72 Am. U. L. Rev. 1177 (2023).
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Abstract
Administrative patent challenge proceedings, the most prominent form of which is inter partes review, have attracted much controversy. In particular, the pharmaceutical industry and its supporters have criticized the proceedings as unfairly biased toward canceling valuable drug patents. Yet there has been little study of the real-world, practical impact of these administrative proceedings on drug patents or pharmaceutical markets.
This Article reviews the universe of administrative challenges on drug patents that have proceeded through appeal to the Federal Circuit. The majority of patents challenged this way are deemed unpatentable at both the agency and appellate levels, and, that administrative cancellation of drug patents is regularly followed by subsequent generic drug competition and reduced drug prices—over 97% savings in some cases, on blockbuster prostate cancer and heart, disease drugs. The reviewed cases suggest, that these effects are not due to bias against patents, but rather because of the expertise of administrative adjudicators and the remarkably low quality of the drug patents challenged. Indeed, nuanced aspects of these administrative proceedings, particularly at the appellate level, in fact are biased in the opposite direction—against patent challengers. These findings suggest that inter partes review and other administrative challenge proceedings likely serve an important purpose for lowering the costs of medicines, and those proceedings could potentially be improved.
* Assistant Professor (starting fall 2023) and Senior Policy Fellow with the Program on Information Justice and Intellectual Property, American University Washington. College of Law, Postdoctoral Fellow, Cornell Tech. This Article is based in part on amicus curiae briefs that the author filed in United States v. Arthrex, Inc., 141 S. Ct. 1970 (2021), and in Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc., 896 F.3d 1322 (Fed. Cir. 2018). I would like to thank Sapna Kumar, Chris Morten, Arti Rai, and Matthew Lane for thoughts and insights that contributed to the content of this Article, as well as the Law Library of Congress staff for their generous research assistance and the American University Law Review for its thoughtful edits and suggestions. All errors are my own, and the views expressed in this Article are my own and do not necessarily reflect the views of institutions I am affiliated with.