Amgen v. Sanofi: The Supreme Court Takes up the Enablement Requirement in the Context of Therapeutic Monoclonal Antibodies

Abstract

On November 4, 2022, the U. S. Supreme Court granted certiorari in the case of Amgen v. Sanofi. This is the first time that the Court has addressed patent laws enablement requirement, or for that matter any of the adequate disclosure requirements of 35 USC 112(a), i.e., the written description and best mode requirements, since the enactment of the Patent Act of 1952. This article summarize the Federal Circuit decision that is the subject of the grant of certiorari, and then delve into some of the main arguments that were raised in Amgen’s petition for certiorari; Sanofi’s brief in opposition to grant of certiorari; GlaxoSmithKline’s amicus curiae brief supporting grant of certiorari; an amici curiae brief supporting grant of certiorari follow behalf of a coalition including Association of University Technology Transfer Managers, Biogen, Bristol-Myers Squibb, Corning Inc., MerckSharp & Dohme, and St. Jude Children’s Research Hospital; and an amicus curiae brief filed on behalf of the U. S. government by the Solicitor General recommending that the Court not grant certiorari.

Keywords: patents, enablement, pharmaceuticals, Amgen, Sanofi, Supreme Court