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World Trade Organization Canada First Notice to Manufacture Generic Drug for Export

Published online by Cambridge University Press:  27 February 2017

Abstract

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Type
International Legal Materials
Copyright
Copyright © American Society of International Law 2007

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References

Endnotes

1 Canadian Intellectual Property Office (CIPO), Use of Patents for International Humanitarian Purposes to Address Public Health Problems (Canada's Access to Medicines Regime), Applications for Authorizations Received by CIPO, Apotex, Inc., Authorization under Section 21.04 of the Patent Act, Sept. 19, 2007, at <http://strategis.ic.gc.ca/sc_mrksv/cipo/jcpa/p4e.html>.

2 The Glaxo patents, as identified by the authorization, are numbers CA 2311988, CA 2070230, CA 2068790, CA 2286126 and CA 2105487. The Shire patents are numbers CA 2059263 and CA 2009637. The Boehringer Ingelheim patent is number CA 2030056. See Authorization, id. Glaxo's basic patent on AZT for use in the treatment of HIV-AIDS has been the subject of significant controversy in the United States and Canada because, inter alia, the claimed invention substantially relied on research conducted at the U.S. National Institutes of Health. See Burroughs Wellcome v. Barr Laboratories, 40 F. 3d 1223 (Fed. Cir. 1994) and Apotex v. Wellcome, 2002 SCC File No. 28287 (Supt Ct. Can. 2002.

3 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (Aug. 30, 2003), Doc. WT/L/540 (Sept. 1, 2003). The August 30 Decision will be transformed into the first formal amendment of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement“) upon acceptance by two-thirds of the WTO's Members of a Protocol of Amendment adopted on December 6, 2005. See generally Frederick M. Abbott. The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health, 99 AM. J. INT'L L. 317 (2004), Frederick M. Abbott and Rudolph V. 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), and Frederick M. Abbott and Jerome H. Reichman, The Doha Round's Public Health Legacy: Strategies for the Production and Diffusion of Patented Medicines Under the Amended TRIPS Provisions, 10 J. INT'L ECON L. 921 (2007).

4 Canada's Minister of Industry has recently laid before Parliament a report on his review of the CAMR as provided for in Section 21.2 of the Patent Act. See Report on the Statutory Review of Sections 21.01 to 21.19 of the Patent Act, Dec. 14, 2007, available at http://camr-rcam.hc-sc.gc.ca/reviewreviser/camr_rcam_report_rapport_e.html> (hereinafter “Minister's Review“). The Minister's Review includes discussion of the results of a meeting convened by Canadian NGOs, attended by a range of government representatives, to consider potential amendments to the CAMR. See North- South Institute and Canadian HIV/AIDS Legal Network. Meeting Report, Access to Medicines and Intellectual Property: An International Expert Meeting on Canada's Access to Medicines Regime, Global Developments, and New Strategies for Improving Access, 19-21 April 2007, Ottawa, Canada, available at <http://www.aidslaw.ca/publications/interfacesdownloadFile.php?ref=1205> (hereinafter “NSI Meeting Report“).

5 Steven Chase and Drew Fagan, Drug companies balk at Ottawa's AIDS plan, Globe and Mail, Sept. 27, 2003.

6 Bill C-9, An Act to Amend the Patent Act and the Food and Drugs Act (The Jean Chretien Pledge to Africa), R.S.C., c. P-4 (2004).

7 R.S.C., c. P-4, s. 21.02. See Minister's Review, inter alia, at 9-11; NSI Meeting Report, inter alia, at 28-32.

8 NSI Meeting Report, e.g., at 36.

9 See NSI Meeting Report, at 28; Minister's Review, at 31.

10 See Apotex Press Release, Life Saving AIDS Drug for Africa Gets Final Clearance, Sept. 20, 2007, available at <http://www.apotex.com/PressReleases/Default.asp?flash=Yes>; NSI Meeting Report, at 34.

11 See generally, NSI Meeting Report, and Minister's Review

12 See Minister's Review, at 32; NSI Meeting Report, at 34-35. On July 17, 2007, Rwanda transmitted notification to the WTO, pursuant to paragraph 2(a) of the August 30 Decision, of its intention to import Triaver from Apotex in Canada. Council for Trade-Related Aspects of Intellectual Property Rights, 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 July 2007.

13 August 30 Decision, supra note 3, at para. 2(b).

14 See NSI Meeting Report, inter alia, at 34-35.

15 See Minister's Review, at 16-17.

16 See, e.g., Government of Canada, Canada's Access to Medicines Regime, available at <http://camr-rcam.hc-sc.gc.ca/doc/ link-liens/index_e.html> Canadian Intellectual Property Office, Use of Patents for International Humanitarian Purposes to Address Public Health Problems (Canada's Access to Medicines Regime), available at <http://strategis.ic.gc.ca/ sc_mrksv/cipo/jcpa/content-e.html>.

* This text was reproduced and reformatted from the text appearing at the WTO website: (visited December 3, 2007) http://www.wto.org/english/news_e/news07_e/canada_notification_oct_e.doc

1 Canada's Commissioner of Patents authorization can also be found at <http://strategis.gc.ca/sc_mrksv/cipo/new/CAMR_Authorization.pdf>

2 The WTO General Council Decision was implemented in Canada by an Act to amend the Patent Act and the Food and Drugs Act ﹛The Jean Chretien Pledge to Africa Act), of 2004. The text of Canada's Patent Act may be found at <http://laws.justice.gc.ca/en/showdoc/cs/P-4/bo-ga:s_21_01// en#anchorbo-ga: s_21 _01 >