On May 8, 2025, the Court of Appeals for the Third Circuit affirmed the district court’s dismissal of AstraZeneca’s challenges to the Inflation Reduction Act’s Drug Price Negotiation Program and CMS’s Guidance implementing...more
5/16/2025
/ Administrative Procedure Act ,
Appeals ,
Article III ,
AstraZeneca ,
Centers for Medicare & Medicaid Services (CMS) ,
Constitutional Challenges ,
Drug Pricing ,
Inflation Reduction Act (IRA) ,
Judicial Review ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
Standing
As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big...more
1/15/2025
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Celltrion ,
FDA Approval ,
Inflation Reduction Act (IRA) ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz
On March 19, 2015, the District Court for Northern District of California (Judge Seeborg), issued an order providing one of the first judicial interpretations of the patent dispute resolution provisions laid out in subsection...more