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| - • Home |
| • > Journals |
| • > Journal of Law, Medicine & Ethics |
| • > Volume 37 Issue 2 |
| • > Comment: Compulsory Licensing of Patented |
| Pharmaceutical... |
| • English |
| • Français |
| --- |
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| [image] Journal of Law, Medicine & Ethics |
|
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| # Article contents |
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| - • Extract |
| • References |
| ## Comment: Compulsory Licensing of Patented Pharmaceutical Inventions: Evaluating the Options |
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| Published online by Cambridge University Press: 01 January 2021 |
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| Jerome H. Reichman |
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| - • Article |
| • Metrics |
| Article contents |
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| - • Extract |
| • References |
| Get access |
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| [image] Share [image] Cite [image]Rights & Permissions [Opens in a new window] |
|
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| ## Extract |
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| Few topics in international intellectual property law have been as |
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| --- |
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| controversial in recent years as the one we are about to examine. In the 1980s and early 1990s, a Diplomatic Conference attempted to revise the oldest international convention providing some protection for patented inventions outside of the domestic laws. Those efforts broke down, largely because developed and developing countries could not agree on the powers that governments should retain to issue compulsory licenses or on the grounds for which these powers could be exercised. The failure of this Conference, held under the auspices of the World Intellectual Property Organization (WIPO), persuaded the technology-exporting countries to link future negotiations concerning international intellectual property protection to the Multilateral Trade Negotiations, known as the Uruguay Round, which got underway in 1986. The end result was Annex IC of the Agreement Establishing the World Trade Organization of 1994, which incorporated a new, comprehensive and relatively elevated set of international minimum standards of patent protection into the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). |
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| ## Information |
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| Type Symposium Information Journal of Law, Medicine & Ethics, Volume 37, Issue 2, Summer 2009, pp. 247 - 263 DOI: https://doi.org/10.1111/j.1748-720X.2009.00369.x [Opens in a new window] Copyright Copyright © American Society of Law, Medicine and Ethics 2009 |
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| personal access. Content may require purchase if you do not have access.) |
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| ## Article purchase |
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| Temporarily unavailable |
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| ## References |
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| 1 |
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| Paris Convention for the Protection of Industrial Property, March 20, 1883, as revised at Stockholm (1967), 21 UST 1583, 828 UNTS 305 [hereinafter cited as Paris Convention].Google Scholar |
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| 2 |
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| See, e.g., Reichman, J. H. with Hasenzahl, C., Non-Voluntary Licensing of Patented Inventions: Historical Perspective, Legal Framework under TRIPS, and an Overview of the Practice in Canada and the U.S.A., U.N. Conference on Trade & Development [UNCTAD] & International Centre for Trade & Sustainable Development [ICTSD], Project on IPRs and Sustainable Development, Issue Paper No. 5, June 2003, available at < http:// |
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| ictsd.net/i/publications/11764/> (last visited April 17, 2009) |
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| [hereinafter cited as Reichman with Hasenzahl]. |
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| +(last + visited + April + 17, |
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| + 2009) + [hereinafter + cited + as + Reichman + with + Hasenzahl]. > Google Scholar |
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| 3 |
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| For comprehensive accounts of this process, see Drahos, P. and Braithwaite, J., Information Feudalism: Who Owns the Knowledge Economy? (London: Earthscan Publications, 2002); Sell, S. K., Power and Ideas: North-South Politics of Intellectual Property and Antitrust (Albany, New York: State University of New York Press, 1998); Sell, S. K., Private Power, Public Law: The Globalization of Intellectual Property Rights (Cambridge, U.K./New York: Cambridge University Press, 2003); Helfer, L. R., “Regime Shifting: The TRIPS Agreement and New Dynamics of International Intellectual Property Lawmaking, ” Yale Journal of International Law 29, no. 1 (2004): 1-83.Google Scholar |
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| 4 |
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| See Agreement on Trade-Related Aspects of Intellectual Property Rights, April 15, 1994, 33 I.L.M. 81, art. 27–34 (1994), available at <http://www.wto.org/english/docs_e/legal_e/27-trips.pdf> [hereinafter cited as TRIPS]; Marrakesh Agreement Establishing the World Trade Organization, April 15, 1994, 1867 UNTS 154; 33 ILM 1144 (1994), available at <http://www.wto.org/english/docs_e/ legal_e/legal_e.htm> (last visited April 17, 2009). The United States implemented the WTO Agreements in the Uruguay Round Agreements Act, Public Law 103–465, 108 Stat. 4809 (1994). |
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| + [hereinafter + cited + as + TRIPS]; + Marrakesh + Agreement + Establishing + the + World + Trade + Organization + April + 15, + 1994, + 1867 + UNTS + 154; + 33 + ILM + 1144 + (1994), + available + at + + (last + visited + April + 17, + 2009). + The + United + States + implemented + the + WTO + Agreements + in + the + + Public + Law + 103–465, + 108 + Stat. + 4809 + (1994). > Google Scholar |
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| ## 5 |
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| Id. (TRIPS), at art. 65–66, 70; World Trade Organization, Declaration on the TRIPS Agreement and Public Health, November 20, 2001, WT/MIN(01)/DEC/2, at para. 4, available at <http:// www.wto.org/english/thewto e/minist e/min01 e/ mindecl_trips e.htm> (last visited April 17, 2009) [hereinafter cited as Declaration on TRIPS]. From this date on, developing countries were required to provide at least 20 years of patent protection to a broad range of products, including pharmaceutical products, and mailboxes with pending patent applications were opened and began being processed. A few least-developed countries (LDCs) remain exempt from protecting patents until 2013 and patents on pharmaceuticals until 2016. See Extension of the Transition Period Under Article 66.1 for Least-Developed Country Members, Decision of the Council for TRIPS of 19 November 2005, WTO doc. IP/C/40, November 30, 2005; 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 the Council for TRIPS of 27 June 2002, WTO doc. IP/C/25, July 1, 2002. + (last + visited + April + 17, + 2009) + [hereinafter + cited + as + Declaration + on + TRIPS]. + From + this + date + on, |
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| --- |
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| + developing + countries + were + required + to + provide + at + least + 20 + y + including + pharmaceutical + products, + and + mailboxes + with + pending + patent + applications + were + opened + A + few + leastdeveloped + countries + (LDCs) + remain + exempt + from + protecting + pate + See + Extension + of + the + Transition + Period + Under + Article + 66.1 + f . Developed + Country + Members, + Decision + of + the + Council + for + TRIPS + of + 19 + November + 2005, + WTO + doc. + IP/C/40, + November + 30, + 2005; + Extension + of + the + Transition + Period + under + Article + 66.1 + of + the . Developed + Country + Members + for + Certain + Obligations + with + Respect + Decision + of + the + Council + for + TRIPS + of + 27 + June + 2002, + WTO + doc. + IP/C/25, + July + 1, + 2002. > Google Scholar |
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| 6 |
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| Understanding on Rules and Procedures Governing the Settlement of Disputes, April 15, 1994, 33 ILM 1226, art. 23 (1994), available at <http://www.wto.org/english/tratop_e/dispu_e/dsu_e.htm> (last visited April 17, 2009) [hereinafter cited as DSU]; see infra note 166 and accompanying text. + (last + visited + April + 17, + 2009) + [hereinafter + cited + as + DSU]; + see + infra + note + 166 + and + accompanying + text. > Google Scholar |
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| 7 |
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| See TRIPS, supra note 4, at art. 31.Google Scholar 8 |
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| See Watal, J., Intellectual Property Rights in the WTO and Developing Countries (Boston: Kluwer Law International, 2002): at 33–44.Google Scholar |
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| 9 |
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| Compare Paris Convention, supra note 1, at art. 5A, with TRIPS, supra note 4, art. 31; see Reichman, and Hasenzahl, , supra note 2.Google Scholar |
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| 10 |
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| See TRIPS, supra note 4, at art. 31(b).Google Scholar |
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| 11 |
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| Indeed, it was the United States' inability to distinguish its routine exercise of government use licenses from other compulsory licenses that led to the breadth of article 31 in the first place. See, e.g., Watal,, supra note 8.Google Scholar |
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| 12 |
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| --- |
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| See Paris Convention, supra note 1, at art. 1.Google Scholar 13 |
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| See Reichman, with Hasenzahl, , supra note 2.Google Scholar 14 |
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| Debrulle, J., De Cort, L. and Petit, M., “La license obligatoire belge pour raison de santé publique,” in van Overwalle, G., ed., Gene Patents and Public Health (Brussels: Bruylant, 2007): at 159 (note: English translation and summary available at 199); van Zimmeren, E. and Requena, G., “Exofficio Licensing in the Medical Sector: The French Model,” in van Overwalle, G., ed., Gene Patents and Public Health (Brussels: Bruylant, 2007): at 123.Google Scholar 15 |
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| For the reasons, see Flynn, S., Hollis, A. and Palmedo, M., “An Economic Justification for Open Access to Essential Medicine Patents in Developing Countries,” Journal of Law, Medicine & Ethics 37, no. 2 (2009): 184–209.CrossRefGoogle Scholar 16 |
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| See Declaration on TRIPS, supra note 5, at para. 4 (emphasis added).Google Scholar |
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| 17 Id., at para. 4–5.Google Scholar |
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| 18 |
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| Id., at para. 5.b.Google Scholar 19 |
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| Abbott, F. M. and Reichman, J. H., “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 10, no. 4 (2007): 921–987, at 929; see Declaration on TRIPS, supra note 5, at para. 6; TRIPS, supra note 4, at art. 31(f).CrossRefGoogle Scholar 20 |
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| See id. (Abbott & Reichman), at 937.Google Scholar 21 |
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| For a detailed article analyzing Article 31's disease scope, see Outterson, K., “Disease-Based Limitations on Compulsory Licenses under Articles 31 and 31bis,” in Correa, C., ed., Research Handbook on Intellectual Property Law and the WTO (forthcoming 2009). An earlier version of this paper can be found at: Outterson, K., “Should Access to Medicines and TRIPS Flexibilities Be Limited to Specific Diseases?” American Journal of Law & Medicine 34, nos. 2–3 |
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| --- |
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| (2008): 279–301 [hereinafter Access to Medicine and TRIPS].CrossRefGoogle Scholar |
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| 22 |
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