Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
As we previously reported, on February 11, 2021, a three-judge panel of the Federal Circuit affirmed the District Court for the District of Delaware’s grant of Sanofi’s motion for judgment as a matter of law that the asserted...more
As we previously reported in August 2019, the District Court for the District of Delaware issued an opinion granting Sanofi’s motion for judgment as a matter of law that the asserted claims of two of Amgen’s patents, U.S....more
As we previously reported, on July 20, the Southern District of Florida granted Amgen’s motion for judgment on partial findings that the ’138 patent was not proven invalid on grounds of anticipation, lack of written...more
As we previously reported, on July 5, the Federal Circuit affirmed the district court’s grant of a preliminary injunction enjoining Apotex from launching its biosimilar version of Amgen’s Neulasta (pegfilgrastim) until it...more