Is the Chemical Genus Claim Really “Dead” at the Federal Circuit?: Part II

A 2020 law review article entitled The Death of the Genus Claim (“Death”) purports to document a dramatic shift in the Federal Circuit’s interpretation of 35 U.S.C. 112(a)’s enablement and written description requirements, particularly as applied to chemical genus claims. According to the authors of Death, it has become nearly impossible to obtain a chemical genus claim that will be upheld as valid in the face of a challenge for overbreadth under Section 112(a). Death was cited extensively in Amgens’s successful petition for certiorari in Amgen v. Sanofi, a case asking the Supreme Court to overturn the Federal Circuit’s decision finding Amgen’s claims reciting genuses of monoclonal antibodies to be invalid for lack of enablement. Death raise important issues for pharmaceutical innovation, a number of which I address in this second installment (“Part II”) of a two-part article). I begin by explaining why it is that I disagree with a particular assertion made in Death, i.e., the suggestion that patentees could circumvent the Federal Circuit’s purported heightened application of 112(a) to chemical genus claims by drafting broader claims that define chemical genuses solely in structural terms, without the inclusion of any functional limitations. The article then reviews a substantial number of judicial decisions involving chemical genus claims, and basically show that there is little evidence of a pronounced change in the application of 112(a) to chemical genus claims over the time span which Death identifies as corresponding to a purported dramatic shift in the law. ∗ Christopher M. Holman, Professor of Law, University of Missouri-Kansas City School of Law; Senior Scholar, Center for Intellectual Property x Innovation Policy (CIP-2), George Mason University, Antonin Scalia Law School; and Executive Editor, Biotechnology Law Report.