In July, the State Drug Administration and the CNIPA jointly issued the Measures for the Implementation of the Early Settlement Mechanism for Drug Patent Disputes (for Trial Implementation), and the Supreme People's Court (SPC) promulgated the Provisions on Several Issues Concerning the Application of Law for Hearing Civil Cases of Patent Disputes Related to Drug Applications for Registration. These documents provide specific operational guidelines for the newly established early settlement mechanism for drug patent disputes.

The Measures has 16 articles, covering relevant platform construction and information disclosure system, patent right registration, generic drug patent declaration, judicial and administrative linkage mechanism, drug review and approval classification and the corresponding processes, and possible market exclusivity for first generic drugs.

The relevant drug patents covered by this early resolution mechanism of drug patent disputes include: patents for compounds of active ingredients of chemical drugs, patents for drug compositions containing active ingredients and patents for pharmaceutical uses of chemical drugs (excluding drug substances); patents for compositions of Chinese medicines, patents for extracts of Chinese medicines and patents for pharmaceutical uses of Chinese medicines; patents for sequence structures of active ingredients and patents for pharmaceutical uses of biological products. The relevant patents do not include patents on intermediates, metabolites, crystalline forms, preparation methods, detection methods, etc.

If a patent owner or interested party disagrees with the patent statement of a chemical generic drug registration application, they may file a lawsuit with the people's court or request an administrative ruling from the patent administration department of the State Council within 45 days from the date of disclosure of the drug marketing authorization application by the State Drug Evaluation Agency on whether the relevant technical solution of the drug application falls within the scope of protection of the relevant patent right. The State Council's drug administration department sets a 9-month waiting period for chemical generic drug registration applications.

The SPC's Provisions has 14 articles, explaining the court's jurisdiction over such disputes, the specific cause of action, the material requirements for a suit, the exercise of the right to sue, the linkage of the administrative and judicial procedures, acceptable defenses, protection of trade secrets in litigation, behavior preservation, counter-compensation for failure to sue, service of process, etc.

We will review the policies in more details in future issues of our newsletter.

A quick look of the official documents in Chinese is available at

https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210703223942131.html

http://www.court.gov.cn/fabu-xiangqing-311791.html

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