On October 29, 2020, in follow up the approval of the amended Patent Law introducing Patent Linkage, China’s Supreme People’s Court released the Draft Regulations on Several Issues Concerning the Application of Law in the Trial of Civil Cases Involving Patent Linkage (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)). Earlier this year, before the approval of the amended Patent Law, China’s National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA) jointly issued the draft Implementing Measures for Drug Patent Dispute Early Resolution Mechanism (Trial for Implementation) (Draft for Public Opinions) (药品专利纠纷早期解决机制实施办法（试行)( 征求意见稿)).
According to the draft, the Beijing IP Court has sole jurisdiction to hear patent linkage cases. The patent linkage cases can only be based on patents registered with China’s proposed “Orange Book.”
Evidence that must submitted during litigation include:
1. Information on related patents registered on the patent information registration platform for listed drugs in China;
2. The relevant information of the drug applied for registration published on the information platform of the National Medical Products Administration and the declaration that it does not fall into the protection scope of relevant patent rights;
3. Preliminary evidence on whether the drug applied for registration falls within the protection scope of the relevant patent right.
Further, Applicants for drug marketing authorization shall submit to the people’s court the copies of the technical materials that they have declared to the National Medical Products Administration and whether they fall within the scope of protection of the relevant patent rights.
The Beijing IP Court will not issue a stay for parallel administrative adjudication and will generally not issue a stay for parallel invalidation proceedings.
Defenses available include a prior art defense and an invalidity defense (although it is unclear how these would differ in practice and invalidity is handled by CNIPA).
Parties have an obligation to keep confidential any trade secrets obtained during the litigation.
The generic manufacturer can sue for damages if the rights holder abuses their rights by initiating a lawsuit without justifiable reasons or the litigation is not supported. This presumably relates to the good faith requirement in the amended Patent Law (Article 20: Applying for patents and exercising patent rights shall follow the principle of good faith. The patent rights shall not be abused to harm public interests or the legitimate rights and interests of others.).
What is not in the Supreme People’s Court draft is a time limit for issuing a decision. That is, the NMPA draft has a 9-month time limit for litigation to conclude but the Supreme People’s Court draft does not. Failure to conclude the litigation within 9 months allows the NMPA to end the moratorium on approval. As the NMPA does not suspend evaluation during the moratorium, it is possible that the NMPA could issue marketing approval before litigation concludes. The NMPA will not revoke marketing approval even if the Beijing IP Court rules against the generic manufacturer, rendering the patent linkage litigation moot.
Comments to Supreme People’s Court are due December 14, 2020.