On April 2, 2025, Accord received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for two denosumab biosimilars: OSVYRTI and JUBEREQ. OSVYRTI is indicated for the...more
On April 3, 2025, GlaxoSmithKline (GSK) and Pfizer filed a stipulation to dismiss with prejudice GSK’s litigation in the United States District Court for the District of Delaware....more
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
Last week, GlaxoSmithKline and Northwestern University filed separate lawsuits against Moderna, accusing its mRNA-based vaccines of patent infringement....more
There have been several recent developments in the PTAB with respect to Regeneron’s aflibercept-dosing patents.
On July 8, Regeneron voluntarily dismissed its appeals to the Federal Circuit (Case Nos. 2023-1395 and...more
We previously reported on the litigation brought by ModernaTX, Inc. and Moderna US, Inc. (collectively, “Moderna”) against BioNTech SE, BioNTech Manufacturing GmbH, BioNTech US Inc. (collectively, “BioNTech”), and Pfizer Inc....more
Late last month, a Patent Trial and Appeal Board (“PTAB”) panel instituted two petitions that were filed separately by Celltrion and Biocon for inter partes review (“IPR”) of Regeneron’s U.S. Patent 11,253,572 (“the ’572...more