The Beijing Intellectual Property Court (BIPC) has issued a judgment that reaffirms the validity and enforceability of a core patent for Swiss pharmaceutical giant Novartis’s (NYSE: NVS) hypertension therapy, Entresto (sacubitril, valsartan), based on modified claims. The patent in question, No. ZL200680001733.0, titled “drug combination product of angiotensin II receptor antagonist and NEP inhibitor,” is one of two core patents covering the active ingredients of Entresto. The other core patent remains valid without ongoing disputes, with both patents set to enjoy 20-year protection until November 8, 2026.
Challenges to Entresto’s Patent and CNIPA’s Previous Decisions
The challenge to Entresto’s core patent was initiated by Salubris, CSPC (HKG: 1093), and Chia Tai Tianqing. The China National Intellectual Property Administration (CNIPA) had previously issued three decisions in July 2021, all confirming the patent’s validity. Following these decisions, two generic developers filed administrative litigation with the BIPC. The BIPC has now ruled on both administrative lawsuits, supporting the CNIPA’s decision to maintain the patent’s validity based on revised claims. The involved generic companies have the option to appeal the BIPC’s recent judgment to the Supreme People’s Court.
Entresto’s Market Position and Previous Patent Challenges
Novartis’s core product, Entresto, used for the treatment of hypertension and heart failure, was first approved in China in 2017. The product has faced frequent legal challenges, with the No. ZL201110029600.7 patent being found invalid in 2018 and 2019. Novartis successfully appealed these decisions. In contrast to China, a US District Court decided to cancel a combination patent, No. 11,096,918, covering Entresto’s ingredients earlier this month. Novartis is appealing this decision with the US Federal Court to prevent generic entry from Mylan, Alembic, Crystal Pharmaceutical, MSN Pharmaceuticals, and China’s Noratech. If successful, Entresto’s US patent will remain valid until November 2026.-Fineline Info & Tech
