The trigger is the patent declaration a generic applicant has to make when it files for marketing authorization.
How it works. Against the patents listed for the reference drug on China's Patent Information Registration Platform for Marketed Drugs, the applicant must declare one of four positions:
1. no patent information is registered for the reference drug;
2. the listed patent has lapsed or expired or been declared invalid, or the applicant holds a license under it;
3. the applicant undertakes not to market the generic until the listed patent expires; or
4. the listed patent should be declared invalid, or the generic falls outside its scope.
Once the declaration is published, the patentee or an interested party has 45 days to bring a civil action, or to seek an administrative ruling from CNIPA, on whether the generic falls within the scope of the patent. Filing within that window triggers a 9-month stay on approval of the generic application. The stay applies to chemical generics only.
Practical points. Search the platform and run an infringement comparison before you file. The position you declare sets the dispute route that follows, and the delay it carries. If you intend to challenge a listed patent, assess the prospects of invalidating it before you file, not after.
