Patent linkage system in China: foreign entities may meet new challenges in court


With the introduction of 4th revision of China’s Patent Law on 1 June, 2021, we have reported the new developments of China’s patent linkage system, which we cover in the articles below:

According to the new Article 76 in the 4th revision of the Patent Law, “In the process of the marketing review and approval of new drugs, where a dispute arises, due to the right of the patent concerning the drug in the application for registration, between the applicant for the drug marketing authorization and the concerned patentee or interested party, any of the parties may institute legal proceedings in the people’s court, requesting for a judgment on whether the technical solutions related to the drug applying for registration fall within the protection scope of the other party’s drug-related patent right”.

On December 31, 2021, the Beijing Intellectual Property Court (BIPC) issued a Reference for Case Filing in Civil Cases involving Patent Disputes Related to Drugs of Which Applications for Registration are Filed (Trial Implementation) (“Reference”), to specify related provisions for filing a lawsuit involving the patent linkage system. The English version of the complete Reference, provided as a complementary, non-legally binding text and its interpretation, can be found here.

According to Article VI of the Reference, “Where the patentee or interested party fails to file a lawsuit within 45 days from the date when the national drug evaluation institution discloses the application for drug marketing authorization, the applicant for the marketing of a drug may file a lawsuit.” It is also stipulated in Article VII of the Reference that a foreigner, foreign enterprise or organisation as the plaintiff shall provide lawfully notarised and legalised (“authenticated”) subject qualification materials when filing a lawsuit. Item 3 of the interpretation makes specific clarification that as the case involving patent disputes related to drugs of which applications for registration are field belonging to a civil case, provisions for administrative trials with an additional three months extension for providing the notarised and legalised POA to court are not applicable.

In brief, the foreign entities as plaintiff shall submit the lawfully notarised and legalised subject qualification materials within 45 days. Considering the time-consuming process for getting documents legalised abroad, foreign entities may face huge challenges to file a lawsuit in time.

As the Reference is now in a trial implementation phase, we hope there will be some adjustments to this strict limitation later on which considers the actual situation of foreign entities. While delays of the court proceedings are not of public interest, the ability to enjoy the rights to sue in court within feasible timeframes for providing legalised documents should be of consideration otherwise foreign plaintiffs would practically have to be excluded from the court path. As a consequence of the rules, foreign entities shall pay special attention to legalisation proceedings. It may be preferred to not only keep a close eye on the disclosure of the applications for new drug marketing authorisations, but also to anticipate them and prepare legal documents in advance.

If you have any further questions or if you would like further details, please do not hesitate to contact us.

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