BEIJING—In a recent development for the pharmaceutical industry, Sanofi’s multiple sclerosis therapy Aubagio (teriflunomide) has suffered a significant setback in China. According to the latest information, three decisions from China’s Supreme Court in May 2024 have upheld the cancellation of Sanofi’s formulation patents for Aubagio tablets, as requested by an unnamed domestic generic drug company .
The China Intellectual Property Administration (CNIPA) had previously made two administrative decisions, which were appealed by Sanofi. However, the Supreme Court’s affirmation of these decisions effectively invalidates Sanofi’s patents (ZL201510052300.9 and ZL201510052299.X), that would have otherwise been in force until 2030 .
Additionally, a civil infringement proceeding was dismissed by the court in February 2024, after it upheld CNIPA’s invalidity decisions. This suggests that Sanofi is unlikely to have further legal avenues to defend Aubagio’s patent rights in China .
The impact of this decision is substantial, as two generic companies, CGeneTech (Suzhou, China) Co., Ltd, and Cisen Pharmaceutical Co., Ltd, already have valid production approvals for teriflunomide, awarded in 2021 and June 2024 respectively . Given that Aubagio has already come off patent in the US and Europe from 2023, the Chinese market presents a key area of focus for Sanofi’s strategy moving forward .
This ruling could pave the way for increased competition in the treatment of multiple sclerosis in China, potentially leading to more affordable options for patients. Aubagio, first approved globally by the US FDA in September 2012 for relapsing forms of MS in adults, has been a dominant therapy in the country since its approval in China in 2019, and its inclusion in the National Reimbursement Drug List the same year .- Flcube.com
