 Atkinson et al, above note 22.
52 OECD, Patents and Innovation: Trends and Policy Changes (Paris: OECD; 2004) at 2.
53 Human Genome Organisation, Statement on the Scope of Gene Patents, Research Exemption, and Licensing of Patented Gene Sequences for Diagnostics (2003) at 3-4; G Van Overwalle et al, “Models for Facilitating Access to Patents on Genetic Inventions” (2006) 7 Nature Review Genetics 143.
54 E Van Zimmeren et al, “A Clearing House for Diagnostic Testing: the Solution to Ensure Access To and Use of Patented Genetic Inventions?” (2006) 84 Bulletin of the World Health Organisation 352.
55 See Cho et al and Merz et al, above note 21.
56 Note that PIPRA is funded by the Rockefeller and McKnight Foundations.
57 This is the approach taken by PIPRA. See http://www.pipra.org/
58 For example Benkler, above note 44.
59 M Shaffer Van Houweling, “Cultivating Open Information Platforms: A Land Trust Model” (2002) 1 Journal of Telecommunications and High Technology Law 12
60 Hope, above note 2.
61 “International Strategy Meeting Agrees Principles of Early Data Release for Human Genome Sequencing” (1996), press release by the Wellcome Trust, London, 17 April 1996. Participating countries included the UK, the USA, France, Germany and Japan. See also DR Bentley, “Genomic Sequence Information Should Be Released Immediately and Freely in the Public Domain” (1996) 274 Science 533.
62 http://www.ncbi.nlm.nih.gov/.
63 One of the lead funding agencies of both projects, the Wellcome Trust, describes these ventures as two global partnerships that are characterising variations in the human genome. It states that single nucleotide polymorphisms (“SNPs”) are changes to single letters of the DNA code, which occur in about one in every 1000 nucleotides. The SNP Consortium is mapping these SNPs, whereas the HapMap Project is investigating the combinations of SNPs that are inherited together: Wellcome Trust, The SNP Consortium and the International HapMap Project (2005) @ http://www.wellcome.ac.uk/doc_WTD003500.html. See also DA Chokshi and DP Kwiatowski, “Ethical Challenges of Genomic Epidemiology in Developing Countries (2005) 1/1 Genomics, Society and Policy 1.
64 J Sulston and G Ferry, The Common Thread (Random House: London; 2002) pp211–213.
65 http://www.hapmap.org/cgi-perl/registration. See also Chokshi and Kwiatkowski, ibid at 8. Free access to data is a common feature of all large scale international public sequencing projects. See: The Wellcome Trust, Sharing Data from Large-scale Biological Research Projects: a System of Tripartite Responsibility, Report of a meeting organised by the Wellcome Trust and held on 14-15 January 2003 at Fort Lauderdale, USA @ http://www.wellcome.ac.uk/doc_wtd003208.html.
66 A Kent, “Patients and IP – Should We Care?” (2006) 3 SCRIPT-ed 260.
67 http://www.fnih.org/GAIN/GAIN_home.shtml
68 http://sciencecommons.org/
69 http://sciencecommons.org/licensing/scmta
70 http://parts.mit.edu. See also The Bio Fab Group, “Engineering Life: Building a Fab for Biology” (2006) 294 Scientific American 34; A Rai and J Boyle, “Synthetic Biology: Caught between Property Rights, the Public Domain and the Commons” (2007) 5(3) PLoS Biol e58.
71 On this point see also A Rai, “Open and Collaborative Research: a New Model for Biomedicine” in R Hahn (ed) Intellectual Property Rights in New Technologies: Biotech and Software (AEI-Brookings Press; 2005).
72 The Wellcome Trust was the main funding agency for the UK component of the Human Genome Project, the SNP Project and the HapMap Project.
73 R Eisenberg and R Nelson “Public vs. Proprietary Science: a Fruitful Tension?” (2002) 77 Academic Medicine 1392
74 D Nicol and J Nielsen “The Australian Medical Biotechnology Industry and Access to Intellectual Property: Issues for Patent Law Development” (2001) 23 Sydney Law Review 347
75 The most obvious example is the United States, where specific legislation has been enacted for this purpose: the Bayh Dole Act 1980.
76 Australian Law Reform Commission, above note 27 at 289.
77 This quote is part of the Centre for Law and Genetics’ submission to the Australian Law Reform Commission inquiry, extracted by the Australian Law Reform Commission, above note 27 at 285.
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<h1 class="ep_tm_pagetitle">Cooperative Intellectual Property in Biotechnology</h1>
<p style="margin-bottom: 1em" class="not_ep_block"><span class="person_name">Nicol, Dianne</span> (2007) <xhtml:em>Cooperative Intellectual Property in Biotechnology.</xhtml:em> SCRIPT-ed, 4 (1). pp. 136-151. ISSN 1744-2567</p><p style="margin-bottom: 1em" class="not_ep_block"></p><table style="margin-bottom: 1em" class="not_ep_block"><tr><td valign="top" style="text-align:center"><a href="http://eprints.utas.edu.au/2567/1/nicol_script-ed.pdf"><img alt="[img]" src="http://eprints.utas.edu.au/style/images/fileicons/application_pdf.png" class="ep_doc_icon" border="0" /></a></td><td valign="top"><a href="http://eprints.utas.edu.au/2567/1/nicol_script-ed.pdf"><span class="ep_document_citation">PDF</span></a> - Full text restricted - Requires a PDF viewer<br />229Kb</td><td><form method="get" accept-charset="utf-8" action="http://eprints.utas.edu.au/cgi/request_doc"><input accept-charset="utf-8" value="3375" name="docid" type="hidden" /><div class=""><input value="Request a copy" name="_action_null" class="ep_form_action_button" onclick="return EPJS_button_pushed( '_action_null' )" type="submit" /> </div></form></td></tr></table><p style="margin-bottom: 1em" class="not_ep_block">Official URL: <a href="http://dx.doi.org/10.2966/scrip.040107.136">http://dx.doi.org/10.2966/scrip.040107.136</a></p><div class="not_ep_block"><h2>Abstract</h2><p style="padding-bottom: 16px; text-align: left; margin: 1em auto 0em auto">This paper briefly considers some of the perceived problems associated with the exclusive rights model of patent management in biotechnology. It then goes on to explore the range of legal options for dealing with some of these perceived problems, together with alternative co-operative approaches that are currently under discussion in various forums, including open access models. This review shows that there are many parallels in the issues currently being debated in the information technology and biotechnology industries in relation to the copyright and patent regimes of intellectual property.</p></div><table style="margin-bottom: 1em" cellpadding="3" class="not_ep_block" border="0"><tr><th valign="top" class="ep_row">Item Type:</th><td valign="top" class="ep_row">Article</td></tr><tr><th valign="top" class="ep_row">Subjects:</th><td valign="top" class="ep_row"><a href="http://eprints.utas.edu.au/view/subjects/390114.html">390000 Law, Justice and Law Enforcement > 390100 Law > 390114 Intellectual Property</a></td></tr><tr><th valign="top" class="ep_row">ID Code:</th><td valign="top" class="ep_row">2567</td></tr><tr><th valign="top" class="ep_row">Deposited By:</th><td valign="top" class="ep_row"><span class="ep_name_citation"><span class="person_name">A/Prof Dianne Nicol</span></span></td></tr><tr><th valign="top" class="ep_row">Deposited On:</th><td valign="top" class="ep_row">30 Nov 2007 15:43</td></tr><tr><th valign="top" class="ep_row">Last Modified:</th><td valign="top" class="ep_row">09 Jan 2008 02:30</td></tr><tr><th valign="top" class="ep_row">ePrint Statistics:</th><td valign="top" class="ep_row"><a target="ePrintStats" href="/es/index.php?action=show_detail_eprint;id=2567;">View statistics for this ePrint</a></td></tr></table><p align="right">Repository Staff Only: <a href="http://eprints.utas.edu.au/cgi/users/home?screen=EPrint::View&eprintid=2567">item control page</a></p>
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