The China National Intellectual Property Administration (CNIPA) has released the latest batch of completed patent linkage cases, following the new legal framework introduced with China’s amended Patent Law, which came into effect from July 2021.<\/p>\n\n\n\n
Decisions on Generic and Originator Patents<\/strong> Notable Withdrawals and Challenges<\/strong> Macitentan and Gilenya:Challenges and Opportunities in the Chinese Market<\/strong> Fingolimod, a sphingosine 1-phosphate receptor (S1PR) modulator for MS, was approved as a first-line treatment for MS recurrence in the US in September 2010 and in China in July 2019. It entered the NRDL in December 2020. HEC Pharm Group and Continent Pharma have active approval filings for generics under consideration and challenged two patents set to expire on April 6, 2024.<\/p>\n\n\n\n
The decisions covered 9 molecules and 19 patent challenge verdicts, involving 11 generic makers and 11 originator patents. CNIPA determined that only 2 molecules, Novartis\u2019s Jakavi (ruxolitinib) and Daiichi Sankyo Co., Ltd\u2019s Lixiana\/Savaysa (edoxaban), had generic drugs infringing on an originator\u2019s patent. In all other instances, CNIPA either judged there was no infringement or the case was withdrawn by the originator company, effectively allowing generic challenges to proceed.<\/p>\n\n\n\n
Among the decisions were Johnson & Johnson\u2019s Opsumit (macitentan) for pulmonary arterial hypertension (PAH) and Novartis\u2019s Gilenya (fingolimod) for multiple sclerosis (MS), both of which are designated rare disease therapies in China. Both J&J and Novartis voluntarily withdrew their cases.<\/p>\n\n\n\n
Macitentan, an endothelin receptor antagonist (ERA) originated by J&J, was first approved in the US in October 2013 and entered China in September 2017. It was included in the National Reimbursement Drug List (NRDL) two years later. The successfully challenged China patent is set to expire on September 10, 2026. Several companies, including Sinotherapeutics, Chia Tai Tianqing, Huadong Medicine, Zeheng Pharma, Qilu Pharma, and Shanghai Pharma, have filed generic versions for approval. Zeheng Pharma made a Category 4.2 declaration regarding the drug, and the originator voluntarily withdrew the request for a ruling on March 28, 2023.<\/p>\n\n\n\n