NEWS

China Establishes Early Resolution Mechanism for Drug Patent Disputes

Release time:

2021-07-08 14:05

China establishes early resolution mechanism for drug patent disputes Issuance of Trial Implementation Measures

Under the framework of the relevant provisions of the newly amended Patent Law, the State Food and Drug Administration and the State intellectual property Office have organized and formulated the measures for the implementation of the Early Resolution Mechanism for Drug Patent disputes (for trial implementation), with the consent of the State Council.July4issued and implemented on the day.

The early resolution mechanism of drug patent disputes refers to the system that connects the relevant drug listing approval procedures with the relevant drug patent dispute resolution procedures. The "Measures" aims to provide a mechanism for the parties to resolve relevant patent disputes in the review and approval of relevant drugs, protect the legitimate rights and interests of drug patentees, and reduce the risk of patent infringement after the listing of generic drugs.

The main contents of the Measures include: platform construction and information disclosure system, patent registration system, generic drug patent declaration system, judicial link and administrative link system, approval waiting period system, drug review and approval classification processing system, first generic drug market exclusive period system, etc.

The "Measures" proposed that the drug regulatory authority of the State Council organize the establishment of a China-listed drug patent information registration platform for drug marketing license holders to register drug-related patent information registered and listed in China. The national drug review agency shall be responsible for establishing and maintaining the patent information registration platform for drugs on the market in China, and making public the relevant patent information of the approved drugs on the market.

When submitting an application for drug marketing license, an applicant for a chemical generic drug shall make a statement for each relevant drug patent of the generic drug against the patent information disclosed on the patent information registration platform of the listed drug in China.

It is understood that the specific drug patents that can be registered in China's listed drug patent information registration platform include: chemical drugs(excluding APIs) patents on pharmaceutical active ingredient compounds, patents on pharmaceutical compositions containing active ingredients, patents on pharmaceutical uses; patents on Chinese medicine compositions, patents on Chinese medicine extracts, patents on pharmaceutical uses; patents on the sequence structure of active ingredients of biological products, patents on pharmaceutical uses. Related patents do not include intermediates, metabolites, crystal forms, preparation methods, detection methods and other patents.

Patent, drug, listing, system, related, information, China, registration, dispute