Jay J. Cho
Patterson Belknap Webb & Tyler LLP
Articles
FDA’s Draft Guidance for Industry Seeks to Answer Questions on Biosimilar Interchangeability
USA - November 30 2020 FDA has published new draft guidance for industry titled "Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and…
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…
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®)…
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…
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…
