Novartis to appeal to uphold validity of Entresto combination patent

Novartis announced that the U.S. District Court for the District of Delaware issued a negative decision regarding the validity of a patent covering Entresto and combinations of sacubitril and valsartan, which expires in 2025 with its pediatric exclusivity. “Novartis strongly believes the combination patent is valid and will appeal to the U.S. Court of Appeals for the Federal Circuit to reverse the District Court’s decision. The company will continue to defend vigorously its intellectual property rights relating to Entresto, including the combination patent as well as multiple patents covering additional innovations. Currently no generic Entresto products have tentative or final FDA approval. If approved, any commercial launch of a generic Entresto product prior to the final outcome of Novartis appeal, or ongoing infringement litigations involving other patents, may be at risk of later litigation developments. Novartis maintains its confidence in the growth and profitability outlook for both the short and mid-term, based on the future growth potential of other key brands including Kisqali, Pluvicto, Leqvio, Kesimpta, Scemblix and iptacopan,” the company stated.