The U.S. Supreme Court’s recent holding in Amgen v. Sanofi affirmed a decision by the U.S. Court of Appeals for the Federal Circuit in which they found the claims of Amgen’s patents invalid for failure to satisfy the enablement requirement of 35 U.S.C. Section 112(a). See Amgen v. Sanofi, 2023 U.S. LEXIS 2058 (U.S. May 18, 2023). In its reasoning, the court explained that “if a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class.” “In other words, the specification must enable the full scope of the invention. The more one claims, the more one must enable.”

What Is 35 U.S.C. Section 112?

35 U.S.C. Section 112 is a cornerstone of patent law that ensures clarity and transparency in the patenting process. Specifically, Section 112(a) stipulates that inventors must provide both an adequate written description and enablement of their invention in the patent specification. The written description requirement is intended, in part, to assure the public and the USPTO that the applicant actually possesses the invention at the time of filing. The enablement requirement is directed toward ensuring that one of ordinary skill in the field is able to follow the instructions of the inventors and be able make and use the invention without undue experimentation. Without these requirements the public would gain nothing in return for the time-limited protection offered to a patent owner.

Procedural Posture