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.
Decisions on Generic and Originator Patents
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’s Jakavi (ruxolitinib) and Daiichi Sankyo Co., Ltd’s Lixiana/Savaysa (edoxaban), had generic drugs infringing on an originator’s 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 In all other instances, CNIPA either judged there was no infringement or the case was withdrawn by the originator company, effectively allowing generic challenges to proceed.
Notable Withdrawals and Challenges
Among the decisions were Johnson & Johnson’s Opsumit (macitentan) for pulmonary arterial hypertension (PAH) and Novartis’s 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.
Macitentan and Gilenya:Challenges and Opportunities in the Chinese Market
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.
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.
Other Molecules and Patent Challenges
Other molecules where challenges were not adjudicated or closed included sitagliptin+metformin, gliclazide, and ruxolitinib. CNIPA recognized that the generic drug for sitagliptin+metformin does not fall within the scope of the originator patent. Meanwhile, gliclazide saw its patent declared invalid on January 4, 2023. CNIPA indicated that a generic version of ruxolitinib fell within the scope of the originator’s patent protection.
Current Status of Category 4 Declarations
As of May 11, 2023, a total of 73 drugs were filed for Category 4 declarations, involving 112 generic manufacturers and 53 originator companies. This release is CNIPA’s first batch of announcements since October last year. To date, CNIPA has publicized definite patent linkage decisions/judgements in relation to 13 drugs, a tally increased to 18 by today’s release.-Fineline Info & Tech
