Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
On March 14, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s denial of a preliminary injunction against Amgen Inc. (“Amgen”) in the ongoing...more
Last month, a three-judge panel of the Federal Circuit affirmed a Delaware district court’s judgment of infringement against Hospira and $70 million damages award to Amgen in the parties’ BPCIA litigation regarding Hospira’s...more
The US Court of Appeals for the Federal Circuit affirmed a summary judgment non-infringement ruling, finding that where both the claim language and the specification require that the disclosed steps be performed in the order...more
This month we highlight a new law requiring notification to the Federal Trade Commission and Department of Justice of biosimilar litigation settlements and perhaps the end of a long-running Mylan venue dispute in Delaware....more
A few BPCIA litigation updates to wrap up the week for our readers, looking ahead to next week: ..The Federal Circuit issued its formal mandate in Amgen v. Apotex yesterday. With the issuance of the formal mandate, the...more