reading # 8

reading # 8 - Required reading: pp. 247-250 Optional...

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Comment: Compulsory Licensing of Patented Pharmaceutical Inventions: Evaluating the Options Jerome H. Reichman I. How Compulsory Licensing Survived the TRIPS Agreement of 1994 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 old- est international convention providing some protec- tion for patented inventions outside of the domes- tic laws.1 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.2 The failure of this Con- ference, held under the auspices of the World Intel- lectual Property Organization (WIPO), persuaded the technology-exporting countries to link future nego- tiations concerning international intellectual prop- erty protection to the Multilateral Trade Negotiations, known as the Uruguay Round, which got underway in 1986.3 The end result was Annex IC of the Agree- ment 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).4 A. What the TRiPSAgreement Did Not Give the Pharmaceutical Sector Taken together, the TRIPS Agreement's standards amounted to a veritable revolution in international intellectual property law from which the research- based pharmaceutical industry emerged as one of the biggest winners. Faced with a "take it or leave it deci- sion," all developing-country Members of the WTO, including those with growing pharmaceutical produc- tion capabilities, such as India, Brazil, and eventually China, agreed to respect relatively stringent world- wide norms of patent protection no later than 2005.5 In return, these countries were given greater access to developed markets for traditional manufactured goods plus a commitment of the developed countries to stop imposing unilateral trade sanctions for alleg- edly inadequate protection of foreign intellectual property rights (IPRs). 6 Ironically, if the developing countries lost the war, in the sense that their generic pharmaceutical indus- tries could no longer freely reverse-engineer the costly products of foreign research and development under the shield of domestic laws that ignored pharmaceuti- Jerome H. Reichman, J.D., is the Bunyan S. Womble Pro- fessor ofLaw at Duke University School of Law in Durham, N.C. PHARMACEUTICAL REGULATIONS - SUMMER 2009 247
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SYMPOSIUM cal patents, then they won a great battle with specific regard to the question of compulsory licenses,7 which had triggered the drive for the TRIPS Agreement in the first place. Thanks largely to the fortitude and analytical skills of the Indian delegation,8 the right of governments to grant compulsory licenses on virtually
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reading # 8 - Required reading: pp. 247-250 Optional...

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