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

41 BIOTECHNOLOGY LAW REPORT 58 (2022)

30 Pages Posted: 1 Mar 2023 Last revised: 2 Mar 2023

See all articles by Christopher M. Holman

Christopher M. Holman

University of Missouri - Kansas City School of Law

Abstract

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 Amgen’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.

Part I available https://ssrn.com/abstract=4369873

Keywords: patents, genus claims, pharmaceuticals, enablement, written description

Suggested Citation

Holman, Christopher M., Is the Chemical Genus Claim Really 'Dead' at the Federal Circuit?: Part II. 41 BIOTECHNOLOGY LAW REPORT 58 (2022), Available at SSRN: https://ssrn.com/abstract=4369878 or http://dx.doi.org/10.2139/ssrn.4369878

Christopher M. Holman (Contact Author)

University of Missouri - Kansas City School of Law ( email )

5100 Rockhill Road
Kansas City, MO 64110-2499
United States

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