USPTO Chinese Law Translations Available

USPTO has graciously made available here its unofficial translations of 19 IP related final and/or draft IPR Laws, Regulations, drafting descriptions of Regulations, Rules, explanations on the Rules, as well as judicial documents which had been released from April 20, 2020 until November 2020. The  drafting agencies include: the NPC (The National People’s Congress), MOJ (Ministry of Justice), CNIPA (China National Intellectual Property Administration), SAMR (State Administration for Market Regulation), NMPA (National Medical Products Administration), SPC (The Supreme People’s Court), SPP (Supreme People’s Procuratorate), and MPS (Ministry of Public Security). The index to these files with a link to the Chinese original is here. In certain cases, the draft laws have been superseded by published laws, regulations, or judicial interpretations.  The index contains links to the Chinese original of these drafts and the final version. For your convenience, we have also included a zip file with all the original Chinese.  

Please do not undertake any legal course of action on the basis of these documents.  These documents are intended to assist in better understanding and researching Chinese law, and should not be construed as either official or any form of legal advice or opinion. This blog has no copyright interest in a US government work or publication. The index was not prepared by USPTO.

Here is a list of the documents provided:

 Chinese TitleTitle as Used in File (as translated by the USPTO)
12020—2021 年贯彻落实《关于强化知识产权保护的意见》推进计划2020-2021 Plan for Implementing the “Opinions on Strengthening IP Protection” – Bilingual
2《中华人民共和国著作权法》修改对照Copyright Law Comparison Table before/after Amendment
3刑法修正案草案知识产权条款Draft Criminal Law Amendments IP Provisions  
4《商业秘密保护规定(征求意见稿)》Draft Rules of Trade Secret Protection
5关于《商业秘密保护规定(征求意见稿)》的说明SAMR Explanations Draft Rules of Trade Secret Protection
6《药品专利纠纷早期解决机制实施办法(试行)(征求意见稿)》Draft Trial Implementing Measures of Early Resolution Mechanism for Drug Patent Disputes
7《药品专利纠纷早期解决机制实施办法(试行)》(征求意见稿)起草说明Explanation for Trial Implementing Measures of Early Resolution Mechanism for Drug Patent Disputes
8《关于强化行政许可过程中商业秘密和保密商务信息保护的指导意见(征求意见稿)》Guidelines for Strengthening Protection of Trade Secrets and Confidential Business Information during Administrative Licensing
9《关于强化行政许可过程中商业秘密和保密商务信息保护的指导意见(征求意见稿)》的起草说明Drafting Description of the Guidelines for Strengthening Protection of Trade Secrets and Confidential Business Information during Administrative Licensing
10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(征求意见稿)Provisions of the Supreme People’s Court on Several Issues Concerning Application of Law to the Trial of Patent Civil Cases Involving the Review and Approval for Drug Marketing
11《关于审理涉电子商务平台知识产权民事案件的指导意见(征求意见稿)》Guiding Opinions of the Supreme People’s Court on the Trial of Cases of Intellectual Property Right Disputes Involving E-Commerce Platforms
12最高法关于涉网络知识产权侵权纠纷几个法律适用问题的批复Official Reply of the Supreme People’s Court on the Application of Law on Disputes over Online Infringements on Intellectual Property Rights
13全国打击侵犯知识产权和制售假冒伪劣商品工作领导小组办公室等单位关于公开征求《关于加强侵权假冒商品销毁工作的意见(征求意见稿)》意见的公告Notice on Collecting Public Comments on the Opinions on Strengthening the Destruction of Infringing and Counterfeit Goods (Draft for Public Comments) by the Office of the National Leading Group for the Crackdown on IPR Infringing and Counterfeit Goods
14关于加强侵权假冒商品销毁工作的意见(征求意见稿)Opinions on Strengthening the Destruction of Infringing and Counterfeit Goods    
15行政执法机关移送涉嫌犯罪案件的规定 (修订征求意见稿)Provisions on the Transfer of Suspectable Criminal Cases by Administrative Organs for Law Enforcement – Bilingual
16最高人民法院《关于知识产权民事诉讼证据的若干规定(征求意见稿)》Certain Provisions of the Supreme People’s Court on Evidence in Civil Intellectual Property Litigation  
17最高人民法院关于依法加大知识产权侵权行为惩治力度的意见 《关于加大知识产权侵权行为制裁力度的意见(征求意见稿)》Opinions of the Supreme People’s Court on Strengthening Punishment Intensity of Acts Infringing Intellectual Property Rights
18最高人民法院、最高人民检察院就《关于办理侵犯知识产权刑事案件具体应用法律若干问题的解释(三)(征求意见稿)》向社会公开征求意见的通知Soliciting Public Comments on the draft “Interpretation III on Several Issues Concerning the Application of Law in Handling Criminal Cases of Infringement of Intellectual Property Rights (Draft)”
19最高检、公安部就《关于修改〈最高人民检察院 公安部关于公安机关管辖的刑事案件立案追诉标准的规定(二)〉侵犯商业秘密案立案追诉标准的补充规定(征求意见稿)》向社会公开征集意见Supplementary Regulations Concerning Amendment of the Standards on Docketing for Prosecution of Infringements on Trade Secrets in the Regulations of the Supreme People’s Procuratorate and the Ministry of Public Security Concerning Standards on Filing Criminal Cases under the Jurisdiction of Public Security Organs (II)

Draft Judicial Interpretation on Patent Linkage Released by SPC

On October 29, 2020, the Supreme People’s Court issued the its draft patent linkage Judicial Interpretation, the  “Provisions on Several Issues Concerning the Application of Law in the Trial of Civil Cases Involving Drug Marketing Review and Approval of Patent” (Draft for Solicitation of Comments)” 《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》(征求意见稿)(the “JI“).  The deadline for submission of comments on the JI is Dec. 14.

 Among the highlights of the JI are:

  1. The Beijing IP Court will have jurisdiction over patent linkage cases.  Jurisdiction will attach even if administrative proceedings have commenced
  2. The Court may consolidate lawsuits involving the same patent or generic drug in most cases.
  3. Applicants are required to submit to the Court the relevant technical materials related to the disputed patents that were submitted to NMPA for marketing approval. 
  4. Patentees or interested parties may apply for preliminary injunctions upon payment of a bond. 
  5. Each party is under a duty of confidentiality with respect to trade secrets in the disputes.
  6. Generic companies s can claim damages suffered by delays in market launch due to the abuse of litigation rights by patentees and interested parties, if the patent linkage case is withdrawn without justification and the claims were not supported by the Court (Art. 17). This is similar to Canada’s patent linkage regulations, which permits claiming of damages (but not profits) by reason of abusive litigation.  

The JI might help define the scope of a possible jurisdictional battle between the courts and administrative agencies in adjudicating patent linkage cases.  This was briefly discussed in my blog of October 28, 2020: “The Cart Before the Horse in China’s Patent Linkage Regime.” This jurisdictional issue raises the interesting possibility of a domestic Anti-Suit Injunction (“ASI”) under Article 100 of the Civil Procedure Law to stay administrative proceedings. China has recently been aggressively exploring use of ASI’s to address jurisdictional conflicts in standards essential patent cases.  ASI’s were also used in the United Kingdom to address domestic conflicts between the jurisdiction of courts of law and equity and have also been used to address conflicts between arbitration and judicial proceedings. ASI’s could be necessary to prevent misuse or arbitrage between administrative and civil patent linkage proceedings.

Update of October 29-30, 2020: IPO has submitted comments on the draft NMPA/CNIPA rules on linkage.  The comments are here, and my blog about those rules is here.

Update of November 20, 2020: USPTO has made available its translation of the JI here.

Draft NMPA and CNIPA Rules on Patent Linkage Released for Public Comment

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.