On August 24, 2023, generic versions of Novartis’ (NYSE: NVS) heart failure therapy Entresto (sacubitril, valsartan) received market approvals, with Chinese firms Nanjing F&S Pharmatech Co., Ltd and CSPC Pharmaceutical Group Ltd (HKG: 1093) receiving the honors. This development prompted a statement from Novartis on August 28, 2023, asserting that the active ingredients of Entresto, sacubitril + valsartan, are still protected under Chinese patents No. ZL200680001733.0 and ZL201210191052.2, both of which remain valid through November 2026.
Novartis’ Patent Protection and Legal Stance
According to Article 11 of the Chinese Patent Law, no enterprise or individual is permitted to manufacture, use, promise to sell, sell, or import products that fall within the scope of patent protection before the expiration of the aforementioned patent period without Novartis’ authorization. Any such actions would constitute patent infringement, and Novartis reserves the right to pursue its patent rights against infringing imitations through relevant judicial and/or administrative authorities.
Patent History and Core Patent Validity
The Orange Book lists six patents related to the drug registered in China, all concerning “Pharmaceutical composition containing valsartan and NEP inhibitor” (Patent No.: ZL201110029600.7). This patent was declared invalid in April 2017, a decision later reconfirmed by CNIPA in 2018 and confirmed by the People’s Court in 2019. However, this was not sufficient to allow generics onto the market. In 2021, CNIPA confirmed that the drug’s core patent remained valid, with the 20-year patent protection period for both of Entresto’s core patents set to expire on November 8, 2026.-Fineline Info & Tech
