On June 21, 2021, the Federal Circuit denied Amgen’s petition for en banc review of the court’s February 2021 decision in Amgen Inc. et al. v. Sanofi, Aventisub LLC, et al., 987 F.3d 1080 (Fed. Cir. 2021), which found that Amgen’s two patents covering the cholesterol-lowering antibody drug Repatha® are invalid for lack of enablement.  For more details on the February 2021 decision, please see our previous post here.

The court did not provide detailed comments in its order.  However, Judge Lourie, joined by Judges Prost and Hughes, wrote a separate opinion on the denial of Amgen’s petition.

Amgen had argued that the court’s February 2021 decision announced a new test for the enablement requirement, under which “enablement is evaluated by the ‘time and effort’ required ‘to reach the full scope of claimed embodiments,’” rather than focusing on “whether it would require undue experimentation.”  The Amici supporting Amgen’s petition also argued that the court had “adopted a ‘numbers-based standard’ to evaluate enablement asking not whether experimentation is undue but how long it would take to make and screen every species.”  In denying the petition, the Federal Circuit stated the argument “mischaracterizes our law.”  The court argued that “[w]hat is new today is not the law, but generic claims to biological materials that are not fully enabled.”  The court further reasoned that “[t]he problem was not simply that the claimed genus was numerous—it was that it was so broad, extending far beyond the examples and guidance provided.  Likewise, it was not that it would take a long time to collect the full set of each and every embodiment—it was that the narrow and limited guidance in the specification made far corners of the claimed landscape that were particularly inaccessible or uncertain to make unenabled.”

Amgen further argued that the court should overrule case law that holds enablement is a question of law.  Although acknowledging that one can reasonably ask why enablement is a question of law while written description is not, the court argued that they are bound by their longtime precedent and Amgen’s arguments “provide no compelling reason to introduce such a seismic shift.”

The court also rejected Amgen’s argument that the February 2021 decision will “threaten innovation” and “devastate the incentives to invest in drug discovery.”  The court argued that “if one considers that one has invented a group of compositions defined by a genus but does not know enough to fully enable that genus, one would suppress innovation if one were able to claim such a broad genus, not enhance it.”  Invoking a consolation prize to urge that the sky is not falling, the court noted that Amgen has a patent protecting Repatha®, which is U.S. Patent No. 8,030,457 claiming CDRs in the anti-PCSK9 antibody.  Thus, taking a post hoc view, the court cited Amgen’s good fortune in later obtaining a narrower patent on its antibody as a reason why Amgen should not complain about having its earlier, broader patent invalidated.

Amgen has not yet indicated whether it will take further actions, such as filing a petition for a writ of certiorari to the Supreme Court.  We will keep monitoring this case and report on future developments.