The Doha round's public health legacy: Strategies for the production and diffusion of patented medicines under the amended TRIPS provisions

Journal of International Economic Law

Volumn 10, Issue 4, 2007, Pages 921-987

  Abbott, Frederick M ^a   Reichman, Jerome H ^b  

^a FLORIDA STATE UNIVERSITY   (United States)

^b DUKE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 36949017215     PISSN: 13693034     EISSN: 14643758     Source Type: Journal    
DOI: 10.1093/jiel/jgm040     Document Type: Article

References (363)

1. Agreement on Trade-Related Aspects of Intellectual Property Rights, Marrakesh Agreement Establishing the World Trade Organization, Annex IC, 15 April 1994, in World Trade Organization, The Legal Texts: The Results of The Uruguay Round of Multilateral Trade Negotiations 321 (1999) [hereinafter TRIPS Agreement], available at http://www.wto.org.
2. See generally, UNCTAD-ICTSD Resource Book on TRIPS and Development, (Cambridge University Press 2005), available at http://www.iprsonline.org.
3. Frederick M. Abbott, 'Protecting First World Assets in the Third World: Intellectual Property Negotiations in the GATT Multilateral Framework', 22Vand J Transnat'l L 689 (1989 )
4. and Jerome H. Reichman, 'From Free Riders to Fair Followers: Global Competition Under the TRIPS Agreement' 29 NYU J. Int'l L. Pol. 11 (1996).
5. See Paris Convention for the Protection of Industrial Property (1883), as last amended 1967, Article 2(1);
6. Microsoft Corp. v AT&T Corp., 127 S. Ct. 1746 (2007);
7. ITC Limited v Punchgini, Inc., 482F.3d 135 (2d Cir. 2007) (holding that US trademark law remains territorial and cannot provide internationally required protection of famous marks under the TRIPS Agreement until Congress adopts implementing legislation).
8. Keith E. Maskus, 'Intellectual Property Rights In the Global Economy (HE 2002)';
9. Jane Ginsburg, Toward Supranational Copyright Law? The WTO Panel Decision and the "Three Step Test" for Copyright Exceptions, 187 Revue Internationale du Droit d'Auteur 3, 2001.
10. See also Rochelle Cooper Dreyfus and Andreas L. Lowenfeld, 'Two Achievements of the Uruguay Round: Putting TRIPS and Dispute Settlement Together', 37 Va J Int'l L 275 (1997).
11. See above n 1.
12. See e.g. Frederick M. Abbott, 'Toward a New Era of Objective Assessment in the Field of TRIPS and Variable Geometry for the Preservation of Multilateralism', 8 J Int'l Econ L 77 (2005), and references cited at n 13.
13. Keith E. Maskus and Jerome H. Reichman, 'The Globalization of Private Knowledge Goods and the Privatization of Global Public Goods', in K.E. Maskus and J.H. Reichman (eds), International Public Goods and Transfer of Technology Under a Globalized Intellectual Property Regime 3-45 (Cambridge University Press 2005) [hereinafter 'IP and International Public Goods'].
14. See e.g. Joseph Straus, 'The Impact of the New World Order on Economic Development: The Role of Intellectual Property Rights Systems', 6 J Marshall Rev Intell Prop 1 (2006);
15. Keith E. Maskus, Kamal Saggi and Thitima Puttitanum, 'Patent Rights and International Technology Transfer', in IP and International Public Goods, above n 7, 265-81.
16. At the multilateral level, see e.g. WIPO Copyright Treaty (1996);
17. WIPO Performers and Phonogram Producers Treaty (1996), available at .
18. See also negotiations on a draft SPLT, documents available at ;
19. John Barton et al., Views on the Future of the Intellectual Property System, UNCTAD-ICTSD Selected Issue Briefs No. 1 (April 2007), available at http://www.iprsonline.org, and; further discussion below nn 187-211 text, regarding regional and bilateral FTAs.
20. Carsten Fink and Patrick Reichenmiller, 'Tightening TRIPS: The Intellectual Property Provisions of Recent US Free Trade Agreements' (World Bank Trade Note No. 20, 2005).
21. See e.g. Margaret Chon, 'Intellectual Property and the Development Divide', 27 Cardozo L Rev 2821 (2006);
22. Ruth Okediji, 'Public Welfare and the Role of the WTO: Reconsidering the TRIPS Agreement', 17 Emory Int'l L Rev 819 (2003,
23. Peter K. Yu et al., 'China and the WTO: Progress, Perils, and Prospects', 17 Colum J Asian L 1 (2003).
24. See discussion of Uruguay Round reciprocal bargain assumptions in Abbott, 'Protecting First World Assets', above n 2.
25. Maskus and Reichman, 'The Globalization of Private Knowledge Goods', above n 7.
26. See also, Joseph Stiglitz, Knowledge as a Global Public Good (1998), available at http://www.worldbank.org/knowledge/chiefecon/articles/undpk2/index. htm;
27. Peter Drahos, 'The Regulation of Public Goods', in IP and International Public Goods, above n 7, 46-64.
28. See generally IP and International Public Goods, above n 7.
29. See e.g. Susan K. Sell, Private Power, Public Law: The Globalization of Intellectual Property Rights (Cambridge: 2003);
30. Christopher May and Susan K. Sell, Intellectual Property: A Critical History (Lynne Rienner: 2005);
31. Peter Drahos and John Braithwaite, Information Feudalism: Who Owns the Knowledge Economy (Earthscan 2002).
32. General Agreement on Tariffs and Trade (1994) and (1947), available at http://www.wto.org. See generally, John H. Jackson, World Trade and the Law of GATT (Bobbs-Merrill 1969)
33. and John H. Jackson, The Jurisprudence of GATT and the WTO: Insights on Treaty Law and Economic Relations (Cambridge 2000).
34. See e.g. Peter Gerhart, 'Distributive Values and Institutional Design in the Provision of Public Goods', in IP and International Public Goods, above n 7, 69-77.
35. See e.g. Rochelle C. Dreyfus, 'TRIPS-Round II: Should Users Strike Back?', 71 U Chi L R 21 (2004);
36. Graeme B. Dinwoodie and Rochelle Cooper Dreyfuss, 'WTO Dispute Resolution and the Preservation of the Public Domain of Science under International Law', in IP and International Public Goods, above n 7, 861-83;
37. Gregory Shaffer, 'Recognizing Public Goods in WTO Dispute Settlement: Who Participates, Who Decides? The Case of TRIPS and Pharmaceutical Patents Protection', in IP and International Public Goods, above n 7, 884-908.
38. See e.g. Digital Millennium Copyright Act 17 USC 1201 et seq., and European Parliament and Council Directive on the Harmonization of Certain Aspects of Copyright and Related Rights in the Information Society, Directive 2001/29/EC, O.J. 2001 No. L 167.
39. See generally, Jerome H. Reichman, Graeme Dinwoodie and Pamela Samuelson, 'A Reverse Notice and Takedown Regime to Enable Public Interest Uses of Technically Protected Copyrighted Works', 22 Berkeley J Law and Tech (forthcoming 2007).
40. See above n 9 and below nn 187-211 and accompanying text. However, these pressures have begun to elicit increasingly stronger countervailing reactions.
41. See e.g. WIPO Development Agenda, below n 174.
42. See also Jerome H. Reichman and Rochelle Cooper Dreyfuss, 'Harmonization without Consensus: Critical Reflections on Drafting a Substantive Patent Law Treaty', 57 Duke L J:5 (2007);
43. CPTech proposed Treaty on Access to Knowledge, draft of 9 May 2005, available at http://www.cptech.org/a2k/a2k_treaty_may9.pdf.
44. See e.g. Frederick M. Abbott, 'Managing the Hydra: The Herculean Task of Ensuring Access to Essential Medicines', in IP and International Public Goods, above n 7
45. and Frederick M. Abbott, TRIPS II, Asia and the Mercantile Pharmaceutical War: Implications for Innovation and Access, Stanford Center for International Development, Working Paper No. 308 (December 2006).
46. See above n 3. For historical background and information on operation of the Paris Convention,
47. see F. Abbott, T. Cottier and F. Gurry, International Intellectual Property in an Integrated World Economy 161-77 (Aspen 2007).
48. E.g. Paris Convention, above n 3, Articles 2(1) and 4bis.
49. E.g. Switzerland and Italy did not provide patent protection for pharmaceutical products until 1977 and 1978, respectively. Fabio Pammolli, Laura Magazzini and Luigi Orsenigo, "The Intensity of Competition after Patent Expiry in Pharmaceuticals: A Cross-Country Analysis', 99 Rev d'Econ Indus (2002), http://rei.revues.org/documentll.html. India did not provide pharmaceutical product patent protection until 2005.
50. See e.g. Maskus, Intellectual Property Rights in the Global Economy, above n 4 (stressing positive impact of TRIPS norms on the availability of high-tech products for acquisition by developing countries, apart from licensing opportunities as such);
51. Keith E. Maskus, Transfer of Technology and Technological Capacity Building, ICTSD-UNCTAD Dialogue, 2nd Bellagio Series on Development and Intellectual Property, 18-21 September 03, available at .
52. See also, Alan O. Sykes, 'Public Health and International Law: TRIPS, Pharmaceuticals, Developing Countries, and the Doha "Solution"' 3 Chi J Int'l 1 47 (2002) (addressing need for international incentives in risky pharmaceutical sector).
53. See Abbott, TRIPS II, above n 21.
54. See Frederick M. Abbott, "The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health', 99 Am J Int'l L 317, 320-24 (2004) [hereinafter 'Abbott, WTO Medicines Decision'].
55. Ibid
56. and Janice M. Mueller, The Tiger Awakens: The Tumultuous Transformation of India's Patent System and the Rise of Indian Pharmaceutical Innovation (August 2006). University of Pittsburgh School of Law Working Paper Series. Working Paper 43, at http:/Aaw.bepress.com/pittlwps/papers/art43.
57. See e.g. MSF Access to Medicines Campaign, The Second-Line AIDS Crisis: Condemned to Repeat?, 11 April 2007, at < http://www.doctorswithoutborders. org/news/access/thailand_briefingdoc_04-l1-2007.cfm>.
58. Although many blockbuster patents in the United States will soon expire, this does not directly affect the status of such patents abroad. See Paris Convention, above n 3, Article 4 bis (2).
59. See discussion of draft Substantive Law Patent Treaty (SPLT), below text accompanying nn 172-83.
60. See e.g. Frederick M. Abbott, The Doha Declaration on the TRIPS Agreement and Public Health and the Contradictory Trend in Bilateral and Regional Free Trade Agreements, Quaker United Nations Office (Geneva), Occasional Paper No. 14, April 2004
61. and Frederick M. Abbott, Trade Diplomacy, the Rule of Law and the Problem of Asymmetric Risks in TRIPS, Quaker United Nations Office (Geneva), Occasional Paper No. 13, September 2003.
62. Declaration on the TRIPS Agreement and Public Health (14 November 2001), Doc. WT/MIN(01)/DEC/2 (20 November 2001) [hereinafter Doha Declaration].
63. Ibid, para 5(b).
64. See Jerome H. Reichman with Catherine Hasenzahl, Nonvoluntary Licensing of Patented Inventions, ICTSD/UNCTAD Issue Paper No. 5 (2003);
65. Frederick M. Abbott, 'The Doha Declaration on the TRIPS Agreement and Public Health: Lighting a Dark Corner at the WTO', 5 J Int'l Econ L 469 (2002).
66. For the foundational authority, see Doha Declaration on Public Health, above n 33, para 6, and discussion in Abbott, 'WTO Medicines Decision', above n 27.
67. Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (30 August 2003), Doc. WT/L/540 (1 September 2003) [hereinafter 'Waiver Decision'].
68. WTO General Council Decision of 6 December 2005, Amendment of the TRIPS Agreement, WT/L/641, 8 Dec. 2005, with attachment 'Protocol Amending the TRIPS Agreement' (with Annex setting out Article 31bis) [hereinafter 'Protocol of Amendment' or 'Amendment']. Article 32bis incorporates an 'Annex to the TRIPS Agreement". Further references to "Annex" herein are to this "Annex to the TRIPS Agreement" incorporated by Article 31bis.
69. See Ministry of Public Health and National Health Security Office, Thailand, Facts and Evidence on the 10 Burning Issues Related to the Government Use of Patents on Three Patented Essential Drugs in Thailand, February 2007, ISBN 978-974-94591-5-7 [hereinafter the 'Thai White Paper'].
70. Regulation of the European Parliament and of the Council on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems, 2004/0258 (COD), PE-CONS 3674/05, Brussels, 12 April 2006.
71. Developments are reported on the website of the European Parliament. The debates and Resolution adopted by the Parliament in July 2007 pertaining to the ratification process are available at http://www.europarl.europa.eu/sides/ getDoc.do?pubRef=-//EP//TEXT+TA+P6-TA-2007-0353+0+DOC+XML+V0//EN&language= EN.
72. See e.g. MSF Access to Medicines Campaign, Doha Derailed, A Progress Report on TRIPS and Access to Medicines, 27 August 2003
73. and Neither Expeditious, Nor A Solution: The WTO August 30th Decision Is Unworkable: An illustration through Canada's Jean Chrétien Pledge to Africa, Prepared for the XVI International AIDS Conference, Toronto, August 2006,
74. and Oxfam International, Patents versus Patients, Five years after the Doha Declaration, Oxfam Briefing Paper 95, November 2006.
75. Directorate-General for External Policies of the Union, Specifications, No. EXPO/B/INTA/2007/14.
76. Frederick M. Abbott and Jerome H. Reichman, Study, Access to Essential Medicines: Lessons Learned Since the Doha Declaration on the TRIPS Agreement and Public Health, and Policy Options for the European Union, Directorate General External Policies of the European Union, EXPO/B/INTA/2007/14 June 2007 PE 381.392 (prepared for the International Trade Committee, European Parliament) [hereinafter 'Abbott and Reichman, Study'].
77. European Parliament resolution of 12 July 2007 on the TRIPS Agreement and access to medicines, P6_TA-PROV(2007)0353, available at
78. See also David Cronin, Parliament Delays WTO IP Health Deal Till EU Boosts Bilateral Drug Access, IP-Watch, 12 July 2007.
79. On October 24, 2007, the European Parliament gave its assent to acceptance by the European Community of the Protocol of Amendment. See European Parliament legislative resolution of 24 October 2007 on the proposal for a Council decision on the acceptance, on behalf of the European Community, of the Protocol amending the TRIPS Agreement, done at Geneva on 6 December 2005 (8934/2006-C6-0359/2006-2006/0060(AVC), P6_TA(2007) 0459. This was preceded by the reading of a Statement by the Council reflecting certain Key understandings (text in authors' files), (to ed: doc. attached).
80. As of 13 September 2007, 10 WTO Members had formally accepted the Amendment: (i) United States (17 December 2005); (ii) Switzerland (13 September 2006); (iii) El Salvador (19 September 2006); (iv) Rep. of Korea (24 January 2007); (v) Norway (5 February 2007); (vi) India (26 March 2007); (vii) Philippines (30 March 2007); (viii) Israel (10 August 2007); (ix) Japan (31 August 2007) (x) Australia (12 September 2007). Information from WTO website at
81. See above n 37.
82. See above n 36.
83. See generally, Abbott, 'WTO Medicines Decision', above n 27
84. and Frederick M. Abbott and Rudolph van Puymbroeck, Compulsory Licensing for Public Health, A Guide and Model Documents for Implementation of the Doha Declaration Paragraph 6 Decision, World Bank Working Paper No. 61 (2005) [hereinafter 'World Bank Models'].
85. See above n 41. It is interesting to note that while the EU was arguably the key architect of most of the limitations incorporated into the Amendment, the EU has adopted a Regulation to implement the Waiver Decision that shows a strong appreciation for the flexibilities that remain open to countries in making use of the system.
86. See Abbott and Reichman, Study, above n 43 (analyzing the EU Implementing Regulation), above n 39.
87. The current G-8 focus on IP enforcement led by the German presidency, and the negotiating texts of EU Economic Partnership Agreements, suggest that the EU would not negotiate again today certain more permissive aspects of the Amendment, that it accepted in the past.
88. Including Canada, China, the EU, India, Norway and Switzerland (in process). See e.g. Abbott, 'WTO Medicines Decision', above n 27.
89. See Rwanda, Notification Under Paragraph 2(a) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, Circulated 17 July 2007, WTO Council for TRIPS, IP/N/9/RWA/1, 19 July 2007.
90. See Waiver Decision, above n 36, at para 11.
91. See Reichman with Hasenzahl, above n 34.
92. TRIPS Agreement, above n 1, Article 31(f).
93. CIPLA offered annual per patient ARV treatment at about US$350 when the originator prices were in the $10,000 range. This revolutionized the HIV-AIDS treatment environment in the developing world. See Médecins Sans Frontieres (MSF), Untangling the web of price reductions, a pricing guide for the purchase of ARVs for developing countries, 8th edn, at 10, available at .
94. See also Abbott, 'WTO Medicines Decision', above n 27, at 320-24. It appeared that a substantial part of the first-line ARV drug library was invented and patented outside India prior to initiation of the mailbox requirement on 1 January 1995, and those drugs (at least in noncombination form) would not be subject to patenting. There was some question with regard to combinations, such as the widely used 'Combivir' patented outside India by Glaxo. The potential for patenting of combinations may depend on interpretation of the specific terms of India's new patent legislation. For a few ARVs, there might be issues regarding the appropriate filing and/or priority date that would influence whether or not the drugs would come under patent.
95. See above n 57.
96. General Council, Council for Trade-Related Aspects of Intellectual Property Rights, Proposal by the African Group, et al., IP/C/W/312, WT/GC/W/450, 4 October 2001 (01-4803), available at http://www.wto.org.
97. See suggestion in Communication from the European Communities and Their Member States, The relationship between the provisions of the TRIPS agreement and access to medicines, IP/C/W/280, 12 June 2001 and EU Commission, Compulsory Licensing and Data Protection, Legal Issues related to Compulsory Licensing under the TRIPS Agreement (referenced in para 13 of Communication to TRIPS Council), ibid.
98. See further elaboration in Frederick M. Abbott, The TRIPS Agreement, Access to Medicines and the WTO Doha Ministerial Conference, Quaker United Nations Office (QUNO), Occasional Paper 7, 8 September 2001, at 13-15 [also published in 5 JWIP 15 (2002)],
99. and Frederick M. Abbott, Compulsory Licensing for Public Health Needs: The TRIPS Agenda at the WTO after the Doha Declaration on Public Health, QUNO Occasional Paper No. 9, February 2002, at 29.
100. See below text accompanying nn 87-105.
101. Para 6 of the Doha Declaration, above n 33, provides: 'We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002.'
102. In fact, the bureaucratic complications which are ultimately reflected in the Amendment largely emanated from the European Commission. Consider, for example, the proposal from the EC to the TRIPS Council in June 2002, Communication from the European Communities and their Member States, Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, IP/C/W/352, 20 June 2002.
103. For a detailed analysis of the negotiating history of the August 30 Decision see Abbott, 'WTO Medicines Decision'. See also above n 27.
104. Substantive and Procedural Elements of a Report to the General Council under Paragraph 6 of the Declaration on the TRIPS Agreement and Public Health, Non-Paper Submitted to the Council for Trade-Related Aspects of Intellectual Property Rights by South Africa, 4 November 2002, WTO Ref: Job(02)/156.
105. For list of supporting countries, see Abbott, 'WTO Medicines Decision', above n 27, at 328-29.
106. It is worth noting that the United States initially proposed limiting permissible exporting countries to developing countries, but this was not strongly pursued. Moreover, the United States, like the European Union, was opposed to allowing use of the presumptively more liberal Article 30 approach, as distinct from the presumptively more restrictive Article 31 approach. For evidence that many or most of the key restrictions in the August 30 Decision and the Protocol of Amendment originated with, or were strongly supported by the EU, after considerable internal deliberation in the 133 Committee of the European Council, see e.g. MD: 494/02 REV 1, dated 29 October 2002, with interlineated suggestions from the Commission.
107. Paragraph 6 of the Doha Declaration on the TRIPs Agreement and Public Health: Elements for a compromise solution, Reprinted in Inside US Trade as Text: EU TRIPS Paper, 1 November 2002. The same EC proposal sought to require that formulation of active ingredients into final products was to take place in the importing Member if it maintained the capacity for formulation. This would in some cases require territorial division of the manufacturing process in a way that would make little sense from a cost-efficiency standpoint. The EC further sought to require that the patent holder should always have the right to make an offer of products at 'strongly reduced prices', which could be rejected on 'reasonable grounds'.
108. Para 1(a), Waiver Decision, above n 36;
109. Para 2, Article 31bis, above n 37 .
110. The Financial Times and the Wall Street Journal, recently opined, in response to the grant of a compulsory license on Plavix (clopidogrel) by Thailand, that WTO compulsory licensing rules were never intended to cover conditions such as heart disease. As noted below, members of the European Commission have expressed similar views. Although these opinions were offered in the context of Thailand's use of Article 31 of the TRIPS Agreement, and not the August 30 Decision, they provide continuing evidence that Pharma's advertising and lobbying influence efforts will seek to distort the plain language of the TRIPS Agreement and Doha Declaration when it suits their purpose.
111. Para 1(b), Article 31bis, Annex, above n 37.
112. Ibid.
113. See below text accompanying nn 97-8.
114. See World Bank Models, above n 49.
115. See below, text accompanying nn 146-58.
116. US Representative Joe Barton (R-Tx) Holds a Hearing on Pandemic Flu Preparedness, House Energy And Commerce Committee, FDCH Political Transcripts, 8 November 2005, (exchange between HHS Sec'y Michael Leavitt and Representative Tom Allen), Lexis-Nexis News database. Roche agreed to increase its manufacturing of Tamiflu within the United States at the insistence of Health and Human Services following studies indicating that foreign sources of supply would be unreliable in a crisis.
117. See also Roche Press Release, infra n. 125.
118. In fact, the United States makes greater routine use of compulsory licensing of patent inventions for a variety of government purposes than most other countries combined. See generally, Jerome H. Reichman with Catherine Hasenzahl, Non-Voluntary Licensing of Patented Inventions: The Law and Practice of the United States, (Part III) (ICTSD/UNCTAD 2003) (citing authorities).
119. Para 2(a)(ii), Article 31bis, Annex, and Appendix to Annex, above n 37.
120. Ibid.
121. See above n 67. The 'Chairperson's Statement', discussed below, text accompanying nn 113-15, indicates that 'To promote transparency and avoid controversy, notifications under paragraph 2(a)(ii) of the Decision would include information on how the Member in question had established, in accordance with the Annex, that it has insufficient or no manufacturing capacities in the pharmaceutical sector.' Irrespective of the legal status of the Chairperson's Statement, this adds nothing material to the Amendment. A statement that the importing country had examined relevant available data would suffice.
122. See Para 2(a) (iii) and n 6 Waiver Decision, above n 36, and World Bank Models, above n 49, at 19-21.
123. See Para 2(a)(iii) Waiver Decision, above n 36.
124. See e.g. para 2(a)(iii), ibid, for continued applicability of Article 31, except as otherwise amended. In addition, the possibility for injunctive relief need not be available with respect to government use.
125. TRIPS Agreement, above n 1, Article 31(k).
126. Ibid.
127. Ibid.
128. See generally, Thomas Cottier, 'The Doha Waiver and Its Effects on the Nature of the TRIPS System and on Competition Law-The Impact of Human Rights', in Intellectual Property, Public Policy, and International Trade, I. Govaere and H. Ullrich (eds), College of Europe Studies, No. 61, 2006, 173, 196-8 (viewing Waiver Decision as substitute for undeveloped competition law and policies in poor countries).
129. See e.g. Press Release, Pharmaceuticals: Antitrust Authority Rules Merck Must Grant Free Licences For The Active Ingredient Finasteride, A3 64 - Merck - Active Ingredients (Conclusion of Investigation), http://www.agcm.it/agcm_eng/ COSTAMPA/E_PRESS.NSF/92e82eb9012a8bc6c125652a00287fbd/28653 b373e56772acl2572ab003a4d68
130. Para 2(a)(i) Article 31Ws, Annex, above n 37.
131. See e.g. MSF Access to Medicines Campaign, Neither Expeditious, Nor A Solution, above n 41, at 4.
132. See e.g. World Bank Models, above n 49, at 23-24.
133. See e.g. MSF Access to Medicines Campaign, Neither Expeditious, Nor a solution, above n 41, at 4.
134. See below section 'Making the Amendment System Work'.
135. See Rwanda notification, above n 53;
136. see also World Bank Models, above n 49, at 19-20.
137. Canadian Access to Medicines Regime, Ch 23, Statutes of Canada (2004).
138. Para 2(b), Article 31bis, Annex, above n 37.
139. Para 2(b)(i), Ibid.
140. Para 2(b)(ii), Ibid. This provision is also addressed in the Chairperson Statement, below nn 113-115. Irrespective of the legal status of the Chairperson Statement, it is unlikely to affect this aspect of the Amendment.
141. Para 2(b)(iii), Article 31bis, Annex, above n 37.
142. Para 2(c), Ibid.
143. See e.g. para 2(a)(iii), Ibid (specifying continued applicability of Article 31, except as otherwise amended).
144. The 'fast-track' terminology in this regard was initially adopted by a European Commission negotiating team and used in an article on the Waiver Decision published subsequent to its adoption. See Paul Vandoren and Jean Charles Van Eeckhaute, 'The WTO Decision on Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: Making It Work', 6J World Intell Prop L 779, 783 (2003) (stating that under Article 31 'procedures to grant compulsory licenses are not necessarily cumbersome and lengthy' but, rather, 'minimal and flexible').
145. See Abbott, 'WTO Medicines Decision', above n 27, at 342, for earlier reference to this Canadian position. The position was reiterated, and attributed to the Ministry of Justice, at a public meeting on review of Canada's legislation held in Ottawa on 19-21 April 2007 (author's notes). It is self-evident that the entire object and purpose of negotiation of the Waiver and Amendment was to allow an exporting Member to make use of the 'fast-track' procedure to address a situation of emergency, extreme urgency or public noncommercial use in the eligible importing Member. The whole process is designed to meet the public health needs of the importing country that lacks manufacturing capacity.
146. The language of the Amendment suggests that a producer should not be required to purchase new formulation or stamping equipment solely for this purpose, but might make some adjustments to existing production processes.
147. See below section 'Making the Amendment System Work'.
148. Para 2, Article 31bis.
149. Para 3, Ibid.
150. Para 4, Ibid.
151. Ibid.
152. Para 3, Article 31bis.
153. For suggestions about pooling such licenses, see below text accompanying nn 232-41.
154. The provision for assistance in regional patenting was viewed by developing country negotiators as part of an EU strategy for making it easier for EU pharmaceutical companies to control the market.
155. Para 4, Article 31 bis.
156. See e.g. UNCTAD-ICTSD Resource Book, above n 1, at 668 ff.
157. See above text accompanying nn 65-9. For details, including US statement to TRIPS Council, see Abbott, 'WTO Medicines Decision', above n 27, at 331.
158. Text of Chairperson's Statement is available at http://www/wto.org.
159. Nonetheless, there is considerable controversy concerning the legal status of the Chairperson's Statement.
160. Para 6, Article 31bis,
161. Annex, above n 37.
162. TRIPS Agreement, above n 1, Article 61.2, requires developed country members to 'provide incentives to enterprises and institutions in their territories for the purpose of promoting and encouraging technology transfer', to LDCs, so that the latter 'may create a sound and viable technological base'.
163. Frederick Abbott has served as technical expert for a project funded by USAID regarding transfer of technology in the pharmaceutical sector with respect to Colombia, which project has also involved extensive consultations in Brazil. Such projects are over and above the requirements of Article 66.2, which addresses LDCs.
164. See e.g. European Parliament, Committee on International Trade, Report on the Proposal for a Regulation of the European Parliament and of the Council on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems [(Com (2004)] 0737-C60168/2004-2004/0258 (COD), A6-0242/2005, at 7 [hereinafter EP Committee on International Trade, Report (2005)] (recommending that the Community should 'encourage . . . the transfer of technology, research, capacity strengthening regional supply systems and help with registration in order to facilitate and increase the production of pharmaceutical products by the developing countries themselves'.).
165. Proposal for a Regulation of the European Parliament and of the Council on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems, Brussels, COM(2004) 737 final, 29 October 2004.
166. See also Carlos M. Correa, Policy Paper, Assessment of the Proposed EU Regulation on the Compulsory Licensing of Generic Drugs for Export to Developing Countries, Policy Department, European Parliament, EP/ExPol/2004/07 01/02/2005.
167. Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems, OJ L 157/1, 9 June 2006, available at . For a detailed explanation of the flexibilities in the EU Regulation,
168. see Abbott and Reichman Study, above n 43 at 19-21.
169. Kathrin Hille, Taiwan employs compulsory licensing for Tamiflu, FT.com, 25 November 2005. The report notes that Taiwan issued a domestic license with a number of limitations. However, its decision appeared to trigger announcements by other countries of plans to issue compulsory licenses, suggesting an incipient global movement to override the Roche patent, which might well have included export-import arrangements.
170. Roche Media News, Roche update on Tamiflu global supply to meet future world demands-from partnerships to regional sub-licenses, Basel, 12 December 2005 (reporting voluntary license to Shanghai Pharmaceutical Group, and identification of twelve potential sub-licensees);
171. Roche, Factsheet Tamiful, 17 November 2006, at http://www.roche.com/ med_mbtamiflu05e.pdf.
172. The Chinese license was reportedly issued under threat of compulsory license. See James Packard Love, Recent Examples of the Use of Compulsory Licensing on Patents, KEI Research Note 2007 (2), revised as of 6 May 2007, available at http://www.keionline.org/misc-docs/recent_cls.pdf.
173. See e.g. California State Senate Health Committee Staff Analysis of Senate Bill 1763, April 2006, noting that, on 26 October 2005, 10 members of Congress sent a letter to Health and Human Services Secretary Michael Leavitt stating that compromising public health needs to protect patent rights is 'inexcusable' 'and requesting the immediate issuance of compulsory licenses for Tamiflu and Relenza so that generic manufacturers could begin producing necessary drugs to meet stockpile goals. In December of 2005, Roche reached a voluntary agreement with two US generic drug companies to increase production of Tamiflu.' See .
174. Roche recorded conference call MP3 file, 26 April 2007, from http://www.roche.com/home/media/med_events/med_events_mb0407.htm.
175. See Reichman with Hasenzahl, Non-Voluntary Licenses of Patented Inventions, above n 34
176. See also Cottier, The Doha Waiver, above n 85 (finding that 'the Waiver and Amendment have made an impact as one among many other factors'.).
177. See Abbott, WTO Medicines Decision, above n 27, at 320-3.
178. The Patents Act of 1970 (India), as amended 2005, section 11A(7). See GlaxoSmithKline Press Release, 10 August 2006, GSK patents and patent applications for Combivir, http://www.gsk.com/ControllerServlet?appId= 4&pageId=402&newsid=874.
179. See e.g. Intellectual Property in the Context of the WTO TRIPS Agreement: Challenges for Public Health J. Bermudez and M.A. Oliveria (eds) (2004), Chs 7-9;
180. Claudia Ines Chamas, Developing Innovative Capacity in Brazil to Meet Health Needs, MIHR Report to CIPIH, April 2005, WHO Ref. CIPIH Study 10d (DGR);
181. O. Fabienne, D. Cristina, L. Hasenclever and C. Benjamin, TRIPS-Post 2005 in Southern Countries: The Sustainability of Public Health Policies at Stake, DIME Conference, London, September 2006,
182. and Luciana Xavier de Lemos Capanema, A Indüstria Farmacêutica Brasiliera e a Atuação do BNDES, 23 BNDES Setorial 193 (2006).
183. Date regarding Brazil's pre-TRIPS APIs production is in Chamas, ibid., at 81-82.
184. TRIPS Agreement, above n 1, Article 65.4.
185. Provided that their products had not been previously introduced on the Brazilian market.
186. The decision to pursue voluntary settlements had been criticized by important actors in the Brazilian public health sector because (i) in some cases, the results were perceived as too favorable to the foreign supplier and too restrictive on Brazilian public health authorities, and (ii) because the failure to initiate production in Brazil limits the learning experience and capacity of public and private pharmaceutical producers. In the end, reliance on foreign patent-holding suppliers continues at the present time.
187. See Q&A from the Brazilian Ministry of Health on the Efavirenz CL - official translation from the Ministry of Health available on www.aids.gov.br, posted on IP-Health List Serve, 26 April 2007.
188. In Brazil, through its affiliate 'Merck Sharp and Dohme'. Ibid.
189. 'Efavirenz is in the class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), which helps keep the AIDS virus from reproducing in cells. This antiretroviral drug is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.' US Food and Drug Administration, FDA Tentatively Approves Generic Efavirenz-Product Eligible To Be Considered Under the President's Emergency Plan for AIDS Relief, FDA News, 24 June 2005.
190. See Brazil MoH, above n 134, and Joe Cohen, 'Brazil, Thailand Override Big Pharma Patents', Science Mag, 11 May 2007, at 816.
191. See above n 137.
192. Marcia Wonghon, 'Brazil Decides to Make Own AIDS Drug After Talks With Merck Collapse', Brazil Mag, 3 May 2007, available at http://www.brazzilmag.com/content/view/8220/54/.
193. See e.g. PEPFAR, Critical Intervention in the Focus Countries: Treatment, at, e.g. Tables 2.8 and 2.9, referring, inter alia, to generic versions of Efavirenz, http://www.pepfar.gov/documents/organization/81024.pdf.
194. A comprehensive description of Thailand's public health approach to the provision of medicines can be found at Ministry of Public Health and National Health Security Office, Thailand, Facts and Evidences on the 10 Burning Issues Related to the Government Use of Patents on Three Patented Essential Drugs in Thailand, February 2007, ISBN 978-974-94591-5-7 [hereinafter the 'Thai White Paper'].
195. Documents evidencing the grants of the compulsory license are attached to the Thai White Paper, above n 141.
196. Ibid, at 29 an d Document 21 (Merck Press Release).
197. Thai White Paper, above n 141, at 14-15.
198. Theerawut Sathitphattarakul and Apiradee Treerutkuarkul, 'Govt buys heart drug from India', Bangkok Post, 23 August 2007.
199. See e.g. Nicholas Zamiska, 'Abbott Escalates Thai Patent Rift, Firm Pulls Plans to Offer New Drugs in Spat with Regime', Wall St J, 14 March 2007;
200. Merck & Co, Inc. Statement on Brazilian Government's Decision To Issue Compulsory License for STOCRIN™, 4 May 2007, available at
201. See e.g. PhRMA Press Release, Protecting Patent Rights in Thailand, 1 December 2006;
202. PhRMA Press Release, PhRMA Response to 2007 Special 301 Report, 30 April 2007, available at http://phrma.org;
203. US Chamber of Commerce Press Statement, Brazil Takes Major Step Backward on Intellectual Property Rights, Says U.S. Chamber, 4 May 2007.
204. 'New challenge to Thai drug licensing (Breaking News)', Bangkok Post, 1 September 2007.
205. USTR 2007 Special 301 Report, available at .
206. See United States - Sections 301-310 of the Trade Act of 1974, Report of the Panel, WT/DS152/R, 22 December 1999.
207. Official exchange of correspondence between European Commmission and Thai officials in authors' files. Reported on in, e.g. David Cronin, EU Split Arises Over Thai Effort To Obtain Cheaper Patented Drugs, IP-Watch, 5 September 2007.
208. European Parliament resolution of 12 July 2007 on the TRIPS Agreement and access to medicines, P6_TA-PROV(2007)0353, para 9, available at 〈http://www.europarl.europa.eu/sides/getDoc.do?Type=TA&Reference= P6-TA-2007-0353&language=EN〉 [hereinafter EP Resolution of 12 July 2007].
209. See above n 151.
210. Letter from Peter Mandelson, above n 151.
211. Letter from Dr Mongkol Na Songkhla, Thailand Ministery of Public Health, to Peter Mandelson, dated 21 August 2007.
212. Doha Declaration, above n 33, para 5(b).
213. See also ibid, para 4, which provides: We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all. [Emphasis added]
214. See above n 86 and accompanying text. For the problems with price regulation in the EU,
215. see Klaus Stegeman, 'International Price Discrimination and Market Segmentation for Patented Pharmaceuticals in the EU - A Social Welfare Analysis', in Intellectual Property, Public Policy, and International Trade, above n 85, at 145-68.
216. David Cronin, EU Split Arises Over Thai Effort To Obtain Cheaper Patented Drugs, IP-Watch, 5 September 2007.
217. But see the efforts to abolish compulsory licenses in Kenya, which were barely thwarted on 14 September 2007.
218. Paul Carwood, Kenya Rejects Bid to Remove Governmental Compulsory Licensing Flexibilities, IP Watch, 14 September 2007.
219. See Para 5, Article 31bis, above n 37.
220. See above nn 56-61.
221. See also Christine Godt, 'The So-Called "Waiver Compromise" of Doha and Hong Kong: About Contested Concepts of the Nature of the International Intellectual Property System', in International Intellectual Property, Public Policy, and International Trade, above n 85, at 201, 209-210, 227-28 (stressing legitimacy of 'controlled extraterritorial effects' under TRIPS Articles 7-8, 30).
222. Canada - Patent Protection of Pharmaceutical Products, WTO Doc. WT/DS1141R (adopted 7 April 2000).
223. See e.g. Robert L. Howse, 'The Canadian Generic Medicines Panel - A Dangerous Precedent in Dangerous Times', 3 J World Intell Prop 495 (2000).
224. See Christopher Garrison, Exceptions to Patent Rights in Developing Countries, UNCTAD-ICTSD Issue Paper No. 17 (2006).
225. See EP Resolution of 12 July 2007, above n 152, para 10.
226. See e.g. implementing legislation of Canada, the EU and Norway.
227. See generally, J.H. Reichman, 'From Free Riders to Fair Followers: Global Competition under the TRIPS Agreement', 29 N Y U J Int'l L & Pol 11 (1997).
228. See e.g. Janis M. Mueller, 'Taking TRIPS to India - Novartis, Patent Law, and Access to Medicines', 356 New England J Medicine 541;
229. Janis M. Mueller, The Tiger Awakens, above n 28.
230. See Novartis v India, W.P. Nos. 24759 of 2006 and 24760 of 2006, High Court of Madras (India), decided 6 August 2007.
231. It is worth noting that the US PTO applied an efficacy test to claimed pharmaceutical inventions prior to the decision by the Federal Circuit in In re Brana, 51 F.3d 1560 (Fed. Cir 1995).
232. Novartis v India above n 169.
233. Andrew Jack, Novartis to move Indian R&D, FT.com, 22 August 2007.
234. The legal challenge to India's statute mounted by Novartis is reminiscent of the unsuccessful effort by major originator pharmaceutical companies to derail South Africa's progressive Medicines and Related Substances Control Amendment Act of 1997. The South Africa case riveted public attention because it was wrongfully pursued under the TRIPS Agreement in the face of a mushrooming HIV-AIDS pandemic, and it appeared to show a blatant disregard for the public health consequences of blindly pursuing enforcement of international trade and patent rules (without legal justification).
235. See e.g. Maskus and Reichman, 'The Globalization of Private Knowledge Goods', above n 7.
236. See Standing Committee on the Law of Patents (SCP), Draft Substantive Patent Law Treaty (SPLT), 10th Sess., 10-14 May 2004, WIPO doc. SCP/10/2, 30 September 2003;
237. Standing Committee on the Law of Patents (SCP), Information on Certain Recent Developments in Relation to the Draft Substantive Patent Law Treaty (SPLT), 10th Sess., 10-14 May 2004, WIPO doc. SCP/10/8, 17 March 2004;
238. Standing Committee on the Law of Patents, (SCP), Report, 10th Sess., 10-14 May 2004, WIPO doc. SCP/10/11, 1 June 2005.
239. Karen M. Hauda, 'The Role of the United States in World-Wide Protection of Industrial Property', in The Future of Intellectual Property in the Global Market of the Information Society 91, 97 (2003) ('This approach was adopted in an attempt to avoid the controversial hurdles to agreement that were found in the past.').
240. See also Philippe Baechtold, The Future Role of WIPO, in the Area of Industrial Property, ibid at 139, 142-3 (highlighting the need to cover other topics such as patentable subject matter, the requirement of technical character of an invention, exceptions from patentability, novelty grace period and issue of equivalents). All of these issues constitute 'flexibilities' under the TRIPS Agreement, of which compulsory licensing is but one very important component.
241. See generally, Carlos Correa, Trade-Related Aspects of Intellectual Property Rights: A Commentary On The Trips Agreement (Oxford University Press 2007).
242. On 4 October 2004, the General Assembly of the World Intellectual Property Organization agreed to adopt a proposal presented by the Group of Friends of Development (namely: Argentina and Brazil), for the establishment of a Development Agenda for WIPO, Doc. WO/ GA/31/11. Since then, many other proposals have been presented and discussed,
243. see e.g. Provisional Committee on Proposals Related to a WIPO Development Agenda, Proposal for a Decision of the PCDA on the Establishment of a WIPO Development Agenda, PCDA/2/2 (22 June 2006), available at http://www. stakeholderforum.org/22june2006.html.
244. See also James Boyle, 'A Manifesto on WIPO and the Future of Intellectual Property', 2004 Duke L & Tech Rev 9 (2004).
245. See generally, papers presented at the World Intellectual Property Organization's Open Forum on the Draft Substantive Patent Law Treaty (SPLT), International Conference Center (ICC), Geneva, Switzerland, 1-3 March 2006 [hereinafter WIPO Open Forum], available at http://www.wipo.int/meetings/en/ 2006/scp_of_ge_06/scp_of_ge_06_infl.html.
246. Jerome H. Reichman and Rochelle Cooper Dreyfuss, 'Harmonization without Consensus: Critical Reflections on Drafting a Substantive Patent Law Treaty', 57 Duke L J 85 (2007).
247. Ibid.
248. Reichman and Cooper Dreyfuss, above n 179.
249. See also Maskus and Reichman, above n 7;
250. Joseph Stiglitz, The Economic Foundations of Intellectual Property, Frei Lecture, Duke University School of Law, 16 February 2007, available at http://www.law.duke.edu/webcast/; Margaret Chon, above 11.
251. Reichman and Cooper Dreyfuss, above n 179.
252. See e.g. E-Bay v MercExchange, 126 Sup. Ct. 1837 (2006);
253. Merck v Integra Lifeseciences, 125 S. Ct. 2372 (2005),
254. and KSR v Teleflex, 127 Sup. Ct. 1727 (2007).
255. EPO, The Future of Patent Law (2007).
256. Reichman and Cooper Dreyfuss, above n 179.
257. See Maskus and Reichman, 'The Globalization of Private Knowledge Goods, above' n 7.
258. For an economic assessment, see Carsten Fink and Patrick Reichenmiller, above n 10. For legal analysis and additional references see Abbott, WTO Medianes Decision, above n 27 at 349 ff and
259. Frederick M. Abbott, Intellectual Property Provisions of Bilateral and Regional Trade Agreements in Light of U.S. Federal Law, UNCTAD - ICTSD Project on IPRs and Sustainable Development, Issue Paper No. 12, February 2006.
260. See e.g. North American Free Trade Agreement (NAFTA) Articles 1709 and 1711, available at http://www.nafta-sec-alena.org.
261. Texts generally available at 〈http://www.ustr.gov〉.
262. See Abbott, WTO Medicines Decision, above n 27, at 352-3 (discussing USTR's position regarding the legal effect of public health side letters).
263. TRIPS Agreement, above n 1, Article 4. Regional agreements entered into subsequent to entry into force of the TRIPS Agreement do not enjoy an exclusion from the requirement of extending MFN [pursuant to Article 4(d) of the TRIPS Agreement]. See UNCTAD-ICTSD Resource Book on Trips and Development, above n 1 at 77-82;
264. Abbott, BTO Medicines Decision, above n 27 at 357 (stressing trade barrier effects of intellectual property provisions).
265. See e.g. USTR, Bipartisan Agreement on Trade Policy: Intellectual Property, May 2007, Trade Facts, available at 〈http://www.ustr.gov〉.
266. Available at http://www.wto.gov.
267. Ibid.
268. Whether the template allows for 'cost sharing' rather than exclusivity in some circumstances also remains unclear. For the view that 'cost sharing' should have been the preferred approach, see Jerome H. Reichman, 'The International Legal Status of Undisclosed Clinical Trial Data: From Private to Public Goods?', in Negotiating Health-Intellectual Property and Access to Medicines, P. Roffe et al., (eds), (Earthscan 2006), 133-46 [hereinafter Negotiating Health].
269. See above n 193.
270. The new template changes the products affected by marketing exclusivity from 'new pharmaceutical product' to 'new chemical entity'. 'New pharmaceutical product' had been further defined to refer to products not previously approved in the national territory, which appeared to require treating products not previously approved only in other countries as 'new'. The new template does not further define 'new chemical entity', providing some discretion as to how that term will be applied. However, because of language in the new template indicating when marketing exclusivity need not be provided, some clarification of the intent of the new terms will be needed.
271. See above n 193.
272. This specific obligation which did not appear previously in the enforcement section of the IP chapter template, is accompanied by a requirement that the patent holder be given adequate notice and sufficient time to bring such an action prior to the marketing of the allegedly infringing product. Note that, in many developing countries, preliminary injunctions can effectively hinder generic producers seeking to enter the market. Moreover, while 'method of use' language was used in the prior template, the context was subtly different which may also raise issues in some legal systems.
273. And this is leaving aside the fact that the EU has required countries joining the Union to accept the full panoply of EU regulations respecting pharmaceuticals, which in some cases (e.g. Hungary) adversely affected local generic producers.
274. Patent Cooperation Treaty, 19 June 1970, 28 UST 7645, 1160 UNTS 231.
275. Patent Law Treaty, 1 June 2000, 39 ILM 1047 (2000).
276. See Maximiliano Santa Cruz S., Intellectual Property Provisions in European Union Trade Agreements, ICTSD Issue Paper No. 20 (2007).
277. Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights, OJ L 195/16, 2 June 2004.
278. The authors have received draft texts in confidence from negotiators and do not consider that further identification of source is necessary or appropriate here.
279. See TRIPS Agreement, above n 1, Article 50.
280. See e.g. ibid, Articles 50.6 and 50.7.
281. For example, Article 4 of the EU Enforcement Directive, above n 204, replicated in draft EPAs, provides that: 'Member States shall recognize as persons entitled to seek application of the measures, procedures and remedies referred to in this chapter:... (d) professional defence bodies which are regularly recognized as having a right to represent holders of IPRs, in so far as permitted by and in accordance with the provisions of die applicable law.' Here the EU aims to provide 'friends of Pharma' with an explicit right to initiate legal claims against generic producers seeking entry into the national market.
282. European Parliament resolution of 23 May 2007 on Economic Partnership Agreements (2005/2246(INI)) P6_TA-PROV(2007)0204, at para 45. The European Parliament renewed this request in the resolution adopted on 12 July 2007, above n 152.
283. The United States government (and the EC in the case of EPAs) may play a substantial role in proposing and reviewing the rules at the local level, which is consistent with US practise concerning oversight of the implementation of FTA obligations.
284. European Parliament resolution of 12 July 2007 on the TRIPS Agreement and access to medicines, above n 152, para 11.
285. Documents available at http://www.who.int/phi/en/.
286. However, Eric Stein's seminal article concerning the democratization process at the WHO should provide a note of caution regarding expectations in this regard. See Eric Stein, 'International Integration and Democracy: No Love at First Sight', 95 AJIL 489 (2001).
287. See e.g. Submissions of Brazil, Kenya, Thailand and others regarding 'Elements of a global strategy and plan of action', A/PHI/IGWG/1/5, available at http://www.who.int/phi/en/.
288. See e.g. Comments by the EU, Consultations on 'Elements of a global strategy and plan of action' (A/PHI/IGWG/1/5), 28/02/2007, available at http://www.who.int.
289. See e.g. Heinz Klug, 'Access to Essential Medicines: Promoting Human Rights Over Free Trade and Intellectual Property Claims', in IP and International Public Goods, above n 7, 481-92.
290. See also Tracy R. Lewis, Jerome H. Reichman and Anthony D. So, 'The Case for Public Funding and Public Oversight of Clinical Trials', Economists' Voice (January 2007), available at www.bepress.com/ev;
291. Gregory Schaffer, 'Recognizing Public Goods in WTO Dispute Settlement', in IP and International Public Goods, above n 7, 884-908;
292. Graeme Dinwoodie and Rochelle Cooper Dreyfuss, 'WTO Dispute Resolution and the Preservation of die Public Domain of Science Under International Law', in IP and International Public Goods, above n 7, 861-883.
293. See above n 101 and accompanying text.
294. However, this conclusion presupposes suitable Indian implementing regulations, that are yet to be adopted.
295. See remarks of Greg Perry, Director-General, European Generic Medicines Association, hearing before the European Parliament International Trade Committee, 5 June 2007.
296. The positive views of the Indian generic association were expressed by Dilip Shah, Director-General of the Indian Pharmaceutical Alliance, inter alia, at a Roundtable on Global Pharmaceutical Regulation held at Florida State University College of Law, 5-7 April 2007.
297. See e.g. Canada-Patent Protection of Pharmaceutical Products, WTO Doc. WT/DS114/R (adopted 7 April 2000);
298. UNCTAD-ICTSD, Resource Book, above n 1, at 118-33 (discussing TRIPS Articles 7-8).
299. See e.g. Thai White Paper, above n 141.
300. See above n 130-40 and accompanying text (case of Brazil).
301. See Reichman with Hasenzahl, 'Non-Voluntary Licensing of Patented Inventions: The Canadian Experience, (ICTSD/UNCTAD 2003).
302. Kevin Outterson, 'Patent Buy-Outs for Global Disease Innovations for Low- and Middle-Income Countries, 32 Am J Law & Med 159, 161 (2006).
303. See above text accompanying nn 144-45.
304. See e.g. Outterson, above n 224; Letter from Al Engleberg (on file with the authors).
305. See e.g. Patricia M. Danzon and Adrian Towse, 'Theory and Implementation of Differential Pricing for Pharmaceuticals', in IP and International Public Goods, above n 7 at 425-56.
306. See e.g. Harvey E. Bale Jr, 'The Conflicts Between Parallel Trade and Product Access and Innovation: The Case of Pharmaceuticals', IJ Int'l Econ L 637 (1998);
307. see also Klaus Stegman, above n 157 (discussing problems of imperfect market segmentation in EU).
308. The authors do not imply that originator practices in areas such as marketing and executive compensation are presently appropriate and reasonable, but rather they indicate a premise for discussion. See e.g. Carsten Fink, 'Comment', in International Intellectual Property, Public Policy, and International Trade, above n 85, at 169, 171 (noting high marketing expenditures of US industry).
309. See e.g. Letter from Al Engleberg, above n 226.
310. See e.g. Allan O Sykes, above n 25.
311. See generally Mark Lemley, 'Ex Ante Versus Ex Post Justifications for Intellectual Property', 71 U Chi L Rev 129 (2004).
312. This and die following sections are drawn from Jerome H. Reichman, 'Procuring Essential Medicines Under the Amended TRIPS Provisions: The Prospects for Regional Pharmaceutical Supply Centers', Paper prepared for the Seminar on Intellectual Property Arrangements: Implications for Developing Country Productive Capabilities in the Supply of Essential Medicines, United Nations Conference on Trade and Development (UNCTAD), Palais des Nations, Geneva, Switzerland, 18-20 October 2006.
313. Paris Convention above n 3, Articles 2(1), 4bis(2).
314. See K. Outterson, above n 224, at 171-73.
315. See e.g. various proposals by James Love, including Proposal for Patent Pool for Essential Medicines (PPEM), Addis Ababa - 3 March 2005, available at http://www.cptech.org/cm/addisababa03032005.html.
316. See also Anthony D. So, 'Enabling Conditions for the Scientific Commons', presented at the conference, Technology Development in the Life Sciences: Intellectual Property and Public Investment in Pharmaceuticals and Agriculture/, hosted by the Program on Science, Technology and Global Development, The Earth Institute at Columbia University (20-21 May 2004; New York City). Available at: www.earthinstitute.columbia.edu/cgsd/events/documents/so.ppt.
317. The concept of territorial segmentation of patent rights was strongly advocated by the late Prof. Jean Lanjouw in various papers (e.g. J. O. Lanjouw, Beyond TRIPS: A New Global Patent Regime, Policy Brief No. 3, The Center for Global Development, July 2002, at http://www.cgdev.org/fellows/lanjouw.html;
318. J. O. Lanjouw, 'A Patent Policy for Global Diseases: US and International Legal Issues', 16 Harv J L & Tech, 86 (2002);
319. J. O. Lanjouw, A Patent Proposal for Global Diseases, Policy Brief No. 84, The Brookings Institution, June 2001;
320. and J. O. Lanjouw, Intellectual Property and the Availability of Pharmaceuticals in Poor Countries, Center for Global Development Working Paper No. 5, April 2002), and has since found its way into practical application by institutions such as the Drugs for Neglected Diseases initiative (DNDi), in licensing arrangements with originator enterprises.
321. While Pharma enterprises could, in principle, threaten to walk away, as they have in the past, some recent statements by a spokesman for the industry have suggested a more cooperative attitude, with assurances that the companies would not walk away from these markets. See I.P. Watch (2006). This attitude may reflect a more realistic assessment of the potential future value of the African market and of the growing capacity of others to enter it.
322. Cf. James Love, 'Four Practical Measures to Enhance Access to Medical Technologies', in Negotiating Health, above n 195, at 241, 246-7.
323. WTO Ministers agreed in Paragraph 7 of the Doha Declaration that Least Developed Members should not be obligated to implement or apply TRIPS provisions for pharmaceutical product patents or data protection until 1 January 2016. Just as important, they agreed that Least Developed Members already allowing for such protection did not need to 'enforce' such rules until that later date. The TRIPS Council adopted a decision confirming this flexibility. Decision of the Council for TRIPS of 27 June 2002. The WTO General Council added a waiver of Least Developed Members' obligations regarding so-called exclusive marketing rights that might otherwise have been used as a substitute for patent protection to block production, import, and sale of medicines. WTO General Council, WT/L/478, 12 July 2002 Least-Developed Country Members-Obligations Under Article 70.9 of the TRIPS Agreement with Respect to Pharmaceutical Products, Decision of 8 July 2002.
324. Para 3, Article 31bis, above n 37.
325. See above nn 108-10 and accompanying text.
326. See above text accompanying nn 234-6.
327. See European Parliament Resolution of 12 July 2007, above n 44, paras 3-6.
328. Doha Declaration, above n 33, para 7, and implementing action by Council for TRIPS and General Council, (Decision of the Council for TRIPS of 27 June 2002, and Decision of the General Council of 8 July 2002, available at http://www.wto.org).
329. See note 239 above and also above n 27 and accompanying text.
330. See e.g. Graham Dutfield, 'Legal and Economic Aspects of Traditional Knowledge', in IP and International Public Goods, above n 7, at 495-520;
331. Jerome H. Reichman and Tracy Lewis, 'Using Liability Rules to Stimulate Local Innovation in Developing Countries: Application to Traditional Knowledge', in International Public Goods, above n 7, at 337-66;
332. Emanuela Arezzo, 'Struggling Around the "Natural" Divide: The Protection of Tangible and Intangible Indigenous Property', 25 Cardozo Arts & Ent L J 367-415 (2007).
333. See European Parliament 12 July 2007 Resolution, above n 44, to this effect.
334. See K. Outterson, above n 224, at 171, (noting that under a buyout proposal 'the present IP system is retained for more than 80% of the global patent-based cash flow of the pharmaceutical companies'.)
335. Ibid. The purchasers would then offer 'an open, nonexclusive, no royalty license to any legitimate generic manufacturer, but only for sale in the target markets'. OECD countries would continue to practise normal patent-based pricing.
336. Ibid.
337. Ibid, at 173.
338. Ibid.
339. For a very restrictive common law approach taken by the Court of Appeals for the Federal Circuit in the United Sates., see Madey v Duke University, 307 F.3d 1351 (Fed. Cir. 2002). But, for a liberal statutory approach taken by the US Supreme Court in respect of pharmaceutical research,
340. see Merck v Integra Lifesciences, 125 S. Ct. 2372 (2005).
341. See above nn 141-59 and accompanying text. cf. Kal Raustiala, 'Compliance & Effectiveness in International Regulatory Cooperation', 32 Case West Reserve J Int'l L 387 (2000);
342. J. H. Reichman, 'The TRIPS Agreement Comes of Age: Conflict or Cooperation with the Developed Countries?', 32 Case Western Res J Int'l L 441 (2000).
343. See above n 149 and accompanying text.
344. See DSU, Article 23;
345. United States-Sections 301-310 of the Trade Act of 1974, Report of the Panel, WT/DS152/R, 22 December 1999.
346. Maskus and Reichman, 'Globalization of Private Knowledge Goods', above n 7.
347. See e.g. Janice Mueller, The Tiger Awakens, above n 28.
348. Cf. Henry Grabowski, 'Increasing R&D Incentives for Neglected Diseases: Lessons from the Orphan Drug Act', in IP and International Public Goods, above n 7, at 457-80.
349. See e.g. the approach of the Drugs for Neglected Diseases initiative (DNDi), described at http://www.dndi.org/.
350. See generally, Lewis, Reichman and So, above n 216.
351. Cf. Drahos, above n 13 at 46-64.
352. See e.g. Sarah Ramsay, 'No closure in sight for the 10/90 health-research gap', 358 Lancet 1348 (2001).
353. See e.g. Nicoletta Dentico, 'DNDi's antimalarial: a new public good for neglected patients, presented at Public Health, Innovation and Intellectual Property Rights: EU Input to the Global Debate, organized by the European Commission Health and Consumer Protection Directorate-General, 2 April 2007. This is not intended to discount the importance of contributions made so far to DNDi by, inter alia, the British and Dutch governments.
354. See e.g. Amy Kapczynski et al., 'Addressing Global Health Inequities: An Open Licensing Approach for University Innovations', 20 Berkeley Tech L J 1031 (2005).
355. See European Parliament 12 July 2007 Resolution, above n 44, to this effect.
356. See European Parliament 12 July 2007 Resolution, above n 44, to this effect.
357. Canada - Patent Protection of Pharmaceutical Products, WT/DS114/R, 17 March 2000.
358. United States - Import Prohibition of Certain Shrimp and Shrimp Products, Report of the Appellate Body, AB-1998-4, WT/DS58/AB/R, 12 October 1998. See also Christine Godt, above n 161, at 227-28 (stressing power of multilateral consent to control extraterritorial effects), and;
359. Garrison above n 164.
360. See e.g. Claudia Chamas, Developing Innovative Capacity in Brazil to Meet Health Needs, MIHR Study for WHO Commission on Intellectual Property Rights, Innovation and Public Health, WHO Ref. CIPIH Study 10d (DGR), April 2005, at 94;
361. Maria Auxiliadora Oliveira et al., 'Pharmaceutical Patent Protection in Brazil: who is benefiting', in J. Bermudez and M. Oliveira (eds), 2004 Intellectual Property in the Context of the WTO TRIPS Agreement: Challenges for Public Health (FIOCRUZ, ENSP, PAHO 2004), at 161, 172-74.
362. Maskus and Reichman, 'Globalization of Private Knowledge Goods', above n 7.
363. See also Thomas Cottier, 'The Doha Waiver', above n 85, at 198 (stressing role of human rights to health and life underlying Doha Waiver and Amendment).