China’s National Medical Products Administration on September 11, 2020, in conjunction with the China National IP Administration released the draft “Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial) (Draft for Comment)” (the “Draft Measures”) for public comment ( 国家药监局综合司 国家知识产权局办公室公开征求《药品专利纠纷早期解决机制实施办法（试行）（征求意见稿）》意见). The announcement includes the text of the draft measures and an accompanying explanation. Note that this drafting is occurring at the same time as the patent law is undergoing amendment, and the Supreme People’s Court had also announced a plan on March 31, 2020 to issue a judicial interpretation on patent linkage (Provisions on Several Issues concerning the Application of Law in the Trial of Pharmaceutical Patent Linkage Dispute Cases 关于审理药品专利链接纠纷案件适用法律若干问题的规定).
Some background: patent linkage is contemplated by the Phase 1 Agreement which calls for an “Effective Mechanism for Early Resolution of Patent Disputes.” (Sec. 1.11), and by the draft patent law amendments released in July 2020 (Art. 75). SAMR’s earlier legislative plans and CNIPA’s 100 IP project list for 2020 did not specifically call for enacting of linkage regulations. The Phase 1 Agreement calls for “procedures for judicial or administrative proceedings and expeditious remedies, such as preliminary injunctions or equivalent effective provisional measures, for the timely resolution of disputes concerning the validity or infringement of an applicable patent claiming an approved pharmaceutical product or its approved method of use.” It does not notably, call for only a judicial or administrative system to implement the linkage regime, nor does it identify a requirement of “artificial infringement” whereby a generic company’s seeking to challenge an innovator’s marketing exclusivity would constitute patent infringement. Some observers have thought that the recent experiment by the national appellate IP court combining an infringement and validity trial might serve as a useful judicial pilot for patent linkage determinations.
The Draft Measures refer back to the patent law for authorization, and also appear to govern both judicial and administration actions. Although a detailed analysis will require further examination and review, the Draft Measures appear on first glance to be an effort by NMPA and CNIPA to anticipate proposed legislative changes by beginning the work on what might ultimately become an agency rule. NMPA has issued many similar “implementing provisions” over the past several years. A further clue in this regard is that comments are to be prepared on a form, which is then to be sent to NMPA, rather than to the State Council or Ministry of Justice – who normally prepare State Council regulations. Chinese IP agencies have in the past announced draft rules or implemented them in advance of actual legislative changes, perhaps out of confidence in the ultimate passage of superseding legislation, but also, in my view, to advance the discussion on important issues and help advocate for particular positions.
Please send me your comments and any translation that you can share on this important document.
Update of September 16, 2020: Courtesy of King & Wood Mallesons, here is an English translation of the draft proposed rule for public comment.