The CNIPA Received First Batch of Administrative Decisions on Early Resolution Mechanism for Pharmaceutical Patent Disputes (November 2021)

The amended Patent Law has come into effect on June 1, 2021, which stipulated in Article 76 that an applicant for a drug marketing license and the relevant patentee or interested party may request an administrative ruling from the patent administrative department of the State Council in respect of a dispute over patent rights related to the drug applied for registration.  On July 5, 2021, the CNIPA formulated and issued the Measures for Administrative Adjudication of Early Settlement Mechanism of Drug Patent Disputes (hereinafter referred to as the Measures).  The revision of the Patent Law and the issuance of the above Measures provided the legal and institutional basis for the early resolution mechanism of drug patent disputes.

It is reported that as of October 27, 2021, the CNIPA has received 23 case requesting for administrative adjudication of drug patent disputes filed by patentees or drug marketing license holders. The administrative adjudication committee of the early settlement mechanism of drug patent disputes of the CNIPA has conducted a preliminary examination of the aforementioned requests according to the Measures and issued acceptance notifications for 12 requests that meet the acceptance conditions, with cases formally placed on file.

The CNIPA will hear the cases of administrative ruling on the early settlement mechanism of relevant drug patent disputes in accordance with the law and regulations.  At the same time, it will strengthen the information communication and coordination with the state drug administration departments and the People's Court to ensure the smooth implementation of the system, protect the legitimate rights and interests of drug patentees, encourage new drug research and reduce the risk of patent infringement after the generic drugs are marketed.

Adapted from the CNIPA