Supreme Court Rules Amgen Cannot Monopolize Class of Antibodies Based On Function

The Court held in Amgen Inc. v. Sanofi, 598 U.S. __ (2023) that the "full scope" of the invention defined by the claims must be enabled by the specification. "The more one claims, the more one must enable." Id., at p 13.

The Court's holding affirmed the invalidity of certain claims of Amgen's patents, U.S. Patent Nos. 8.859,741 (Oct. 14, 2014) and 8,829,165 (Sept. 9, 2014), for lack of enablement. Amgen's patents fell because the claims attempted to "monopolize an entire class of things defined by their function." Id. at 16. The patents in question claimed a genus of antibodies that "(1) 'bind to specific amino acid residues on PCSK9' and (2) 'block PCSK9 from binding to [LDL receptors].'" Id. at 5. The Court contrasts the broad, functional claims by noting that Amgen identified 26 antibody amino acid sequences, but the claims cover "a 'vast' number of additional antibodies that it has not" described. Id., at 16.

The Court's holding is a warning to patent owners to:

• review the scope of the claims in any issued patent prior to asserting it against an alleged infringer to ensure that the full scope of the claimed invention is enabled and, if necessary, seek corrective measures;
• evaluate the scope of the claims in any pending patent application and, if appropriate, amend the pending claims or file a continuing application with differing claim scope;
• consider the "full scope" enablement requirement when preparing patent applications.

Alleged infringers may find comfort in new arguments for invalidity when liability risk is evaluated.

The patent specification must include “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 make and use the same.” 35 U.S.C. § 112(a). Where an "entire class" is claimed, the specification must enable a person skilled in the art to make and use the entire class." Amgen, 598 U.S., at 13.

The Court fell well short of requiring that a specification describe with particularity how to make and use every single embodiment within a claimed class. "[I]t may suffice to give an example (or a few examples) if the specification also discloses 'some general quality . . . running through' the class that gives it 'a peculiar fitness for the particular purpose.'" Id. at 13 (citing The Incandescent Lamp Patent, 159 U.S. 465, 475 (1895)).

The Court maintains that a specification may require a reasonable amount of experimentation to make and use a patented invention. Reasonableness "will depend on the nature of the invention and the underlying art." Id., at 15. Enablement, however, requires more than providing "research assignments." See, Id., at 16.

Although the contours of a renewed enablement requirement will be revealed over time, one thing appears certain: claiming an invention by its "'use or function' rather than its 'physical characteristics or chemical properties'" is susceptible to challenge. See, Id., at 12.

For now patent owners should evaluate their patent assets for compliance with the enablement requirement, reset expectations for valid claim scope, and increase effort and disclosure when preparing applications.

If you have any questions about the Amgen Inc. v. Sanofi decision, please contact your Quarles attorney or:

• Tolga Gulmen, Ph.D.: (608) 283-2421 / tolga.gulmen@quarles.com
• Tammy VanHeyningen, Ph.D.: (608) 283-2423 / tambryn.vanheyningen@quarles.com