The Doha Declaration on the TRIPS Agreement and Public Health: Lighting a dark corner at the WTO

Journal of International Economic Law

Volumn 5, Issue 2, 2002, Pages 469-505

  Abbott, Frederick M ^a  

^a FLORIDA STATE UNIVERSITY   (United States)

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EID: 0036332486     PISSN: 13693034     EISSN: None     Source Type: Journal    
DOI: 10.1093/jiel/5.2.469     Document Type: Review

References (106)

1. On 28 November 2001, at the European Institute Forum, US Undersecretary of State for Economic Affairs Alan Larson, in addition to the statement quoted above, said 'There's going to be a discussion in the WTO about compulsory licensing for export but my reading of the room at Doha is that no one is seriously interested in this, not the Africans, not the middle income countries with generic drug producing capabilities' (Inside US Trade (30 November 2001)). The report on these statements noted that developing country, industry, and EU representatives did not share the assessment that the TRIPS and public health agenda was exhausted.
2. Ministerial Conference, Fourth Session, Doha, 9-14 November 2001, WT/MIN(01)/DEC/2, 20 November 2001.
3. Controversy regarding the appropriate scope of patent protection, including its application to medicines, is present throughout the historical evolution of the international intellectual property system. See, e.g. Roffe, P., 'The political economy of intellectual property rights - An Historical Perspective', in J. Faundez el al. (eds) Governance, Development and Globalization 397 (Warwick, UK: University Warwick 2000).
4. For US negotiating objectives, see United States Proposal for Negotiations on Trade-Related Aspects of Intellectual Property Rights, 3 November 1987, at Patents (text reprinted in 'US Frame-work Proposal to GATT Concerning Intellectual Property Rights', 4 BNA Int'l Tr Reptr 1371 (4 November 1987)). For EU negotiating objectives, see, e.g. Guidelines and Objectives Proposed by the European Community for the Negotiations on Trade Related Aspects of Substantive Standards of Intellectual Property Rights, Negotiating Group on Trade-Related Aspects of Intellectual Property Rights, including Trade in Counterfeit Goods, MTN.GNG/NG11/W/26, July 1988.
5. See, e.g. statements by delegate of India, Note by the Secretariat, Meeting of Negotiating Group of 12-14 July 1989, Negotiating Group on Trade-Related Aspects of Intellectual Property Rights, including Trade in Counterfeit Goods, MTN.GNG/NG11/14, 12 September 1989, at, e.g. para. 79.1.
6. See contributions on TRIPS in Daniel Kennedy and James Southwick (eds), The Political Economy of International Trade Law: Essays in Honor of Robert Hudec [Political Economy], (Cambridge University Press 2002).
7. The term 'Pharma' is commonly used, and is so used in this article, to refer to the major research-based pharmaceutical enterprises on a worldwide basis. That term is distinct from the related acronym 'PhRMA' that is the identifier of a US-based pharmaceutical industry NGO. See discussion at notes 42 and 43 on pages 478-479.
8. The legal issues at stake in the case brought by 39 pharmaceutical companies against Nelson Mandela and the South African Department of Health are discussed in Study Paper 2a, above n *.
9. See Frederick M. Abbott, 'The TRIPS-Legality of Measures Taken to Address Public Health Crises: Responding to USTR-State-Industry Positions that Undermine the WTO', in Political Economy, above, n 5.
10. See Request for Consultations by the United States, Brazil - Measures Affecting Patent Protection, WT/DS199/1, G/L7385, IP/D/23, 8 June 2000, and Request for the Establishment of a Panel by the United States, Brazil - Measures Affecting Patent Protection, WT/DS199/39, January 2001.
11. See Tina Rosenberg, 'Look at Brazil', NY Times, Sunday Magazine (28 January 2001).
12. See Joint Communication Brazil-United States, 25 June 2001. The US had by this time effectively been condemned by the UN Commission on Human Rights (Resolution 2001/33, Access to Medication in the Context of Pandemics such as HIV/AIDS, 57th Sess. April 2001).
13. Countries that were subject to intensive and well-documented USTR pressures include, e.g. Argentina, the Dominican Republic, Kenya, and Thailand.
14. Working paper by Andrew Creese and Jonathan Quick, 'Differential Pricing Arrangements and Feasibility: Context Setting Paper', World Health Organization, 21 January 2001.
15. This policy debate is described in some detail in CIPR Study 2a, above n *, and was discussed by this author in general terms in an earlier article in this journal, Frederick M. Abbott, 'The Enduring Enigma of TRIPS: A Challenge for the World Economic System', 1 JIEL 497 (1998).
16. A wide-ranging selection of policy papers reflecting the views of the research-based pharmaceutical sector are found or referenced at the PhRMA website, www.phrma.org.
17. Economic studies in support of these points are set out in CIPR Study 2a, above n *.
18. Sheryl Gay Stolberg, 'Buckets for Bioterrorism, But Less for Catalog of Ills', NY Times (5 February 2002), at A20.
19. See CIPR Study Paper 2a, above n *.
20. The state of public health in the developing countries is reported on regularly in WHO publications, see, e.g. WHO Medicines Strategy: Framework for Action in Essential Drugs and Medicines Policy 2000-2003, WHO/EDM/2000.1 (2000).Médecins sans Frontières (MSF)/Doctors Without Borders also extensively reports on public health in developing countries. See Campaign for Access to Essential Medicines, http://www.accessmed-msf.org.
21. Eric Stein has recently described and analyzed the governance structure of the WHO in Eric Stein, 'International Integration and Democracy: No Love at First Sight', 95 AJIL 489 (2001).
22. See, e.g. Globalization and Access to Drugs, Perspectives on the WTO/TRIPS Agreement (revised), Health Economics and Drugs, DAP Series No. 7, Action Programme on Essential Drugs (1998) (Velasquez, German and Boulet, Pascale).
23. See, e.g. Globalization, TRIPS and Access to Pharmaceuticals, WHO Policy Perspectives on Medicines, No 3, March 2001, WHO Geneva.
24. See, e.g. WHO Medicines Strategy: Perspectives on TRIPS and Access to Drugs, Warsaw, September 2001 (meeting materials). Similar meetings were held in Harare, Zimbabwe, in August 2001, and in Ouagadougou, Burkina Faso, in December 2001.
25. See, e.g. P. Benkimoun, Agressions et menaces contre un responsable de l'OMS défenseur de l'accès du tiers-mond aux medicaments, Le Monde (23 Aug 2001) (cited in 't Hoen, below n 31)
26. The WTO Secretariat has directly and indirectly criticized the involvement of WHO in providing advice regarding interpretation and implementation of the TRIPS Agreement. See, e.g. correspondence of Adrian Otten reprinted on IP-Health list server, 'Adrian Otten missive on WTO/WHO cooperation', posting of 21 September 2001. This correspondence was inadvertently attached to a submission to the TRIPS Council.
27. The Set of Multilaterally Agreed Equitable Principles and Rules for the Control of Restrictive Business Practices', adopted by the UN General Assembly.
28. See, e.g. Project on Handbook for TRIPS Negotiators that, while not directed specifically at medicines, necessarily takes into substantial account the need for guidance in this area.
29. See UN High Commissioner for Human Rights, The Impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights on Human Rights, UN Economic and Social Council, E/CN.4/Sub.2/2001/13, June 2001.
30. See, e.g. Conference Report, 'Implementation of the Doha Declaration on the TRIPS Agreement and Public Health: Technical Assistance - How to Get It Right', prepared by MSF Campaign for Access to Essential Medicines, Consumer Project on Technology, Oxfam International and Health Action International, regarding meeting of 28 March 2002, International Conference Centre of Geneva (CICG), available at http://www.accessmed-msf.org.
31. See, e.g. Ellen 't Hoen, 'WTO TRIPS Agreement, Pharmaceutical Patents and Access to Essential Medicines: A Long Way from Seattle to Doha', draft of 18 December 2001, forthcoming in University of Chicago Journal of International Law.
32. See reports on activities of Standing Committee on the Law of Patents (http://wipo.int).
33. Author's discussions with WTO and WIPO delegates and NGO representatives.
34. See World Development Report 2002.
35. See description of IMF activities at http://www.imf.org.
36. Trade Negotiations Committee, Draft Final Act Embodying the Results of the Uruguay Round of Multilateral Trade Negotiations, MTN.TNG/W/FA, 20 December 1991 (generally referred to as the 'Dunkel Draft', with reference to the then GATT Director General, Arthur Dunkel). The policy significance of the Secretariat's role in preparation and distribution of the Dunkel Draft text was first called to this author's attention by Prof. Robert Hudec.
37. In his 23 July 1990 report on the status of work in the TRIPS Negotiating Group, the Chairman (Lars E. R. Anell) presented a draft composite text. The July 1990 draft included alternative 'A' (developed country supported) and 'B' (developing country supported) proposals.
38. This role will be evident from description of the formulation of texts in preparation for Doha. However, the role is evidenced in many other ways, including, for example, review and comment by the Secretariat on WHO interpretations of TRIPS provisions, and the organization of meetings and workshops on TRIPS that inherently place the Secretariat in a position to select actors and define agendas.
39. The extensive efforts made by MSF and other NGOs to provide a public health oriented perspective to European Commission TRIPS policies are chronicled from the Commission's perspective at DG Trade, Towards Sustainable Trade, Assessment by the Chairman of the Health Issue Group/Access to Medicines, 16 January 2001, at http://europa.eu.int/comm/trade.
40. See, e.g. Mark Schoofs, Physicians' Group Defies Patent Law to Bring AIDS Drugs to South Africa, online.wsj.com, updated 30 January 2002. Also reported on by at http://www.accessmed-msf.org.
41. As reported by the Wall Street Journal: The two companies that hold patents on the medicines MSF imported from Brazil - Glaxo-SmithKline PLC and Boehringer Ingelheim GmbH - said they are observing the situation but didn't have immediate plans to take legal action, which would almost certainly bring down a hail of bad publicity. 'You don't tilt against windmills,' said Kevin McKenna, a spokesman for Boehringer Ingelheim South Africa.' (Mark Schoofs, id).
42. Consumer Project on Technology, one of the most active advocates of changes to relevant legislation, reports on its activities at http://cptech.org. These activities include proposals in detail to amend US legislation on compulsory licensing and exceptions to patent rights.
43. The structure of this industry is desribed in some detail in CIPR Study 2a, above n *, referring, inter alia, to Ganibardella et al., Global Competitiveness in Pharmaceuticals, A European Perspective, Report prepared for the Directorate General Enterprise of the European Commission, November 2000, and Organization for Economic Cooperation and Development (OECD), Directorate for Financial, Fiscal and Enterprise Affairs, Committee on Competition Law and Policy, Competition and Regulation Issues in the Pharmaceutical Industry, DAFFE/CLP (2000) 29, 6 February 2001.
44. The structure of this industry is desribed in some detail in CIPR Study 2a, above n *, referring, inter alia, to Ganibardella et al., Global Competitiveness in Pharmaceuticals, A European Perspective, Report prepared for the Directorate General Enterprise of the European Commission, November 2000, and Organization for Economic Cooperation and Development (OECD), Directorate for Financial, Fiscal and Enterprise Affairs, Committee on Competition Law and Policy, Competition and Regulation Issues in the Pharmaceutical Industry, DAFFE/CLP (2000) 29, 6 February 2001.
45. In this regard, the Quaker United Nations Office (QUNO) has actively provided logistic support for developing country delegations.
46. This was evident, for example, in preparations for the TRIPS negotiations that involved extensive coordination among EU, Japanese, and US industry groups, as well as the evolution of common negotiating positions over the course of the round. As Thomas Cottier has noted, there were variable geometries on particular issues, but on the question of pharmaceutical patent protection, for example, the common position was 'firmly considered nonnegotiable'. Thomas Cottier, 'The Prospects for Intellectual Property in GATT', 28 CMLR 383 (1991), reprinted in F. M. Abbott, T. Cottier, and F. Gurry, The International Intellectual Property System: Commentary and Materials, at 686, 687, 695 (Kluwer Law International 1999).
47. This was evident, for example, in preparations for the TRIPS negotiations that involved extensive coordination among EU, Japanese, and US industry groups, as well as the evolution of common negotiating positions over the course of the round. As Thomas Cottier has noted, there were variable geometries on particular issues, but on the question of pharmaceutical patent protection, for example, the common position was 'firmly considered nonnegotiable'. Thomas Cottier, 'The Prospects for Intellectual Property in GATT', 28 CMLR 383 (1991), reprinted in F. M. Abbott, T. Cottier, and F. Gurry, The International Intellectual Property System: Commentary and Materials, at 686, 687, 695 (Kluwer Law International 1999).
48. 'Zoellick Attacks Japan for Failure to Push Ahead WTO Agenda', Inside US Trade (2 November 2002), http://www.insidetrade.com.
49. As a matter of record (see discussion of US-led group below), Japan did follow the US line on TRIPS and medicines, and this was not a foregone conclusion in light of internal (domestic) Japanese concerns (a) about providing the developing countries with support in addressing the HIV/AIDS pandemic and (b) continuing regulatory conflicts with Pharma members concerning price controls.
50. Advance Copy (Unrestricted-IP/C/W/296), Council for TRIPS, 19 June 2001 (final text available at http://www.wto.org).
51. See, e.g. Bolivia, Intervención de la Delgación de Bolivia N. Propiedad intellectual y el acceso a los medicamentos, 21 de junio del año 2001; Brazil, Council for TRIPs, TRIPs and Access to Medications, 20 June 2001; India, Statement of India at the TPJPS Council Meeting on 20 June 2001 on Public Health and Access to Medicines; Kenya, Statement by Kenya on the Impact of TRIPS Agreement on Public Health; Indonesia, Statement by the Indonesian Delegation, WTO-Council Meeting, Geneva 18-22 June 2001; Philippines, Statement of the Philippines; South Africa, Special Discussion on TRIPs and Public Health, South Africa's Statement, 20 June 2001; Sri Lanka, Statement of Sri Lanka Delegation at the TRIPS Council meeting on 20 June 2001 on Public Health & Access to Medicines. The author's files may not presently contain all of the relevant submissions.
52. See, e.g. Statement by ASEAN - TRIPS and Health, 20 June 2001.
53. Note of the Holy See to the Council for TRIPS, Intellectual Property and Access to Basic Medicines, made available 20 June 2001.
54. Communication from the European Communities and their Member States, 'The Relationship Between the Provisions of the TRIPS Agreement and Access to Medicines', 11 June 2001, Council for TRIPS, IP/C/W/280, 12 June 2001.
55. United States, Intellectual Property and Access to Pharmaceutical Products, and US Statement (undated). See also Canada, Canadian Intervention on Intellectual Property and Access to Medicines - 20 June 2001.
56. Statement by Switzerland, Special discussion on 'Intellectual Property and Access to Medicines', 20 June 2001, Council for TRIPS, JOB(01)/97/Add.10, 5 July 2001.
57. See Africa Group et al., above n 48.
58. 'Health experts inform us that the cost of drugs is only one of many important issues that must be addressed in any health crisis.' (Final US Statement, at 2.)
59. 'We would like to understand better what impact the TRIPS Agreement could be having on the health care regimes of least developed country Members given that these Members are not currently obligated to implement the Agreement, including its patent provisions. We are particularly interested because certain Members have suggested that these transition periods be extended, even before these Members have had any experience implementing the Agreement.' (id, at 7)
60. The members of the group (Australia, Canada, Japan, Switzerland, and the United States) were formally linked in the submission of a draft Declaration for Doha discussed below.
61. See Note by the Secretariat, Checklist of Articles of the TRIPS Agreement and matters raised in relation to them at the Council's special discussion on intellectual property and access to medicines of 20 June 2001, JOB(01)/113, 16 July 2001.
62. A brief summary of the latter meetings can be found at http://www.wto.org, along with the texts of proposals by the developing and US/like-minded group.
63. That non-paper is posted at http://www.wto.org.
64. When questions arose after the TRIPS Council meeting about the reference to an unpublished study and the conclusions supposed to be drawn from it, the USTR delegate to the meeting denied having referred to it. The colloquy between various parties involved was a feature of the IP-Health list-server for some weeks, and was finally more or less put to an end when the Brazilian delegate to the meeting quoted the reference from the US paper. The study in fact reflects the results of a paper first commissioned by PhRMA with its Washington think-tank headed by the former Commissioner of Patents, Bruce Lehman, and sent to this author by a Merck lawyer prior to a debate with Merck's public relations director in connection with the South Africa case. The think-tank work was later revised by an adjunct at Harvard. The study reveals nothing more than any competent patent lawyer would anticipate. That is, Pharma members extensively patented their drugs in countries such as South Africa where there was significant capacity for production (and disposable income) and Zimbabwe where (at least until recently) there was sufficient income to establish demand. In least developed sub-Saharan African countries where there was negligible disposable income or prospect for generic competition, patents were not routinely obtained.
65. The US/PhRMA argument is explained and responded to in detail in Abbott, QUNO 7, above n *. Although the Swiss delegation supported USTR's line, the Swiss Federal Supreme Court has expressly and directly rejected the USTR/PhRMA/Swiss delegation position.
66. This preambular draft is available on the WTO website. The US draft operative provisions are not.
67. For example, the US operative provisions draft said: 3. An affected Member government can declare pandemics of life-threatening communicable diseases such as HIV/AIDS, malaria and tuberculosis, as situations of 'national emergency' or as a circumstance of 'extreme urgency' within the meaning of Article 31(b) of the TRIPS Agreement. This formulation is substantially more restrictive than Article 31(b), TRIPS Agreement, with reference only to pandemics. Compare paragraph 5(c), Doha Declaration, affirming Member discretion.
68. EC, Non-Paper, Draft Declaration on TRIPs and access to affordable medicines, 20 September 2001. Since the text was withdrawn, it is not published on the WTO website.
69. MIN-QATARCombined text for distribution (10.10.01).doc.
70. General Council, Preparations for the Fourth Session of the Ministerial Conference, Draft Declaration on Intellectual Property and [Access to Medicines] [Public Health], JOB(01)/155, 27 October 2001.
71. Because journal articles are sometimes referred to in distant years, the author recounts a few relevant facts, recognizing that for the contemporary reader these facts need no recounting.
72. Amy Harmon and Robert Pear, 'Canada Overrides Patent for Cipro to Treat Anthrax', NY Times (19 October 2001). The Canadian government later took the position that the actions of its Health Department had been a mistake, and entered into a settlement with Bayer and the local generics producer. The later actions by the Canadian government were publicly taken in such an air of confusion that, in retrospect, Canadian officials would not be faulted for wondering if they might have been better off playing out their opening hand. See Brian Laghi and Heather Scoffield, 'Ottawa Pays Twice for Cipro', Globe and Mail (23 October 2001).
73. Amy Harmon and Robert Pear, 'Canada Overrides Patent for Cipro to Treat Anthrax', NY Times (19 October 2001). The Canadian government later took the position that the actions of its Health Department had been a mistake, and entered into a settlement with Bayer and the local generics producer. The later actions by the Canadian government were publicly taken in such an air of confusion that, in retrospect, Canadian officials would not be faulted for wondering if they might have been better off playing out their opening hand. See Brian Laghi and Heather Scoffield, 'Ottawa Pays Twice for Cipro', Globe and Mail (23 October 2001).
74. Kristin Jensen, 'Thompson May Seek to Void Cipro Patent If Talks Fail', Bloomberg News Service (Bloomberg.com), dateline Washington, DC, 23 October 2001.
75. Keith Bradsher with Edmund L. Andrews, 'US Says Bayer Will Cut Cost of Its Anthrax Drug', NY Times (23 October 2001).
76. Ministerial Declaration, para 18.
77. Id, para 19.
78. The proposed revised IUPGR included an obligation to pay royalties to a multilateral fund based on patented inventions arising out of use of materials obtained from a resource bank. It was suggested by some negotiating states that obligations directed solely to agricultural patents would violate the TRIPS Article 27:1 prohibition against discrimination based on field of technology. The IUPGR text as adopted avoided reference to patents, referring instead to 'commercialisation'. See, FAO Press Release 01/08 C5, International Treaty on Plant Genetic Resources for Food and Agriculture Approved by FAO Conference, 3 Nov. 2001, and article 14.2(d)(ii) of adopted treaty available at http://www.fao.org.
79. Decision on Implementation Issues, para 11.1.
80. The Vienna Convention on the Law of Treaties (VCLT) provides that treaties are to be interpreted 'in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose' (Article 31(1)). The context comprises, inter alia, 'the text, including its preamble and annexes' (Article 31(2)).
81. Article IX: 1 of the WTO Agreement provides in relevant part: 1. The WTO shall continue the practice of decision-making by consensus followed under GATT 1947. Except as otherwise provided, where a decision cannot be arrived at by consensus, the matter at issue shall be decided by voting. At meetings of the Ministerial Conference and the General Council, each Member of the WTO shall have one vote... Decisions of the Ministerial Conference and the General Council shall be taken by a majority of the votes cast, unless otherwise provided in this Agreement or in the relevant Multilateral Trade Agreement.'
82. Article 31 of the VCLT provides: 3. There shall be taken into account, together with the context: (a) any subsequent agreement between the parties regarding the interpretation of the treaty or the application of its provisions; (b) any subsequent practice in the application of the treaty which establishes the agreement of the parties regarding its interpretation; (Article 31).
83. Article IX:2 of the WTO Agreement provides: The Ministerial Conference and the General Council shall have the exclusive authority to adopt interpretations of this Agreement and of the Multilateral Trade Agreements. In the case of an interpretation of a Multilateral Trade Agreement in Annex 1 [that includes the TRIPS Agreement], they shall exercise their authority on the basis of a recommendation by the Council overseeing the functioning of that Agreement. The decision to adopt an interpretation shall be taken by a three-fourths majority of the Members. This paragraph shall not be used in a manner that would undermine the amendment provisions in Article X.
84. See Abbott, QUNO 9, above n *.
85. Canada - Patent Protection of Pharmaceutical Products, Report of the Panel, WT/DS114/R, 17 March 2000.
86. There are several provisions of the WTO Agreements that inform this conclusion. First, as noted above, Article IX:2 of the WTO Agreement grants to the Ministerial Conference and General Council 'the exclusive authority to adopt interpretations of this Agreement and of the Multilateral Trade Agreements'. Second, Article 3:2 of the Dispute Settlement Understanding (DSU) provides that: 'Recommendations and rulings of the DSB cannot add to or diminish the rights and obligations provided in the covered agreements.' Third, pursuant to Article 3:2 of the DSU, the role of the Dispute Settlement Body (DSB) is: 'to clarify the existing provisions of those agreements in accordance with customary rules of interpretation of public international law'. As a matter of customary international law, a decision of a judicial tribunal involving state parties does not bind states not party to the dispute. Fourth, Article 3:9 of the DSU provides: 9. The provisions of this Understanding are without prejudice to the rights of Members to seek authoritative interpretation of provisions of a covered agreement through decision-making under the WTO Agreement or a covered agreement which is a Plurilateral Trade Agreement. In a DSU proceeding, a WTO Member might be able to challenge another Member on grounds that an 'interpretation' decided by the Ministerial Conference or General Council is WTO inconsistent. The Appellate Body might rule that the interpretation exceeded the bounds of the interpretative power under Article IX:2 of the WTO Agreement and customary international law. Whether the Appellate Body might in such circumstances 'overrule' an interpretative decision of the Ministerial Conference or General Council is a WTO constitutive question that might well be controversial. There is, however, no reason at this juncture to attempt to resolve this issue. For present purposes, the Ministerial Conference and General Council have the power to render formal interpretations of the WTO Agreements (including the TRIPS Agreement) without being bound by prior decisions of panels or the Appellate Body. The TRIPS Council, General Council, and Ministerial Conference are constrained in the interpretation of the TRIPS Agreement by its text, context, object and purpose.
87. Article 31, VCLT.
88. All international agreements carry with them an implicit obligation to act in good faith.
89. See EU and US (with like-minded) negotiating texts presented during pre-Doha negotiations.
90. In the competition law context, to settle government claims patent holders may authorize licensees under so-called 'consent' decrees or undertakings, In these undertakings, the patent holder agrees to remedies without a court trial, though often a consent decree will be affirmed and issued by a court in order to provide a basis for enforcement agency supervision.
91. The leading expert commentator supporting this position is Prof. Carlos Correa. Some additional support may be found in US and EU copyright legislation that provides compulsory licenses for certain music recording, and does not prohibit local resale of recordings.
92. See India - Patent Protection for Pharmaceutical and Agricultural Chemical Products, Report of the Appellate Body, WT/DS50/AB/R 19 December 1997, at, e.g. para 45.
93. Just as an example, a Member could not adopt legislation providing that 'exhaustion' is based on piracy of patented products since that would directly defeat the purpose of providing patent protection.
94. US courts granting compulsory licenses on US patents as remedy for anticompetitive practices have recognized that they are without power to prevent invocation by patent holders of foreign patent rights, although foreign courts may as a matter of 'comity' choose to enforce a US court order. See United States v Imperial Chemical Industries (ICI), (SDNY 1952), 105 F Supp 215, 227-31.
95. In this regard it may be noted that inventors, largely for administrative cost reasons, have rarely sought to patent their inventions in all countries where this might be possible.
96. See Abbott, QUNO Occasional Paper 7, above n *.
97. 'Predominant' is defined as an adjective as: '(1) Having supremacy or ascendancy over others; predominating. (2) Constituting the main or strongest element; prevailing. (3) Rising high over.' New Shorter Oxford Dictionary, at 2329.
98. It might be suggested that 'predominantly' also refers to a situation in which the domestic market of the Member granting the compulsory license takes the greatest share of supply as among those Members receiving supplies. To illustrate: the granting Member may receive forty percent (40%) of the supply, while three other Members each individually receive twenty percent (20%). In that context, supply of the domestic market of the granting Member would predominate over the supply of any other individual WTO Member. The difficulty with this interpretation is that it potentially reduces the term 'predominantly' to a nullity, for example, if there were 80 Members receiving supplies under compulsory license, perhaps only two percent (2%) might need to be supplied to the market of the Member granting the license to maintain its predominance.
99. Imports into country A might be exported to country B. A compulsory licensee that imported to implement the license, but exported a predominant part of the imports, might be acting inconsistently with Article 31 (f).
100. The patent holder may be the same in both Members, and in theory it might consent to export to the Member that has issued the compulsory license regarding its own patent. However, it is difficult to foresee the circumstances in which this might occur.
101. In the US paper submitted to the TRIPS Council in advance of the Doha Ministerial, there is some suggestion of liability on the part of the importing Member, though the reasons for this are not clear. Intervention of the delegation of the United States under item N (Intellectual Property and Access to Medicines) of the agenda of the Council for TRIPS meeting of 18-22 June 2001, JOB(01)/97/Add.5, Council for TRIPS, 28 June 2001.
102. The express text of paragraph 7, second sentence, exempts LDCs from the obligation to implement or apply Sections 5 and 7 of Part II of the TRIPS Agreement, and the obligation to enforce rights provided for under those sections. By its express terms, paragraph 7, second sentence, does not address obligations under Article 70:8 and 70:9 of Part VII of the Agreement. In the absence of some contrary understanding, Article 70:8 would appear to continue to apply, and require least developed Members to maintain 'mailbox' application mechanisms that allow for the receipt and retention of pharmaceutical patent applications until coverage is provided under local law. Pharmaceutical patent applications received before 1 January 2016 would have priority dates preserved and be reviewed under patentability criteria as of the priority dates. Patent protection would be available for the remainder of the patent term counted from the priority date. Absent a contrary understanding, Article 70:9 also appears to apply. If so, exclusive marketing rights should be granted to the patent applicant for a maximum period of five years following marketing approval of the pharmaceutical product in the least developed country, provided that a pharmaceutical patent has been granted and marketing approval has been obtained by the patent applicant in another Member. A pharmaceutical patent applicant with exclusive marketing rights in a least developed Member has the effective equivalent of patent rights because, while it may not have exclusive rights to make or import the covered drugs, it presumptively will be able to prevent the marketing of generic equivalents, and it may thereby control the local market. Exclusive marketing rights may be even more burdensome to LDCs than patents if they are understood not to be subject to the same exceptions (e.g. Article 30, TRIPS Agreement) to which patents are subject, or to compulsory licensing (Article 31, TRIPS Agreement). Since paragraph 7, third sentence, instructs the TRIPS Council to give effect to the mandate of paragraph 7, it is important that the Council clarify the meaning of the Declaration when it takes this action. If the Council fails to implement paragraph 7, second sentence, based on a common understanding that least developed Members are exempt from mailbox and exclusive marketing rights requirements, the legal situation regarding these requirements will be uncertain.
103. Provided also that a patent has been granted and marketing approval obtained in another WTO Member.
104. There is an additional complication in that the drug in India may be subject to exclusive marketing rights, and it is not clear whether such rights would entitle the mailbox application holder to block exportation as well as local supply.
105. The relevant part of paragraph 7 reads: We also agree that the least-developed country Members will not be obliged, with respect to pharmaceutical products, to implement or apply Sections 5 and 7 of Part II of the TRIPS Agreement or to enforce rights provided for under these Sections until 1 January 2016 ... This language might be construed to cover pharmaceutical process patents if those patents are considered issued with respect to pharmaceutical products. The patent 'rights provided for' in Article 28:1 (b) of Section 5, Part II of the TRIPS Agreement are rights in respect to process patents, and those may be construed to be related to the subject matter of 'pharmaceutical products'.
106. Frederick M. Abbott, 'The Enduring Enigma of TRIPS: A Challenge for the World Economic System', 1 JIEL 497, 521 (1998).