Exploring the applicability of its enablement law to life sciences, the Supreme Court of the United States issued a unanimous opinion, concluding that patent claims covering a genus of antibodies defined in part by functional limitations were not enabled by the specification as required by 35 U.S.C. § 112. Amgen Inc., et al. v. Sanofi, et al., Case No. 21-757 (S. Ct. May 18, 2023) (Gorsuch, J.).
Amgen owns a patent covering a class of antibodies that bind to amino acids on the PCSK9 protein and block it from preventing the body from removing cholesterol from the bloodstream. Amgen’s Repatha® product included one such antibody while Sanofi’s Praluent® included another in the class. Amgen sued Sanofi for infringement. After a trial, a US Court of Appeals for the Federal Circuit appeal, a remand and a subsequent trial, the Federal Circuit agreed with Sanofi that Amgen’s patents failed to satisfy the requirement under Section 112(a), which requires that the patent include “a written description of … the manner and process of making [the invention] in such full, clear, concise, and exact terms as to enable any person skilled in the art … to make and use the same.” The Supreme Court granted certiorari to answer the following question:
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.”
After discussing historical enablement cases dealing with inventions like the telegraph and the lightbulb, the Supreme Court reinforced certain principles about enablement law. First, the Court held that the patent specification must enable a person of ordinary skill in the art (POSITA) to make and use the “entire class” when a class is claimed. That said, a specification need not describe every embodiment; rather, the Court explained that it is enough to describe a general quality that would reliably permit a POSITA to make and use the entire claimed scope, “not merely a subset.” To do so, a specification may require a POSITA to perform some adaptation or testing, including reasonable experimentation.
Applying those principles to the challenged claims, the Supreme Court concluded that, while the 26 antibodies it specifically described were enabled, Amgen’s specification failed to enable a POSITA to make and use all the claimed antibodies. It reasoned that the supposed disclosures were little more than “research assignment[s]” that did not sufficiently guide a skilled artisan.
As to the precise issue presented on certiorari, the Supreme Court agreed with Amgen that enablement “is not measured against the cumulative time and effort it takes to make every embodiment within a claim.” Yet, the Court found that the key problem was the “trial and error” approach that the specification required.
Ultimately, the Supreme Court indicated that there was no change in the law, describing the decision as “involv[ing] a new technology,” but with a “legal principle [that] is the same.” It remains to be seen whether the Amgen decision is the end of functional claiming or genus claims or if the case remains an example of well-established principles that will have little impact on the Federal Circuit’s enablement jurisprudence.