CNIPA

Patent Linkage Legislation Available for Today’s Program

There is still time to register for our program on patent linkage in China for today (July 15, 2021) at 5:00 PM.  The registration link is here.    Currently the speaker lineup includes: Judge Randall Rader (ret), He Jing (Genlaw), Douglas Clark (Rouse), John Balzano (Covington & Burling), and Jill Ge (Allen & Overy).  We already have a great group pre-registered. I am looking forward to their questions and observations.

In preparation for this event, He Jing has graciously provided us with translation of the three patent linkage measures introduced to date, with comparisons to earlier drafts: Administrative Adjudication Measures for Early Resolution Mechanism for Drug Patent Disputes No. 435, Published by CNIPA on July 5, 2021; the Provisions of the Supreme People’s Court on Several Issues Concerning the Application of Law in the Trial of Civil Cases of Patent right Disputes Related to Drug Registration Application Fa Shi [2021] No. 13 (Approved at the 1839th Meeting of the Judicial Committee of the Supreme People’s Court on May 24th, 2021, and to come into force since July 5, 2021), and the Implementing Measures for Mechanism for Early Resolution of Drug Patent Disputes  of NMPA and CNIPA (Trial) (CNIPA No. 89, effective July 4, 2021).  The first of these three documents was described Aaron Wininger here; I blogged about the last two here.   According to Toby Mak, the first patent linkage notification has already been instituted by a generic company, involving the Pfizer’s Palbociclib.  Aaron Wininger identified four generic applicants as of yesterday (July 14). 

After today’s event, I hope to summarize my view of this new legislative package – how well they will work for generics and innovators, what they cover, the relative role of the courts and agencies, the impact on patent law and drug registration procedures, and other likely new developments.

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