The U.S. Supreme Court on May 18, 2023 delivered its decision on the scope of the patent enablement requirement, set forth in 35 U.S.C. § 112, in the antibody dispute Amgen, Inc. v. Sanofi.
While patented technology and U.S. patent laws are often complex, the foundation of our patent system is based on a fairly simple quid pro quo. In exchange for publicly disclosing information that advances.
The Supreme Court issued a unanimous decision in the case of Amgen Inc. v. Sanofi finding Amgen’s asserted patents failed to satisfy the enablement requirement under Section 112a of the Patent Act. Patent applicants must understand the importance of including sufficient examples.
The Court held that Amgen had not provided adequate guidance to make and use the claimed antibodies beyond the narrow scope of the working examples although there is no statutory requirement. Court endorsed undue experimentation test for the enablement requirement:
The Supreme Court's consideration of the standards for satisfying the enablement provisions of 35 U.S.C. § 112(a) has been occasioned for the first time in over a century by the Court's.