Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
The Federal Court has granted Alexion a declaration of infringement and an injunction preventing Amgen from manufacturing, using, and selling its proposed biosimilar eculizumab product, BEKEMV, in Canada until the expiration...more
Patent owners generally look to secondary indicia to bolster their nonobvious defenses when prior art and/or knowledge of a person of ordinary skill in the art (“POSA”) seem to make the obviousness decision a close call. This...more
The Federal Circuit in Amgen Inc. v. Coherus Biosciences Inc. affirmed a district court decision that once certain subject matter is clearly and unmistakably surrendered during prosecution, the patentee is barred from...more
Pre-AIA and Post-AIA Issues Presented by the On-Sale Bar - The “on-sale” bar to patentability refers to a sale or offer for sale of an invention that can invalidate the patent for that invention. The...more