China's IP Administration publishes Draft Administrative Adjudication Measures for Patent Linkage

On 9 February 2021, China's National Intellectual Property Administration ("CNIPA") published its Administrative Adjudication Measures For The Early Resolution Mechanism For Drug Patent Disputes (Draft for public comments) ("药品专利纠纷早期解决机制行政裁决办法(征求意见稿"). These Measures are aimed at implementing the patent linkage system adopted by the recently amended Chinese Patent Law, and specifically propose draft rules on how an administrative adjudication procedure aiming to challenge an application for a marketing authorization for a patented drug will be conducted.

Background

As we reported before in our article about the amended Chinese Patent Law (see here), new article 76 of the Patent Law provides a legal framework for China’s long-awaited patent linkage system.

Essentially, a system will be adopted whereby the issuing of marketing authorizations for generic drugs is, to a certain extent, made dependent on (i.e. ‘linked’ to) the absence of infringement claims by patentees. The amendments to the Patent Law provide that during the marketing authorization procedure for a generic drug, a patentee (or stakeholder) can bring either a judicial infringement proceeding before a court or an administrative adjudication procedure before the CNIPA, which would lead to a suspension in issuing a marketing authorization. Implementing measures issued by CNIPA and the National Medical Products Administration, as well as judicial regulations issued by the Supreme People's Court, are meant to put more flesh on these bare bones provided by the Patent Law, before its entry into force on 1 June 2021.

The newly published CNIPA Regulations now propose detailed draft rules regarding the administrative adjudication procedure before the CNIPA. The Supreme People's Court has already proposed detailed draft rules on the judicial procedure before the courts earlier, see here.

The Regulations

The official full text in Chinese of the CNIPA Measures can be found here.

Our unofficial bilingual version of the CNIPA Measures can be found here.

The CNIPA is now gathering comments from the public on these Measures until 27 March 2021 . Please contact our lawyers listed in this article should you have further questions, or if you would like us to submit comments on these Measures on your behalf.

 

 

Authored by Zhen (Katie) Feng and Stefaan Meuwissen.

 

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