Interpretation to Measures for Administrative Adjudication of Early Settlement Mechanism of Drug Patent Disputes (September 2021)

On July 5, 2021, the CNIPA announced and issued the Measures for Administrative Adjudication of Early Settlement Mechanism of Drug Patent Disputes (hereinafter referred to as the Adjudication Measures), which would come into force as of the date of issuance.

The Adjudication Measures include 24 articles, in which they stipulate the subject of request for administrative adjudication, the scope of drug patents that can be adjudicated, the coordination with judicial channels, the relationship between administrative adjudication and invalid procedures, the implementation and publicity of administrative adjudication, the judicial relief of administrative adjudication and other case handling procedures, etc.

(I) Subject Who Can Request Administrative Adjudication

The subject requesting an administrative adjudication is the petitioner.  According to Article 76 of the Patent Law, the petitioner may be the patentee or interested party of the relevant patent and the applicant for drug marketing license. The interested party refers to the licensee of the relevant patent or the registered holder of the drug marketing license.

(II) Time Limit for Requesting Administrative Adjudication

According to the relevant provisions of the measures for the Implementation Measures for Administrative Adjudication of Early Settlement Mechanism of Drug Patent Disputes (Trial), the patentee or interested party may submit an administrative adjudication request to confirm that the drug related technical solution applying for marketing license falls within the scope of relevant patent protection within 45 days from when the national drug evaluation institution opens an application for drug marketing license.

If the patentee or interested party fails to bring a lawsuit to the people's court or file a request for administrative adjudication on the drug patent dispute within 45 days from when the national drug evaluation institution opens applications for drug marketing license, the applicant for drug marketing license may file a request for administrative adjudication confirming that the relevant technical solution of the drug applied for marketing license does not fall within the protection scope of relevant patent rights.

(III) Scope of Drug Patents Subject to Administrative Adjudication

In the Adjudication Measures it stipulates that the drug patents that can be adjudicated must meet the following conditions, that is, the relevant patent information has been registered and disclosed on the China listed drug patent information registration platform, and the patent type complies with the relevant provisions of Implementation Measures for Administrative Adjudication of Early Settlement Mechanism of Drug Patent Disputes (Trial).

Related patents include: patents for pharmaceutical active ingredient compounds, pharmaceutical composition patents containing active ingredients, patents for pharmaceutical use of chemical medicines (excluding API); patents for traditional Chinese medicine composition, patents for traditional Chinese medicine extract and patents for pharmaceutical use of traditional Chinese medicine; patents on the sequence structure of active ingredients and patents for pharmaceutical use of biological products. Relevant patents do not include patents of intermediates, metabolites, crystal forms, preparation methods and inspection methods, etc.

(IV) Coordination between Administrative Adjudication and Judicial Channels

According to Article 4 of the Adjudication Measures, the administrative adjudication filing procedure requires that the relevant patent disputes in the process of drug review and approval have not been filed by the people's court.  If the same patent dispute has been filed by the people's court, the CNIPA will not accept the request for administrative ruling put forward by the parties so as to ensure that the relevant disputes are carried out through either administrative or judicial channels and to avoid waste and conflict of dispute resolution procedures.

(V) Relationship between Administrative Adjudication and Invalid Procedure

According to Article 14 of the Adjudication Measures, if a part of the claims in the patent involved in the administrative adjudication case of drug patent disputes are declared invalid, the CNIPA will make an administrative adjudication on the basis of maintaining the effective claims. If all the claims involved in the patent are declared invalid, the CNIPA will reject the request for administrative adjudication. In addition, if the party concerned makes a request for invalidating the patent involved in the case as it is being processed, Article 16 of the Adjudication Measures mandates that the CNIPA may not suspend the handling of the case.

(VI) Enforcement and Publicity of Administrative Adjudication

In the Adjudication Measures, it stipulates that after the administrative adjudication is made, it shall be delivered tor relevant parties, copied to the drug regulatory department under the State Council, and made public in accordance with relevant provisions. When an administrative adjudication is made public, the information involving trade secrets shall be deleted.

(VII) Judicial Remedy of Administrative Adjudication

Article 19 of the Adjudication Measures stipulates that if a party is not satisfied with the administrative adjudication on drug patent disputes made by the CNIPA, he may file a suit in the people's court according to the law. According to Article 46 of the Administrative Litigation Law of the People's Republic of China, administrative litigation may be filed within 6 months from the date of service of the administrative ruling. 

Adapted from the CNIPA