In Amgen v. Sanofi, the Supreme Court has been asked to review Federal Circuit precedent on the enablement doctrine found in 35 U.S.C. § 112(a). Although still uncertain, the case has a strong chance of being granted certiorari. Most recently, the Supreme Court requested that the US Solicitor General file a brief in the case indicating the views of the U.S. Gov’t. That filing will likely come in December 2022.
The statute requires the patentee to provide “a written description of the invention, and of the manner and process of making and using it [sufficient] to enable any person skilled in the art … to make and use the same.” The petition asks two particular questions:
- Whether enablement is “a question of fact to be determined by the jury” Wood v. Underhill, 46 U.S. (5 How.) 1, 4 (1846), as this Court has held, or “a question of law that [the court] review[s] without deference,” as the Federal Circuit holds.
- 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—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “ ‘time and effort.’ ”
The invalidated patents here are likely worth >$100 million.