Novartis' Leqvio Secures Validation of Another Core Patent in China

Recently, the China National Intellectual Property Administration (CNIPA) made a decision regarding an invalidation request, announcing that a composition patent (Patent No.: ZL201810143112.0) related to Novartis' cholesterol-lowering product Leqvio (Inclisiran Sodium Injection) remains valid based on the amended claims. The term of this patent will expire on December 5, 2033.

Previously, in another patent invalidation proceeding, the China National Intellectual Property Administration (CNIPA) had explicitly upheld the full validity of another composition patent related to Lecanemab (Patent No.: ZL201380063930.5, Patent Expiration Date: December 5, 2033) in early September 2023.

The two effectively maintained patents can continue to provide strong patent protection for the active pharmaceutical ingredient inclisiran in Leqvio. The patentees of the two patents are Alnylam Pharmaceuticals, Inc., Novartis is the exclusive licensee of the two patents and the holder of the marketing authorization for Leqvio in China.

The small interfering RNA drug Leke Wei works by silencing unwanted gene expression within cells. RNA interference is a cutting-edge technology with significant potential in current drug development, attracting many companies to enter this prime field. At the end of last year and the first half of this year, a third party filed invalidation requests for the two patents related to the composition of the above-mentioned substances of Leke Wei. However, the two positive decisions made by the China National Intellectual Property Administration have confirmed the validity of these related patents of Leke Wei.

Leqvio is currently the world's first and only small interfering RNA (siRNA) drug used to lower low-density lipoprotein cholesterol (LDL-C), and it was approved in China this August.

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