Broad Functional Claim Limitations Raise The Bar For Fulfilling Enablement Requirement

Amgen Inc. v. Sanofi, No. 20-1074 (Fed. Cir. Feb. 11, 2021)

The patents at issue describe antibodies that purportedly bind to the PCSK9 protein and lower low-density lipoprotein (LDL) cholesterol levels by blocking the protein from binding to LDL receptors. The parties stipulated to infringement of certain claims, and the district court granted judgment as a matter of law (JMOL) of nonobviousness and no willful infringement. The alleged infringer appealed, and the Federal Circuit remanded for a new trial on issues of written description and enablement.

The alleged infringer again moved for JMOL and, in the alternative, a new trial, after a jury found that it failed to prove invalidity for lack of written description and enablement. The district court granted JMOL for lack of enablement but denied for lack of written description, as well as the motion for a new trial. The Federal Circuit affirmed.