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Reconsidering the U.S. Patent System: Lessons from Generics

PDF · Molly F.M. Chen · Nov-2-2012 · 45 VAND. J. TRANSNAT’L L. 1249 (2012)

Scholars and pharmaceutical industry representatives consider the United States a worldwide leader in pharmaceutical innovation. However, the recent expansion of the international generics market has threatened the strength of the U.S. pharmaceutical industry. The pressure has led to the U.S. market’s overreliance on a patentability standard that blocks generics competition without contributing substantially to the state of the art. This Note contrasts the U.S. nonobviousness standard and patent linkage regime with those of generics giants India and Israel and considers the effects of these policies on the relevant national and international generics industries. This Note proposes that the United States revise its current approach to patent protection of pharmaceuticals by adopting a heightened nonobviousness standard and lengthening the available patent-term-restoration period through modifications to the linkage regime. Only by balancing these two legal mechanisms will the United States maintain its status as the international leader in blockbuster pharmaceuticals.


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