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Why the Nagoya Protocol to the Convention on Biological Diversity Matters to Science and Industry Everywhere

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Intellectual Property and Development: Understanding the Interfaces

Abstract

The once customary view that genetic resources, together with associated traditional knowledge, constituted the “Common Heritage of Mankind” was first directly challenged in 1962, when the United Nations adopted a Resolution on the sovereignty of states over national resources. By the 1990s, when the most developed countries were demanding universal respect for patented microbes and plant breeders’ rights under what eventually became the Agreement on Trade-Related Aspects of Intellectual Property Rights of 1994, the developing countries struck back with “biopiracy” claims of their own. Specifically, they argued that the downstream innovations protected by intellectual property rights in the Global North were often based on genetic resources taken from the biodiversity rich countries, along with associated traditional knowledge of indigenous populations. On this view, unauthorized use of these same genetic resources and traditional knowledge even for public research purposes constituted an illegal encroachment on their territorial sovereignty. In 1992, that thesis became firmly established in the Convention on Biological Diversity (CBD), now signed by some 190 countries. In effect, the CBD asserted territorial sovereignty over all genetic resources and related traditional knowledge, and it conditioned the rights of anyone—including research scientists—to remove or otherwise use such resources on the permission of the relevant government authorities. Taken together, the provisions of the CBD established the premises for an international regime of misappropriation with respect to unauthorized uses of genetic resources—plant, microbial, animal—and all related traditional knowledge originating from the territories of nation states adhering to the CBD. Reasonable as these arrangements may sound, however, they are in practice onerous and often unworkable from the scientific researchers’ perspective. In the first place, provider countries have been slow to enact implementing legislation, and once enacted, these laws tend to be diverse, complicated, and often full of both legal and practical uncertainties. Second, there is no consensus regarding access and benefit-sharing obligations applicable to genetic resources acquired before 1993, when the CBD took effect. This same problem will resurface with the adoption of the Nagoya Protocol to the CBD in 2010.

Bunyan S. Womble Professor of Law, Duke University School of Law, Durham, North Carolina, US. Published by the Center for International Governance Innovation (CIGI), Toronto, Canada (2017). Reprinted here with the permission of CIGI. Jerome H. Reichman©2017.

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Notes

  1. 1.

    See, e.g., McCluskey et al. (2017), stating that “Access to living resources has been foundational to research, health care, agriculture, and industry since the beginning of modern biology”; Godt (2013), pp. 246–268.

  2. 2.

    See Kamau (2013), p. 343, fn. 1.

  3. 3.

    See generally Reichman et al. (2016), Chapter 2, Section I, “Historical importance of genetic resources as global public goods.”

  4. 4.

    CGIAR, Crop Genebank Knowledge Base, http://cropgenebank.sgrp.cgiar.org. Accessed December 2014. See e.g., Halewood (2010). See generally Reichman et al. (2016), pp. 46–50, pp. 112–115, pp. 121–130, explaining the role of the CGIAR under the International Treaty on Plant Genetic Resources for Food and Agriculture of 2001.

  5. 5.

    World Federation for Culture Collections, http://www.wfcc.info/about/. Accessed October 2014. See, e.g., Smith et al. (2013).

  6. 6.

    See generally Reichman et al. (2016), Chapter 1, pp. 37–82, “Between public and private goods: Emergence of the transnational research commons for plant and microbial genetic resources.” One of the world’s major suppliers of ex situ genetic resources—the American Type Culture Collection—has operated on a commercial basis since losing US government funding in the 1960s. See American Type Culture Collection, About ATCC, https://www.lgcstandards-atcc.org/en/About/About_ATCC.aspx. Accessed December 2017.

  7. 7.

    See Food and Agricultural Organization of the United Nations, International Undertaking on Plant Genetic Resources, Resolution 8/83, 22nd Session, 5–23 November 1983. See further Reichman et al. (2016), pp. 50–52, “Short-lived recognition of plant genetic resources as the common heritage of mankind.”

  8. 8.

    See Permanent Sovereignty Over Natural Resources, G.A. Resolution 1803 (XVII), UN Doc. A/RES/1803, 14 December 1962. For a skeptical view of claims to ex situ genetic resources, based on a misunderstood interpretation of the “common heritage” principle, see Curci (2010), p. 9. See also Dutfield (2004), pp. 5–6. For the demise of the common heritage principle and its implications, particularly for plant genetic resources, see Reichman et al. (2016), Chapter 2, Sections I.B and III.A.

  9. 9.

    Agreement on Trade-Related Aspects of Intellectual Property Rights, 15 April 1994, 108 Stat. 4809, 1869 UNTS 299, Article 27; International Convention for the Protection of New Varieties of Plants, 2 December 1961, 33 UST 2703, 815 UNTS 89 (as subsequently amended) 1978 and 1991. See, e.g., Santilli (2012). Plant Variety Protection systems protected new plant varieties that are distinct, uniform, and stable for a limited period of time, initially on a copyright-like model, eventually on a patent-like model. See Reichman (1994), pp. 2465–2472.

  10. 10.

    See, e.g., Burton (2004), pp. 3–4. See also Laird (2002).

  11. 11.

    Convention on Biological Diversity, 5 June 1992, 1760 UNTS 79.

  12. 12.

    US Department of State, Treaties Pending in the Senate (as of May 2017), https://www.state.gov/s/l/treaty/pending/. Accessed December 2017.

  13. 13.

    See, e.g., Maskus (2013); Yu (2007); Reichman (1998).

  14. 14.

    See, e.g., Kamau and Winter (2009); Andersen (2008); McManis, (2007); Dutfield (2004).

  15. 15.

    See CBD, Articles 2, 8, 15–16, 19–20.

  16. 16.

    See CBD, Article 15(2).

  17. 17.

    See CBD, Article 15(4).

  18. 18.

    See CBD, Article 15(5).

  19. 19.

    See CBD, Article 15(7).

  20. 20.

    See CBD, Article 8(j).

  21. 21.

    See CBD, Article 16(3).

  22. 22.

    See, e.g., Young et al. (2009), p. 117. See further Reichman et al. (2016), pp. 91–99.

  23. 23.

    See CBD, Articles 20–21.

  24. 24.

    See, e.g, Young et al. (2009), pp. 98–116.

  25. 25.

    See further Reichman et al. (2016), pp. 91–96 (citing authorities).

  26. 26.

    See, e.g., Bagley and Rai (2013), pp. 16–17. See also Darrell and Dutfield (1996), pp. 147–153, stressing the need for overseas collectors to fulfil conditions acceptable to local providers of biological resources before access is granted as well as the rights of local communities to veto commercial applications and to share the benefits when they agree to commercialization, p. 147.

  27. 27.

    See, e.g., Bagley and Rai (2013), pp. 17–20. See further Greiber et al. (2012) pp. 72–73.

  28. 28.

    Tenth Meeting of the Conference of the Parties to the Convention on Biological Diversity, Nagoya, Japan, 18–29 October 2010, Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity (hereinafter Nagoya Protocol), entered into force on 2 October 2014, after the deposit of the fiftieth instrument of ratification, acceptance, approval, or accession available at http://www.cbd.int/abs/doc/protocol/nagoya-protocol-en.pdf. Accessed February 2014. See also Sixth Meeting of the Conference of the Parties to the Convention on Biological Diversity, The Hague, Netherlands, 17–19 April 2002, Bonn Guidelines on Access to Genetic Resources and Equitable Sharing of the Benefits Arising Out of Their Utilization, UN Doc. UNEP/CBD/COP/6/20, Annex 2, 27 May 2002 (hereinafter Bonn Guidelines).

  29. 29.

    See infra notes 59–82 and accompanying text.

  30. 30.

    See, e.g., Oguamanam (2011), pp. 108–111. See also ATCC, About ATCC, supra note 6.

  31. 31.

    See ATCC, supra note 6. See further Reichman et al. (2016), Chapter 4, “The existing microbial research commons confronts proprietary obstacles.”

  32. 32.

    See Reichman et al. (2016), pp. 100–106, “The threat to public scientific research on plant and microbial genetic resources.”

  33. 33.

    See Reichman et al. (2016), pp. 106–110, “Major weaknesses of the bilateral approach.” See also pp. 250–256.

  34. 34.

    See Reichman et al. (2016), pp. 111–118.

  35. 35.

    See Reichman et al. (2016), Chapter 8, “Fully exploiting data-intensive research opportunities in the networked environment.”

  36. 36.

    See J. H. Reichman, P. F. Uhlir and T. Dedeurwaerdere, Chapter 4, pp. 170–198 (citing authorities). But see Chapter 4, Section III, “Contractual restrictions on access to and use of upstream microbial genetic resources in both developed and developing countries” and Chapter 4, Section III, “The research community pushes back.”

  37. 37.

    See, e.g., Smith (2012), pp. 75–76; Kurtzman, (2011), p. 55; Byerlee and Dubin (2010), pp. 456–457.

  38. 38.

    See, e.g., WFCC (1996). See also European Parliament and Council Regulation (EU) No 511/2014 of 16 April 2014 on Compliance Measures for Users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization in the Union, 2014 OJL 150/59 (hereinafter EU Regulation 511/2014).

  39. 39.

    See Reichman et al. (2016), Chapter 3, Section II, pp. 111–117, “Destabilizing the exchange of plant and microbial genetic resources as global public goods.”

  40. 40.

    International Treaty on Plant Genetic Resources for Food and Agriculture, 3 November 2001, 2400 UNTS 303, entered into force 29 June 2004.

  41. 41.

    See, e.g., Helfer (2005), pp. 217–219.

  42. 42.

    See ITPGRFA, Articles 5–6. For specific crops covered so far, see ITPGRFA, Annex I.

  43. 43.

    See ITPGRFA, Articles 10–15. The Treaty also envisioned that in situ plant genetic resources residing in the public domain of provider countries would likewise be placed under the multilateral regime, but these provisions have so far not been implemented. See ITPGRFA, Articles 4 and 7. For further details about ITPGRFA, see Reichman et al. (2016), pp. 119–130. For the SMTAs, see id, Chapter 3, Section III.B.2.

  44. 44.

    See ITPGRFA, Articles 10–15. See further Kamau (2013), p. 140, pp. 147–148.

  45. 45.

    See ITPGRFA, Article 12.3(b)(e); Kamau (2013), pp. 347–348.

  46. 46.

    See ITPGRFA, Articles 10–15; Reichman et al. (2016), pp. 119–130 (citing authorities). For analysis of the Governing Body, see id, pp. 496–504.

  47. 47.

    Compare Reichman et al. (2016), “Demonstrable achievements”, pp. 131–135 with “Major weaknesses”, pp. 135–142.

  48. 48.

    See FAO Conference, Commission on Genetic Resources for Food and Agriculture, Standard Material Transfer Agreement (2006), 6(8), available at http://www.planttreaty.org/contents/drafting_standard_material_transfer_agreement. Accessed December 2017.

  49. 49.

    See ITPGRFA, Article 13(3). However, a general notification of use must be sent to the Governing Body.

  50. 50.

    See further Reichman et al. (2016), pp. 496–499, “A two-headed governance construct.”

  51. 51.

    Eight CGIAR affiliated IARCs, with a total of nearly 700,000 ex situ accessions, were parties to this agreement. See I. Lopez Noriega et al. (2013), p. 199, p. 205.

  52. 52.

    For details, see Reichman et al. (2016), pp. 121–130 (citing authorities).

  53. 53.

    Interview with Dr. Shakheel Bhatti, former Director General of the ITPGRFA, October 10, 2016.

  54. 54.

    See Halewood et al. (2013), p. 101; Lopez Noriega et al. (2013), pp. 205–206.

  55. 55.

    See Communications by the Secretariat (2016).

  56. 56.

    See Communications by the Secretariat (2016).

  57. 57.

    See Communications by the Secretariat (2016).

  58. 58.

    See Nagoya Protocol, above Note 28.

  59. 59.

    See id, Articles 1–3, 16. For broad definitions of “utilization of genetic resources”, “biotechnology”, and “derivatives”, all covered by the CBD, see especially Nagoya Protocol, Article 2.

  60. 60.

    See, e.g., Nijar (2011), p. 35.

  61. 61.

    See Report of the meeting of the group of legal and technical experts on concepts, terms, working definitions, and sectoral approaches, UN Doc. UNEP/CBD/WC-ABS/7/2, 12 December 2008.

  62. 62.

    See Nagoya Protocol, Articles 6–7, 12–16.

  63. 63.

    See Nagoya Protocol, Articles 7, 12 and 16. According to Prof. Nijar, “nothing in the Protocol allows for access to publicly available [Traditional Knowledge] or [Traditional Knowledge] that is diffused and has no identifiable holders (and is consequently held by the State) without PIC and MAT.” See Nijar (2011), p. 36.

  64. 64.

    See Nagoya Protocol, Article 11.

  65. 65.

    See Nagoya Protocol, Articles 15–16.

  66. 66.

    See Nagoya Protocol, Article 19.

  67. 67.

    See Nagoya Protocol, Articles 6, 13, 15–16, 17(2).

  68. 68.

    See Nagoya Protocol, Articles 6–7, 17(3).

  69. 69.

    See TRIPS Agreement, Articles 41–61.

  70. 70.

    See TRIPS Agreement, Articles 51–60.

  71. 71.

    See Nagoya Protocol, Articles 11, 14–18.

  72. 72.

    See TRIPS Agreement, Article 13.

  73. 73.

    See Nagoya Protocol, Articles 11, 14–18.

  74. 74.

    See Nagoya Protocol, Articles 5(4), 8(a), 9 (promoting research). See also Kamau et al. (2010), p. 256 (envisioning future work on issues of scientific research).

  75. 75.

    See Nagoya Protocol, Articles 4(1), (4). The Preamble to the Nagoya Protocol also expressly acknowledges the fundamental role of the ITPGRFA “for achieving food security worldwide and for sustainable development of agriculture …and climate change,” and for the multilateral system of access and benefit-sharing to be established under the Treaty.

  76. 76.

    See Nagoya Protocol, Articles 4(2), 4(4). The Preamble also expressly acknowledges the importance of the World Health Organization’s efforts to ensure “access to human pathogens for public health preparedness and response purposes.” These efforts culminated in the WHO’s Pandemic Influenza Preparedness Framework in 2011. See World Health Organization (2011). For basic concepts of the PIP Framework and its lessons for analogous pooling arrangements in the future, see Reichman et al. (2016), pp. 233–249.

  77. 77.

    See Nagoya Protocol, Article 8(a). See further Kamau et al. (2010), pp. 258–259.

  78. 78.

    See supra notes 42–46 and accompanying text. For a detailed analysis of the “take and pay” regime (technically a “liability rule” and not an “exclusive property right”) as embodied in the ITPGRFA, see Reichman et al. (2016), pp. 118–142 (analyzing both strengths and weaknesses of the regime).

  79. 79.

    SMTAs can thus cure the legal ambiguity concerning the applicability of the CBD to pre-1993 ex situ genetic resources and related traditional knowledge. See, e.g., Nijar, (2011), p. 34, concerning “Temporal scope.”

  80. 80.

    See ITPGRFA, Articles 13, 16(d)(ii). For the relevant SMTA, see FAO Conference, Commission on Genetic Resources for Food and Agriculture, Standard Material Transfer Agreement (2006), Articles 2, 6, 7 and 8. See generally Halewood (2014). See Reichman et al. (2016), pp. 125–130, “Notification, benefit-sharing and the SMTA” under ITPGRFA.

  81. 81.

    See, e.g., Nagoya Protocol, Article 10, “Global multilateral benefit-sharing mechanism.”

  82. 82.

    See supra note 63 and accompanying text.

  83. 83.

    See Nagoya Protocol, Article 4. See also supra notes 74–76 and accompanying text.

  84. 84.

    See supra notes 3–6 and accompanying text.

  85. 85.

    See Nagoya Protocol, Articles 4–5, 8, 15–16; supra notes 74–77 and accompanying text.

  86. 86.

    See, e.g., Reichman et al. (2016), pp. 214–219, “The core MTA of the European Union Culture Collections Organization.” See also pp. 528–538, “The Global Biological Resource Centers Network (GBRCN)”; id., pp. 542–544, “The microbial research infrastructure (MIRRI).” See generally Smith and Desmeth (2007).

  87. 87.

    See EU Regulation 511/2014.

  88. 88.

    See, e.g., Reichman et al. (2016), pp. 219–225.

  89. 89.

    See EU Regulation 511/2014, Preamble and Articles 3–5, 21.

  90. 90.

    See EU Regulation 511/2014, Articles 4–5.

  91. 91.

    See EU Regulation 511/2014, Article 5(3). See also Davis et al. (2013).

  92. 92.

    See EU Regulation 511/2014, Articles 6–7. See generally, Reichman et al. (2016), pp. 221–225.

  93. 93.

    See EU Regulation 511/2014, Preamble, para. 27.

  94. 94.

    See EU Regulation 511/2014, Preamble, paras. 3, 6, 9, 10.

  95. 95.

    See supra notes 15–25 and accompanying text.

  96. 96.

    See Nagoya Protocol, Article 4(4), legitimizing “specialized international access and benefit-sharing instrument[s]… consistent with… the objectives of the Convention and this Protocol” that may arise in the future. See further Godt (2013), p. 258.

  97. 97.

    See supra notes 75–76 and accompanying text.

  98. 98.

    See supra notes 75–83 and accompanying text.

  99. 99.

    For the geographical scope of the WFCC’s microbial culture collections, see generally Reichman et al. (2016), Chapter 4, “The existing microbial research commons confronts proprietary obstacles”, pp. 167–199 (citing authorities).

  100. 100.

    See, e.g., Reichman et al. (2016), pp. 130–142, “Strengths and weaknesses of the ITPGRFA.”

  101. 101.

    See generally Reichman et al. (2016), Chapter 9, “Institutional models for a transnational research commons”, pp. 473–566. See also Chapter 10, pp. 579–651 (describing a proposed new governance model for a redesigned Microbial Research Commons).

  102. 102.

    See supra notes 43–46 and accompanying text.

  103. 103.

    See Nagoya Protocol, Article 4(1).

  104. 104.

    See Nagoya Protocol, Articles 4(2)–4(4). Cf. supra notes 42–50 and accompanying text (ABS under the ITPGRFA).

  105. 105.

    For a survey of different governance models, see supra note 101.

  106. 106.

    See supra notes 67–99 and accompanying text.

  107. 107.

    See, e.g., Lassen et al. (2016), pp. 7–12. See also Kamau et al. (2010), p. 255.

  108. 108.

    See Lassen et al. (2016), pp. 13–14.

  109. 109.

    See Lassen et al. (2016), pp. 15–16.

  110. 110.

    See Lassen et al. (2016).

  111. 111.

    See Kamau et al. (2010), p. 252, citing Nagoya Protocol, Articles 5(2), 5(5), 6.2(f) and 7.

  112. 112.

    See Nagoya Protocol, Article 12(2).

  113. 113.

    See Nagoya Protocol, Articles 12(1) and 12(3). See further Kamau et al. (2010), p. 252 (also stressing the need for capacity building under Nagoya Protocol, Article 22).

  114. 114.

    See Reichman et al. (2016), Chapter 9, Part II.

  115. 115.

    For on empirical view of such a regime, see the Global Biological Resources Centers Network Demonstration Project, discussed at length in Reichman et al. (2016), pp. 526–541.

  116. 116.

    See, e.g., Kamau et al. (2010), p. 256 (emphasizing uncertainties regarding basic research under Articles 5(2) and 6(3) of the Nagoya Protocol still to be worked out by the drafters of model ABS Agreements).

  117. 117.

    See, e.g., supra notes 47–50 and accompanying text.

  118. 118.

    For detailed proposals to this effect, see Reichman et al. (2016), Chapter 5, Part II, “Designing a third option: Ex ante ‘take and pay’ rules for stimulating research and applications”, pp. 260–319. For related governance considerations, see Chapter 10, Part III, “Implementing the multilateral regime for facilitated access to ex situ microbial genetic resources”, pp. 598–650.

  119. 119.

    See Reichman et al. (2016), pp. 73–174 (unique strain identifiers in WFCC standard practice).

  120. 120.

    See supra notes 47–50 and accompanying text.

  121. 121.

    See Reichman et al. (2016), pp. 426–429 and pp. 624–628 (discussing WDCM).

  122. 122.

    See generally Reichman et al. (2016), pp. 495–504, “The global crop commons: A treaty based intergovernmental entity.”

  123. 123.

    See generally id., Chapter 10, pp. 579–598, “Organizational and structural considerations.”

  124. 124.

    See generally id., Chapter 9, Part II, pp. 494–544, “Selected empirically relevant governance approaches.”

  125. 125.

    See generally id., Part III, “In search of a politically acceptable and scientifically productive operational framework”, pp. 544–567.

  126. 126.

    See, e.g., Frischmann et al. (2014); Ostrom (1996).

  127. 127.

    See Collaborative Management Platform for Detection and Analysis of (Re-)emerging and Foodborne Outbreaks in Europe (COMPARE), http://www.compare-europe.eu/about. Accessed September 2017. See also id., Pilot Project on Machine Learning and Anti-Microbial Resistance, 2017.

  128. 128.

    See supra note 76 and accompanying text.

  129. 129.

    See supra note 121 and accompanying text.

  130. 130.

    See National Research Council (2009). See further Reichman et al. (2016), pp. 19–36.

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  1. Duke University, Durham, North Carolina, USA

    Jerome H. Reichman

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  1. Jerome H. Reichman
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Correspondence to Jerome H. Reichman .

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  1. Centre for Interdisciplinary Studies on Industrial Property and Economics Law (CEIDIE), University of Buenos Aires, Buenos Aires, Argentina

    Carlos Correa

  2. Centre for International Intellectual Property Studies (CEIPI), Université de Strasbourg, Strasbourg, France

    Xavier Seuba

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Reichman, J.H. (2019). Why the Nagoya Protocol to the Convention on Biological Diversity Matters to Science and Industry Everywhere. In: Correa, C., Seuba, X. (eds) Intellectual Property and Development: Understanding the Interfaces. Springer, Singapore. https://doi.org/10.1007/978-981-13-2856-5_14

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  • DOI: https://doi.org/10.1007/978-981-13-2856-5_14

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