Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
On January 29, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entries of preliminary injunction preventing Samsung Bioepis Co., Ltd....more
The Federal Circuit held recently that the "all substantive rights" test, used heretofore to determine the identity of the "patentee" for purposes of satisfying 35 U.S.C. § 281, should be the standard for determining common...more