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Federal Circuit Walks Back Its “Exceptional” Stance on the Doctrine of Equivalents in the Latest Amgen v. Sandoz Decision

In Amgen’s long-running dispute with biosimilar-maker Sandoz over biosimilar versions of Amgen’s filgrastim (Neupogen®) and pegfilgrastim (Neulasta®) biologics, the Federal Circuit earlier this year affirmed summary judgment...more

Prosecution History Estoppel Bars Amgen’s Doctrine-of-Equivalents Infringement Claim Against Neulasta (Pegfilgrastim) Biosimilar...

Amgen Inc. v. Coherus Biosciences Inc., No. 2018-1993, Slip op. at 6 (Fed. Cir. July 29, 2019) stems from a Biologics Price Competition and Innovation Act action brought by Amgen against Coherus seeking FDA approval to market...more

Federal Circuit Invalidates Polynucleotide-Labeling Claims for Lack of Enablement

In Enzo Life Sciences v. Roche Molecular Systems, No. 2017-2498, 2017-2499, 2017-2545, 2017-2546, Slip op. (Fed. Cir. July 5, 2019), the Federal Circuit affirmed summary judgment of invalidity for lack of enablement of Enzo’s...more

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