Take Me Out to the Law Game: China’s Patent Linkage Doubleheader

Many Americans watched baseball on the July 4th weekend (America’s “national day”), including doubleheaders between my hometown teams – the New York Yankees and the Mets.  Across the Pacific, China played out a different kind of doubleheader, of a legislative nature.

The first “game” was played on July 4 by CNIPA and NMPA when they enacted their patent linkage procedures, the Measures for the Implementation of Early Resolution Mechanisms for Pharmaceutical Patent Disputes (Trial) 药品专利纠纷早期解决机制实施办法(试行)(the “Measures”).  The Measures are docketed by CNIPA as the 89th Document for 2021 (2021年第89号), with an effective date of July 4, 2021.  CNIPA and NMPA also issued a background document on the Measures.

The Measures are intended to implement Article 76 of the Patent Law, which authorized CNIPA and NMPA to issue implementing procedures for the Patent Law.  The background to this legislative process was described in my blog regarding the public comment draft of these Measures: “The Cart Before the Horse in China’s Patent Linkage Regime.”

The second “game” of the legislative double header was the Provisions on Several Issues Concerning the Application of Law in the Trial of Civil Cases of Patent Disputes Related to Pharmaceutical Registration Application and Registration (关于审理申请注册的药品相关的专利权纠纷民事案件适用法律若干问题的规定).  This Judicial Interpretation, also on patent linkage, was issued by the Supreme People’s Court on July 5, at 6 AM.  Unlike the CNIPA/NMPA draft, the SPC JI’s name was changed slightly ­from the original title “Provisions on Several Issues Concerning the Application of Law in the Trial of Civil Cases Involving Pharmaceutical Marketing Review and Patent Approval” (关于审理涉药品上市审评审批专利民事案件适用法律若干问题的规定).  I previously blogged on this draft JI. 

Curiously, the SPC JI had been adopted by the SPC on May 24, 2021.   The JI release was  also accompanied by answers to questions from journalists.  The journalists were from the Supreme People’s Court newspaper, and the questions had been addressed to a spokesperson for the Number 3 Civil Division of the SPC (the IP Division).   There is no date provided for the date of the questioning.

There are several oddities around the timing of these documents. Was the selection of July 4 for promulgation intentional – a kind of Independence Day gift to the United States, which had asked for a patent linkage regime in the Phase 1 Trade Agreement?  Regarding the sequence of the two documents, did the SPC hold a press conference in the middle of the night of July 4, or was there a much earlier press conference?  If so, why did the SPC hold back on promulgating the JI until now? Was it because the SPC needed to wait until promulgation of the Measures or  implementing regulations  to the patent law? How critical was it that the Measures were issued one day earlier than the SPC JI?  Finally, and most importantly, will these two documents help advance China in establishing an effective patent linkage regime?

I  look forward to discussing the substance of these new measures in the near future.   Stay tuned.

Update of July 8, 2021: Aaron Wininger published two blogs on July 6 on the CNIPA/NMPA  Measures and the SPC Judicial Interpretation that provide useful additional background.

On July 15th, Berkeley Law will be hosting a one-hour discussion on this new legislation and its implications.  Please join me, He Jing, Douglas Clark, Judge Randall Rader (ret.) and others for a lively discussion, from 5:00 to 6:30 PM PDT.

Categories: Berkeley, China IPR, Programs

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