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.  Further, “[b]iological compositions not actually prepared need to be described constructively, if required to enable the full scope of the claims, with procedures and names of resultant compositions, as with chemical compositions.”  Id.
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