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Post-Grant Adjudication Of Drug Patents: Agency And/Or Court?, Arti K. Rai, Saurabh Vishnubhakat, Jorge Lemus, Erik Hovenkamp

Faculty Scholarship

The America Invents Act of 2011 (AIA) created a robust administrative system—the Patent Trial and Appeal Board (PTAB)—that provides a route for challenging the validity of granted patents outside of district courts. Congress determined that administrative adjudication of the validity of initial patent grants could be cheaper and more scientifically accurate than district court adjudication of such validity.

For private economic value per patent, few areas of technology can match the biopharmaceutical industry. This is particularly true for small-molecule drugs. A billion-dollar drug monopoly may be protected from competition by a relatively small number of patents. Accordingly, the social cost …