Novartis Pharmaceuticals Corporation v. Torrent Pharma Inc., No. 23-2218 (Fed. Cir. 2025) ' On January 10, 2025, the Federal Circuit reversed the district court's opinion that claims of a Novartis patent are invalid for lack of adequate written description, but affirmed the district court's finding that the claims were not proven invalid for lacking enablement or being obvious over the asserted prior art. The Federal Circuit emphasized that the proper analysis for enablement and written description challenges is focused on the claims and after-arising technology need not be enabled or described in the specification'even when the after-arising technology is found to infringe the claims because the issues of patentability and infringement are distinct. "It is only after the claims have been construed without reference to the accused device that the claims, as so construed, are applied to the accused device to determine infringement."
Background
Novartis Pharmaceuticals Corporation ("Novartis") sued multiple defendants accusing them of infringing all claims (1-4) of U.S. Patent No. 8,101,659 ("the '659 patent") titled "Methods of treatment and pharmaceutical composition." The '659 patent relates to a pharmaceutical composition comprising a combination of valsartan and sacubitril, which Novartis markets and sells as a treatment for heart failure under the brand name Entresto'.
The U.S. District Court for the District of Delaware found that although the claims of the '659 patent were not shown to be invalid as being obvious, indefinite, nor lacking enablement, the claims were shown to be invalid for lacking a written description. The district court "construed the asserted claims [of the '659 patent] to cover valsartan and sacubitril as a physical combination and as a complex." After claim construction, defendants MSN Pharmaceuticals, Inc., MSN Laboratories Private Ltd., and MSN Life Sciences Private Ltd...
