Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
On December 17, 2024, after a seven-day jury trial in Case No. 1:22-cv-00035 (D. Del.), the jury returned its verdict, finding Lindis Biotech’s U.S. Patent Nos. 8,709,421 (claims 3, 8, and 15) and 10,071,158 (claims 1, 12,...more
AMGEN INC. v. HOSPIRA, INC. Before Moore, Bryson, and Chen. Appeal from the United States District Court for the District of Delaware. Summary: Biological engineering activity that would otherwise constitute patent...more
In the continuing Amgen v. Sanofi saga, Amgen has asked SCOTUS to take up the issue of written description, which is currently established by showing “whether the disclosure…reasonably conveys…that the inventor had possession...more