The Vienna Convention on the law of treaties, the dispute settlement system of the WTO and the Doha Declaration on the TRIPs Agreement

Journal of World Trade

Volumn 36, Issue 4, 2002, Pages 721-772

  Shanker, Daya ^a  

^a UNIVERSITY OF WOLLONGONG   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

TRADE AGREEMENT; WORLD TRADE ORGANIZATION;

EID: 26044444222     PISSN: 10116702     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1020370104498     Document Type: Review

References (202)

1. Declaration on the TRIPs Agreement and Public Health, Ministerial Conference, Fourth Session, Doha, 9-14 November 2001, WT/MIN(01)/DEC/W/2, dated 14 November 2001 (hereinafter Declaration).
2. The EC, Trade and Development: Access to Essential Medicines-EU tables proposals on access to medicines for developing countries with no drug production, Press Release, Brussels, 5 March 2002.
3. Article IX(2) of the Marrakesh Agreement Establishing the World Trade Organization (hereinafter Marrakesh Agreement) dealing with Decision Making states, "The Ministerial Conference and the General Council shall have the exclusive authority to adopt interpretation of a Multilateral Trade Agreement in Annex 1...".
4. Declaration: the relevant part of the Declaration states: "(4) We agree that the TRIPs Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, we affirm mat the Agreement can and should be interpreted and implemented in a manner supportive of WTO Member's right to protect public health arid, in particular, to promote access to medicines for all. In this connection, we reaffirm the right of WTO members to use, to the full, the provisions in the TRIPs Agreement, which provide flexibility for this purpose. (5) Accordingly and in the light of paragraph 4 above, while maintaining our commitments in the TRIPs Agreement, we recognize that these flexibilities include: (a) In 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".
5. Vienna Convention on Law of International Treaties, done at Vienna, 23 May 1969, 1155 UNTS 331 (hereinafter Vienna Convention).
6. Doha Declaration, para. 6: "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."
7. Canada - Patent Protection of Pharmaceutical Products (Canada - Patent Protection), WTO doc. WT/DS114/R, dated 6 March 2000, Report of the Panel
8. P. Nicholls, GATT doctrine, 2 Virginia J. Int'l L. (1996), p. 380.
9. Lorand Bartels, Applicable Law in WTO Dispute Settlement Proceeding, 35 J.WT. 3 (2001), pp. 499-519.
10. Petros C. Mavroidis, Remedies in the WTO Legal System: Between a Rock and a Hard Place, European Journal of International Law, 4 (2000), p. 763.
11. David Palmeter and Petros C. Mavroidis, Dispute Settlement in the World Trade Organization (The Hague and Boston: Kluwer Law International, 1999).
12. Chapter 3 was published as The WTO Legal System: Sources of Law, 92 A.J.I.L. (1998), p. 398.
13. Vienna Convention, as note 5 above.
14. Rochelle Cooper Dreyfuss and Andreas L. Lowenfeld, Two Achievements of the Uruguay Round: Putting TRIPs and Dispute Settlement Together, 37 Vanderbilt J. Int'l L. (1997), p. 275.
15. Appellate Body Report, Argentina - Safeguard Measures an Imports of Footwear (Argentina - Footwear Safeguard), WT/DS121/AB/R, adopted 12 January 2000, para. 118, Appellate Body Report
16. US - Wheat Gluten Safeguard, WT/DS166/AB/R, adopted 19 January 2001, paras 147-151;
17. Appellate Body Report, US-Safeguard Measures an Imports of Fresh, Chilled or Frozen Limb Meat from New Zealand and Australia (US - Lmnb Safeguard), WT/DS177/AB/R, WT/DS178/AB/R, adopted 16 May 2001, paras 101-116:
18. Appellate Body Report US Transitional Safeguard Measure on Combed Cotton Yarn from Pakistan, WT/DS192/AB/R, dated 8 October 2001.
19. Appellate Body Report EC - Measures Concerning Meat and Meat Products (Hormones), WT/DS26/AB/R, WT/DS48/AB/R, adopted 13 February 1998, DSR 1998:1, 135, para. 117.
20. US - Standard for Reformulated and Conventional Gasoline (US - Gasoline), Report of the Appellate Body, WT/DS2/39, adopted 20 May 1996
21. Japan - Taxes on Alcoholic Beverages, WT/DS8/AB/R, WT/DS10/AB/R, WT/DS11/AB/R, dated 4 October 1996.
22. Japan - Taxes on Alcoholic Beverages, Ibid., at p. 9.
23. E.g., Territorial Dispute Case (Libyan Arab Jamahiriya v. Chad), (1994), ICJ Reports, p. 6 (International Court of Justice);
24. Golder v. United Kingdom, ECHR, Series A, (1995) No. 18 (European Court of Human Rights);
25. Restrictions to the Death Penalty Cases, (1986) 70 ILR 449 (Inter-American Court of Human Rights);
26. Jimenez de Arechaga, International Law in the Past Third Century, 159 Recueil des Cours 1 (1978), p. 42;
27. D. Carreau, Droit International (3rd edn, 1991) p. 140;
28. R. Jennings and A Watts (eds), Oppenheim's International Law (9th edn, London: Longman, 1992), Vol. 1, pp. 1271-1275.
29. Report of the Appellate Body US - Gasoline, WT/DS2/AB/R, at p. 17.
30. US - Import Prohibition of Certain Shrimp and Shrimp Products, WT/DS58/AB/R, dated 12 October 1998, AB-1998-4.
31. US - Gasoline, WT/DS2/AB/R, adopted 20 May 1996;
32. Japan - Taxas an Alcoholic Beverages, adopted 1 November 1996, WT/DS8/AB/R, WT/DS10/AB/R, WT/DS11/AB/R, pp. 10-12, 17;
33. India - Patent Protection for Pharmaceutical and Agricultural Chemical Products, adopted 16 January 1998, WT/DS50/AB/R, paras 45-46;
34. Argentina - Measures Affecting Imports of Footwear, Textiles and Other Items, adopted 13 February 1998, WT/DS56/AB/R, para. 47;
35. and EC - Customs Classification of Certain Computer Equipment, adopted 22 June 1998, WT/DS62/AB/R, WT/DS68/AB/R, para. 85.
36. Appellate Body Report in US - Import Prohibition of Certain Shrimp and Shrimp Products.
37. 8 Irit'l Legal Materials (1969), p. 679.
38. See, e.g., Territorial Dispute Case, as note 19 above;
39. Golder v. United Kingdom, as note 19 above;
40. Restrictions to the Death Penalty Cases, as note 19 above;
41. Arechaga, as note 19 above;
42. Carreau, as note 19 above;
43. Oppenheim's International Law, as note 19 above.
44. US - Gasoline, p. 17.
45. Report of the Panel US - Sections 301-310 of the Trade Act of 1974, WT/DS152/R, dated 22 December 1999.
46. Yearbook of the ILC (1966), Vol. II, pp. 219-220.
47. Argentina - Footwear Safeguard, WT/DS121/AB/R, adopted 12 January 2000, para. 81.
48. James Cameron and Kevin R. Gray, Principles of International Law in the WTO Dispute Settlement Body, 50 Int'l & Comparative L. Quarterly (2001), p. 256, observed that "The link between Articles 31 and 32 of the VCLT and interpretation requirement stated in Article 3:2 of the DSU is now entrenched in WTO law. This connection has emerged into a legal test from which Panels cannot deviate when reviewing provisions in the WTO Agreements. Failing to apply this test or using alternative methods of treaty interpretation can result in overturned rulings, (note 37. The Panel in the LAN Computers was overruled by the Appellate body, for its failure to examine the context of a tariff schedule or the object and purpose of the WTO Agreement and the GATT 1994, before resorting to an examination of the legitimate expectations of the parties (Section V, para. 88)). In the Shrimp - Turtle dispute, the Panel was criticized by the Appellate Body for not following all of the steps in applying the customary rules of interpretation of public international law. The correct process entails looking at the text of the provision first, followed by ascertaining the object and purpose of the treaty where the meaning of the text is equivocal or inconclusive or where the correctness of the reading of the text is desired.
49. Vienna Convention, as note 5 above;
50. 8 Int'l Legal Materials (1969), p. 679.
51. Article 32 - Supplementary means of interpretation: "Recourse may be had to supplementary means of interpretation, including the preparatory work if 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."
52. US - Gasoline, WT/DS/9, adopted 20 May 1996, p. 23.
53. Cameron and Gray, as note 30 above, p. 253.
54. Korea - Measures Affecting Government Procurement (Korea - Government Procurement), as note 36 below.
55. Korea - Government Procurement, WT/DS163/R, 1 May 2000, para. 7.96, n. 753.
56. Report of the Appellate Body in Japan - Taxes on Alcoholic Beverages, WT/DS8/AB/R, WT/DS10/AB/R, WT/DS11/AB/R, dated 4 October 1996, AB-1996-2, p. 14.
57. Japan - Taxes on Alcoholic Beverages, 1996, p. 14. Ibid.
58. Report of the Appellate Body, US - Import Prohibition of Certain Shrimp and Shrimp Products: Recourse to Article 21.5 of the DSU by Malaysia, dated 22 October 2001, AB 2001-4, p. 31.
59. David Palmeter and Petros C. Mavroidis, The WTO Legal System, 92 AJIL (1998), pp. 398-413, at p. 402.
60. Argentina - Measures Affecting Imports of Footwear, Textiles, Apparel and Other Items, WT/DS56/R, at n. 176 (John H. Jackson), 184 (Keith Highet), 185 (Mojtaba Kazazi);
61. India - Patent Protection for Pharmaceutical and Agricultural Chemicals Products, WT/DS/AB/R, dated 19 December 1997, at n. 26 (F. Roessler, E.-U. Petersmann), 28 (E.-U. Petersmann), 52 (I. Brownlie);
62. EC - Measures Concerning Meat and Meat Products (Hormones), n. 92 (P. Sands, J. Cameron, J. Aboucher, P. Birnie, A. Boyle, L. Gundling, A. deMestral, D. Bodansky).
63. Japan - Taxes on Alcoholic Beverages, WT/DS8/AB/R, WT/DS10/AB/R, WT/DS11/AB/R, dated 4 October 1996, at n. 17; Arechaga, as note 9 above;
64. (Sinclair, I, Oppenheim's International Law (9th edn, Jenninigs and Watts (eds), 1992), 24;
65. Yasseen, Mustafa Kamil, L'interpretation des traits d'apres la Convention de. Vienne sur le Droit des Traites, 151 Recueil des Cours (1976-III), p. 1, 48-49.
66. David Palmeter and Petros C. Mavroidis, The WTO Legal System: Sources of Law, A.J.I.L., July 1998, (92), p. 398-418, 407.
67. The general principle of international law found in the Vienna Convention pertaining to the retroactivity of treaties has been approved in Canada - Term of Patent Protection, WT/DS170/AB/R, para. 71, at p. 21;
68. Appellate Body Report, Brazil - Measures Affecting Desiccated Coconut, WT/DS22/AB/R, adopted on 20 March 1997, p. 15;
69. and in Appellate Body Report, EC - Regime for the Importation, Sale and Distribution of Bananas, WT/DS27/AB/R, adopted 25 September 1997, para. 235.
70. D. Rauschning (ed.), Vienna Convention on the Law of Treaties, Travaux Préparatoires (Frankfurt: Alfred Metzner, 1978), observation 3 on Article 28 of the International Law Commission Final Draft, p. 220, and observation 3 on the Waldock Report VI, p. 218.
71. Korea - Government Procurement, Report of the Panel, WT/DS163/R, dated 1 May 2000, p. 181, para. 7.93. The Panel further observed: "It seems clear that good faith performance has been agreed by the WTO Members to include subsequent actions which might nullify or impair the benefits reasonably expected to accrue to other parties to the negotiations in question. The consistency of such an interpretation with the general principles of customary international law is confirmed by reference to the negotiating history of the Vienna Convention. According to the Report of the International Law Commission to the General Assembly, this issue was considered by the members negotiating the Convention in the following manner: 'Some members felt that there would be advantage in also stating that a party must abstain from acts calculated to frustrate the object and purpose of the treaty. The Commission, however, considered that this was clearly implicit in the obligation to perform the treaty in good faith and preferred to state the pacta sunt servanda rule in as simple a form as possible'."
72. US - Tax Treatment for "Foreign Sales Corporation", WT/DS108/AB/R, dated 24 February 2000;
73. and US Shrimp, footnote 99, para. 158;
74. E.-U. Petersmann, From the Hobbesian International Law of Coexistence to Modern Integration Law: The WTO Dispute Settlement System, 1 JIEL 175 (1998), pp. 189-191.
75. EC - Measures Concerning Meat and Meat Products (Hormones) - Original Complaints by the US - Recourse to Arbitration by the European Communities under Article 22.6 of the DSU, Decision by Arbitrators, WT/DS26/ARB, dated 12 July 1999, para. 51.
76. Brazil - Export Financing Programme for Aircraft - Recourse to Arbitration by Brazil Under Article 22.6 of the DSU and Article 4.1 of the SCM Agreement, Decision by Arbitrators, WT/DS46/ARB, dated 28 August 2000, para. 3.10.
77. Legal Status of Eastern Greenland, (1933) PCIJ, series A/B, No. 53, p. 22, at p. 71, and dissenting opinion of Judge Anzilotti, at pp. 91-92.
78. Case concerning the Temple of Preah Vihenr, ICJ Reports, 1962, p. 6, at pp. 26-27.
79. Korea - Govrnment Procurement, WT/DS163/R, p. 181, n. 753.
80. EC - Customs Classification of Certain Computer Equipment, WT/DS62/AB/R, WT/DS67/AB/R, WT/DS68/AB/R, dated 5 June 1998, p. 38, para. 86.
81. I. Sinclair, The Vienna Convention on the Law of Treaties (2nd edn, Manchester: Manchester University Press, 1984), p. 141.
82. Commentary, Year Book of International Law Commission (1966), II, p. 223.
83. Arnold McNair, The Law of Treaties (2nd edn, Oxford: Oxford University Press, 1986), p. 421.
84. Treaty Conference Records (1968), p. 178.
85. Treaty Conference Records Ibid., p. 176.
86. [1981] A.C. 251, 283.
87. Border and Transborder Armed Actions (Nicaragua/Honduras), Jurisdiction and Admissibility, Judgment, ICJ Reports, 1988, p. 69.
88. Treaty Conference Records (1968), p. 167.
89. Fitzmaurice, G. (1957) 33 BYIL, 203.
90. DJ. Harris, Cases and Material on International Law (5th edn, London: Sweet and Maxwell, 1998).
91. ICJ Reports, 1952, p. 92.
92. PCIJ Reports, (1922), Series B. No. 2, pp. 39-40.
93. (GATT Basic Instruments and Selected documents - BISD 37S/80, 86).
94. Canada/European Communities - Article XXVII Rights, Report by the Arbitrator, 26 October 1990, DS12/R, BISD 37S/80, at 86.
95. ICJ Reports, 1992, p. 351, at p. 586.
96. ICJ Reports, 1993, p. 38, at p. 51.
97. Korea - Government Procurement.
98. Daya Shanker, Brazil, the Pharmaceutical Industry and the WTO, 5 J. World Intellectual Property 1 (January 2002), p. 53.
99. Brazil - Measures Affecting Patent Protection, Request for the Establishment of a Panel by the United States, WT/DS199/3, dated 9 January 2001.
100. Canada - Patent Protection, Report of the Panel, WT/DS114/R, dated 17 March 2000, para. 4.11, p. 17.
101. Canada - Patent Protection of Pharmaceutical Products, Request for the Establishment of a Panel by the European Communities, WT/DS114/5, dated 12 November 1998.
102. MacKay J. in Apotex Inc. v. Attorney General of Canada, 71 CPR (3d), at p. 170.
103. Canada - Patent Protection, n. 147.
104. Trade Related Intellectual Property Rights: Submission by Austria (8 December 1989), MTN.GNG/NG11/W/55, para. 5.3.
105. Switzerland: Standards and Principles Concerning the Availability, Scope and Use of Trade-related Intellectual Property Rights: Communication from Switzerland (11 July 1989), MTN.GNG/NG11/W/38, p. 3.
106. Canada - Patent Protection, p. 150, para. 7.14.
107. Canada - Patent Protection, para. 7.92.
108. Canada - Patent Protection, p. 52.
109. Canada - Patent Protection, para. 4.30(a)(I), indent 5.
110. Canada - Patent Protection, para. 4.30(a), p. 50. In the following paragraph, the EC makes its point that the object and purpose as mentioned in the TRIPs Agreement carries no meaning. In indent 2 of para. 4.30(a), the EC further says: "It was one of the major features of the TRIPs Agreement that its implementation was in principle neutral vis-à-vis societal values. This principle was most clearly expressed in Article 8.1 of the Agreement: 'Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures an consistent with this provisions of this Agreement' (emphasis added by the EC). This provision made it utterly clear that none of the public policy considerations, referred to in the first half sentence, could be invoked to justify measures which were consistent with provisions of the TRIPs Agreement. This principle of neutrality ris-à-ris societal values was also confirmed if one compared the exception provision in Article 30 with the exception provisions contained in Article XX of the GATT."
111. Canada - Patent Protection, para. 4.40(2), indent 12, p. 86.
112. Canada - Patent Protection, para. 4.30(a), indent 3.
113. Collier's Dictionary, Victoria Neufeldt (ed.) (New York: 1994).
114. Justice Douglas in Special Equipment Co. 324 US 370 (1945).
115. 324 US 370, 382.
116. Daya Shanker, India, Pharmaceutical Industry and the Validity of TRIPs, The Journal of World Intellectual Property, Vol. 5 No. 3 (2002) pp. 315-371.
117. Canada - Patent Protection, 4.30(a)(I), indent 9.
118. Appellate Body Report in US - Import Prohibition of Certain Shrimp and Shrimp Products.
119. Canada - Patent Protection, WT/DS114/R, dated 17 March 2000.
120. Canada - Patent Protection, para. 7.92.
121. Canada - Patent Protection, para. 7.35, p. 156.
122. Canada - Patent Protection, p. 156. Ibid.
123. Canada - Patent Protection, p. 156. Ibid.
124. Canada - Patent Protection, para. 4.27. The EC further continued: "If one were to follow the Canadian interpretation that Article 30 overrode the non-discrimination provisions in Article 27.1, this would necessarily lead to the result that exceptions could also be made as to the place of invention or whether products were imported or locally produced. In other words, exceptions could be made if the place of invention was outside Canada without making the same exception if the invention had been made in Canada. Equally, one could confine the exception to imported products and not apply it to locally produced products. Clearly, these consequences were not intended by the TRIPs negotiating parties." In fact, when such arguments were made by the EC, both the European Patent Convention and a number of member countries of the EC including the UK were having local working provision in their Patent Acts. The presence of such local working provisions has been discussed by Daya Shanker, as note 22 above, and note 70 above.
125. Canada - Patent Protection, para. 7.90.
126. Canada - Patent Protection, WT/DS114/R, dated 17 March 2000, para. 4.10, pp. 16-17. Canada argued that Sections 55.2(1) and 55.2(2): "(a) in any event, took into account Canada's national interest in measures conducive to social welfare and the achievement of a balance between rights and obligations, both of which were recognized in Article 7 of the TRIPs Agreement; and (b) they sought to protect public health - value recognized in Article 8.1 of the TRIPs Agreement - through promoting access to cost-effective generic medicines following patent expiry and, in this connection, they took into account the legitimate interests of individuals, private insurers and public sector entities that financed health care in maintaining access to affordable medicines."
127. Canada argued that it removed compulsory licensing because the Uruguay Round negotiations along with NAFTA were trying to eliminate compulsory licensing. Compulsory licensing had been an integral part of the Dunkel Draft (TNC.MGN/W/FA, dated 20 December 1991), and the Paris Convention was as much part of Dunkel Text as it is of current TRIPs.
128. Canada - Patent Protection, pp. 68-69, para. 4.36.
129. Canada - Patent Protection, pp. 68-69, para. 4.36.
130. Canada - Patent Protection, para. 4.17.
131. Canada - Patent Protection, para. 7.92.
132. Canada - Patent Protection, nn. 74, 75.
133. Draft Agreement on Trade Related Aspects of Intellectual Property Rights, GATT Doc. MTN.GNG/NG11/W68, dated 29 March 1990-Negotiating Group on Trade Related Aspects of Intellectual Property Rights including Trade in Counterfeiting Goods received from the European Commission.
134. Draft Agreement on the Trade Related Aspects of Intellectual Property Rights: GATT Doc. MTN.GNG/NG11/70, dated 11 May 1990: Communication from the United States.
135. GATT Doc. MTN.GNG/NG11/W/74, dated 15 May 1990.
136. Ibid.
137. Annex 1 GATT Doc. MTN/GNG/NG11/W/71, dated 14 May 1990.
138. Korea - Government Procurement.
139. Canada - Patent Protection, para. 7.91.
140. Canada - Patent Protection, para. 7.92.
141. Canada - Patent Protection, para. 7.26.
142. Robert Hudec, "Transcending the Ostensible": Some Reflections on the Nature of Litigation Between Governments, Minnesota L. Rev. 72 (1988), p. 211, where Hudec observed, "The effectiveness of international litigation machinery in most international legal institutions usually falls short of comparable domestic litigation procedures. The right to initiate litigation is riot as certain, the procedure does not move forward as rapidly, decisions are not made with same degree of objectivity, and legal rulings are not enforced as well."
143. Hudec, as note 114, above, at pp. 212-213: "To the contrary, international legal arrangements have relatively more in common with law of primitive societies studied by anthropologists, in which litigation is still emerging as a rather tenuous alternative to dispute resolution by force. International litigation is an institution of indeterminate character. It isn't an inevitable response to legal disputes, nor does it supply a conclusive outcome."
144. Canada - Patent Protection, pp. 85-86, para. 4.40, indent 5.
145. Canada - Patent Protection, pp. 85-86, Ibid.
146. "[O]ur negotiators ensured that the TRIPs Agreement permits the Bolar Exemption to be maintained."
147. 103d Congress, 2d Session, House Document 103-316, Vol. 1, p. 986, "Article 28 specifies that a patent must include the right to exclude others from making, using, offering for sale, selling, or importing the product. The Agreement permits limited exceptions to the exclusive rights conferred by a patent if certain conditions are met. US law contains some such exceptions, such as those set out in Section 271(e) of the Patent Act (35 USC s. 271(e))."
148. Canada - Patent Protection, para. 7.47.
149. Japan - Taxes on Alcoholic Beverages, WT/DS8/AB/R, WT/DS10/AB/R, WT/DS11/AB/R, pp. 12-13.
150. Sinclair, as note 53 above;
151. M.K. Yasseen, L'interpretation des traités d'après la Convention At Vienne sur le Droit des Traités, 151 Recueil des Cours 3 (1976), p. 1, at p. 48
152. Report of the Appellate Body, EC - Customs Classifitation of Certain Computer Equipment, WT/DS62/AB/R, WT/DS67/AB/R, WT/DS68/AB/R, dated 5 June 1998.
153. D.J. Harris, Cases and Materials on International Law (5th edn, London: Sweet and Maxwell, 1998), pp. 815-816.
154. ICJ Reports, 1952, p. 92
155. ICJ Reports, 1950, p. 135.
156. 4.41(a)(I) indent 3, "it was in the immediate aftermath that a treaty like this generated both legislative activity and documents like the US Statement of Administrative Action, when the parties were actively engaged in the exercise of interpreting the new agreement and putting it in their own words, and closely reviewing the legislative activity of other Members. Far from being irrelevant, the implementation period had a vital importance far exceeding what might transpire later."
157. PCIJ Reports, Series B, No. 2, pp. 39-40.
158. 35 USC s. 271(e).
159. Intermedic, Inc. v. Ventritex, Inc., 775 F. Supp. 1269 p. 1284 (N.D. Cal. 1991).
160. 733 F. 2d 858; Cert. Denied 221 USPQ 937; 469 US 856 (1984).
161. 103d Congress, 2d Session, House Document 103-316, Vol. 1, p. 986.
162. Para. 4A.2 of Section 5 of composite draft MTN.GNG.NG11/W/76, dated 23 July 1990, had a specific clause: "PARTIES are encouraged to extend the term of patent protection in appropriate cases, to compensate for delays regarding the exploitation of the patented invention caused by regulatory approval processes." This was taken from the Draft Proposal of the EC and the USA. It was removed from the final draft.
163. Canada - Patent Protection, para. 7.48.
164. Canada - Patent Protection, para. 7.81.
165. Canada - Patent Protection, para. 7.82.
166. MTN.GNG/NG11/W/76, 23 July 1990, Status of Work in the Negotiating Group. Chairman's Report to the Group of Negotiations on Goods, Part III, Section 5, para. 4A.2.
167. Canada - Patent Protection: EC Second (Rebuttal) Submission, pp. 62-64, 80-81, para. 7.53.
168. J.H. Reichmim, Securing Compliance with the TRIPs Agreement After US v. India, JIEL (1998), pp. 585-601, at pp. 596-597: "Yet, as the Appellate Body makes clear, position papers deposited in the course of the negotiations do not constitute sources of law because only the black-letter rules apply and the means of implementing them are expressly reserved to local law in Article 1 of the TRIPs Agreement."
169. Brazil - Measures Affecting Patent Protection, Request for the Establishment of a Panel by the United States, WT/ DS199/3, dated 9 January 2001: "Article 68 of Brazil's 1996 industrial property law (Law No. 9,279 of 14 May 1996; effective May 1997) however imposes a 'local working' requirement which stipulates that a patent shall be subject to compulsory licensing if the subject matter of the patent is not 'worked' in the territory of Brazil. Specifically, a compulsory licence shall be granted on a patent if the patented product is not manufactured in Brazil or if the patented process is not used in Brazil. In addition, if a patent owner chooses to exploit the patent through importation rather than 'local working', then Article 68 will allow others to import either the patented product or the product obtained from the patented process.
170. Article 68 of Brazil's 1996 industrial property law discriminates against US owners of Brazilian patents whose products are imported into, but not locally produced in, Brazil. Article 68 also curtails the exclusive rights conferred on these owners by their patents. As such, Brazil's local working requirement appears inconsistent with its obligations under Article 27.1 and Article 28.1 of the TRIPs Agreement."
171. Daya Shanker, Brazil, the Pharmaceutical Industry and the WTO, 5 J. World Intellectual Property 1 (January 2002), pp. 53-104.
172. USTR Press Release dated 25 June 2001 at 〈www.ustr.gov〉.
173. Amir Attaran and Lee Gillespie-White, Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatment in Africa?, 286 J. American Medical Association 15 (17 October 2001).
174. Special 301 on Intellectual Property Rights, Fact Sheet released by the Office of the US Trade Representative, Executive Office of the President, Washington, DC (1 May 2001).
175. The proposal was signed by the African Group, Bangladesh, Barbados, Bolivia, Brazil, Cuba, Dominican Republic, Ecuador, Haiti, Honduras, India, Indonesia, Jamaica, Pakistan, Paraguay, Philippines, Peru, Sri Lanka, Thailand and Venezuela, IP/C/W/312, WT/GC/W/450, dated 4 October 2001.
176. Developing country group's paper for Council Discussion on Access to Medicines, 20 June 2001, para. 2.
177. Ibid., para. 22.
178. Ibid., para. 33.
179. The paper was signed by the African Group, Bangladesh, Barbados, Bolivia, Brazil, Cuba, Dominican Republic, Ecuador, Haiti, Honduras, India, Indonesia, Jamaica, Pakistan, Paraguay, Philippines, Peru, Sri Lanka, Thailand and Venezuela, IP/C/W296, 20 June 2001.
180. Article 39.3 is not an isolated provision. It is part of Article 39.1, which says: "In the course of ensuring effective protection against unfair competition as provided in Article 10bis of the Paris Convention (1967), members shall protect undisclosed information in accordance with paragraph 2 and data submitted to governments or governmental agencies in accordance with paragraph 3." Only in circumstances as mentioned in Article 10bis of the Paris Convention, Article 39.3 would come in play. The limited role of Article 39.3 is evident from the introduction and continuation of Hatch Waxman Act 1984, dealing with submission of ANDA (Abbreviated New Drug Approval system). It is true that the US and the EC have provided a time period only after which such actions can be taken but in case of TRIPs, only limiting and guiding factor is Article 10bis of the Paris Convention.
181. Alan O. Sykes, TRIPs, Pharmaceuticals, Developing Countries, and the Doha "Solution", 3 Chicago J. Int'l L. 1 (Spring 2002)
182. published as John M. Olin Law and Economics Working Paper No. 140 (2nd Series), The Law School, University of Chicago.
183. Law and Economics Working Paper No. 140 (2nd Series), Ibid., p. 9.
184. Law and Economics Working Paper No. 140 (2nd Series), Ibid., p. 24.
185. Sykes comment "To my knowledge, developing nations have not suggested that they may rely on Article 30 to deal with the pharmaceutical issue" is one of the factual weaknesses. The Draft Ministerial Declaration, IP/C/W/312, WT/GC/W/450, dated 4 October 2001, at para. 9, states: "Under Article 30 of the TRIPs Agreement, members may, among others, authorize the production and export of medicines by persons other than holders of patents on those medicines to address public health needs in importing Members."
186. Ministerial Declaration on the TRIPs Agreement and Public Health, WTO, IP/C/W/312, WT/GC/W/450, dated 4 October 2001.
187. Concept Paper for Approaches Relating to Paragraph 6 of the Doha Declaration on the TRIPs Agreement and Public Health, Communication from the European Communities and their Member States to the TRIPs Council, dated 1 February 2002.
188. EU's Paper: Paper Submitted by the EU to the TRIPs Council, for the special discussion on intellectual property and access to medicines, 20 June 2001, TRIPs: Council Discussion on Access to Medicines, IP/C/W/280 dated 12 June 2001, WTO.
189. Communication from the European Communities and their Member States to the TRIPs Council-Concept Paper for Approaches Relating to Paragraph 6 of the Doha Declaration on the TRIPs Agreement and Public Health, H/public/post Doha/ 3d country CL/Communication 3DCL version 6 01/02/2002, para. 27.
190. Ibid., para. 29 of the Concept Paper gives a partial explanation when it says: "The basic principle of such a construction would be that the juxtaposition of distinct legal situations in two distinct members would allow a country without sufficient manufacturing capacity to give full effect to a compulsory licence on its territory. On the other hand, we would have a country without a sufficient manufacturing capacity for pharmaceuticals which, pursuant to Article 31 of the TRIPs Agreement, grants a compulsory licence to an economic operator, authorizing him to import and sell a patented pharmaceutical on its territory. On the other hand, we have another member which would make use of a limited exception under its patent law (based on Article 30 of the TRIPs Agreement), which allows manufacturers designated by the beneficiary of the compulsory licence, to manufacture that product, without the authorization of the patent holder, for export to the first member when a number of conditions are fulfilled."
191. Trade and Development Access to Essential Medicines: WTO Ministerial Declaration on the TRIPs Agreement and Public Health - the issues at stake, Explanatory Note, Brussels, 11 December 2001. In reply to question (3) What clarification does paragraph 4 bring?, the Explanatory Note says: "... a member of which legislation, in particular in the area of patents is being challenged by another member because of alleged incompatibility with the TRIPs Agreement, can refer to the contents of this Declaration, which, although it was not meant to affect member's rights and obligations, expresses the members' views and intentions. Hence, the Declaration is part of the context of the TRIPs Agreement which, according to the rules of the treaty interpretation, has to be taken into account when interpreting the Agreement."
192. in Frederick M. Abbott, WTO TRIPs Agreement and Its Implications for Access to Medicines in Developing Countries, report commissioned by the CIPR as a background paper, Study Paper 2a, Commission on Intellectual Property Rights, 14 February 2002;
193. Abbott, Compulsory Licensing for Public Health Needs: The TRIPs at the WTO after the Doha Declaration on Public Health, Occasional Paper 9 (Geneva: Quaker United Nations Office, Friends World Committee for Consultation, February 2002;
194. Abbott, The TRIPs Agreement, Access Medicines and the WTO Doha Ministerial Conference, Public Law and Legal Theory, Working Paper No. 36 (College of Law, Florida State University, October 2001)
195. published in 5 J. World Intellectual Property 1 (2002).
196. Frederick Abbott, WTO TRIPs Agreement and its Implications for Access to Medicines in Developing Countries, Study Paper 2a (Commission on Intellectual Property Rights), p. 27.
197. WTO TRIPs Agreement and Its Implications for Access to Medicines in Developing Countries, Ibid., p. 30.
198. WTO TRIPs Agreement and Its Implications for Access to Medicines in Developing Countries, Ibid., p. 29.
199. WTO TRIPs Agreement and Its Implications for Access to Medicines in Developing Countries, Ibid.
200. Canada - Patent Protection, at pp. 80-81, references omitted.
201. EC - Measures Concerning Meat and Meat Products (Hormones), WT/DS26/AB/R, WTO Doc. AB-1997-4, and WT/DS48/AB/R, dated 16 January 1998, para. 104.
202. Joost Pauwelyn, Enforcement and Countermensures in the WTO: Rules are Rules - Towards a More Collective Approach, A.J.I.L. 94 (April 2000), pp. 335-347, at p. 341