On March 13, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed a five-year patent term extension (“PTE”) for Merck’s sugammadex patent, holding that the district court had correctly calculated PTE based on the...more
3/20/2025
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Patent Litigation ,
Patent Reissue Applications ,
Patent Term Extensions ,
Patent Terms ,
Patents ,
Pharmaceutical Industry ,
USPTO
On January 29, 2025, the Federal Circuit issued paired decisions addressing Samsung Bioepis’s (“SB”) and Formycon AG’s (“Formycon”) appeals of preliminary injunctions entered in ongoing aflibercept biosimilar litigations with...more
1/31/2025
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Biosimilars ,
Food and Drug Administration (FDA) ,
Foreign Corporations ,
Generic Drugs ,
Hatch-Waxman ,
Life Sciences ,
Marketing ,
Patent Litigation ,
Personal Jurisdiction ,
Pharmaceutical Patents ,
Preliminary Injunctions