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FDA’s Draft Guidance for Industry Seeks to Answer Questions on Biosimilar Interchangeability

USA - November 30 2020 FDA has published new draft guidance for industry titled "Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and…

Jordan Engelhardt

FDA Finalizes New Definition of Biological Product

USA - February 27 2020 Last week, the U.S. Food and Drug Administration (“FDA”) issued a final rule to amend its regulation that defines the term “biological product” in…

Jordan Engelhardt

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

USA - September 6 2019 In Amgen’s long-running dispute with biosimilar-maker Sandoz over biosimilar versions of Amgen’s filgrastim (Neupogen®) and pegfilgrastim (Neulasta®)…

Andrew D. Cohen, Jordan Engelhardt

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

USA - July 31 2019 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…

Jordan Engelhardt

Federal Circuit Invalidates Polynucleotide-Labeling Claims for Lack of Enablement

USA - July 16 2019 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…

Jordan Engelhardt