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Intellectual Property from a Global Environmental Law Perspective: Lessons from Patent Disclosure Requirements for Genetic Resources and Traditional Knowledge

Published online by Cambridge University Press:  28 August 2019

Claudio Chiarolla*
Affiliation:
Regional project specialist and international law adviser specialized in intellectual property law and biodiversity governance, Istanbul (Turkey). Email: [email protected]; https://www.linkedin.com/in/claudiochiarolla/.

Abstract

This commentary considers the intellectual property (IP) system from a global environmental law perspective by exploring the extent to which patent-related treaties, such as the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights and the World Intellectual Property Organization Patent Cooperation Treaty, can facilitate implementation of global environmental standards in the field of biodiversity law. It provides practical guidance to countries that wish to introduce patent disclosure-related mechanisms into their legal systems with a view to mainstreaming instances of global justice, fairness and equity, and raises awareness of the limitations arising from their extant IP obligations. Global environmental law standards have exercised an undeniable influence on the political discourse in international IP policy making in the field of patent disclosure. Still, many patent disclosure requirements that pre-date the Nagoya Protocol apply only to genetic resources the provenance of which is the same country that established the requirement. However, if a country designates its patent or IP office as a compliance checkpoint under the Nagoya Protocol, then the disclosure requirement should encompass at least the genetic resources originating from all countries that are contracting parties to this instrument. This could allow the fulfilment of a core monitoring obligation of the latter, while enabling wider synergies and transparency within the IP system.

Type
Symposium Commentary
Copyright
Copyright © Cambridge University Press 2019 

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Footnotes

This contribution is part of a collection of articles growing out of the conference ‘Global Environmental Law’, held at the Strathclyde Centre for Environmental Law and Governance, University of Strathclyde, Glasgow (United Kingdom), 4–5 Sept. 2017.

The views expressed in this commentary are solely those of the author and they are expressed in his personal capacity. The author would like thank Elisa Morgera, Alejandro Lago, and three anonymous reviewers for Transnational Environmental Law for feedback on previous versions of this commentary. Sections 2, 3 and 4 of the commentary are based on the World Intellectual Property Organization (WIPO) Study, Key Questions on Patent Disclosure Requirements for Genetic Resources and Traditional Knowledge (WIPO, 2017) by Claudio Chiarolla and Burcu Kılıç, used under CC BY 3.0 IGO. This work is licensed under CC BY 3.0 IGO by Claudio Chiarolla. Substantive modifications, adaptations and improvements have been made from the original work, which may be found on the WIPO website, available at: http://www.wipo.int/publications/en/details.jsp?id=4194b.

References

1 S.A. Laird, ‘Bioscience at a Crossroads: Access and Benefit Sharing in a Time of Scientific, Technological and Industry Change’ (CBD Secretariat, 2013), available at: https://www.cbd.int/abs/policy-brief.

2 Nagoya (Japan), 29 Oct. 2010, in force 12 Oct. 2014, available at: https://www.cbd.int/abs/doc/protocol/nagoya-protocol-en.pdf.

3 Rio de Janeiro (Brazil), 5 June 1992, in force 29 Dec. 1993, available at: http://www.cbd.int/convention.

4 Robinson, D.F., Confronting Biopiracy: Challenges, Cases and International Debates (Earthscan, 2010)CrossRefGoogle Scholar.

5 Papadopoulou, F., The Protection of Traditional Knowledge on Genetic Resources (Edward Elgar, 2018)CrossRefGoogle Scholar.

6 In her last report, the Special Rapporteur on the Rights of Indigenous Peoples was ‘gravely concerned at the drastic increase in attacks and acts of violence against, criminalization of and threats aimed at indigenous peoples, particularly those arising in the context of large-scale projects involving extractive industries, agribusiness, infrastructure, hydroelectric dams and logging. These violations are occurring in the context of intensified competition for and exploitation of natural resources’: V. Tauli-Corpuz, ‘Report of the Special Rapporteur on the Rights of Indigenous Peoples to the 39th Session of the Human Rights Council, 10–28 Sept. 2018’, UN Doc. A/HRC/39/17, 10 Aug. 2018, para. 4, available at: http://unsr.vtaulicorpuz.org/site/images/docs/annual/2018-annual-a-hrc-39-17-en.pdf. See also BeneLex Project, BeneLex Learning Module on Benefit-Sharing and the Rights of Indigenous Peoples over Natural Resources, Jan. 2019, available at: https://namati.org/resources/benelex-learning-module-benefits-rights-indigenous-peoples-natural-resources.

7 Global justice can be understood broadly as ‘any conception of justice that treats the planet as a whole as the ultimate unit of assessment’: Walker, N., ‘The Gap between Global Law and Global Justice: A Preliminary Analysis’, in Halpin, A. & Roughan, N. (eds), In Pursuit of Pluralist Jurisprudence (Cambridge University Press, 2017), pp. 216–38CrossRefGoogle Scholar; also available in Edinburgh School of Law Research Paper No. 2016/30, 21 Dec. 2016, pp. 11–2, available at: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2888557.

8 B. Kılıç, ‘Patent Disclosure Requirements in Free Trade Agreements’, paper commissioned by the Centre for WTO Studies for the International Conference on TRIPS-CBD linkages, Geneva (Switzerland), 7–8 June 2018, available at: http://wtocentre.iift.ac.in/workingpaper/WorkingPaper49.pdf.

9 G. Dutfield, ‘What is Biopiracy?’, paper presented at the International Expert Workshop on Access to Genetic Resources and Benefit Sharing, Cuernavaca (Mexico), 24–27 Oct. 2004, available at: http://moderncms.ecosystemmarketplace.com/repository/moderncms_documents/I.3.pdf.

10 Act on the Protection of Access to Peruvian Biological Diversity and the Collective Knowledge of Indigenous Peoples, Law No. 28216, 30 Apr. 2004, para. 3 of the supplementary and final provisions, available at: https://wipolex.wipo.int/en/text/497328.

11 In the context of the CBD and the Nagoya Protocol, the expression ‘contracting party’, whether in the singular or plural form, refers to any country that has consented to be bound by these treaties. In the above example, such providing party shall be also a ‘legitimate provider’ in the sense that it must be either ‘the country of origin of such resources or a party that has acquired the genetic resources in accordance with the [CBD]’: Art. 5.1 Nagoya Protocol.

12 However, such monitoring obligations apply only to the utilization of genetic resources. The Nagoya Protocol does not include any obligation to monitor the use of traditional knowledge associated with genetic resources. From the perspective of developing countries and traditional knowledge holders, this is one of the most important gaps, which was left entirely unresolved during the negotiations of the Nagoya Protocol. For a critical account of how this gap came into being, see Nijar, G.S., The Nagoya Protocol on Access and Benefit Sharing of Genetic Resources: An Analysis (Centre of Excellence for Biodiversity Law in collaboration with University of Malaya, 2011), pp. 34Google Scholar, 29 & box 3, available at: https://www.mybis.gov.my/pb/1631.

13 Chiarolla, C. & Kılıç, B., Key Questions on Patent Disclosure Requirements for Genetic Resources and Traditional Knowledge (WIPO, 2017), p. 50Google Scholar, available at: https://www.wipo.int/publications/en/details.jsp?id=4194b.

14 WIPO, ‘Disclosure Requirements Table’, in Chiarolla & Kılıç, n. 13 above, Annex, pp. 62–91; also separately available at: https://www.wipo.int/export/sites/www/tk/en/documents/pdf/genetic_resources_disclosure.pdf.

15 CBD, n. 3 above.

16 For instance, Correa argues that ‘[t]he incorporation of [patent disclosure] requirements into national laws has addressed some of the concerns of developing countries regarding the misappropriation of these resources and knowledge. However, their effectiveness is likely to be limited in the absence of an international rule that sets out the terms of the obligation and the consequences of non-compliance. This limitation is particularly problematic if the obligation is not recognized and enforced in the markets where the commercialization of the protected inventions may be most profitable’: C.M. Correa, ‘A Possible Plurilateral Framework to Address the Misappropriation of Genetic Resources and Traditional Knowledge’, paper commissioned by the Centre for WTO Studies for the International Conference on TRIPS-CBD Linkages, Geneva (Switzerland), 7–8 June 2018, p. 1, available at: http://wtocentre.iift.ac.in/workingpaper/WorkingPaper50.pdf (emphasis in original).

17 P. Oldham & G. Burton, ‘Defusing Disclosure in Patent Applications’, UN Doc. UNEP/CBD/COP/10/INF/44, 24 Oct. 2010, available at: https://www.cbd.int/doc/meetings/cop/cop-10/information/cop-10-inf-44-en.pdf; and Oldham, P., Hall, S. & Forero, O., ‘Biological Diversity in the Patent System’, PLOS ONE, e78737, 12 Nov. 2013CrossRefGoogle ScholarPubMed, available at: https://doi.org/10.1371/journal.pone.0078737.

18 B. Pisupati, ‘The Ten Questions to be Addressed while Developing National ABS Frameworks’ (2015) Forum for Law, Environment, Development and Governance, pp. 16–7, available at: https://unctad.org/meetings/en/Contribution/ditc-ted-18102016-10-Questions-on-ABS.pdf.

19 In the context of the WIPO Intergovernmental Committee (IGC) see, e.g., Bagley, M.A., ‘Of Disclosure “Straws” and IP System “Camels”: Patents, Innovation, and the Disclosure of Origin Requirement’, in Robinson, D., Roffe, P. & Abdel-Latif, A. (eds), Protecting Traditional Knowledge: The Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (Routledge/Earthscan Press, 2017), pp. 85107Google Scholar; D. Muyldermans, ‘Genetic Resources, Traditional Knowledge and Disclosure Obligations: Some Observations from the Life Science Industry’, in Robinson, Roffe & Abdel-Latif, ibid., pp. 230–6; G. Bauer, C.M. Berger & M. Girsberger, ‘Disclosure Requirements: Switzerland's Perspective’, in Robinson, Roffe & Abdel-Latif, ibid., pp. 244–52. See also WTO, ‘Draft Decision to Enhance Mutual Supportiveness between the TRIPS Agreement and the Convention on Biological Diversity’, WTO Doc. TN/C/W/59, 19 Apr. 2011, available at: http://docsonline.wto.org/imrd/directdoc.asp?DDFDocuments/t/tn/c/W59.doc; and WIPO, ‘Consolidated Document Relating to Intellectual Property and Genetic Resources’, second revision, as at the close of IGC 36 on 29 June 2018), available at: https://www.wipo.int/meetings/en/doc_details.jsp?doc_id=433262.

20 For such analysis, see Chiarolla & Kılıç, n. 13 above. However, this commentary does provide selected examples of relevant national or regional laws to illustrate some general features of extant patent disclosure requirements in Sections 2, 3 and 4 below.

21 Washington, DC (US), 19 June 1970, in force 24 Jan. 1978, modified 3 Oct. 2001, available at: https://wipolex.wipo.int/en/text/288637. Admittedly, the WIPO PCT system has an undeniable economic importance: see Section 5.2 below. However, the PCT system has attracted only limited interest in this area, mainly because the main proposal to amend the PCT (and the WIPO Patent Law Treaty) is associated with the idea that the introduction of such disclosure requirements would remain voluntary and without any (mandatory) consequences for non-compliance: WIPO, ‘Proposals by Switzerland regarding the Declaration of the Source of Genetic Resources and Traditional Knowledge in Patent Applications’, WIPO Doc. PCT/R/WG/5/11 Rev., 19 Nov. 2003, available at: https://www.wipo.int/edocs/mdocs/pct/en/pct_r_wg_5/pct_r_wg_5_11_rev.pdf. See also Bauer, Berger & Girsberger, n. 19 above. Furthermore, developing country demandeurs of patent disclosure have a preference for addressing this issue in the WTO, where a mandatory dispute settlement system is readily available to enforce compliance.

22 Walker, N., Intimations of Public Law (Cambridge University Press, 2015), pp. 128CrossRefGoogle Scholar.

23 Walker (2016), n. 7 above, p. 11.

24 CBD, n. 3 above.

25 Art. 1 CBD.

26 Art. 15 CBD.

27 Lawson, C., ‘Patents and Access and Benefit-Sharing Contracts: Conservation or Just More Red Tape?’ (2011) 30(2) Biotechnology Law Report, pp. 23CrossRefGoogle Scholar, available at: https://research-repository.griffith.edu.au/handle/10072/44925. In the field of agriculture see Chiarolla, C., Intellectual Property, Agriculture and Global Food Security: The Privatisation of Crop Diversity (Edward Elgar, 2011), pp. 74109CrossRefGoogle Scholar.

28 E.g., in the context of the outstanding revision of Art. 27.3(b) of the WTO TRIPS Agreement (n. 65 below), a group of countries led by Brazil and India – which includes also Bolivia, Colombia, Cuba, Dominican Republic, Ecuador, Peru, Thailand, and supported by the African Group and other developing countries – have requested the amendment of the TRIPS Agreement to require patent applicants ‘to disclose the country of origin of genetic resources and traditional knowledge used in the inventions, evidence that they received “prior informed consent”, and evidence of “fair and equitable” benefit sharing’: see WTO, n. 19 above. See also Chiarolla, n. 27 above, pp. 135–7.

29 This example is adapted from Chiarolla & Kılıç, n. 13 above, p. 10.

30 A. Pollack, ‘Patenting Life: A Special Report. “Biological Products Raise Genetic Ownership Issues”’, The New York Times, 26 Nov. 1999, available at: https://www.nytimes.com/1999/11/26/business/patenting-life-special-report-biological-products-raise-genetic-ownership-issues.html.

31 Birch, G.G., Ingredients Handbook: Sweeteners, Ingredients Handbook Series (Leatherhead Food Research Association, 2000)Google Scholar.

32 B.G. Hellekant & D. Ming, ‘Brazzein Sweetener’, U.S. Patent 5326580, issued 5 Jul. 1994.

33 See ‘Pentadiplandra Brazzeana’ in World Heritage Encyclopedia (online), available at: http://www.gutenberg.us/articles/pentadiplandra_brazzeana#cite_note-doc-2.

34 Patents 5,326,580, 5,346,998 and 5,527,555.

35 Patent 684,995.

36 GRAIN, ‘Of Patents & Pirates’, GRAIN Reports, 25 July 2000, available at: https://www.grain.org/article/entries/53-of-patents-pi-ates?print=true.

37 Madeley, J., Hungry for Trade: How the Poor Pay for Free Trade (Zed Books, 2000), pp. 101–3Google Scholar.

38 House of Commons, Select Committee on Environmental Audit Appendices to the Minutes of Evidence, Nov. 1999, available at: http://www.publications.parliament.uk/pa/cm199900/cmselect/cmenvaud/45/4502.htm#evidence.

39 Carmody, P., The New Scramble for Africa (Polity Press, 2011), p. 1970Google Scholar.

40 Robinson, n. 4 above.

41 For an account of various pre-Nagoya Protocol attempts to modify patent law in European countries to meet various objections and public concerns regarding the patenting of traditional knowledge, see van Overwalle, G., ‘Holder and User Perspectives in the Traditional Knowledge Debate: A European View’, in McManis, C. (ed.), Biodiversity and the Law: Intellectual Property, Biotechnology and Traditional Knowledge (Earthscan, 2007), pp. 355–72, at 364–6Google Scholar.

42 For a full list of countries that provide patent disclosure provisions related to genetic resources and associated traditional knowledge, see WIPO, n. 14 above.

43 On the use of the term ‘indigenous peoples’ in the Nagoya Protocol context, see UN Environment Programme, ‘Decision on the Use of the Term “Indigenous Peoples and Local Communities”’, UN Doc. CBD/NP/MOP/DEC/2/7, 10 Dec. 2016, available at: https://www.cbd.int/doc/decisions/np-mop-02/np-mop-02-dec-07-en.pdf.

44 ‘Megadiverse countries’ is a term used to refer to the world's top biodiversity-rich countries: UNEP World Conservation Monitoring Centre, ‘Megadiverse Countries’, available at: http://www.biodiversitya-z.org/content/megadiverse-countries.

45 In the CBD context, the term ‘prior informed consent’ refers to the permission given from the competent national authority of a provider country to a user prior to accessing genetic resources or associated traditional knowledge, in line with the applicable legal and institutional framework. The term ‘mutually agreed terms’ refers to an agreement reached between the providers of genetic resources or associated traditional knowledge and the users on the conditions of access and use of such resources and knowledge, and the benefits to be shared between both parties: WTO, ‘The TRIPS Agreement and Convention on Biological Diversity’, WTO Doc. IP/C/W/368/Rev.1, revised 8 Feb. 2006, pp. 28–31, available at: https://docs.wto.org/dol2fe/Pages/FE_Search/FE_S_S009-DP.aspx?language=E&CatalogueIdList=71013,62129,31989,25697,49523&CurrentCatalogueIdIndex=1&FullTextHash=&HasEnglishRecord=True&HasFrenchRecord=True&HasSpanishRecord=True.

46 Correa, n. 16 above.

47 Hammond, E., Patent Claims on Genetic Resources of Secret Origin (Third World Network (TWN), 2014)Google Scholar, and Hammond, E., More Patent Claims on Genetic Resources of Secret Origin: An Update on Disclosure of Origin in Patent Applications under the [WIPO] Budapest Treaty (TWN, 2016)Google Scholar, available at: https://www.twn.my/title2/series/bkr/bkr004.htm.

48 Information about the origin or source of genetic resources and traditional knowledge may be disclosed voluntarily in a patent application if the applicant believes that it would be required to meet the requirements for patentability, such as novelty, inventive step, and industrial application. It is only in such cases that this information may be considered to be ‘material’ to the patentability of the claimed invention. On conventional disclosure under patent law, see WIPO, ‘Technical Study on Disclosure Requirements in Patent Systems Related to Genetic Resources and Traditional Knowledge’, 2004, p. 2, available at: https://www.wipo.int/publications/en/details.jsp?id=282&plang=EN.

49 For an overview of the WIPO IGC, see D. Robinson, P. Roffe & A. Abdel-Latif, ‘Introduction: Mapping the Evolution, State-of-Play and Future of the WIPO IGC’, in Robinson, Roffe & Abdel-Latif, n. 19 above, pp. 3–9.

50 Chiarolla, C., ‘The Role of Private International Law under the Nagoya Protocol’, in Morgera, E., Buck, M. & Tsioumani, E. (eds), The Nagoya Protocol in Perspective: Implications for International Law and Implementation Challenges (Brill/Martinus Nijhoff, 2013), pp. 423–49Google Scholar.

51 See, e.g., the Patents Amendment Act 2005 of South Africa, Art. 2, available at: https://www.wipo.int/tk/en/databases/tklaws/articles/article_0021.html (which states that an ‘indigenous biological resource’ means an indigenous biological resource as defined in section 1 of the National Environmental Management: Biodiversity Act, 2004 (Act No. 10 of 2004)).

52 See Art. 2 CBD and Art. 2 Nagoya Protocol, as well as the definitions in the document WIPO, ‘Second Revision of the Consolidated Document Relating to Intellectual Property and Genetic Resources (as at the close of IGC 30 on June 3, 2016)’, WIPO/GRTKF/IC/34/4, available at: https://www.wipo.int/meetings/en/doc_details.jsp?doc_id=368344.

53 Glowka, L. et al. (eds), A Guide to the Convention on Biological Diversity (International Union for the Conservation of Nature (IUCN), 1994), pp. 21–2Google Scholar.

54 Chiarolla, C., ‘Genetic Resources’, in Morgera, E. & Kulovesi, K. (eds), Research Handbook on International Law and Natural Resources (Edward Elgar, 2016), pp. 218–42CrossRefGoogle Scholar.

55 WIPO Glossary, available at: www.wipo.int/tk/en/resources/glossary.html#49.

56 Patents Amendment Act 2005 of South Africa, n. 51 above, Art 2.

57 Greiber, T. et al. , Explanatory Guide to the Nagoya Protocol on Access and Benefit-Sharing (IUCN, 2012), p. 67Google Scholar, available at: https://cmsdata.iucn.org/downloads/an_explanatory_guide_to_the_nagoya_protocol.pdf (stating that ‘the biochemical components of genetic resources … are the non-modified chemical components, other than DNA or RNA, formed by the organisms’ metabolic processes that exist in samples of biological materials (that is, active biological components found in collected material) and that have yet to be modified and used in technological applications’).

58 See, e.g., the Namibian Access to Biological and Genetic Resources and Associated Traditional Knowledge Act 2 of 2017, available at: http://www.lac.org.na/laws/annoSTAT/Access%20to%20Biological%20and%20Genetic%20Resources%20and%20Associated%20Traditional%20Knowledge%20Act%202%20of%202017.pdf.

59 E.g., Costa Rican law provides that ‘[b]oth the National Seed Office and the Registers of Intellectual and Industrial Property are obliged to consult with the Technical Office of the Commission before granting protection of intellectual or industrial property to innovations involving components of biodiversity. They must always provide the certificate of origin issued by the Technical Office of the Commission and the prior consent. Justified opposition from the Technical Office will prohibit registration of a patent or protection of the innovation’: Law No. 7788 on Biodiversity of Costa Rica (as last amended by Law No. 8686 of 21 Nov. 2008), Art. 80, available at: https://wipolex.wipo.int/en/text/208691. South African law provides that ‘[e]very applicant who lodges an application for a patent accompanied by a complete specification shall, before acceptance of the application, lodge with the registrar a statement in the prescribed manner stating whether or not the invention for which protection is claimed is based on or derived from an indigenous biological resource, genetic resource, or traditional knowledge or use. The registrar shall call upon the applicant to furnish proof in the prescribed manner as to his or her title or authority to make use of the indigenous biological resource, genetic resource, or of the traditional knowledge or use if an applicant lodges a statement that acknowledges that the invention for which protection is claimed is based on or derived from an indigenous biological resource, genetic resource, or traditional knowledge or use’: Patents Amendment Act of South Africa (Act No. 20 of 2005), s. 30, available at: https://www.wipo.int/tk/en/databases/tklaws/articles/article_0021.html.

60 At the regional level, the Common Industrial Property Regime of the Andean Community states that the patent applicant, where applicable, shall provide ‘a copy of the access contract where the products or processes for which a patent is sought have been obtained or developed from genetic resources or products derived therefrom of which any of the member countries is the country of origin; [and] a copy of the document accrediting the licensing or the authorization of the use of the traditional knowledge of the indigenous Afro-American or local communities of member countries where the products or processes for which protection is sought have been obtained or developed from such knowledge of which any of the member countries is the country of origin, in accordance with the provisions of Decision 391 and such of its amendments and implementing regulations as are in force’: Decision No. 486 (2000) Establishing the Common Industrial Property Regime of the Andean Community, Art. 26, available at: https://www.wipo.int/tk/en/databases/tklaws/articles/article_0027.html.

62 Chiarolla & Kılıç, n. 13 above, pp. 21–2.

63 Ibid., p. 33.

64 Ibid., pp. 36–8.

65 Marrakesh (Morocco), 15 Apr. 1994, in force 1 Jan. 1995, available at: http://www.wto.org/english/docs_e/legal_e/27-trips.pdf.

66 N. 21 above.

67 N. 65 above.

68 Paris (France), 2 Dec. 1961, in force 10 Aug. 1968, available at: http://www.upov.int/upovlex/en/upov_convention.html. See Chiarolla, C., ‘Commodifying Agricultural Biodiversity and Development-related Issues’ (2006) 9(1) Journal of World Intellectual Property, pp. 2560CrossRefGoogle Scholar. A key difference between patents and plant breeders’ rights is that the latter have broader exemptions for research and plant breeding as well as for farmers’ use for their subsistence compared with patents.

69 United Nations Conference on Trade and Development (UNCTAD) – International Centre for Trade and Sustainable Development (ICTSD), Resource Book on TRIPS and Development (Cambridge University Press, 2005), p. 389Google Scholar, available at: https://www.ictsd.org/themes/innovation-and-ip/research/resource-book-on-trips-and-development. For a narrow interpretation of these TRIPS provisions, see C.M. Correa, ‘TRIPS-Related Patent Flexibilities and Food Security: Options for Developing Countries’, QUNO-ICTSD Policy Guide, Sept. 2012, pp. 5–6, available at: https://www.ictsd.org/sites/default/files/research/2012/10/trips-related-patent-flexibilities-and-food-security.pdf.

70 WTO, Doha Ministerial Declaration, WTO Doc. WT/MIN(01)/DEC/1, 14 Nov. 2001, available at: https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_e.htm.

71 WTO, n. 19 above.

72 Correa, n. 16 above.

73 Chiarolla & Kılıç, n. 13 above, p. 23.

74 At the time of writing, no complaint has ever been brought before the WTO dispute settlement body for a violation of the patent-related provisions of the TRIPS Agreement because of their alleged incompatibility with a national patent disclosure requirement on genetic resources and associated traditional knowledge. Other formality requirements may include, e.g., the need to disclose the names of inventors and their addresses, to submit certain documents such as priority documents (i.e., copies and translations of foreign patent applications that form the basis of a claim for priority), and to submit the application in a prescribed format.

75 N. 21 above.

76 WIPO, ‘PCT: The International Patent System’, available at: http://www.wipo.int/pct/en/index.html.

77 WIPO, ‘Annual Financial Report and Financial Statements 2017’, WO/PBC/28/9, Annex II, p. 76, available at: http://www.wipo.int/edocs/mdocs/govbody/en/wo_pbc_28/wo_pbc_28_9.pdf.

78 India National Chapter, PCT National Phase, available at: http://www.wipo.int/pct/guide/en/gdvol2/annexes/in.pdf.

80 Geneva (Switzerland), 1 July 2018, in force 1 July 2018, available at: https://wipolex.wipo.int/en/text/494065.

81 See above in this section the discussion on Rule 51bis 1(a)(ii) of the PCT Regulations.

82 On available remedies and sanctions, see Chiarolla & Kılıç, n. 13 above, pp. 39–43.

83 Art. 27.3(b) TRIPS Agreement.

84 W. Wendland, ‘The Evolution of the IGC from 2001 to 2016: An Insider's Perspective’, in Robinson, Roffe & Abdel-Latif (eds), n. 19 above, pp. 31–55.

85 C. Saez, ‘WIPO IP and Genetic Resources Committee Makes Progress Despite Block at End’, Intellectual Property Watch, 2 July 2018, available at: http://www.ip-watch.org/2018/07/02/wipo-ip-genetic-resources-committee-makes-progress-despite-block-end.

86 E.g., if additional patent disclosure requirements were more widely introduced via the WIPO PCT system, notably in the national phase, as in the Indian example: see Section 5.2 above.

87 United Nations Development Programme (UNDP) & Global Environmental Facility (GEF), ‘ABS is Genetic Resources for Sustainable Development’, 7 Nov. 2018, available at: https://www.undp.org/content/undp/en/home/librarypage/poverty-reduction/abs-is-genetic-resources-for-sustainable-development.html.

88 Loi n° 2016-1087 du 8 août 2016 pour la reconquête de la biodiversité, de la nature et des paysages, available at: https://www.legifrance.gouv.fr/eli/loi/2016/8/8/2016-1087/jo/texte. See also Chiarolla, C., ‘Commentary on the ABS Provisions of the Draft Biodiversity Law of France’, in Dedeurwaerdere, T. et al. (eds), Implementing the Nagoya Protocol: Comparing Access and Benefit-Sharing Regimes in Europe (Brill/Martinus Nijhoff, 2015), pp. 5676Google Scholar.

89 Access to Genetic Resources and Community Knowledge, and Community Rights Proclamation No. 482/2006 of Ethiopia, Art. 17, available at: https://www.wipo.int/tk/en/databases/tklaws/articles/article_0009.html.

90 European Patent Office, ‘Patent Families’, available at: http://www.epo.org/searching-for-patents/helpful-resources/first-time-here/patent-families.html (‘A patent family is a collection of patent applications covering the same or similar technical content. The applications in a family are related to each other through priority claims’).

91 WIPO, ‘Developing a National Strategy on Intellectual Property, Traditional Knowledge and Traditional Cultural Expressions’, Background Brief No. 3, 2016, available at: https://www.wipo.int/publications/en/details.jsp?id=3864.

92 Sobrevila, C., The Role of Indigenous Peoples in Biodiversity Conservation: The Natural but Often Forgotten Partners (World Bank, 2008), p. 5Google Scholar, available at: http://documents.worldbank.org/curated/en/995271468177530126/pdf/443000WP0BOX321onservation01PUBLIC1.pdf.