On June 1, 2026, the China National Intellectual Property Administration (CNIPA) granted a patent term extension (PTE) of 1,826 days for the crystal form patent of Novartis’s sacubitril/valsartan sodium tablets. The patent expiry date was extended from November 2026 to November 2031. This landmark case marks the first instance in China where a 5 year full term PTE was granted solely based on a crystal form patent, fully opening up a long term protection route of “crystal form patent plus pharmaceutical patent term compensation”.

Current patent examination practice for crystalline pharmaceutical products shows distinct characteristics: advantageous crystal forms feature differentiated physicochemical properties and higher stability of inventiveness, acting as a core barrier for originator pharmaceutical companies to safeguard market share. The compsition patent for Entresto (generic trade name of sacubitril/valsartan sodium) had been declared invalid long before. The originator successfully prolonged patent protection relying on its crystal form patent, which verifies the core value of crystal form patent layout in the competition with generic drug.

In terms of PTE prosecution practice, this case clarifies that crystal form patents qualify for patent term compensation as invention patents relating to innovative drugs. Three key compliance requirements shall be strictly observed in practice: first, the crystal form claims must precisely correspond to the approved marketed drug, with the drug marketing authorization and the protected subject matter of the patent fully aligned; second, the statutory ceiling of compensation shall be complied with, and the total patent protection term after drug marketing shall not exceed 14 years; third, hierarchical patent portfolios shall be arranged. After the expiration of compound patents, multi-layer patent protection nets shall be constructed based on crystal forms and their preparation processes.

The annual sales of this product reach several billion RMB. Thirty-five generic drug manufacturers with marketing approvals are forced to postpone their launch schedules and readjust centralized procurement and commercialization strategies. This case delivers a clear industry signal: crystal form patents have become a vital track for pharmaceutical PTE layout. Innovative pharmaceutical enterprises shall advance their crystal form patent planning, while generic drug companies shall conduct early stage FTO (freedom to operate) analysis on crystal form technologies and complete patent circumvention designs.