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Harmonization and its Discontents: A Case Study of TRIPS Implementation in India's Pharmaceutical Sector, 97 Calif. L. Rev. 1571 (2009)


The last few decades have seen a surge of new intellectual property (IP) treaties, part of a trend of “upward harmonization” aimed at making IP rights stronger around the world, and especially in developing countries. The most important of these treaties is the Trade-Related Aspects of Intellectual Property (TRIPS) Agreement, which requires all members of the World Trade Organization (WTO) to adopt and enforce relatively high minimum standards of IP protection. Those who support upward harmonization argue that it will have positive effects on trade, foreign direct investment, and global innovation. Opponents contend that such harmonization could ossify the imperfect IP system of the North and impede development. The most acute criticisms of the trend have focused on the potential impact of TRIPS on health. Because TRIPS requires developing countries to provide patents on pharmaceuticals, it has the potential to limit the access of patients in those countries to less expensive generic versions of new medicines. The effects of the TRIPS Agreement, however, depend on empirical questions that have yet to receive much attention in the literature: Can TRIPS in fact oblige developing countries to “harmonize” their IP laws with those of developed countries? Will the Agreement achieve the primary goal that most agree was set for it—to require developing countries to adopt IP regimes comparable to those in developed countries? Conversely, how much flexibility does the legalistic framework of TRIPS offer developing countries, not only in theory but also in practice? This is an opportune moment to address these questions because we are entering a new age of implementation in international IP law. TRIPS transition periods for developing countries have mostly expired, new multilateral harmonization efforts have foundered, and conversations have shifted toward topics of implementation and enforcement.

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