In two recent decisions in Amgen Inc. v. Sanofi,
Aventisub LLC, the Federal Circuit has made clear that broad
functional patent claims must be fully enabled and underscored the
high bar for enablement of broad biological compound claims
including functional limitations.
Amgen v. Sanofi, Aventisub LLC, 987 F.3d 1080 (Fed.
Cir. 2021). On June 21, the Federal Circuit denied Amgen's
petition for rehearing en banc, and the original panel authored an
opinion responding to Amgen and the amicis' concerns that the
court's decision created a new enablement test or eviscerated
genus claims. Amgen Inc. v. Sanofi, Aventisub LLC, No.
20-1074, 2021 WL 2525530 (Fed. Cir. June 21, 2021). Patentees
claiming biological materials should be aware that
"[e]nablement is required, even for generic claims to
biological materials[,]" and "as with genus claims to
chemical compounds, if they encompass more subject matter than just
a few species, they need to be enabled accordingly."
Id. at *1.
