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Comment: Compulsory Licensing of Patented Pharmaceutical Inventions: Evaluating the Options

Published online by Cambridge University Press:  01 January 2021

Extract

Few topics in international intellectual property law have been as 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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Symposium
Copyright
Copyright © American Society of Law, Medicine and Ethics 2009

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References

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
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://ictsd.net/i/publications/11764/> (last visited April 17, 2009) [hereinafter cited as Reichman with Hasenzahl].+(last+visited+April+17,+2009)+[hereinafter+cited+as+Reichman+with+Hasenzahl].>Google Scholar
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
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).+[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+Uruguay+Round+Agreements+Act,+Public+Law+103–465,+108+Stat.+4809+(1994).>Google Scholar
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,+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.>Google Scholar
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
See TRIPS, supra note 4, at art. 31.Google Scholar
See Watal, J., Intellectual Property Rights in the WTO and Developing Countries (Boston: Kluwer Law International, 2002): at 3344.Google Scholar
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
See TRIPS, supra note 4, at art. 31(b).Google Scholar
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
See Paris Convention, supra note 1, at art. 1.Google Scholar
See Reichman, with Hasenzahl, , supra note 2.Google Scholar
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
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): 184209.CrossRefGoogle Scholar
See Declaration on TRIPS, supra note 5, at para. 4 (emphasis added).Google Scholar
Id., at para. 4–5.Google Scholar
Id., at para. 5.b.Google Scholar
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): 921987, at 929; see Declaration on TRIPS, supra note 5, at para. 6; TRIPS, supra note 4, at art. 31(f).CrossRefGoogle Scholar
See id. (Abbott & Reichman), at 937.Google Scholar
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 (2008): 279301 [hereinafter Access to Medicine and TRIPS].CrossRefGoogle Scholar
World Trade Organization, Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, Decision of the General Council of 30 August 2003, August 30, 2003, WT/L/540, available at <http://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm> (last visited April 17, 2009) [hereinafter cited as Paragraph 6 Decision]; World Trade Organization, Amendment of the TRIPS Agreement, December 6, 2005, WT/L/641, available at <http://www.wto.org/english/tratop_e/trips_e/wtl641_e.htm> (last visited April 17, 2009) [hereinafter cited as Amendment of TRIPS]; see Abbott, and Reichman, , supra note 19.+(last+visited+April+17,+2009)+[hereinafter+cited+as+Paragraph+6+Decision];+World+Trade+Organization,+Amendment+of+the+TRIPS+Agreement,+December+6,+2005,+WT/L/641,+available+at++(last+visited+April+17,+2009)+[hereinafter+cited+as+Amendment+of+TRIPS];+see+Abbott,+and+Reichman,+,+supra+note+19.>Google Scholar
See TRIPS, supra note 4, at art. 31(h). See generally Taubman, A., “Rethinking TRIPS: ‘Adequate Remuneration’ for Non-Voluntary Patent Licensing,” Journal of International Economic Law 11, no. 4 (2008): 927970.CrossRefGoogle Scholar
See Abbott, and Reichman, , supra note 19, at 944.Google Scholar
See Paragraph 6 Decision, supra note 22. See also, e.g., Matthews, D., “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): 73107.CrossRefGoogle Scholar
See Amendment of TRIPS, supra note 22.Google Scholar
Id.; see Abbott, and Reichman, supra note 19, at 929.Google Scholar
See, e.g., Mercurio, B. C., “TRIPS, Patents, and Access to Life-Saving Drugs in the Developing World,” Marquette Intellectual Property Law Review 8, no. 2 (2004): 211; see also Abbott, and Reichman, , supra note 19, at 947.Google Scholar
Goodwin, P. E., “Right Idea, Wrong Result – Canada's Access to Medicines Regime,” American Journal of Law & Medicine 34, no. 4 (2008): 567584.CrossRefGoogle Scholar
Mercurio, B., “TRIPS-Plus Provisions in FTAs: Recent Trends,” in Bartels, L., Ortino, F., eds., Regional Trade Agreements and the WTO Legal System (Oxford: Oxford University Press, 2006): at 215–238; see also Abbott, and Reichman, , supra note 19, at 958–66; Dwyer, L., “Patent Protection and Access to Medicine: The Colombian and Peruvian Trade Promotion Agreements,” Law & Business Review of the Americas 13, no. 4 (2007): 825-857. For an example from a developed country, see Outterson, K., “Agony in the Antipodes: The Generic Drug Provisions in the Australia – US Free Trade Agreement,” Journal of Generic Medicine 2, no. 4 (2005): 316-326.Google Scholar
See Flynn, et al., supra note 15.Google Scholar
Downward pressures on AIDS drugs were further exerted by private foundations (especially the Clinton Foundation) and both national (e.g., PEPFAR in the U.S.) and international aid programs.Google Scholar
Lybecker, K. M. and Fowler, E., “Compulsory Licensing in Canada and Thailand: Comparing Regimes to Ensure Legitimate Use of the WTO Rules,” Journal of Law, Medicine & Ethics 37, no. 2 (2009): 222240.CrossRefGoogle Scholar
See, e.g., Cohen, J., “Brazil, Thailand Override Big Pharma Patents,” Science, May 11, 2007, at 816; Abbott and Reichman, supra note 19, at 950–952 (noting that, until 2007, Brazil had reached negotiated settlements with foreign suppliers without formally issuing a compulsory license).Google Scholar
See Outterson (Access to Medicines and TRIPS), supra note 21, at 320–321; Outterson, K. (Disease-Based Limitations), supra note 21. But see Lybecker, and Fowler, , supra note 33 (who disagree on this point).Google Scholar
See Goodwin, , supra note 29, at 569; Lybecker, and Fowler, , supra note 33, at 2.Google Scholar
Tunsarawuth, S., “Indonesia Mulls Compulsory Licenses on Three More HIV/AIDS Drugs,” Intellectual Property Watch, November 26, 2007, available at <http://www.ip-watch.org/weblog/2007/11/26/indonesia-mulls-compulsory-licences-on-three-more-hivaids-drugs/> (last visited April 21, 2009).+(last+visited+April+21,+2009).>Google Scholar
See van Zimmeren, and Requena, , supra note 14, at 123 and 139 n. 38; Love, J. Packard, “Recent Examples of Compulsory Licensing of Patents,” KEI, May 6, 2007, available at <http://www.keionline.org/index.php?option=com_content&task=view&id=41> (last visited April 21, 2009).+(last+visited+April+21,+2009).>Google Scholar
See van Zimmeren, & Requena, , supra note 14, at 140.Google Scholar
See Love, , supra note 38, at 3; Abbott, and Reichman, , supra note 19, at 939; Carroll, J. and Winslow, R., “Bayer Agrees to Slash Prices for Cipro Drug,” Wall Street Journal, October 25, 2001, at A3 (“The agreement comes after a high-stakes threat by Tommy Thompson, HHS secretary, to break Bayer's patent for Cipro if he didn't get the price he wanted.”) The relevant U.S. compulsory license statutes are 7 U.S.C. § 2404 (2000) (plant variety protection certificates necessary for the nation's fiber, food, or feed supply); 28 U.S.C. § 1498 (2000) (government use of patents); 35 U.S.C. § 203 (2000) (patents developed through the use of government research funding under the Bayh-Dole Act); and 42 U.S.C. § 2183 (2000) (atomic energy). The U.S. compulsory license statutes do not meet all of the restrictions required by Article 31 of TRIPS. See TRIPS, supra note 4, at art. 31.Google Scholar
See van Zimmeren, and Requena, , supra note 14, at 133134.Google Scholar
See Debrulle, et al., supra note 14, at 159 and 163.Google Scholar
Id., at 171; but see infra note 90.Google Scholar
See van Zimmeren, and Requena, , supra note 14, at 137.Google Scholar
See Love, , supra note 38, at 10–11. For details see Coco, R. and Nebbia, P., “Compulsory Licensing and Interim Measures in Merck: A Case for Italy or for Antitrust?” Journal of Intellectual Property Law & Practice 2, no. 7 (2007): 452462.Google Scholar
Castle, S. and Kanter, J., “European Antitrust Regulators Raid Drug Companies,” International Herald Tribune, January 16, 2008, available at <http://www.iht.com/articles/2008/01/16/business/drug.php> (last visited March 7, 2009); DG Competition, Pharmaceutical Sector Inquiry: Preliminary Report, November 28, 2008, available at <http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/preliminary_report.pdf> (last visited March 7, 2009).+(last+visited+March+7,+2009);+DG+Competition,+Pharmaceutical+Sector+Inquiry:+Preliminary+Report,+November+28,+2008,+available+at++(last+visited+March+7,+2009).>Google Scholar
For a view consistent with that of the patent-based drug industry, see Danzon, P. M. and Towse, A., “Differential Pricing for Pharmaceuticals; Reconciling Access, R&D and Patents,” AEI-Brookings Joint Center for Regulatory Studies, Working Paper No. 03–7, 2003, at 28–29, available at <http://papers.ssrn.com/sol3/papers.cfm?abstract_id=422821> (last visited April 21, 2009). For a synthesis more attuned to the problems of access, see Outterson, K., “Pharmaceutical Arbitrage: Balancing Access and Innovation in International Prescription Drug Markets,” Yale Journal Health Policy, Law & Ethics 5, no. 1 (2005): 193-291 [hereinafter cited as Pharmaceutical Arbitrage].+(last+visited+April+21,+2009).+For+a+synthesis+more+attuned+to+the+problems+of+access,+see+Outterson,+K.,+“Pharmaceutical+Arbitrage:+Balancing+Access+and+Innovation+in+International+Prescription+Drug+Markets,”+Yale+Journal+Health+Policy,+Law+&+Ethics+5,+no.+1+(2005):+193-291+[hereinafter+cited+as+Pharmaceutical+Arbitrage].>Google Scholar
Outterson, K. and Kesselheim, A., “Market-Based Licenses for HPV Vaccines in Developing Countries,” Health Affairs 27, no. 1 (2008): 130139, at 136–137.CrossRefGoogle Scholar
Scherer, F. M., “A Note on Global Welfare in Pharmaceutical Patenting,” World Economy 27, no. 27 (2004): 11271142, at 1141.CrossRefGoogle Scholar
Gilead has announced a policy of price discrimination for major AIDS products that has elicited complaints from other companies. See Baron, D. P., Krehbiel, K. and Tayan, B., The Gilead Access Program for HIV Drugs, 2007.Google Scholar
See TRIPS, supra note 4, at art. 6; Declaration on TRIPS, supra note 5, at par. 5(d).Google Scholar
Danzon, P. M. and Towse, A., “Theory and Implementation of Differential Pricing for Pharmaceuticals,” in Maskus, K. E., Reichman, J. H., eds., International Public Goods and Transfer of Technology under a Globalized Intellectual Property Regime (Cambridge: Cambridge University Press, 2005): at 425. See also Dutfield, G., “Delivering Drugs to the Poor: Will the TRIPS Amendment Help?” American Journal of Law & Medicine 34, nos. 2-3 (2008): 107-124, at 114 (citing authorities). The term “reference pricing” is somewhat confusing as it also applies to pricing mechanisms within wealthy countries. An alternative term is “virtual arbitrage.” See Outterson, , supra note 47, at 283.Google Scholar
DiMasi, J. A., Hansen, R. W. and Grabowski, H. G., “The Price of Innovation: New Estimates of Drug Development Costs,” Journal of Health Economics 22, no. 2 (2003): 151185; see also Reichman, J. H., “Rethinking the Role of Clinical Trial Data in International Intellectual Property Law: The Case for a Public Goods Approach,” Marquette Intellectual Property Law Review 13, no. 1 (2009): 1-68, at 9-11 (citing authorities with different estimates).CrossRefGoogle Scholar
See Danzon, and Towse, , supra note 52, at 445.Google Scholar
McElligott, S., “Addressing Supply Side Barriers to Introduction of New Vaccines to the Developing World,” American Journal of Law & Medicine 35 (forthcoming 2009).CrossRefGoogle Scholar
See Flynn, et al., supra note 15.Google Scholar
Id. While relatively few countries may fit the 10–90 matrix of South Africa, the principle could apply equally to other countries where the relevant matrix was 20–80 or 30–70, rather than 10–90.Google Scholar
The Ministry of Public Health & The 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, at 14–15, available at <www.moph.go.th/hot/WhitePaperCL-EN.pdf> (last visited April 23, 2009); see Abbott, and Reichman, , supra note 19, at 953.+(last+visited+April+23,+2009);+see+Abbott,+and+Reichman,+,+supra+note+19,+at+953.>Google Scholar
See Outterson, , supra note 47 at 203–216, 232–235.Google Scholar
Personal communication with Professor Kevin Outterson, March 10, 2009.Google Scholar
See Flynn, et al., supra note 15.Google Scholar
For details, see Reichman, J. H. with Hasenzahl, C., Non-Voluntary Licensing of Patented Inventions: The Canadian Experience, UNCTAD/ICTSD Project on IPRs and Sustainable Development, October 2002, at 37–38; see also McFetridge, D. G., Intellectual Property, Technology, Diffusion and Growth in the Canadian Economy, in Anderson, R. D. and Gallini, N. T., eds., Competition Policy and Intellectual Property Rights in the Knowledge Economy (Calgary: University of Calgary Press, 1998): at 65.Google Scholar
Id. (Reichman with Hasenzahl), at 38–44. Industry Canada has, at various times, expressed satisfaction with the results of this arrangement.Google Scholar
Id., at 42–43; see North American Free Trade Agreement, Canada-U.S.-Mexico, at ch. 17, December 17, 1992, 32 I.L.M. 605 (1993) [hereinafter NAFTA].Google Scholar
See TRIPS, supra note 4, at arts. 31(a), (c).Google Scholar
Id., at art. 31(b). This provision is waived in the case of national emergency, other circumstances of extreme urgency or in cases of governmental use. Id.Google Scholar
Id., at art. 31(g). For example, an abusive use of a patent could be purged, allowing a claim to void such a license.Google Scholar
Id., at art. 31(j).Google Scholar
Id., at art. 31(h). The remuneration must take “into account the economic value of the authorization.” Id. See also Love, J., Remunerations Guidelines for Non-Voluntary Use of a Patent on Medical Technologies, WHO/TCM/2005.1, 2005, available at <http://www.who.int/medicines/areas/technical_cooperation/WHOTCM2005.1_OMS.pdf> (last visited April 23, 2009); see also Taubman, , supra note 23.+(last+visited+April+23,+2009);+see+also+Taubman,+,+supra+note+23.>Google Scholar
See Flynn, et al., supra note 15.Google Scholar
See TRIPS, supra note 4, at art. 31(k).Google Scholar
See, e.g., Hovenkamp, H. J., “The Intellectual Property-Anti-trust Interface,” University of Iowa College of Law, Legal Studies Research Paper No. 08–46, 2008, at 1979–2007, available at <http://ssrn.com/abstract=1287628> (last visited April 23, 2009); Fox, E. M., “Can Antitrust Policy Protect the Global Commons from the Excesses of IPRs?” in Maskus, K. E. and Reichman, J. H., eds., International Public Goods and Transfer of Technology under a Globalized Intellectual Property Regime (Cambridge: Cambridge University Press, 2005): at 758,758–769.Google Scholar
See, e.g., Arezzo, E., “Intellectual Property Rights at the Cross-road between Monopolization and Abuse of a Dominant Position: American and European Approaches Compared,” John Marshall Journal of Computer & Information Law 24, no. 3 (2006): 456494.Google Scholar
See, e.g., Fox, , supra note 77, at 759–64; Ullrich, H., “Expansionist Intellectual Property Protection and Reductionist Competition Rules: A TRIPS Perspective,” in Maskus, K. E. and Reichman, J. H., eds., International Public Goods and Transfer of Technology Under a Globalized Intellectual Property Regime (Cambridge: Cambridge University Press 2005): at 726, 726–757.Google Scholar
See Hovenkamp, , supra note 77, at 1991; Illinois Tool Works v. Indep. Ink, 126 Sup. Ct. 1281 (2006); see also Cotter, T. F., “Misuse,” Houston Law Review 44, no. 4 (2007): 901964; Janis, M. D., “‘Minimal’” Standards for Patent-Related Antitrust Law under TRIPS,” in Maskus, K. E. and Reichman, J. H., eds., International Public Goods and Transfer of Technology under a Globalized Intellectual Property Regime (Cambridge: Cambridge University Press, 2005): 774, 790-792.Google Scholar
See, e.g., Fox, , supra note 77, at 758; Ullrich, , supra note 79, at 726.Google Scholar
See, e.g., Ghidini, G., Intellectual Property and Competition Law: The Innovation Nexus (Cheltenham: Elgar, 2006): 103111.CrossRefGoogle Scholar
See supra note 77; Drexl, J., “The Critical Role of Competition Law in Preserving Public Goods in Conflict with Intellectual Property Rights,” in Maskus, K. E. and Reichman, J. H., eds., International Public Goods and Transfer of Technology under a Globalized Intellectual Property Regime (Cambridge: Cambridge University Press, 2005): at 709725.Google Scholar
See Flynn, et al., supra note 15.Google Scholar
See, e.g., Coco, R., “Antitrust Liability for Refusal to License Intellectual Property: A Comparative Analysis and the International Setting,” Marquette Law Review 12, no. 1 (2008): 1021 (citing authorities).Google Scholar
See Fox, , supra note 77, at 768.Google Scholar
See Paris Convention, supra note 1, at art. 5A; Bodenhausen, G. H. C., Guide to the Application of the Paris Convention for the Protection of Industrial Property, as Revised at Stockholm in 1967, 1968, at 71. However, current precedents governing misuse in the U.S. may no longer support such outcomes. See Hovenkamp, , supra note 77, at 1091–1095; Reichman, with Hasenzahl, , supra note 2; Cotter, , supra note 80.Google Scholar
See TRIPS, supra note 4, at art. 3, 8.2, 40; Paris, Convention, supra note 1, at art. 2(1).Google Scholar
However, for the disappointing story of the first attempt to use the Waiver, see Goodwin, , supra note 29.Google Scholar
For an existing WTO panel decision that casts doubt on efforts to use art. 8 of the TRIPS Agreement to expand the limited exceptions to a patentee's exclusive rights under art. 30 of that Agreement, see Canada-Patent Protection of Pharmaceutical Products, WT/DS114/R, March 17, 2000.Google Scholar
Bird, R. C., “Developing Nations and the Compulsory License: Maximizing Access to Essential Medicines while Minimizing Investment Side Effects,” Journal of Law, Medicine & Ethics 37, no. 2 (2009): 209222.CrossRefGoogle Scholar
Id., at 1 (citing World Health Organization, The World Medicines Situation at 61 (2004)).Google Scholar
See infra text accompanying notes 166–172.Google Scholar
See Abbott, and Reichman, , supra note 19, at 973–980; see infra text accompanying notes 159–160.Google Scholar
See Outterson, , (Access to Medicine and TRIPS), supra note 21, at 289–91.Google Scholar
Id., at 296.Google Scholar
See Abbott, and Reichman, , supra note 19, at 952, 954–956.Google Scholar
See Flynn, et al., supra note 15; Bird, , supra note 91.Google Scholar
See infra note 135 and accompanying text.Google Scholar
See Bird, , supra note 91.Google Scholar
See Lybecker, and Fowler, , supra note 33.Google Scholar
See Goodwin, , supra note 29, at 2.Google Scholar
Compare Abbott, and Reichman, , supra note 19, at 957.Google Scholar
See Lybecker, and Fowler, , supra note 33.Google Scholar
See Abbott, and Reichman, , supra note 19, at 953.Google Scholar
Id., at 952.Google Scholar
See Lybecker, and Fowler, , supra note 33.Google Scholar
See Outterson, (Access to Medicine and TRIPS), supra note 21, at 282.Google Scholar
Id. (citing Declaration on TRIPS, supra note 5, at para. 4, 5[b], 5[c], 5[d]; U.S. Gen. Accounting Office, GAO Report 07–1198, U.S. Trade Policy Guidance on WtO Declaration on Access to Medicines May Need Clarification 15, 19, 23, September 2007); accord Abbott, and Reichman, , supra note 19, at 936–37 (citing Paragraph 6 Decision, supra note 22; Amendment of TRIPS, supra note 22).Google Scholar
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.Google Scholar
See Abbott, and Reichman, , supra note 19, at 947.Google Scholar
See Lybecker, and Fowler, , supra note 33.Google Scholar
See supra note 123 and accompanying text; see also Outterson, , (Access to Medicine and TRIPS), supra note 21.Google Scholar
See TRIPS, supra note 4, at art. 31(b).Google Scholar
See Abbott, and Reichman, , supra note 19, at 952. The extent to which negotiations actually occurred is disputed by both sides.Google Scholar
See id., at 953.Google Scholar
Id., at 952–953 (noting compensation at 0.5%).Google Scholar
See infra notes 166–172 and accompanying text.Google Scholar
See, e.g., Bird, , supra note 91 (case of Pfizer with respect to Viagra in Egypt).Google Scholar
See, e.g., Lybecker, and Fowler, , supra note 33 (case of Abbott Laboratories in Thailand).Google Scholar
See Bird, , supra note 91.Google Scholar
See Lybecker, and Fowler, , supra note 33.Google Scholar
See, e.g., Yu, P., “Intellectual Property, Economic Development, and the China Puzzle,” in Gervais, D., ed., Intellectual Property, Trade and Development (Oxford: Oxford University Press, 2007): 173, 176183.Google Scholar
Maskus, K. E., “The Role of Intellectual Property Rights in Encouraging Foreign Direct Investment and Technology Transfer,” Duke Journal of Comparative & International Law 9, no. 1 (1998): 109161, at 129–130.Google Scholar
See TRIPS, supra note 4, at arts. 2.1 (incorporating Paris Convention arts. 1–12), 27 (novelty); Paris Convention, supra note 1, at arts. 2(1) (national treatment), 4bis(1) (independence of patents).Google Scholar
The task of reverse-engineering key active ingredients (APIs) nonetheless remains difficult and costly for most developing countries. See, e.g., Abbott, F. M. and Dukes, G., Global Pharmaceutical Policy: Ensuring Medicines for Tomorrow's World (Cheltenham: Elgar, forthcoming 2009): at 123–24.CrossRefGoogle Scholar
See TRIPS, supra note 4, at art. 6; Paragraph 6 Decision, supra note 22; Abbott, and Reichman, , supra note 19, at 975–976.Google Scholar
See e.g., Lybecker, and Fowler, , supra note 33; Bird, , supra note 91.Google Scholar
See supra note 22.Google Scholar
Compare Flynn, et al., supra note 15.Google Scholar
See infra text accompanying notes 159–162; compare Reichman, J. H., “The TRIPS Agreement Comes of Age: Conflict or Cooperation with the Developing Countries?” Case Western Reserve Journal of International Law 32, no. 3 (2000): 441470.Google Scholar
See Lybecker, and Fowler, , supra note 33; Bird, , supra note 91; Sykes, A. O., “TRIPs, Pharmaceuticals, Developing Countries, and the Doha ‘Solution,’” Chicago Journal of International Law 3, no. 1 (2002): 4768. But see Bird, , supra note 91, noting contrary empirical studies.Google Scholar
See, e.g., Outterson, K., “Patent Buy-Outs for Global Disease Innovations for Low- and Middle-Income Countries,” American Journal of Law & Medicine 32, nos. 2–3 (2006): 159173, at 161; see also Lanjouw, J. O., Beyond TRIPS: A New Global Patent Regime, Brief No. 3, The Center for Global Development, July 2002 (market segmentation); Love, J., Proposal for Patent Pool for Essential Medicines (PPEM), Addis Ababa, March 13, 2005.Google Scholar
See, e.g., Outterson, and Kesselheim, , supra note 48, at 136–137; Outterson, , supra note 151.Google Scholar
Sykes, Compare, supra note 150.Google Scholar
See Lybecker, and Fowler, , supra note 33.Google Scholar
See Outterson, and Kesselheim, supra note 48, at 136–137; Outterson, , supra note 151, at 159173.Google Scholar
See Moran, M., Ropars, A.-L., Guzman, J., Diaz, J. and Garrison, C., The New Landscape of Neglected Diseases Drug Development, 2005, available at <www.thegeorgeinstitute.org/shadomx/apps/fms/fmsdownload.cfm?file_uuid=F2B06396-EEA0–851E-3049-C9A030AEDE0F&siteName=iih> (last visited April 23, 2009); Drugs for Neglected Diseases Initiative (DNDi), New, Once-a-Day Fixed-Dose Combination Against Malaria Now Available, March 1, 2007; DNDi, MSF and DNDi Call For Scale-Up of R&D For Neglected Diseases, Press Release, February 23, 2009, available at <http://www.msfaccess.org/media-room/press-releases/press-release-detail/?tx_ttnews%5Btt_news%5D=1535&cHash=86e19504b2> (last visited April 23, 2009); Kiechel, J.-R. and Pecoul, B., “Innovative Partnership Brings New ACT Free of Patents,” Guest Blog, PLOS, February 26, 2007, available at <http://www.plos.org/cms/node/208> (last visited April 23, 2009).+(last+visited+April+23,+2009);+Drugs+for+Neglected+Diseases+Initiative+(DNDi),+New,+Once-a-Day+Fixed-Dose+Combination+Against+Malaria+Now+Available,+March+1,+2007;+DNDi,+MSF+and+DNDi+Call+For+Scale-Up+of+R&D+For+Neglected+Diseases,+Press+Release,+February+23,+2009,+available+at++(last+visited+April+23,+2009);+Kiechel,+J.-R.+and+Pecoul,+B.,+“Innovative+Partnership+Brings+New+ACT+Free+of+Patents,”+Guest+Blog,+PLOS,+February+26,+2007,+available+at++(last+visited+April+23,+2009).>Google Scholar
See, e.g., So, A. D., “Enabling Conditions for the Scientific Commons,” paper presented at the Conference on Technology Development in the Life Sciences, Program on Science, Technology and Global Development, The Earth Institute at Columbia University, May 20–21, 2004.Google Scholar
See, e.g., Abbott, and Reichman, , supra note 19, at 981–982.Google Scholar
Id., at 969–981 (“Making the Amendment System Work”).Google Scholar
Id., at 973974.Google Scholar
Id., at 977–978. See also Reichman, J. H. and Lewis, T., “Using Liability Rules to Stimulate Local Innovation in Developing Countries,” in Maskus, K. E. and Reichman, J. H., eds., International Public Goods and Transfer of Technology under a Globalized Intellectual Property Regime (Cambridge: Cambridge University Press, 2005): at 337, 337–366.Google Scholar
See Flynn, et al., supra note 15; Abbott, , Reichman, , supra note 19, at 982 (“Changing the Marketing Model”).Google Scholar
See Bird, , supra note 91; Lybecker, and Fowler, , supra note 33.Google Scholar
See Abbott, and Reichman, , supra note 19, at 954.Google Scholar
Food & Drug Letter, Brazil, Thailand Lose Trading Privileges in Wake of IP Disputes, August 17, 2007. In 2006, Thailand had $4.2 billion in GSP qualified exports to the U.S. Jones, V. C., CRS Report for Congress, Generalized System of Preferences: Background and Renewal Debate, at Table A2, January 25, 2008, available at <http://www.nationalaglawcenter.org/assets/crs/RL33663.pdf> (last visited April 23, 2009).+(last+visited+April+23,+2009).>Google Scholar
The DSU, supra note 6, at art. 23 provides as follows: 1. When Members seek the redress of a violation of obligations or other nullification or impairment of benefits under the covered agreements or an impediment to the attainment of any objective of the covered agreements, they shall have recourse to, and abide by, the rules and procedures of this Understanding. 2. In such cases, Members shall: (a) not make a determination to the effect that a violation has occurred, that benefits have been nullified or impaired or that the attainment of any objective of the covered agreements has been impeded, exceptGoogle Scholar
See Abbott, and Reichman, , supra note 19, at 980–81. Freedom from unilateral action is, indeed, a major reason developing countries signed onto the Agreement Establishing the WTO of 1994 in the first place.Google Scholar
See Panel Report, United States – Sections 301–310 of the Trade Act of 1974, WT/DS152/R, December 22, 1999; Abbott, , Reichman, , supra note 19, at 980–981. While GSP privileges are not bound by GATT, and therefore remain revocable, one may doubt that this revocation can be used as a unilateral sanction for some alleged violation of TRIPS.Google Scholar
See Marrakesh Agreement Establishing the WTO, supra note 4, at art. II (2) (DSU is “binding on all Members”); DSU, supra note 6, at art. 23 (quoted supra note 166).Google Scholar
Vienna Convention on the Law of Treaties, UN Doc. A/Conf.39/27, 1155 UNTS 331, 8 I.L.M. 679, at art. 60 (1969), available at <http://untreaty.un.org/ilc/texts/instruments/english/conventions/1_1_1969.pdf> (last visited April 23, 2009).+(last+visited+April+23,+2009).>Google Scholar
Id., at art 60.2.Google Scholar
See TRIPS, supra note 4, at art. 64.Google Scholar