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market launch due to the abuse of litigation rights by patentees and interested parties, if the patent linkage case is withdrawn without justification and the claims were not supported by the Court (Art. 17).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.

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