Research Handbook on the Protection of Intellectual Property under WTO Rules
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Research Handbook on the Protection of Intellectual Property under WTO Rules

Intellectual Property in the WTO Volume I

Edited by Carlos M. Correa

This comprehensive Handbook provides an in-depth analysis of the origin and main substantive provisions of the TRIPS Agreement, the most influential international treaty on intellectual property currently in force.
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Chapter 19: Disease-based Limitations on Compulsory Licenses Under Articles 31 and 31bis

Kevin Outterson


Kevin Outterson* 1. Disease-based limitations on compulsory licenses in TRIPS Article 31 Article 31 of the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) permits a World Trade Organization (WTO) Member country to issue a compulsory license of a patent under certain conditions.1 Compulsory licenses are not limited to any category of diseases. The text of Article 31 never mentions any specific diseases, a deliberate decision by the negotiating group to avoid any disease-based limitation.2 This provision has been misunderstood – perhaps deliberately so – in the pages of the Wall Street Journal and the Financial Times to imply that Article 31 only applies to national public health emergencies like HIV/AIDS or only to the least-developed countries. When Thailand (a middle-income country) attempted to use TRIPS flexibilities guaranteed and encouraged by the Doha Declaration on drugs for cancer and heart disease, a backlash ensued from the conservative media, pharmaceutical manufacturers, patent blogs, and the governments of the United States and the European Union.3 A Wall Street Journal editorial attacked the * This chapter is a modified and expanded version of Should Access to Medicines And TRIPS Flexibilities Be Limited To Specific Diseases? 34 AM. J. L. & MED. 279 (2008), used by permission. An earlier version of this project was submitted to the WHO IGWG in 2007: A Request for Clarification Concerning the Proper Scope of the IGWG’s Work to Improve Access to Patented Medicines, Submission to the WHO IGWG (September 30, 2007). 1 Section 31 of the TRIPS Agreement does not use...

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