Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more
In light of the 2023 Supreme Court of the United States decision in Amgen Inc. v. Sanofi, the US Patent & Trademark Office (PTO) published guidelines for PTO employees to use, regardless of technology, to ascertain compliance...more
In Baxalta, Inc. v. Genentech, Inc., the Court of Appeals for the Federal Circuit upheld a summary judgment finding from the District of Delaware (Judge Timothy B. Dyk) that claims 1-4, 19 and 20 of Baxalta’s patent directed...more
It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more
Last month, the USPTO issued a memorandum to its patent examining corps clarifying its guidance concerning the written description requirement for claims drawn to antibodies. In the memorandum, the USPTO adopts the Federal...more