A new paper by PIJIP Prof. Charles Duan, forthcoming in the American University Law Review, analyzes administrative challenges to pharmaceutical patents. 

Click here to read the paper.

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 empirical study of the impact of these administrative proceedings on drug patents or pharmaceutical markets.

In this Article, I review the universe of administrative challenges on drug patents that have proceeded through appeal to the Federal Circuit. I find that a large fraction of patents challenged this way are deemed unpatentable at both the agency and appellate levels, and that administrative cancellation of drug patents correlates closely with subsequent generic drug competition and reduced drug prices. The data suggests 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, I find that 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.

About Charles Duan

Prof. is currently Assistant Professor Duan at American University Washington College of Law. He designs and manages research projects at the intersection of intellectual property and public interest policy. His current research is focusing on the impact of patent law on generic drug availability and scientific research, computer software copyrights, and competition and interoperability in digital markets. Duan is currently also a postdoctoral fellow at Cornell Tech, and serves as a member of the Patent Public Advisory Committee of the U.S. Patent and Trademark Office. He was previously the director of technology and innovation policy at the R Street Institute, director of the patent reform project at Public Knowledge, a research fellow with Professor Paul Ohm at Colorado Law School, and a patent attorney at the law firm Knobbe Martens.