Amgen Inc. v. Sanofi (Fed. Cir. 2021)

By Kevin E. Noonan — A little less than four years ago, the Federal Circuit rendered a decision in Amgen Inc. v. Sanofi that brought clarity to how the Court (and U.S. Patent and Trademark Office) should apply the written description requirement in 35 U.S.C. § 112(a) to properly circumscribe the scope of claims to monoclonal antibodies. Earlier this month, on an appeal from remand, the Court took aim at the enablement requirement for antibody claims, with similar, scope-limiting results. The case arose when Amgen sued Sanofi and Regeneron over sales of Praluent® (alirocumab), which allegedly competes with Amgen’s Repatha™…