China’s National Intellectual Property Administration Issues Interpretation of Administrative Adjudication of Patent Linkage Measures

On September 18, 2021, the China National Intellectual Property Agency released the Interpretation of “Administrative Adjudication Measures for Early Resolution Mechanisms for Drug Patent Disputes”. The Interpretation clarifies some issues in the Measures, including deadlines.

Requester

The requester can be the patentee, applicant for drug marketing license or interested person. Interested person includes the licensee or the registered drug marketing license holder.

Time Limit

The time limit for filing a lawsuit or requesting administrative adjudication is 45 days after the Center for Medication Evaluation of the National Medical Products Administration publishes the drug marketing authorisation application (CDE of the NMPA). If no suit or administrative adjudication request is filed within 45 days, the drug marketing authorization applicant may file a request for confirmation that the marketing authorization’s drug-related technological solutions do not fall within the scope of the applicable patent rights.

Scope of Drug Patents Subject to Administrative Adjudication

The “Adjudication Measures” state that arbitrable drug patents must meet the following conditions: the relevant patent information must be registered and disclosed on the Chinese listed drug patent information registration platform, and the type of patent must be in accordance with the “Implementation Measures for the Early Resolution of Drug Patent Disputes (Trial)”.

Duplicate Disputes

To prevent wasting resources, CNIPA will not hear a case if the same patent dispute has already been filed with a People’s Court (i.e., the Beijing IP Court).

Invalidation

If a patent has been partially invalidated, CNIPA will issue an administrative decision based on the remaining claims. If all claims are found to be invalid, CNIPA will not hear the case. If a party requests invalidation of the relevant patent, CNIPA will not suspend the proceeding.

Enforcement and Disclosure

Administrative decisions will be made available to the parties, and a copy will be forwarded to the NMPA. The decisions will also be made public, albeit any information containing trade secrets will be removed. The patentee or interested party must still submit the decision to the CDE within 10 working days after obtaining it.

Appeal

Parties can appeal by filing a litigation with a People’s Court (i.e., Beijing IP Court) within 6 months from the date of service of the administrative ruling.