The Patent Act requires that a patent’s “specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains … to make and use the same”—commonly known as the “enablement requirement.” 35 U.S.C. §112(a) (emphasis added). In November, the Supreme Court granted certiorari to review courts’ application of this statutory enablement requirement.

The Supreme Court in Amgen v. Sanofi, No. 21-757, 2022 WL 16703751 (Nov. 4, 2022), is now set to consider whether a patent, in order to comply with the enablement requirement under 35 U.S.C. §112, must include merely enough detail such that those skilled in the art can “make and use” the claimed invention, or, instead, whether there must be sufficient detail to “reach the full scope” of the claimed embodiments—a heightened standard imposed by the Federal Circuit in this case below. See Petition for Writ of Certiorari, Amgen, No. 21-757. The decision has the potential to have a significant impact on inventors and patent drafters, and the breadth with which they may be able to claim their inventions.

Enablement Requirement Under 35 U.S.C. §112 and the Federal Circuit