The Supreme Court heard the opening oral arguments in the Amgen v Sanofi case (2020-1074; No. 21-757) this week. The case arises from a Federal Court decision which invalidated claims in two Amgen patents (8,829,165 and 8,859,741) relating to Repatha® (evolocumab) which it asserted against Sanofi/Regeneron regarding Praluent® (alirocumab). Repatha® is a monoclonal antibody indicated for the treatment of hyperlipidemia that generated US$1.5B for Amgen in 2022. Repatha® is a monoclonal antibody indicated for the treatment of hyperlipidemia that generated US$1.5B for Amgen in 2022.
In November 2022, the Supreme Court granted Amgen’s petition for certiorari in relation to ‘whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. §112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation.’ A decision is expected by the end of June 2023.