Patenting of research results related to genetic resources from areas beyond National Jurisdiction: The crossroads of the law of the sea and intellectual property law

Review of European Community and International Environmental Law

Volumn 16, Issue 1, 2007, Pages 12-23

  Salpin, Charlotte ^a   Germani, Valentina ^a  

^a UNITED NATIONS   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIODIVERSITY; GENETIC RESOURCE; INTELLECTUAL PROPERTY RIGHTS; LAW OF THE SEA; NATURE CONSERVATION; POLICY MAKING; SUSTAINABLE DEVELOPMENT;

EID: 34147153380     PISSN: 09628797     EISSN: 14679388     Source Type: Journal    
DOI: 10.1111/j.1467-9388.2007.00538.x     Document Type: Article

References (75)

1. S. Arico and C. Salpin, Bioprospecting of Genetic Resources in the Deep Seabed: Scientific, Legal and Policy Aspects (United Nations University Institute of Advanced Studies, 2005), at 21.
2. Addendum Report of the Secretary General on Oceans and the Law of the Sea to the Sixtieth Session of the General Assembly (60/63/Add.1, 15 July 2005), para. 125, available at http://daccessdds.un.org/doc/ UNDOC/GEN/N05/425/11/PDF/N0542511.pdf?OpenElement.
3. The Oxford University Press Dictionary of Biology defines microorganisms as organisms that 'can be observed only with the aid of a microscope [and] include bacteria, viruses, protoctists (including certain algae), and fungi'. Intellectual property rights instruments, while allowing patenting of micro-organisms, do not define what these are. See S. Arico and C. Salpin, n. 1 above, at 16. The present article adopts the definition of genetic resources provided in Article 2 of the Convention on Biological Diversity as 'genetic material of actual or potential value', with genetic material being 'any material of plant, animal, microbial or other origin containing functional units of heredity'. See Convention on Biological Diversity (Rio de Janeiro, 5 June 1992), Article 2.
4. See S. Arico and C. Salpin, n. 1 above, at 27.
5. See Addendum Report of the Secretary General, n. 2 above, para. 80.
6. See S. Arico and C. Salpin, n. 1 above, at 20-21.
7. See CBD, n. 3 above.
8. Report of the Subsidiary Body on Scientific, Technical and Technological Advice on the Work of its Eighth Meeting (UNEP/CBD/COP/7/3, 9 April 2003), available at http://www.biodiv.org/doc/meetings/cop/cop-07/ official/cop-07-03-en.doc. See, in particular, Recommendation VIII/3, Marine and Coastal Biological Diversity: Review, Further Elaboration and Refinement of the Programme of Work, contained in Annex I.
9. Conservation and Sustainable Use of Deep Seabed Genetic Resources Beyond National Jurisdiction: Study of the Relationship between the Convention on Biological Diversity and the United Nations Convention on the Law of the Sea, Revised Note by the Executive Secretary (UNEP/CBD/SBSTTA/8/9/ Add.3/Rev.1, 20 February 2003); Study of the Relationship between the Convention on Biological Diversity and the United Nations Convention on the Law of the Sea with regard to the Conservation and Sustainable Use of Genetic Resources on the Deep Seabed (Decision II/10 of the Conference of the Parties to the Convention on Biological Diversity) (UNEP/CBD/SBSTTA/8/INF/3/Rev.1, 22 February 2003), available at http://www.biodiv.org/doc/meetings/sbstta/sbstta-08/information/ sbstta-08-inf-03-rev1-en.doc.
10. CBD Decision VII/5, Marine and Coastal Biological Diversity, found in Report of the Seventh Meeting of the Conference of the Parties to the Convention on Biological Diversity (UNEP/CBD/COP/7/21, 13 April 2004), Annex, available at http://www.biodiv.org/doc/meetings/cop/cop-07/ official/cop-07-21-part2-en.doc.
11. CBD Decision VIII/21, Marine and Coastal Biological Diversity: Conservation and Sustainable Use of Deep Seabed Genetic Resources beyond the Limits of National Jurisdiction, found in Report of the Eighth Meeting of the Conference of the Parties to the Convention on Biological Diversity (UNEP/CBD/COP/8/31, 15 June 2006), Annex I, available at http://www.biodiv.org/doc/meetings/cop/cop-08/official/cop-08-31-en.pdf.
12. CBD Decision VI/24, Access and Benefit Sharing as related to Genetic Resources, found in Report of the Sixth Meeting of the Conference of the Parties to the Convention on Biological Diversity (UNEP/CBD/COP/6/20, 27 May 2002), Annex, available at http://www.biodiv.org/doc/meetings/ cop/cop-06/official/cop-06-20-part2-en.doc.
13. See CBD Decision VII/19 D, International Regime on Access to Genetic Resources and Benefit Sharing, Document UNEP/CBD/COP/7/21, n. 10 above, Annex, and CBD Decision VIII/4, Access and Benefit Sharing, Document UNEP/CBD/COP/8/31, n. 11 above, Annex I.
14. See, for example, Report of the World Intellectual Property Organization (WIPO), Interrelation Access to Genetic Resources and Disclosure Requirements in Applications for Intellectual Property Rights (UNEP/CBD/ COP/8/INF/7, 16 January 2006), available at http://www.biodiv.org/ doc/meetings/cop/cop-08/information/cop-08-inf-07-en.pdf.
15. The Consultative Process was established in 1999 by the General Assembly in order to facilitate its annual review of developments in ocean affairs (Results of the Review by the Commission on Sustainable Development of the Sectoral Theme of 'Oceans and seas': International Coordination and Cooperation (General Assembly Resolution 54/33, 24 November 1999)).
16. Report on the Work of the United Nations Open-Ended Informal Consultative Process at its Fifth Meeting (A/59/122, 1 July 2004), para. 2, available at http://daccessdds.un.org/doc/UNDOC/GEN/N04/412/21/ PDF/N0441221.pdf?OpenElement.
17. Report of the Ad Hoc Open-Ended Informal Working Group to Study Issues relating to the Conservation and Sustainable Use of Marine Biological Diversity beyond Areas of National Jurisdiction (A/61/65, 20 March 2006), available at http://daccessdds.un.org/doc/UNDOC/GEN/N06/277/ 50/PDF/N0627750.pdf?OpenElement.
18. The conference, which was organized by the French Government and sponsored by the United Nations Educational, Scientific and Cultural Organization, adopted a Conference Statement and the 'Paris Declaration on Biodiversity', available at http://160.92.130.199/biodiv2005paris/ en/index.htm.
19. N. Beintema et al., 'Summary Report of the Third Global Conference on Oceans, Coasts and Islands "Moving the Global Oceans Agenda Forward"', 68:3 Third Global Conference on Oceans, Coasts and Islands Bulletin (30 January 2006), at 9-10 and 15, available at http://www.globaloceans.org/globalconferences/2006/pdf/ FINAL_ENB_REPORT.pdf.
20. The relationship between UNCLOS and intellectual property rights in relation to MSR undertaken under national jurisdiction has been the subject of a comprehensive study by Monserrat Gorina-Ysern; see M. Gorina-Ysern, An International Regime for Marine Scientific Research (Transnational Publishers, 2003).
21. This is as of 20 September 2006.
22. United Nations Convention on the Law of the Sea (Montego Bay, 10 December 1982), Preamble.
23. See CBD, n. 3 above, Article 22.
24. Ibid., Article 4.
25. See UNCLOS, n. 22 above.
26. See Report of the Ad Hoc Open-Ended Informal Working Group, n. 17 above, paras 29-31.
27. In situ sampling is unlikely to have any impact on the target organism itself in terms of depletion of the species, since only small quantities are usually taken in the first phase. However, the methods used for collection of the resources may have harmful environmental impacts on the ecosystems of which they are part, such as destruction of corals or non-target species.
28. S. Arico and C. Salpin, n. 1 above, at 19.
29. Ibid., at 15.
30. For a summary of the negotiations on the definition of MSR, see 'Article 238', in M.H. Nordquist et al., United Nations Conference on the Law Sea 1982: A Commentary, Vol. IV (Martinus Nijhoff Publishers, 1991), at 438.
31. See Report on the Work of the United Nations Open-Ended Informal Consultative Process, n. 16 above, para. 92.
32. See Addendum Report of the Secretary General, n. 2 above, para. 202.
33. See Report of the Ad Hoc Open-Ended Informal Working Group, n. 17 above, para. 29; and Intervention by the Mexican Delegation at the Ad Hoc Open-Ended Informal Working Group - Item 5 (B) Scientific, Technical, Economic, Environmental, Socio-Economic, and Legal Issues (New York, 14 February 2005), available at http://www.un.int/mexico/2006/ interv_021406ing.htm.
34. For an analysis of the relation between bioprospecting and MSR, see T. Scovazzi, 'Mining, Protection of the Environment, Scientific Research and Bioprospecting: Some Considerations on the Role of the International Seabed Authority', 19:4 The International Journal of Marine and Coastal Law (2004), 383, at 399.
35. See UNCLOS, n. 22 above, Article 246.5(a).
36. Regulations on Prospecting and Exploration for Polymetallic Nodules (ISBA/6/A/18, 4 October 2000), Annex, Regulation 1(3)(e), available at http://www.isa.org.jm/en/default.htm.
37. See UNCLOS, n. 22 above, Article 87.
38. Ibid., Article 143.1.
39. Ibid., Article 143.2.
40. Ibid., Article 143.3.
41. P. Oldham, Global Status and Trends in Intellectual Property Claims: Genomics, Proteomics and Biotechnology (Centre for Economic and Social Aspects of Genomics, 2004).
42. World Intellectual Property Organization, Understanding Industrial Property (Publication No 895(E)), available at http://www.wipo.int/ freepublications/en/intproperty/895/wipo_pub_895.pdf.
43. World Intellectual Property Organization, Intellectual Property Handbook: Policy, Law and Use (Publication No 489(E), 2004), at 18, available at http://www.wipo.int/about-ip/en/iprm/index.htm.
44. See P. Oldham, n. 41 above.
45. J. Jabour-Green and D. Nicol, 'Bioprospecting in Areas Outside National Jurisdiction: Antarctica and the Southern Ocean', 4:1 Melbourne Journal of International Law (2003), 76, at 88.
46. Organization for Economic Cooperation and Development, Genetic Inventions, Intellectual Property Rights and Licensing Practices: Evidence and Policies (OECD, 2002), available at http://www.oecd.org/ dataoecd/42/21/2491084.pdf. It is worth noting that while Canada allows patentability of single cell organisms, such as yeasts and bacteria, the Supreme Court of Canada found that higher life forms, in the specific case a modified mouse, were not patentable because they were not an invention as defined by Canada's Patent Act. See Harvard College v. Canada (Commissioner of Patents) [2002] 4 SCR 45. For a brief review of the practice in other States, see J. Jabour-Green and D. Nicol, n. 45 above, at 90-91.
47. J. Jabour-Green and D. Nicol, n. 45 above, at 92.
48. M. Gorina-Ysern and J.H. Jones, 'International Law of the Sea, Access and Benefit Sharing Agreements, and the Use of Biotechnology in the Development, Patenting and Commercialization of Marine Natural Products as Therapeutic Agents', 20 Ocean Yearbook (2006), 221, at 232.
49. Ibid., at 249, n. 108.
50. Agreement on Trade Related Aspects of Intellectual Property, Including Trade in Counterfeit Goods (Marrakesh, 15 April 1994) ('TRIPS Agreement').
51. Budapest Treaty on the International Recognition of the Deposit of Micro-organisms for the Purposes of Patent Procedure (Budapest, 28 April), Article 3(1).
52. Membership in the World Trade Organization entails automatic participation in the agreements concluded under its auspices.
53. See TRIPS Agreement, n. 50 above, Article 27(2).
54. Ibid., Article 27(3)(a).
55. Ibid., Article 27(3)(b).
56. Ibid., Article 28.
57. Ibid., Article 29.
58. For a review of technological constraints to carry out research in the deep sea, see Addendum Report of the Secretary General, n. 2 above, at 15-25.
59. See Budapest Treaty, n. 51 above, Articles 7 and 6(2).
60. See S. Arico and C. Salpin, n. 1 above, at 43.
61. Gorina-Ysern, who proposes a similar reasoning, also proposes a scenario according to which MSR activities shall not be used to assert any claims to the exclusive use and exploitation of data, samples and results arising from MSR activities. This, in our view, relates to the issue of wide dissemination of data and research results. See M. Gorina-Ysern, n. 20 above, at 369.
62. Pursuant to Articles 31 and 32 of the Vienna Convention on the Law of Treaties (Vienna, 23 May 1969), besides the ordinary meaning of the terms of a treaty, its preparatory work and the circumstances of its conclusion are a valid means of supplementary interpretation.
63. The Committee on the Peaceful Uses of the Seabed and the Ocean Floor Beyond the Limits of National Jurisdiction was mandated by General Assembly Resolution 2750C (XXV) of 17 December 1970 to study the elaboration of legal principles and norms to promote international cooperation in the exploration and use of the seabed and the ocean floor and the subsoil thereof beyond the limits of national jurisdiction. The Committee established Sub-Committee III to address the preservation of the environment and scientific research. At the first session of the Third United Nations Conference on the Law of the Sea (New York, 3-15 December 1973), it was decided that three committees would be established to deal each with the subject matter previously dealt with by the Seabed Committee. The Third Committee was entrusted with carrying out the work undertaken by Sub-Committee III of the Seabed Committee, and considered negotiating texts, which consolidated the work undertaken thus far. The texts examined by Sub-Committee III therefore form the basis for the final text of Part XIII of UNCLOS.
64. See 'Article 241', in M.H. Nordquist et al., n. 30 above, at 463.
65. See TRIPS Agreement, n. 50 above, Article 30.
66. Research Use of Patented Knowledge: A Review (OECD Working Paper 2006/2), available at http://www.oecd.org/dataoecd/15/16/36311146.pdf.
67. See TRIPS Agreement, n. 50 above, Article 31.
68. For a brief overview of the issues raised by compulsory licensing, see Organization for Economic Cooperation and Development, n. 46 above, at 72. See also World Trade Organization, Pharmaceutical Patents and the TRIPS Agreement, Technical Note (WTO, 21 September 2006), available at http://www.wto.org/english/tratop_e/trips_e/pharma_ato186_e.htm.
69. Working Paper submitted by the Canadian Delegation (A/AC/138/SC.III/ L.18, 25 July 1972), partly reproduced in Division for Ocean Affairs and the Law of the Sea, Office of Legal Affairs, Marine Scientific Research - Legislative History of Article 246 of the United Nations Convention on the Law of the Sea (United Nations Publications E.94.V.9, April 1994), at 11. During the general debate, the Canadian representative stated that 'the results of marine research should, where appropriate, be exempt from the principle of free and open access to all'; ibid., at 39.
70. Pursuant to the rules of procedure of the Third United Nations Conference on the Law of the Sea, the full records of the negotiations were never released in their entirety. Only those that attended all of the sessions from 1974 to 1982 would therefore be in a position to provide guidance on the concerns raised regarding intellectual property rights and proprietary information in the context of MSR.
71. See J. Jabour-Green and D. Nicol, n. 45 above, at 98.
72. Texts on Items 13 and 14 (Marine Scientific Research and Development and Transfer of Technology) (A/Conf.62/C.3/L.17, 23 August 1974), reproduced in Official Records of the Third United Nations Conference on the Law of the Sea, Second Session, Caracas, 20 June-29 August 1974 (Third Committee).
73. The OECD's Report on Genetic Inventions, Intellectual Property Rights and Licensing Practices (see n. 46 above) suggests that inflexible attitudes on the part of biotech patent owners have resulted in abusive monopoly positions relating to health screening tests. The report also recognizes that the public loses whether a strong system of intellectual property rights protection is, or is not, in place, because the price for medicines is high with an intellectual property rights system, but needed medicines and other therapeutic agents may not be produced without one in place.
74. See UNCLOS, n. 22 above, Preamble.
75. Ibid.