The China National Intellectual Property Administration (CNIPA) has rejected another challenge from Junshi Biosciences (SHA: 688180) against an Alnylam Pharmaceutical (NASDAQ: ALNY) patent (ZL201810143112.0) related to the development of PCSK9-targeted small-interfering RNA (siRNA) therapies. This decision ensures the patent’s validity remains intact until December 5, 2033.
Details of the Patent Challenge
The invalidation declaration was filed by Li Caihui, an IP executive at Junshi, under case number “4W115598,” with an oral hearing conducted on July 18, 2023. This ruling marks the second instance where Junshi’s patent challenges concerning PCSK9-targeted siRNA inclisiran have been unsuccessful, affirming the ongoing validity of the patents named “PCSK9 iRNA Composition and Its Use Method.”
Background on Inclisiran and Market Implications
Alnylam was instrumental in the discovery and development of inclisiran, which it licensed to The Medicines Company. Novartis subsequently acquired the drug through its 2019 acquisition of The Medicines Co. for USD 9.7 billion. Inclisiran received its first approval in Europe in December 2020 as a treatment for adult hypercholesterolemia and mixed dyslipidemia, followed by US approval in 2021. The drug’s regimen of only two injections per year offers a significant convenience compared to the more frequent dosing required by PCSK9-targeted competitors or daily statins. Inclisiran was approved in China in August of this year for treating adult patients with primary hypercholesterolemia or mixed type dyslipidemia.
Junshi’s siRNA Drug Development Efforts
Junshi Biosciences, which operates a comparable siRNA drug development platform, continues to advance its own PCSK9 drug candidates. The CNIPA’s decision underscores the strength of Alnylam’s intellectual property and the competitive landscape in the development of innovative lipid-lowering therapies.-Fineline Info & Tech
