China's Patent Linkage System Is Finally Up and Running

Pharmaceutical and biotechnology companies in China will now have the benefit of Hatch-Waxman-style litigation, thanks to the launch of China’s patent linkage system in June 2021. Patent owners will be able to obtain a nine-month stay of approval on generic drugs they believe infringe their products. They must list the relevant patents on an Orange Book-style IP registry and file an infringement action within 45 days of the publication of the generic drug’s market approval application. A court decision will then be issued within nine months. IAM interviewed Finnegan partner Li Feng for her thoughts on the new system.

Although the new system launched, the wording of some of the rules has left some uncertainty. Li said, “They state that the NMPA [National Medical Products Administration] must publish the certification within 10 days of receiving it. After a semi-colon, they state that the generic must also inform the patent owner, but do not explicitly state a time-limit. Because the language is not very clear, I would advise the patent owners to continue to monitor the system.”

However, the rules surrounding parallel infringement proceedings have been clarified. Li said, “The final rules make it clear that if your suit is accepted by the court, you can no longer pursue the case in the administrative forum.” She added, “Because a patent owner only has 45 days to file suit, it is important to make sure that your suit is accepted by at least one of the two forums. So, patent owners may want initially to file suit in both forums.”

Read “China's Patent Linkage System Is Finally Up and Running”