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Amendments to the Patent Linkage Mechanism in the Latest “Measures for the Administration of Drug Registration (Revised Draft)” 

by Rui LUO

Published: July, 2016

Submission: September, 2016


On July 25, 2016, China Food and Drug Administration (“CFDA”) published the latest "Measures for the Administration of Drug Registration (revised draft)” (“Latest Revised Draft”) for public comments1 . Compared with the existing version effective since 2007 (“Existing Measures”), the Latest Revised Draft cancels certain time limitation rules dedicated to the protection of patent rights in the existing patent linkage mechanism and indicates that CFDA is minimizing its involvement in patent disputes related to the drug registration application. Specifically, with respect to those drug registration applications which are about drugs covered by existing patents, the Latest Revised Draft cancels the limitations about when certificates can be issued or effective, and keeps the previous revision of cancelling the limitations about when drug registration applications can be filed. In the meantime, according to previous explanation of CFDA as well as relevant content in the Latest Revised Draft, the dispute resolution mechanism newly introduced in the Latest Revised Draft is not likely to be available to patent disputes.

On July 25, 2016, CFDA published the latest "Measures for the Administration of Drug Registration (revised) for public comments on its official website. The public can send their comments on the Latest Revised Draft to the CFDA through emails before August 26, 2016.

Compared with the Existing Measures, the Latest Revised Draft specifies more detailed and explicit rules regarding drug examination, wherein the changes in the patent linkage mechanism are worth noting. The changes indicate that CDFA does not want to be too much involved in patent protection but hopes the new patent linkage mechanism, including applicants’ ownership statements of patents related to the drug registration application and non-infringement declaration about other parties’ domestic patents, can balance the legitimate interests of parties concerned. It seems that the intention of CFDA is to leave patent infringement disputes totally to judicial or other administrative proceedings. The major changes related to the patent linkage mechanism in the Latest Revised Draft are as follows:

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