China's amended Patent Law, which came into effect on 1 June 2021, has introduced the patent term extension and patent linkage system, both of which are closely related to the pharmaceutical industry. 

The legislative development reflects China's determination to promote the research and development of innovative drugs in the pharmaceutical industry and is a milestone in the patent regulatory framework in China. 

The China National Intellectual Property Administration (CNIPA), the National Medical Products Administration (NMPA) and the Supreme People's Court (SPC) recently issued further rules to complete the establishment of the patent linkage system. As for patent term extension, the CNIPA has issued some temporary measures to address this as the amended Implementing Rules of the Patent Law are yet to be issued. 

The patent term extension and patent linkage system brought about by the Patent Law amendments will impact both branded drugs and generic drugs in the pharmaceutical industry. Pharmaceutical companies should be prepared for disputes related to patent linkage which would in turn shape the further development of the linkage system.

Please see our client alert for details.