Recently, all eyes have been on China as the fundamental patent covering semaglutide, the active ingredient in Ozempic® and Wegovy®, will expire on March 20, 2026. It goes without saying that generics are ramping up bigtime in China (and also around the world), preparing to manufacture and sell this blockbuster drug to one of the biggest markets in the world. Any shortening of the patent term for this key semaglutide patent in China could cause an immediately shift in the Chinese Ozempic market (not to mention directly impacting Novo Nordisk). Novo Nordisk’s Semaglutide Patent in China On September 5, 2022, the China National Intellectual Property Association (China’s patent administrative office,…
-
-
A More Detailed Overview of China’s Patent Term Extension (PTE) System
Although PTE has been in the Chinese Patent Law since the 4th Amendment of the law came into effect June 1, 2021, we didn’t really know the exact details of how it operated until the Implementation Regulations and Examination Guidelines (“Implementation Regulations”) were finally released in December 2023. New Rules 77-84 in the Implementation Regulations discuss patent term compensation due to regulatory delay (“PTE”). In this article, we consolidate our summary about PTE based on these latest updates. Highlights Patent Term Extension (PTE) Article 42.3 of the Patent Law states that “[i]n order to compensate for the time taken for the review and approval process before the marketing of a…
