China update – patent linkage system in China: judicial provisions and administrative measures come into effect


We recently reported the Measures for Implementation of an Early Resolution Mechanism for Pharmaceutical Patent Disputes (Trial Implementation) which came into effect on 4th July 2021. These measures cover the judicial path and administration path for enforcement in the bifurcated system.

On 5th July 2021, the Supreme Court issued Provisions on Several Issues Concerning the Application of Law in the Trial of Civil Cases of Patent Disputes Related to Drugs Applied for Registration (“Provisions”) and the China National Intellectual Property Administration (“CNIPA”) released the Administrative Adjudication Measures for Early Resolution Mechanisms for Drug Patent Disputes (“Measures”), both of which immediately came into effect.

We introduce the Provisions and Measures in a comparative manner in the below table to show the similarities and differences between the two paths in the bifurcated system.

Judicial ProvisionsAdministrative Measures
Competent Court / Administrative DepartmentBeijing Intellectual Property Court for the first instanceAdministrative Adjudication Board for Early Resolution of Drug Patent Disputes newly established by CNIPA
Parties eligible to initiate a case
  • Patentees / Interested parties (i.e., Marketing authorisation holders (“MAH”) and patent licensees)
  • Generic applicants for drug marketing authorisation (if patentees or interested parties do not file a lawsuit or request for administrative adjudication within 45 days from the disclosure of the application for marketing authorisation)
Key documents / information required
  • Formality documents (e.g., certificate of incorporation);
  • Relevant information of patent registered in the Drug Patent Information Record Platform (“the Platform”);
  • Relevant information of the drug applied for registration published on the Platform, including the name, type, registration category, and the corresponding relationship with the involved marketed drug, etc.;
  • Category IV declaration and the grounds of the declaration;
  • Generic applicant for drug marketing authorisation should, within the time limit for response, submit to the Court the copy of necessary technical materials filed with the Centre for Drug Evaluation (“CDE”).
  • Formality documents (e.g., certificate of incorporation);
  • Relevant information of patent registered in the Platform;
  • Application for drug marketing authorisation registered in the Platform;
  • Category IV declaration and the grounds of the declaration;
  • If generic applicant for drug marketing authorisation requests an administrative adjudication, the applicant should submit the relevant technical solution of the drug applied for registration.
    [Note: CNIPA is entitled to confirm relevant evidence with the National Medical Products Administration (“NMPA”) upon request or where necessary]
DefensesPrior art defense and prior use defense available

[No express stipulation, but the Provisions is the law and will be applied in the administrative adjudication]

Stay of Action due to patent invalidation requestedGenerally no stayMay not stay the action
Duty of confidentialityYesYes
Choosing both paths, simultaneouslyNo stay of action if a request for stay is on the grounds that a request for administrative adjudication was already acceptedNo acceptance of administrative adjudication if a lawsuit was already accepted

Additional remarks


Neither the Provisions nor the Measures specify a definite timeline to make a judicial judgement or an administrative decision. The nine-month waiting period can be tight for making available an effective judicial judgement, especially if either party appeals. For foreign parties, if the Beijing Intellectual Property Court’s practice on the notarisation and legalisation requirement remains unchanged for such patent linkage litigation, the nine-month waiting period can become extremely tight. If the Court aims to be the first choice of dispute resolution, it can be reasonably expected that a special proceeding may be set to expedite the procedure.

Interim Injunctions

Interim Injunctions can still be applied for additionally according to current law. However, they would not prevent an ongoing technical review of the drug approval or prevent a marketing authorisation from issuing.

Bad faith

Articles 9 and 12 of the Provisions stipulate the legal liability for bad faith of parties.

For drug marketing authorisation applicants, if the relevant technical solutions submitted with the Court are obviously inconsistent with the technical material filed with the National Medical Products Administration (“NMPA”), it may lead to obstruction of justice that will be punished under Article 111 of the Civil Procedure Law or even criminal liability.

If the patentee or the interested party knows or should have known that the patent right claimed should be invalidated, or the relevant technical solution of the drug applied for registration does not fall into the protection scope of a patent, and still proceed to file a lawsuit or request for administrative adjudication, the Applicant for drug marketing authorisation may file a lawsuit through the Beijing Intellectual Property Court for compensation.

Brief summary

As seen from the comparison above, there is no significant or substantive difference between the two paths. Timelines are an important factor to be considered when deciding on the appropriate path to take, since it is possible to obtain an administrative decision within the waiting period, but it can be problematic to have an effective judicial judgement in time. On the other hand, uncertainty associated with the administrative path is also a factor that needs to be considered, because the decision can be made subject to judicial review.

If you have any questions or if you would like further details, please do not hesitate to contact us.

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