Patent practitioners are intimately familiar with the requirement of 35 U.S.C. § 112 that the “written description of the invention, and of the manner and process of making and using it, [shall be presented] in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.”  However, the various embodiments in which the invention may eventually take form – the combination of limited variables set forth in the specification that can be mixed together to produce a version of the invention – may be described in the manner of only a limited set of examples, including, as designated by  § 112, “the best mode contemplated by the inventor[(s)].”

In the life sciences arts in particular, these limited sets of variables are often set forth in “genus” patent claims that abstract the handful of examples, presented using specific chemicals or compounds, to an entire set of related chemicals or compounds (i.e., the genus). In Amgen Inc. v. Sanofi, 987 F. 3d 1080 (Fed. Cir. 2021), the contested genus claim relates to a functionally claimed genus of antibodies sharing the ability to bind certain parts of the PCSK9 antigen.

The difficulty in genus claims is that chemistry and biology are not predictable mix and match sciences.  This leads to another basic construct of patent enablement, that “the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation.” MPEP 2164.01, citing In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).  To ensure the undue experimentation requirement is met, the Amgen Court followed an established line of Federal Circuit precedent requiring that the specification, as worded in Amgen’s petition for a writ of certiorari, “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.’” Pet.App. 14a.

Despite the Solicitor General’s Brief recommending denial, the Supreme Court has decided to delve into the enablement requirement.  The SCOTUS decision weighs the future of broad coverage for trailblazers in the biopharma industry versus greater opportunity for incremental developments by competitors.  Whichever way the decision pans out, the outcome is certain to create a significant impact on patent litigation strategies, as well as claims strategies and application drafting strategies, for the bio-pharma industries.