The U.S. Supreme Court has granted certiorari in Amgen v. Sanofi, (Appeal No. 2021-0757 (Fed. Cir. 2022)), a case that challenges the current interpretation of the requirements applicable to patent claims directed to antibodies, small molecules, and other pharmaceutical agents. The question presented on appeal is:
Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to "make and use" the claimed invention, or whether it must instead enable those skilled in the art "to reach the full scope of claimed embodiments" without undue experimentation — i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial "time and effort."