Enablement in a Post-Amgen Era

It has been a year since the Supreme Court declared Amgen’s patent claims invalid under the enablement requirement of 35 U.S.C. § 112(a). Amgen Inc. v. Sanofi, 598 U.S. 594 (2023). In the year following, Amgen has been cited in at least sixteen district and Federal Circuit cases and at last eight times by the Patent Trademark and Appeal Board.

However, even with these courts “adopting” the precedent set forth in Amgen, the question still remains: Did Amgen actually change anything regarding enablement, or did it simply reaffirm existing precedent?

This article will begin with an overview of the Supreme Court’s opinion in Amgen. It will follow with a discussion of the Wand Factors used to determine if the claims require “undue experimentation.” It will conclude with specific cases that have cited Amgen in recent opinions and an analysis of what impact Amgen has had if any.

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