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 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.