1-Hour Program

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The amended Chinese Patent Law (which came into effect on June 1, 2021), for the first time introduced the patent linkage system, which provides a mechanism for early resolution of drug patent disputes during the marketing approval process of generic drugs.  The National Medical Products Administration ("NMPA"), China National Intellectual Property Administration ("CNIPA") and China's Supreme People's Court have issued regulations and/or judicial interpretation relating to the details of the patent linkage mechanism in China.  Equivalent to the Orange Book system in the US, drug marketing authorization holders in China can register patents and generic applicants can file patent certifications in the platform operated by NMPA.  As of January 23, 2022, the platform has received registrations for 590 chemical drugs, 86 biosimilars, and 292 traditional Chinese medicines, as well as 1,131 patent certifications.  The Beijing Intellectual Property Court accepted the first patent linkage case in November 2021. 

Panelists will discuss:

  • Legal framework – 10 minutes
  • How marketing authorization holders can register patents in the patent linkage system – 8 minutes
  • The filing of patent certifications by generic drug applicants – 7 minutes
  • How disputes are resolved: Civil actions v. administrative complaints – 15 minutes
  • The market exclusivity period and patent invalidity challenges – 10 minutes
  • The first patent linkage case in China – 5 minutes
  • Key differences and similarities between the process in the US and China – 5 minutes





Gary M. Hnath

Mayer Brown LLP


Tingting Liao

Fangda Partners


Hans She

Fangda Partners


Jing Zhang

Mayer Brown LLP


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