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” (《药品专利纠纷早期解决机制行政裁决办法》解读).  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 to sue or request administrative adjudication is 45 days from publication of the drug marketing authorization application by the Center for Drug Evaluation of the National Medical Products Administration (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 its drug-related technical solutions of the marketing authorization do not fall into the protection scope of the relevant patent rights.

Scope of Drug Patents Subject to Administrative Adjudication

The ” Adjudication Measures ” stipulate that arbitrable drug patents must meet the following conditions, that is, the relevant patent information has been registered and disclosed on the Chinese listed drug patent information registration platform, and the type of patent is in compliance with the ” Implementation Measures for the Early Resolution of Drug Patent Disputes (Trial)”》.

Duplicate Disputes

CNIPA will not adjudicate a case if the same patent dispute has been filed with with a People’s Court (i.e., the Beijing IP Court) to avoid a waste of resources.

Invalidation

If a patent was partially invalidated, CNIPA will make an administrative adjudication based on the remaining claims. If all claims were ruled invalid, then CNIPA will not adjudicate. CNIPA will not suspend a case if a party requests invalidation of the subject patent.

Enforcement and Disclosure

Administrative decisions will be disclosed to the parties and a copy sent to the NMPA. The decisions will also be published although information involving trade secrets will be deleted.  The patentee or interested party still needs to submit that decision to the CDE within 10 working days of receiving the decision.

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.

The full text is available here (Chinese only).