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Case Name: In re Entresto (Sacubitril/Valsartan) Patent Litigation, C.A. Nos. 19-1979, 19-2021, 19-2053, 2023 WL 4405464 (D. Del. July 7, 2023) (Andrews, J.) - Drug Product and. ....
The Supreme Court’s decision in Amgen Inc. v. Sanofi found that antibody claims defined by their binding and blocking function lacked enablement..The consensus seems to be that Amgen generally forecloses broad genus claims in the biotechnology field. ....
Novartis is currently involved in a multi-district patent litigation campaign to block generic entrants for its blockbuster heart medication. On July 7, the district court invalidated the patent for lack of written description despite rejecting an enablement defense based upon the same evidence. ....
On 25 February 2021 Chief Judge Stark of the US District Court for the District of Delaware ruled in favour of Novartis Pharmaceuticals Corporation against the generic defendants Torrent Pharma Inc and Torrent Pharmaceuticals Ltd in In re: Entresto (Sacubitril/Valsartan) Patent Litigation (MDL No 20-2930-LPS (D Del)). At the conclusion of oral arguments, Stark ruled in Novartis s favour, denying Torrent s motion for judgment on the pleadings of non-infringement of US Patents 8,877,938 and 9,388,134. These patents cover Novartis s Entresto product and its approved use. Agreeing with Novartis, Stark found that Torrent had not met its burden of clearly proving that no material issue of fact remained to be resolved and that Torrent was entitled to judgment as a matter of law. Rather, Stark found that Novartis had presented plausible theories for infringement and should be permitted to present additional evidence in support of those theories. Stark further found that Novartis ....