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

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].

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].

For comprehensive accounts of this process, see Drahos P. 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.

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).

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.

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.

See TRIPS, supra note 4, at art. 31.

See Watal J. , Intellectual Property Rights in the WTO and Developing Countries (Boston: Kluwer Law International, 2002): at 33–44.

Compare Paris Convention, supra note 1, at art. 5A, with TRIPS, supra note 4, art. 31; see Reichman Hasenzahl , supra note 2.

See TRIPS, supra note 4, at art. 31(b).

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.

See Paris Convention, supra note 1, at art. 1.

See Reichman with Hasenzahl , supra note 2.

Debrulle J. De Cort L. 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. 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.

For the reasons, see Flynn S. Hollis A. 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.

See Declaration on TRIPS, supra note 5, at para. 4 (emphasis added).

Id., at para. 4–5.

Id., at para. 5.b.

Abbott F. M. 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).

See id. (Abbott & Reichman), at 937.

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): 279–301 [hereinafter Access to Medicine and TRIPS].

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 Reichman , supra note 19.

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): 927–970.

See Abbott Reichman , supra note 19, at 944.

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): 73–107.

See Amendment of TRIPS, supra note 22.

Id.; see Abbott Reichman supra note 19, at 929.

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 Reichman , supra note 19, at 947.

Goodwin P. E. , “Right Idea, Wrong Result – Canada's Access to Medicines Regime,” American Journal of Law & Medicine 34, no. 4 (2008): 567–584.

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 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.

See Flynn , supra note 15.

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.

Lybecker K. M. 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): 222–240.

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).

See Outterson (Access to Medicines and TRIPS), supra note 21, at 320–321; Outterson K. (Disease-Based Limitations), supra note 21. But see Lybecker Fowler , supra note 33 (who disagree on this point).

See Goodwin , supra note 29, at 569; Lybecker Fowler , supra note 33, at 2.

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).

See van Zimmeren Requena , supra note 14, at 123 and 139 n. 38; Packard Love J. , “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).

See van Zimmeren Requena , supra note 14, at 140.

See Love , supra note 38, at 3; Abbott Reichman , supra note 19, at 939; Carroll J. 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.

See van Zimmeren Requena , supra note 14, at 133–134.

See Debrulle , supra note 14, at 159 and 163.

Id., at 171; but see infra note 90.

See van Zimmeren Requena , supra note 14, at 137.

See Love , supra note 38, at 10–11. For details see Coco R. 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): 452–462.

Castle S. 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).

For a view consistent with that of the patent-based drug industry, see Danzon P. M. 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].

Outterson K. Kesselheim A. , “Market-Based Licenses for HPV Vaccines in Developing Countries,” Health Affairs 27, no. 1 (2008): 130–139, at 136–137.

Scherer F. M. , “A Note on Global Welfare in Pharmaceutical Patenting,” World Economy 27, no. 27 (2004): 1127–1142, at 1141.

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. Tayan B. , The Gilead Access Program for HIV Drugs, 2007.

See TRIPS, supra note 4, at art. 6; Declaration on TRIPS, supra note 5, at par. 5(d).

Danzon P. M. 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.

DiMasi J. A. Hansen R. W. Grabowski H. G. , “The Price of Innovation: New Estimates of Drug Development Costs,” Journal of Health Economics 22, no. 2 (2003): 151–185; 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).

See Danzon Towse , supra note 52, at 445.

McElligott S. , “Addressing Supply Side Barriers to Introduction of New Vaccines to the Developing World,” American Journal of Law & Medicine 35 (forthcoming 2009).

See Flynn , supra note 15.

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.

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 Reichman , supra note 19, at 953.

See Outterson , supra note 47 at 203–216, 232–235.

Personal communication with Professor Kevin Outterson, March 10, 2009.

See Flynn , supra note 15.

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. Gallini N. T. , eds., Competition Policy and Intellectual Property Rights in the Knowledge Economy (Calgary: University of Calgary Press, 1998): at 65.

Id. (Reichman with Hasenzahl), at 38–44. Industry Canada has, at various times, expressed satisfaction with the results of this arrangement.

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].

See TRIPS, supra note 4, at arts. 31(a), (c).

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.

Id., at art. 31(g). For example, an abusive use of a patent could be purged, allowing a claim to void such a license.

Id., at art. 31(j).

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.

See Flynn , supra note 15.

See TRIPS, supra note 4, at art. 31(k).

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. 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.

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): 456–494.

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. 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.

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): 901–964; Janis M. D. , “‘Minimal’” Standards for Patent-Related Antitrust Law under TRIPS,” 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): 774, 790–792.

See, e.g., Fox , supra note 77, at 758; Ullrich , supra note 79, at 726.

See, e.g., Ghidini G. , Intellectual Property and Competition Law: The Innovation Nexus (Cheltenham: Elgar, 2006): 103–111.

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. Reichman J. H. , eds., International Public Goods and Transfer of Technology under a Globalized Intellectual Property Regime (Cambridge: Cambridge University Press, 2005): at 709–725.

See Flynn , supra note 15.

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): 10–21 (citing authorities).

See Fox , supra note 77, at 768.

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.

See TRIPS, supra note 4, at art. 3, 8.2, 40; Paris Convention, supra note 1, at art. 2(1).

However, for the disappointing story of the first attempt to use the Waiver, see Goodwin , supra note 29.

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.

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): 209–222.

Id., at 1 (citing World Health Organization, The World Medicines Situation at 61 (2004)).

See infra text accompanying notes 166–172.

See Abbott Reichman , supra note 19, at 973–980; see infra text accompanying notes 159–160.

See Outterson , (Access to Medicine and TRIPS), supra note 21, at 289–91.

Id., at 296.

See Abbott Reichman , supra note 19, at 952, 954–956.

See Flynn , supra note 15; Bird , supra note 91.

See infra note 135 and accompanying text.

See Bird , supra note 91.

See Lybecker Fowler , supra note 33.

See Goodwin , supra note 29, at 2.

Compare Abbott Reichman , supra note 19, at 957.

See Lybecker Fowler , supra note 33.

See Abbott Reichman , supra note 19, at 953.

Id., at 952.

See Lybecker Fowler , supra note 33.

See Outterson ( Access to Medicine and TRIPS ), supra note 21, at 282.

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 Reichman , supra note 19, at 936–37 (citing Paragraph 6 Decision, supra note 22; Amendment of TRIPS, supra note 22).

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.

See Abbott Reichman , supra note 19, at 947.

See Lybecker Fowler , supra note 33.

See supra note 123 and accompanying text; see also Outterson , ( Access to Medicine and TRIPS ), supra note 21.

See TRIPS, supra note 4, at art. 31(b).

See Abbott Reichman , supra note 19, at 952. The extent to which negotiations actually occurred is disputed by both sides.

See id., at 953.

Id., at 952–953 (noting compensation at 0.5%).

See infra notes 166–172 and accompanying text.

See, e.g., Bird , supra note 91 (case of Pfizer with respect to Viagra in Egypt).

See, e.g., Lybecker Fowler , supra note 33 (case of Abbott Laboratories in Thailand).

See Bird , supra note 91.

See Lybecker Fowler , supra note 33.

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, 176–183.

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): 109–161, at 129–130.

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).

The task of reverse-engineering key active ingredients (APIs) nonetheless remains difficult and costly for most developing countries. See, e.g., Abbott F. M. Dukes G. , Global Pharmaceutical Policy: Ensuring Medicines for Tomorrow's World (Cheltenham: Elgar, forthcoming 2009): at 123–24.

See TRIPS, supra note 4, at art. 6; Paragraph 6 Decision, supra note 22; Abbott Reichman , supra note 19, at 975–976.

See e.g., Lybecker Fowler , supra note 33; Bird , supra note 91.

See supra note 22.

Flynn Compare , supra note 15.

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): 441–470.

See Lybecker 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): 47–68. But see Bird , supra note 91, noting contrary empirical studies.

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): 159–173, 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.

See, e.g., Outterson Kesselheim , supra note 48, at 136–137; Outterson , supra note 151.

Sykes Compare , supra note 150.

See Lybecker Fowler , supra note 33.

See Outterson Kesselheim supra note 48, at 136–137; Outterson , supra note 151, at 159–173.

See Moran M. Ropars A.-L. Guzman J. Diaz J. 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. Pecoul B. , “Innovative Partnership Brings New ACT Free of Patents,” Blog Guest , PLOS , February 26, 2007, available at <http://www.plos.org/cms/node/208> (last visited April 23, 2009).

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.

See, e.g., Abbott Reichman , supra note 19, at 981–982.

Id., at 969–981 (“Making the Amendment System Work”).

Id., at 973–974.

Id., at 977–978. See also Reichman J. H. Lewis T. , “Using Liability Rules to Stimulate Local Innovation in Developing Countries,” 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 337, 337–366.

See Flynn , supra note 15; Abbott Reichman , supra note 19, at 982 (“Changing the Marketing Model”).

See Bird , supra note 91; Lybecker Fowler , supra note 33.

See Abbott Reichman , supra note 19, at 954.

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 Jones U.S. 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).

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, except through recourse to dispute settlement in accordance with the rules and procedures of this Understanding, and shall make any such determination consistent with the findings contained in the panel or Appellate Body report adopted by the DSB or an arbitration award rendered under this Understanding; (b) follow the procedures set forth in Article 21 to determine the reasonable period of time for the Member concerned to implement the recommendations and rulings; and (c) follow the procedures set forth in Article 22 to determine the level of suspension of concessions or other obligations and obtain DSB authorization in accordance with those procedures before suspending concessions or other obligations under the covered agreements in response to the failure of the Member concerned to implement the recommendations and rulings within that reasonable period of time.

See Abbott 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.

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.

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).

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).

Id., at art 60.2.

See TRIPS, supra note 4, at art. 64.