Patents and public health in the WTO, FTAS and beyond: Tension and conflict in international law

Journal of World Trade

Volumn 43, Issue 3, 2009, Pages 571-601

  Mitchell, Andrew D ^a   Voon, Tania ^a  

^a UNIVERSITY OF MELBOURNE   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

BILATERAL AGREEMENT; DEVELOPING WORLD; IMPORT; INTELLECTUAL PROPERTY RIGHTS; INTERNATIONAL LAW; INTERNATIONAL TRADE; MEDICINE; PUBLIC HEALTH; TRADE AGREEMENT; WORLD TRADE ORGANIZATION;

UNITED STATES;

EID: 78049461982     PISSN: 10116702     EISSN: None     Source Type: Journal    
DOI: 10.54648/trad2009023     Document Type: Article

References (247)

1. Mitchell, Andrew D. & Tania Voon. 'Patents and Public Health in the WTO, FTAs and Beyond: Tension and Conflict in International Law'. Journal of World Trade 43, no. 3 (2009): 571-601.
2. 'First Generic Drugs En Route to Africa under 5-Year-Old WTO Deal', Bridges Weekly Trade News Digest 12, no. 31 (2008): 5.
3. The heading to Art. 7 is 'Objectives'.
4. The heading to Art. 8 is 'Principles'.
5. Emphasis added.
6. Article 31(1) of the VCLT provides: 'A treaty shall be interpreted in good faith in accordance with the ordinarymeaning to be given to the terms of the treaty in their context and in the light of its object and purpose'. 7 1155 UNTS 331 (adopted 22 May 1969). Arts 31 and 32 of the VCLT are widely recognized as reflecting both customary international law and 'customary rules of interpretation of public international law', which therefore apply in interpreting the WTO agreements pursuant to Art. 3.2 of WTO's Understanding on Rules and Procedures Governing the Settlement of Disputes (DSU): see, e.g., Appellate Body Report, United States - Standards for Reformulated and Conventional Gasoline,WT/DS2/AB/R (circulated 29 Apr. 1996, adopted 20 May 1996) 16-17; Note
7. Michael Lennard, 'Navigating by the Stars: Interpreting the WTO Agreements', Journal of International Economic Law 5, no. 1 (2002): 17, 18-19.
8. The WTO Ministerial Conference has confirmed that, '[i]n applying the customary rules of interpretation of public international law, each provision of the TRIPS Agreement shall be read in the light of the object and purpose of the Agreement as expressed, in particular, in its objectives and principles': WTO Ministerial Conference, Declaration on the TRIPS Agreement and Public Health Adopted on 14 November 2001, WT/MIN(01)/DEC/2 (20 Nov. 2001) ('Declaration') [5(a)].
9. See above n. 6.
10. Exceptions include excluding inventions from patentability where 'necessary to protect ordre public or morality, including to protect human, animal or plant life or health', but 'provided that such exclusion is not made merely because the [commercial exploitation of the invention] is prohibited by their law': TRIPS Agreement, Art. 27.2 (original emphasis)
11. Michael Lennard., Art. 27.1.
12. Michael Lennard., Art. 28.1(a).
13. Frederick Abbott, 'The Doha Declaration on the TRIPS Agreement and Public Health: Lighting a Dark Corner at the WTO', Journal of International Economic Law 5, no. 2 (2002): 469, 472;
14. Declaration, [3];
15. Jillian Cohen-Kohler, Lisa Forman & Nathaniel Lipkus, 'Addressing Legal and Political Barriers to Global Pharmaceutical Access: Options for Remedying the Impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the Imposition of TRIPSPlus Standards', Health Economics, Policy and Law 3 (2008): 229, 231-232.
16. TRIPS Agreement, Arts 65.1, 65.2, 65.4.
17. Jillian Cohen-Kohler., Art. 66.1.
18. Commission on Intellectual Property Rights, Innovation and Public Health, Public Health: Innovation and Intellectual Property Rights (Geneva: World Health Organization, 2007), 134-135.
19. The WTO agreements contain a wide range of provisions designed to provide 'special and differential treatment' for developing countries. However, these are frequently derided as being vague and unenforceable. Accordingly, in 2001, upon the launch of the Doha Round, the WTO Ministerial Conference agreed to a review of all special and differential treatment provisions 'with a view to strengthening them and making them more precise, effective and operational': WTO Ministerial Conference, Ministerial Declaration adopted on 14 Nov. 2001, WT/MIN(01)/DEC/1 (20 Nov. 2001) [44] ('Doha Declaration').
20. Panel Report, Canada - Patent Protection of Pharmaceutical Products (Canada-Pharmaceutical Patents), WT/DS114/R (circulated 17 Mar. 2000, adopted 7 Apr. 2000 without appeal).
21. Article 31 applies '[w]here the law of a Member allows for other use of the subject matter of a patent without the authorization of the right holder', and footnote 7 to Art. 31 provides that 'other use' refers to 'use other than that allowed under Art. 30.
22. See above n. 19.
23. Subject to Art. 31(k). On the 'adequate remuneration' requirement, see generally
24. F.M. Scherer & Jayashree Watal, 'Post-TRIPS Options for Access to Patented Medicines in Developing Nations', Journal of International Economic Law 5, no. 4 (2002): 913.
25. Arvind Subramanian, 'The AIDS Crisis, Differential Pricing of Drugs, and the TRIPS Agreement', Journal of World Intellectual Property 4, no. 3 (2001): 323, 332-335.
26. In these instances, the patent owner must still be notified 'as soon as reasonably practicable' (in the case of a national emergency or other circumstances of extreme urgency) or 'promptly' (in the case of public non-commercial use, 'where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government'): TRIPS Agreement, Art. 31(b). See above Section 2.1.3.
27. See WTO Dispute Settlement Body (Special Session), Further Contribution of the United States on Improving Flexibility and Member Control in WTO Dispute Settlement, TN/DS/W/82/Add.1 (25 Oct. 2005), 2.
28. A few other limited possibilities exist for sourcing lower-priced medicines, including, in particular, the patent might have expired in the exporting country, the patent owner might have chosen not to patent them in the exporting country, the exporting country might be an LDC Member still subject to an extended transition period pursuant to Art. 66.1 of the TRIPS Agreement, or the exporting country might be a non-WTO Member or a recently acceded Member still enjoying a transition period.
29. Abbott, above n. 13, 497;
30. Subramanian, above n. 21, 326.
31. Carlos Correa, Trade Related Aspects of Intellectual Property Rights: A Commentary on the TRIPS Agreement (Oxford: Oxford University Press, 2007), 321.
32. TRIPS Agreement, Arts 3 and 4. This means that, although Members may choose what approach to adopt in relation to exhaustion, they must do so on a consistent basis (not discriminating against or between other Members).
33. Article 6 is not to be interpreted as being limited to dispute settlement such that, e.g., the substantive TRIPS provisions on patent could be read as mandating international exhaustion: Declaration, [5(d)]; Note
34. Jayashree Watal, Intellectual Property Rights in the WTO and Developing Countries (The Hague: Kluwer Law International, 2001), 296-297.
35. Intermediate approaches such as 'regional exhaustion' could also be possible. For discussion of approaches taken in the European Union and the United States.
36. Jeffery Atik & Hans Henrik Lidgard, 'Embracing Price Discrimination-TRIPS and Parallel Trade in Pharmaceuticals', University of Pennsylvania Journal of International Economic Law 28 (2007): 1043, 1059-1069.
37. Warwick Rothnie, Parallel Imports (London: Sweet & Maxwell, 1993), 1.
38. For further discussion of exhaustion and its status in the TRIPS Agreement, see generally
39. Vincent Chiappetta, 'The Desirability of Agreeing to Disagree: The WTO, TRIPS, International Exhaustion and a Few Other Things', Michigan Journal of International Law 21, no. 3 (2000): 333.
40. Scherer & Watal, above n. 21, 927-930, 933-934;
41. Kamal Saggi, 'Trade-Related Policy Coherence and Access to Essential Medicines', Journal of World Trade 42, no. 4 (2008): 619, 630-632.
42. Abbott, above n. 13, 495-497.
43. For discussion of the negotiations leading to this Declaration,
44. Abbott, 480-490.
45. Declaration, [4].
46. Abbott., [5(b)].
47. Abbott., [5(d)].
48. See also above n. 8, 27 and corresponding text.
49. And undisclosed information.
50. Declaration, [7];
51. WTO Council for TRIPS, Extension of the Transition Period under Article 66.1 of the TRIPS Agreement for Least-Developed Country Members for Certain Obligations with Respect to Pharmaceutical Products: Decision of 27 June 2002, IP/C/25 (1 Jul. 2002) [1];
52. WTO General Council, Least-Developed Country Members - Obligations Under Article 70.9 of the TRIPS Agreement with Respect to Pharmaceutical Products: Decision of 8 July 2002, WT/L/478 (12 Jul. 2002) [1].
53. LDC Members may nevertheless have to establish a 'mailbox' system for accepting patent applications;
54. Abbott, above n. 13, 502-503.
55. WTO General Council, Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: Decision of 30 August 2003, WT/L/540 (1 Sep. 2003).
56. For discussion of the negotiations leading to the Decision,
57. Duncan Matthews, 'WTO Decision on Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: A Solution to the Access to Essential Medicines Problem?', Journal of International Economic Law 7, no. 1 (2004): 73, 83-98;
58. Frederick Abbott, 'The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health', American Journal of International Law 99, no. 2 (2005): 317, 326-345.
59. Decision, [1(a)].
60. Declaration, [1].
61. Decision, [1(b)].
62. The following Members indicated in the Decision itself that they would not use the system as importers: 'Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Japan, Luxembourg, the Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, the United Kingdom and the United States' (n. 3). The following Members indicated that they would only use the system as importers in situations of national emergency or other circumstances of extreme urgency: 'Hong Kong, China; Israel; Korea; otes. Kuwait; Macao China; Mexico; Note
63. Qatar; Singapore; the Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu;
64. Turkey and the United Arab Emirates'. In addition, '[u]ntil their accession to the European Union, the Czech Republic, Cyprus, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, the Slovak Republic and Slovenia agree[d] that they would only use the system as importers in situations of national emergency or other circumstances of extreme urgency. These countries further agree[d] that upon their accession to the European Union, they w[ould] opt out of using the system as importers': WTO General Council, Minutes of Meeting Held in the Centre William Rappard on 25, 26 and 30 August 2003, WT/GC/M/82 (13 Nov. 2003) [29].
65. Decision, [2(a)].
66. Frederick Abbott., [2(b)(1)-(2)].
67. Frederick Abbott., [2(c)].
68. Frederick Abbott., [4].
69. Arguably, the obligations on exporting and importing Members to distinguish products sold under the system and to take steps to prevent trade diversion respectively affect the TRIPS Agreement's 'neutral' stance towards exhaustion (see above Section 2.1.4), moving to prevent parallel imports in this sector at least: Atik & Lidgard, above n. 28, 1076.
70. Frederick Abbott., [3].
71. For further discussion of the legal status of the Declaration, see generally
72. James Gathii, 'The Legal Status of the Doha Declaration on TRIPS and Public Health under the Vienna Convention on the Law of Treaties', Harvard Journal of Law and Technology 15, no. 2 (2002): 291.
73. Abbott, above n. 13, 491-492.
74. Article IX:2 of the Marrakesh Agreement states: 'The Ministerial Conference and the General Council shall have the exclusive authority to adopt interpretations of this Agreement and of the Multilateral Trade Agreements .... This paragraph (cont.) shall not be used in a manner that would undermine the amendment provisions in Article X'. For detailed analysis reaching the same conclusion, Note
75. Holger Hestermeyer, Human Rights and the WTO: The Case of Patents and Access to Medicines (Oxford: Oxford University Press, 2007), 279-282.
76. For more detailed analysis reaching the same conclusion,
77. Hestermeyer, ibid., 285.
78. WTO General Council, Amendment of the TRIPS Agreement: Decision of 6 December 2005, WT/L/641 (8 Dec.2005) [11].
79. The statement is reproduced in WTO General Council, Minutes of Meeting Held in the Centre William Rappard on 25, 26 and 30 August 2003, WT/GC/M/82 (13 Nov. 2003) [29].
80. WTO Council for TRIPS, Minutes of Meeting Held in the Centre William Rappard on 28 August 2003, IP/C/M/41 (7 Nov. 2003) [4]-[8].
81. WTO General Council, Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: Decision of 30 August 2003 - Corrigendum, WT/L/540/Corr.1 (29 Jul. 2005) (original emphasis).
82. See also below n. 65 and corresponding text.
83. For detailed analysis reaching the same conclusion,
84. Hestermeyer, above n. 50, 285-286 (concluding that the statement constitutes relevant context for the purpose of interpreting the Decision).
85. See above n. 6.
86. Article 32 of the VCLT provides: 'Recourse may be had to supplementary means of interpretation, including the preparatory work of the treaty and the circumstances of its conclusion, in order to confirm the meaning resulting from the application of Article 31, or to determine the meaning when the interpretation according to Article 31: (a) leaves the meaning ambiguous or obscure; or (b) leads to a result which is manifestly absurd or unreasonable'.
87. Paragraph 9 of the Decision states: 'This Decision is without prejudice to the rights, obligations and flexibilities that Members have under the provisions of the TRIPS Agreement other than paragraphs (f) and (h) of Article 31, including those reaffirmed by the Declaration, and to their interpretation'.
88. Declaration, [5(c)]. As regards the legal effect of the Declaration on the interpretation of the TRIPS Agreement, see above Section 2.2.3.
89. See above Section 2.1.1.
90. WTO General Council, above n. 52, [1].
91. Ibid., Protocol [1].
92. The Protocol does not refer to the Chairman's statement. See above Section 2.2.4.
93. WTO General Council, above n. 52, [3], Protocol [4].
94. Marrakesh Agreement, Art. X:3.
95. WTO, Members and Observers www.wto.org/english/thewto_e/whatis_e/tif_e/org6_e.htm at 31 Oct. 2008.
96. WTO General Council, above n. 52, [2], Protocol [3].
97. WTO General Council, Amendment of the TRIPS Agreement - Extension of the Period for the Acceptance by Members of the Protocol Amending the TRIPS Agreement: Decision of 18 December 2007, WT/L/711 (21 Dec. 2007).
98. See also Council for (cont.) TRIPS, Amendment of the TRIPS Agreement: Proposal for a Decision on an Extension of the Period for the Acceptance By Members of the Protocol Amending the TRIPS Agreement, IP/C/45 (29 Oct. 2007).
99. WTO, Members accepting amendment of the TRIPS Agreement www.wto.org/english/tratop_e/trips_e/amendment_e.htm at 30 Apr. 2009.
100. Council of the European Union, Instrument of Acceptance, SGS7/16652 (Brussels, 19 Nov. 2007).
101. WTO Members may modify their schedules, which form part of the WTO Agreements, subject to certain conditions. Several Members have done so.
102. For notes on the reactions to the Decision by Members, non-governmental organizations and pharmaceutical companies,
103. Abbott, above n. 40, 317-318.
104. Decision, [2].
105. Council for TRIPS, 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, IP/N/9/RWA/1 (19 Jul. 2007).
106. Council for TRIPS, Canada - Notification under Paragraph 2(C) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, IP/N/10/CAN/1 (8 Oct. 2007).
107. Matthew Rimmer, 'The Jean Chrétien Pledge to Africa Act: Patent Law and Humanitarian Aid', Expert Opinion on Therapeutic Patents 15, no. 7 (2005): 889, 891-895.
108. WTO, Notifications by Importing Members www.wto.org/english/tratop_e/trips_e/public_health_notif_import_e.htm at 31 Oct. 2008.
109. WTO, Notifications by Exporting Members www.wto.org/english/tratop_e/trips_e/public_health_notif_export_e.htm at 31 Oct. 2008.
110. WTO, Notifications by Importing Members www.wto.org/english/tratop_e/trips_e/public_health_notif_import_e.htm at 31 Oct. 2008.
111. WTO Council for TRIPS, Annual Review of the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: Report to the General Council, IP/C/46 (1 Nov. 2007) [19] (Switzerland);
112. Council for TRIPS, Annual Review of the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: Report to the General Council, IP/C/42 (2 Nov. 2006) [5] (European Communities);
113. Council for TRIPS, Annual Review of the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: Report to the General Council, IP/C/37 (3 Nov. 2005) [5] (Canada), [6] (India), [7] (Korea);
114. Council for TRIPS, Annual Review of the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: Report to the General Council, IP/C/33 (8 Dec. 2004) [4] (Norway).
115. Rimmer, above n. 77, 891-905;
116. Matthew Rimmer, 'Race against Time: The Export of Essential Medicines to Rwanda' (2008) Public Health Ethics (advance access version 14 May 2008), 2.
117. See above n. 71 and corresponding text.
118. Commission on Intellectual Property Rights, Innovation and Public Health, above n. 16, 139.
119. Ibid., 136.
120. Cohen-Kohler, Forman & Lipkus, above n. 13, 237, 240, 247;
121. Correa, above n. 25, 339-342;
122. Hestermeyer, above n. 50, 271-272, 275-276;
123. Matthew Rimmer, 'A Joint Submission to the Joint Standing Committee on Treaties: The Hong Kong Amendment to the TRIPs Agreement' (Submission 2, 9 May 2007) (cited in Joint Standing Committee on Treaties, Parliament of Australia, Report 86: Treaties tabled on 27 March and 9 May 2007 (2007) Ch. 9);
124. Médecins Sans Frontières, Neither Expeditious, Nor a Solution: The WTO August 30th Decision is Unworkable (August 2006) www.accessmedmsf.org/fileadmin/user_upload/medinnov_accesspatents/WTOaugustreport.pdf at 31 Oct. 2008.
125. See above n. 46 and corresponding text.
126. See above n. 45 and corresponding text.
127. See above Sections 2.1.3 and 2.1.4.
128. See Correa, above n. 25, 330, 334.
129. Decision, [2(b)(ii)].
130. Rimmer, Race against Time: The Export of Essential Medicines to Rwanda' (2008) n. 81, 4/5, 9-10.
131. Matthew Rimmer., 9.
132. Matthew Rimmer., 12.
133. Decision, [6(i)];
134. WTO General Council, above n. 52, Art. 31bis(3).
135. FTAs (also known as regional trade agreements or preferential trade agreements) may be bilateral, regional, or plurilateral (between three or more countries that are not necessarily located in the same 'region').
136. The Decision (para. 6(i)) and the Protocol (para. 3 of Art. 31bis) refer to 'a regional trade agreement within the meaning of Article XXIV of the GATT 1994' without specifying any particular paras of Art. XXIV or whether a regional trade agreement means a free-trade area, a customs union, or both. On the many uncertainties concerning Arts XXIV:5 and XXIV:8, Note
137. Nicolas Lockhart & Andrew Mitchell, 'Regional Trade Agreements under GATT 1994: An Exception and Its Limits', in Challenges and Prospects for the WTO, ed. Andrew Mitchell (London: Cameron, May 2005), 217.
138. James Mathis, Regional Trade Agreements in the GATT/WTO: Article XXIV and the Internal Trade Requirement (The Hague: TMC Asser Press, 2002);
139. Joel Trachtman, 'International Trade: Regionalism', in Research Handbook in International Economic Law, eds Andrew Guzman & Alan Sykes (Cheltenham: Edward Elgar, 2007), 151.
140. Decision on Differential and More Favourable Treatment, Reciprocity, and Fuller Participation of Developing Countries, L/4903, BISD 26S/203 (28 Nov. 1979) ('Enabling Clause'). The Enabling Clause forms part of the GATT 1994: para. 1(b) (iv) of the language of Annex 1A incorporating the GATT 1994 into the Marrakesh Agreement.
141. Decision, [6(i)];
142. WTO General Council, above n. 52, Art. 31bis(3).
143. UN Committee for Development Policy, Report on the sixth session (29 March-2 April 2004), UN ESCOR, supp. 13, UN Doc E/2004/33 (2004), 15.
144. Decision, [6(i)];
145. WTO General Council, above n. 52, Art. 31bis(3).
146. See above n. 96;
147. Joost Pauwelyn, 'The Puzzle of WTO Safeguards and Regional Trade Agreements', Journal of International Economic Law 7, no. 1 (2004): 109, 119-124.
148. Appellate Body Report, European Communities - Conditions for the Granting of Tariff Preferences to Developing Countries, WT/DS246/AB/R (circulated 7 Apr. 2004, adopted 20 Apr. 2004). For a critique of this judgment, Note
149. Gene Grossman & Alan Sykes, 'A Preference for Development: The Law and Economics of GSP', World Trade Review 4, no. 1 (2005): 41, 52-66.
150. We thank Professor Noah Benjamin Novogrodsky for his helpful comments on this issue at the Australian National University's workshop on Incentives for Global Health: Patent Law and Access to Essential Medicines (Canberra, 26-28 May 2008).
151. The twelve LDC Member States are Benin, Burkina Faso, Cape Verde, Gambia, Guinea, Guinea-Bissau, Liberia, Mali, Niger, Senegal, Sierra Leone, and Togo. The three non-LDC Member States are Côte d'Ivoire, Ghana, and Nigeria: ECOWAS, ECOWAS Member States www.ecowas.int/ at 31 Oct. 2008.
152. WTO Committee on Trade and Development, Economic Community of West African States (ECOWAS) - Revised Treaty: Notification from the Parties to the Agreement, WT/COMTD/N/21 (26 Sep. 2005).
153. WTO, Regional Trade Agreements Notified to the GATT/WTO and in Force: A-Z Table www.wto.org/english/tratop_e/region_e/a_z_e.xls at 31 Oct. 2008.
154. WTO, Accessions: Republic of Liberia www.wto.org/english/thewto_e/acc_e/a1_liberia_e.htm at 31 Oct. 2008.
155. Cape Verde (another LDC Member State of ECOWAS) became the WTO's 153rd Member in Jul. 2008: WTO, Cape Verde to join WTO on 23 July 2008 www.wto.org/english/news_e/news08_e/acc_capverde_june08_e.htm at 31 Oct. 2008.
156. The six LDC Member States are Lesotho, Madagascar, Malawi, Mozambique, Tanzania, and Zambia. The six non-LDC Member States are Botswana, Mauritius, Namibia, South Africa, Swaziland, and Zimbabwe. Angola and the Democratic Republic of the Congo are Member States of the SADC but have not yet joined the free trade area pursuant to the Protocol on Trade: SADC, Background to the Free Trade Area www.sadc.int/fta/index/browse/page/57 at 23 Apr. 2009; Note
157. WTO Committee on Regional Trade Agreements, Factual Presentation - Protocol on Trade in the Southern African Development Community (SADC): Report by the Secretariat, WT/REG176/4 (12 Mar. 2007) [1]. The Seychelles recently rejoined SADC: SADC, 'Final Communiqué of the 28th Summit of SADC Heads of State and Government, [17] www.sadc.int/index/browse/page/203 at 31 Oct. 2008.
158. WTO Committee on Regional Trade Agreements, Protocol on Trade in the Southern African Development Community: Notification by Tanzania - Revision, WT/REG176/N/1/Rev.1 (27 Aug. 2004).
159. See above n. 6 and corresponding text.
160. Sarah Perkins & Melanie de Wit, 'The African Private Sector Steps in to Fill the Drug Gap', The Lancet 370, no. 9589 (2007): 722, 723.
161. Decision, [6(i)];
162. WTO General Council, above n. 52, Art. 31bis(3).
163. Peter Yu, 'Access to Medicines, BRICS Alliances, and Collective Action', American Journal of Law and Medicine 34 (2008): 345, 346;
164. Sisule Musungu, Susan Villanueva & Roxana Blasetti, Utilizing TRIPS Flexibilities for Public Health Protection through South-South Regional Frameworks (Geneva: South Centre, 2004), 35-81.
165. Decision, [6];
166. WTO General Council, above n. 52, Annex to the TRIPS Agreement [5].
167. Decision, [6(ii)] (referring to 'the above Members');
168. WTO General Council, above n. 52, Annex to the TRIPS Agreement [5] (referring to 'the Members described in para. 3 of Art. 31bis). Neither the Decision nor the Protocol is explicit as to whether regional patents should be promoted in developing country and LDC Members generally or only in those countries that are party to the FTAs described earlier.
169. Decision, [6(ii)];
170. WTO General Council, above n. 52, Annex to the TRIPS Agreement [5].
171. See above n. 17 and corresponding text.
172. IP provisions in FTAs may also affect developed country Members' access to affordable medicines:
173. Bryan Mercurio, 'TRIPS-Plus Provisions in FTAs: Recent Trends', in Regional Trade Agreements and the WTO Legal System, eds Lorand Bartels & Federico Ortino (Oxford: Oxford University Press, 2006), 215, 222.
174. See generally Ibid.;
175. Assafa Endeshaw, 'Free Trade Agreements as Surrogates for TRIPs-Plus', European Intellectual Property Review 28 (2006): 374;
176. Oxfam, 'All Costs, No Benefits: How TRIPS-Plus Intellectual Property Rules in the USJordan FTA Affect Access to Medicines' (Oxfam briefing paper, Mar. 2007) www.oxfam.org/files/all%20costs,%20no%20benefits.pdf at 31 Oct. 2008.
177. Carlos Correa, 'Implications of Bilateral Free Trade Agreements on Access to Medicines', Bulletin of the World Health Organization 84, no. 5 (2006): 399;
178. Jakkrit Kuanpoth, 'TRIPS-Plus Intellectual Property Rules: Impact on Thailand's Public Health', Journal of World Intellectual Property 9, no. 5 (2006): 573;
179. Frederick Abbott, The Doha Declaration on the TRIPS Agreement and Public Health and the Contradictory Trend in Bilateral and Regional Free Trade Agreements (Occasional Paper 14, Quaker United Nations Office, Apr. 2004);
180. Abbott, above n. 40, 349-353;
181. Carsten Fink & Patrick Reichenmiller, Tightening TRIPS: The Intellectual Property Provisions of Recent US Free Trade Agreements (World Bank Trade n. 20, 7 Feb. 2005), 2-3.
182. Australia-United States Free Trade Agreement ('AUSFTA') (signed 18 May 2004, entered into force 1 Jan. 2005), Art. 17.9.8. See also, e.g., United States-Singapore Free Trade Agreement (signed 6 May 2003, entered into force 1 Jan. 2004) ('USSFTA'), Arts 16.7.7, 16.8.4(a); United States-Chile Free Trade Agreement (signed 6 Jun. 2003, entered into force 1 Jan. 2004) ('USCFTA'), Arts 17.9.6, 17.10.2(a).
183. AUSFTA, Art. 17.10.1(a). See also, e.g., USSFTA, Art. 16.8.1; USCFTA, Art. 17.10.1.
184. AUSFTA, Art. 17.10.4(a). See also, e.g., USSFTA, Art. 16.8.4(c); USCFTA, Art. 17.10.2(c).
185. AUSFTA, Art. 17.9.4. See also, e.g., USSFTA, Art. 16.7.2; United States-Morocco Free Trade Agreement (signed 15 Jun. 2004, entered into force 1 Jan. 2006), Art. 15.9.4.
186. See above Section 2.1.4.
187. See Correa, above n. 25, 314-315, 318-319.
188. Declaration, [5(b)].
189. See above n. 43.
190. See above n. 41-42 and corresponding text.
191. AUSFTA, Art. 17.9.7. See also USSFTA, Art. 16.7.6; Agreement between the United States of America and the Hashemite Kingdom of Jordan on the Establishment of a Free Trade Area (signed 24 Oct. 2000, entered into force 17 Dec. 2001), Art. 4.20. Art. 31(b) of the TRIPS Agreement provides that in those circumstances the Member may waive the requirement to 'ma[k]e efforts to obtain authorization from the right holder on reasonable commercial terms and conditions'. These circumstances are not a prerequisite to compulsory licensing per se.
192. Letters dated 15 Jun. 2004 between Taïb Fassi Fihri, Minister Delegate for Foreign Affairs and Cooperation, Kingdom of Morocco, and Robert B Zoellick, United States Trade Representative.
193. For further discussion, see
194. A Mercurio, above n. 118, 234-235.
195. Signed 12 Apr. 2006, amended 25 Jun. 2007, entered into force 1 Feb. 2009.
196. Office of the United States Trade Representative, 'Bipartisan Trade Deal' (Trade Facts, May 2007) www.ustr.gov/assets/Document_Library/Fact_Sheets/2007/asset_upload_file127_11319.pdf at 31 Oct. 2008; Note
197. Steven Weisman, 'Democrats Divided as House Passes Peru Trade Bill', New York Times (New York), 8 Nov. 2007;
198. Peter Goodman, 'Election Alters Trade Climate: Democrats Eye Environmental, Labor Clauses', (Washington, D.C.), 14 Nov. 2006.
199. Henry Waxman et al. To Susah Schwab, United States Trade Representative, 12 Mar. 2007 www.oversight.house.gov/Documents/20070312150354-57129.pdf at 31 Oct. 2008.
200. Office of the United States Trade Representative, 'Intellectual Property' (Trade Facts, May 2007) www.ustr.gov/assets/Document_Library/Fact_Sheets/2007/asset_upload_file312_11283.pdf at 31 Oct. 2008.
201. Office of the United States Trade Representative, Statement from Ambassador Susan C. Schwab on US trade agenda www.ustr.gov/Document_Library/Press_Releases/2007/May/Statement_from_Ambassador_Susan_C_Schwab_on_US_trade_agenda.html at 31 Oct. 2008;
202. 'White House, Democrats Reach Deal on Bilateral FTAs, Sparking Hopes for TPA', Bridges Weekly Trade News Digest 11, no. 17 (2007): 2, 3;
203. The Associated Press, 'US Officials Reach Agreement on Trade Deals to Open Way for Peru, Panama, and Other Pacts', International Herald Tribune (New York), 10 May 2007.
204. 'Congressional Democrats' Concept Statement on Peru and Panama FTA Changes', 10 May 2007, 7-8 www.cpath.org/sitebuildercontent/sitebuilderfiles/2007_new_trade_policy_details5-10-07.pdf at 31 Oct. 2008.
205. 'New FTA Template Alters Brand-Name Drug Protections', Inside US Trade, 11 May 2007;
206. 'Brand-Name Drug Industry Alarmed at IPR Precedent of FTA Template', Inside US Trade, 18 May 2007.
207. 'Peru IPR Text Reflects FTA Template, Shows Reduced PhRMA Sway', Inside U.S. Trade, 6 Jul. 2007.
208. PTPA, Art. 16.9.6(b).
209. Ibid., Art. 16.9.6(c).
210. Signed 5 Aug. 2004, entered into force between the United States and El Salvador 1 Mar. 2006 (Honduras and Nicaragua 1 Apr. 2006; Guatemala 1 Jul. 2006; Dominican Republic 1 Mar. 2007; Costa Rica 1 Jan. 2009: Export. Gov, US-CAFTA-DR Free Trade Agreement www.export.gov/fta/cafta/ at 30 Apr. 2009.
211. CAFTA-DR, Art. 15.9.6.
212. PTPA, Art. 16.10.2(e).
213. Essential Action and Health GAP, 'Comments and Analysis on Revised IP and Access to Medicines Provisions', 2 Jul. 2007 www.essentialaction.org/access/index.php?/archives/94-Comments-and-Analysis-on-Revised-IP-and-Access-to-Medicines-Provisions.html at 31 Oct. 2008.
214. Tania Voon, Cultural Products and the World Trade Organization (Cambridge: Cambridge University Press, 2007), 214-215.
215. See above n. 96 and corresponding text.
216. For example, under Art. XXIV:8(b), a 'free-trade area shall be understood to mean a group of two or more customs territories in which the duties and other restrictive regulations of commerce ... are eliminated on substantially all the trade between the constituent territories in products originating in such territories'.
217. Ernst-Ulrich Petersmann, 'From Negative to Positive Integration in the WTO: The TRIPs Agreement and the WTO Constitution', in Intellectual Property: Trade, Competition, and Sustainable Development, eds Thomas Cottier & Petros Mavroidis (Ann Arbor: University of Michigan Press, 2003), 21, 22-23;
218. William Davey & Werner Zdouc, 'The Triangle of TRIPS, GATT and GATS', in Intellectual Property: Trade, Competition, and Sustainable Development, eds Thomas Cottier & Petros Mavroidis (Ann Arbor: University of Michigan Press, 2003), 53, 54;
219. Thomas Cottier, 'The Agreement on Trade-Related Aspects of Intellectual Property Rights', in The World Trade Organization: Legal, Economic and Political Analysis, eds Patrick Macrory, Arthur Appleton & Michael Plummer, vol. 1 (New York: Springer, 2005), 1041, 1054.
220. See above Section 3.2.1.
221. Tariffs must generally be applied on an MFN basis: GATT 1994, Arts I, II.
222. See above Section 3.2.3.
223. See above Section 3.2.3 on the legal status of the Declaration and the Decision.
224. See the objectives and principles in TRIPS Agreement, Arts 7 and 8.1, as discussed in Section 2.1.1 above.
225. But see Panel Report, Canada - Certain Measures Affecting the Automotive Industry ('Canada-Autos'), WT/DS139/R, WT/DS142/R (circulated 11 Feb. 2000, adopted 19 Jun. 2000) (this issue not appealed) and Appellate Body Report, Turkey - Restrictions on Imports of Textile and Clothing Products ('Turkey-Textiles'), WT/DS34/AB/R (circulated 31 May 1999, adopted 19 Nov. 1999).
226. See above n. 96 and corresponding text.
227. USTR, 2008 Special 301 Report (2008) 18.
228. Ibid.
229. See Cohen-Kohler, Forman & Lipkus, above n. 13, 240-241.
230. USTR, 2008 Special 301 Report (2008), 2.
231. Sara Ford, 'Compulsory Licensing Provisions under the TRIPs Agreement: Balancing Pills and Patents', American University International Law Review 15 (1999-2000): 941, 950-956;
232. Duncan Matthews, 'WTO Decision on Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: A Solution to the Access to Essential Medicines Problem?', Journal of International Economic Law 7, no. 1 (2004): 73, 78-80;
233. Duane Nash, 'South Africa's Medicines and Related Substances Control Amendment Act of 1997', Berkeley Technology Law Journal 15 (2000): 485;
234. Subramanian, above n. 21, 327;
235. Haochen Sun, 'The Road to Doha and Beyond: Some Reflections on the TRIPS Agreement and Public Health', European Journal of International Law 15, no. 1 (2004): 123, 131-132.
236. Abbott, above n. 13, 471-472;
237. Paul Champ & Amir Attaran, 'Patent Rights and Local Working under the WTO TRIPS Agreement: An Analysis of the U.S.-Brazil Patent Dispute', Yale Journal of International Law 27, no. 2 (2002): 365;
238. Matthews, above n. 160, 80;
239. Sun, above n. 160, 132-133.
240. Neil Lewis, 'U.S. Industry to Drop AIDS Drug Lawsuit against South Africa', New York Times (New York), 10 Sep. 1999;
241. WTO, Brazil - Measures Affecting Patent Protection: Notification of Mutually Agreed Solution, WT/DS199/4, G/L/454, IP/D/23/Add.1 (19 Jul. 2001).
242. USTR, 2008 Special 301 Report (2007), 27.
243. Henry Waxman et al. To Susah Schwab, United States Trade Representative, 9 Apr. 2008, 1 oversight. house.gov/documents/20080409144118.pdf at 31 Oct. 2008.
244. USTR, 2008 Special 301 Report (2007), 37.
245. See Commission on Intellectual Property Rights, Innovation and Public Health, above n. 16, 139-140.
246. Musungu, Villanueva & Blasetti, above n. 113, 23.
247. Declaration, [4].