Provisions of the Supreme People's Court on Several Issues Concerning the Application of Laws to the Trial of Civil Cases of Patent Disputes Relating to Pharmaceutical Products for which Registration has Been Applied (Issued in 2021)

Issuing Department: Supreme People's Court

Issue No.: Legal Interpretation [2021] No. 13

Issue Date: 2021.07.04

Implementation Date: 2021.07.05

Announcement of the Supreme People's Court of the People's Republic of China

The Provisions of the Supreme People's Court on Several Issues Concerning the Application of Law to the Trial of Civil Cases of Patent Disputes Relating to Drugs Applied for Registration were adopted by the Trial Committee of the Supreme People's Court at its 1839th meeting on May 24, 2021, and are hereby promulgated to come into effect as of July 5, 2021.

Supreme People's Court

July 4, 2021

Provisions of the Supreme People's Court on Several Issues Concerning the Application of Law to the Trial of Civil Cases of Disputes over Patent Rights Relating to Pharmaceutical Products Applied for Registration (Adopted at the 1839th meeting of the Trial Committee of the Supreme People's Court on May 24, 2021, and shall come into effect on July 5, 2021). Patent Law of the People's Republic of China", "Civil Procedure Law of the People's Republic of China" and other relevant laws and regulations, combined with the actual practice of intellectual property adjudication, the formulation of the provisions.

Article 1 The Beijing Intellectual Property Court shall have jurisdiction over the cases of first instance brought by the parties under Article 76 of the Patent Law to confirm whether the disputes fall within the scope of protection of the patent right.

Article 2 The relevant patents referred to in Article 76 of the Patent Law refer to the patents to which the relevant administrative departments of the State Council's specific convergence measures on the settlement of disputes over patent rights at the stage of approval of marketing authorization of drugs and application for marketing authorization of drugs (hereinafter referred to as convergence measures) apply. The interested party referred to in Article 76 of the Patent Law refers to the licensee of the patent referred to in the preceding paragraph and the holder of the relevant pharmaceutical marketing authorization.

Article 3 Where a patentee or an interested party sues under Article 76 of the Patent Law, the following materials shall be submitted in accordance with the provisions of Article 119(3) of the Civil Procedure Law:

(1) the relevant patent information registered in the platform established by the relevant administrative department of the State Council in accordance with the Measures for Convergence, including the name of the patent, the patent number, and the relevant claims;

(ii) the relevant information of the drug applied for registration, including the name of the drug, the type of the drug, the category of registration, and the correspondence between the drug applied for registration and the listed drug involved, etc., made public in the platform set up by the relevant administrative department of the State Council in accordance with the Measures for Convergence;

(iii) the four types of declaration made by the applicant for marketing authorization of the drug in accordance with the convergence measures and the basis of the declaration. The applicant for marketing authorization of pharmaceutical products shall, within the defense period of the first instance, submit to the People's Court a copy of the necessary technical information declared by the applicant to the national drug evaluation agency and corresponding to the determination of whether or not it falls within the scope of protection of the relevant patent right.

Article 4 The patentee or interested party in the articulation measures within the time limit did not file a lawsuit to the people's court, the applicant for marketing authorization of drugs can be sued to the people's court, requesting confirmation of the application for registration of drugs do not fall within the scope of protection of the relevant patent rights.

Article 5 Where the parties claim that the administrative administrative department under the state council has accepted the request for administrative ruling referred to in Article 76 of the Patent Law on the ground that the litigation referred to in Article 76 of the Patent Law should not be accepted or the people's court shall not support the application for suspension of the litigation.

Article 6 After the parties have filed a lawsuit under Article 76 of the Patent Law, the people's court shall not support the application for discontinuance of litigation on the ground that the patent administrative department under the State Council has already accepted the request for declaring the invalidity of the relevant patent right.

Article 7 The applicant for marketing authorization of pharmaceutical products claiming to have Article 67 of the Patent Law, Article 75, paragraph 2 of the circumstances, the people's court, after examination, may confirm that the application for registration of pharmaceutical products related to the technical solutions do not fall within the scope of protection of the relevant patent rights.

Article 8 The parties shall bear civil liability in accordance with law if they are under the obligation of confidentiality for the commercial secrets or other commercial information that needs to be kept confidential, and if they disclose them without authorization or use them or allow others to use them outside of such litigation activities. Where the situation constitutes the provisions of Article 111 of the Civil Procedure Law, the people's court shall deal with it according to law.

Article 9 Where an applicant for a marketing authorization for a pharmaceutical product submits to the people's court a technical plan relating to the pharmaceutical product for which registration is sought, which is obviously inconsistent with the technical information declared by the applicant to the national drug evaluation agency and obstructs the hearing of the case by the people's court, the people's court shall deal with the case in accordance with the provisions of Article 111 of the Civil Procedure Law.

Article 10 If the patentee or interested party applies for behavioral preservation in the litigation referred to in Article 76 of the Patent Law, and requests to prohibit the applicant for marketing authorization of the pharmaceutical product from implementing the acts stipulated in Article 11 of the Patent Law within the validity period of the patent right, the people's court shall deal with the case in accordance with the relevant provisions of the Patent Law and the Civil Litigation Law; and if the applicant requests to prohibit the application for marketing of the pharmaceutical product or the review and approval of the pharmaceutical product, the people's court shall not support the application.

Article 11 In the infringement of patent rights or confirmation of non-infringement of patent rights for the same patent and application for registration of drugs, the parties claim that based on the effective judgment of the litigation referred to in Article 76 of the Patent Law to determine whether the drug technology program falls within the scope of protection of the relevant patent, the people's court shall generally support. However, unless there is evidence proving that the technical program of the infringed drug is inconsistent with the relevant technical program of the drug for which registration is applied for, or that the newly claimed cause is established.

Article 12 If the patentee or the interested party knows or should know that the patent right claimed by the patentee shall be declared invalid or the relevant technical plan of the drug applied for registration does not fall within the scope of protection of the patent right, but still files a lawsuit or requests for an administrative ruling as referred to in Article 76 of the Patent Law, the applicant for a marketing authorization of the drug can file a lawsuit for damages with the Intellectual Property Court in Beijing.

Article 13 Service by the People's Court to the parties in accordance with the law to the contact person, mailing address, e-mail, etc. posted on the platform established by the relevant administrative department of the State Council in accordance with the convergence measures shall be deemed to be effective service. After the parties have submitted to the people's court a confirmation of the address of service, the people's court may also serve to the address of service set out in the confirmation.

Article 14 These Provisions shall come into force on July 5, 2021. Where the relevant judicial interpretations previously issued by the Court are inconsistent with these provisions, these provisions shall prevail.