THE SUPREME COURT TAKES UP THE PATENT ACT’S ENABLEMENT STANDARD
November 14, 2022
Written by: Warren Conway and Andrew Alexander
Last week, the Supreme Court granted a petition for certiorari in Amgen Inc. v. Sanofi, Aventisub LLC—a highly-anticipated case that raises a key issue for patent protections: the Patent Act’s “enablement” standard, particularly as it relates to “genus” patent claims.
The patents at issue in Amgen claim monoclonal antibodies used to help reduce LDL-C levels. Amgen filed suit for infringement in the District of Delaware in 2019 against Sanofi and Regeneron Pharmaceuticals (collectively, “Sanofi”). Sanofi stipulated to infringing three claims in two Amgen patents but challenged those claims’ validity on enablement grounds. Codified at 35 U.S.C. § 112(a), the enablement standard requires that a patent application disclose the “manner and process of making and using” the invention “in such full, clear, concise, and exact terms as to enable any person skilled in the art . . . to make and use” the invention. Sanofi argued primarily that the patent’s so-called “genus” claims extend well beyond what was enabled in the written description elsewhere in the patent. The claims at issue here have “functional” limitations, meaning the claim covers not just one specific structural chemical, but a group—or genus—of related chemicals defined by one or more of their functions.
At the District Court, Sanofi argued that the claims at issue encompass a large quantity of potential antibody candidates, and that the specifications lack sufficient guidance to allow a person of skill in the art to create or identify them all without undue experimentation in the form of substantial trial and error—and thus fail to satisfy section 112(a). A jury ruled in favor of Amgen. However, the District Court rejected the jury verdict and sided with the Sanofi. On appeal, the Federal Circuit affirmed the District Court. The Federal Circuit analogized Amgen’s claims for a genus of functionally-alike structures to a plot of land—explaining that the if genus of claims were a plot of land, the disclosed examples would occupy merely a corner of that genus. The Federal Circuit held that the written description was insufficient to satisfy enablement for that genus of functional structures.
On petition to the Supreme Court, Amgen argued that the Federal Circuit erred by, first, deciding enablement as a matter of law (rather than as a fact question for a jury) and, second, by requiring that the patent’s specification allows skilled artisans “to cumulatively identify and make all or nearly all possible variations of the invention . . . without substantial time and effort.” Cert. Pet. at 2 (internal quotations omitted). The Supreme Court granted certiorari only on the second issue. The Court will thus determine whether enablement requires showing how to make and use the full scope of the invention without undue time and experimentation—or whether some lesser standard will suffice. The decision will have a significant impact on functional patent claims and will be particularly impactful for pharmaceutical patents. Supreme Court review is also welcome news for Amgen, which previously won several battles in its high-stakes international dispute with Sanofi and Regeneron. The Supreme Court has not yet set the case for argument. Amgen Inc. v. Sanofi, Case No. 21-757.