Judicial Interpretation [2021] No. 13
(Adopted at the 1,839th Session of the Judicial Committee of the Supreme People’s Court on May 24, 2021, and coming into force on July 5, 2021)
For the purposes of correctly trying civil cases involving patent disputes related to drugs under registration, these Provisions are formulated in accordance with the Patent Law of the People's Republic of China, the Civil Procedure Law of the People's Republic of China, and other relevant laws, and in light of judicial practice in intellectual property cases.
Article 1 A first-instance case, involving disputes over the confirmation on whether [a technical scheme of a drug for which a registration application is filed] falls within the scope of a patent, filed by a party in accordance with Article 76 of the Patent Law shall be subject to the jurisdiction of the Beijing Intellectual Property Court.
Article 2 The term “patent related” under Article 76 of the Patent Law, means a patent subject to the specific coordination measures of the relevant administrative department under the State Council for the resolution of patent disputes at the stages of drug marketing approval and drug marketing aplication (hereinafter referred to as the “coordination measures”).
The term “interested party” under Article 76 of the Patent Law, means the licensee of the patent mentioned in the preceding paragraph or the marketing authorization holder for the relevant drug.
Article 3 A patentee or an interested party that files a lawsuit in accordance with Article 76 of the Patent Law shall submit the following materials in accordance with the provision of subparagraph (3) of Article 119 of the Civil Procedure Law:
(1) Relevant patent information registered in the platform established by the relevant administrative department under the State Council in accordance with the coordination measures, including title of the patent, patent number and relevant claims;
(2) Relevant information about the drug under registration published on the platform established by the relevant administrative departments under the State Council in accordance with the coordination measures, including the name, type and registration category of the drug and the correspondence between the drug under registration and the marketed drug involved;
(3) Type IV declaration and basis of the declaration made by the applicant for drug marketing authorization in accordance with the coordination measures.
The applicant for drug marketing authorization shall, within the period of defense of the first instance, submit to the People’s Court a copy of the necessary technical data that it has declared to the State drug evaluation institution and that correspond to the determination of whether the drug falls within the scope of protection of the relevant patent.
Article 4 Where the patentee or any interested party has not instituted a suit in a People’s Court within the time limit prescribed by the coordination measures, the applicant for drug marketing authorization may institute a suit in a People’s Court to request confirmation that the drug under registration does not fall within the scope of protection of the relevant patent.
Article 5 If a party claims that the suit mentioned in Article 76 of the Patent Law shall not be accepted or applies for suspension of the suit on the grounds that the patent administration department under the State Council has already accepted the request for administrative adjudication mentioned in Article 76 of the Patent Law, the People’s Court shall not support it.
Article 6 Where a party, after instituting a suit pursuant to Article 76 of the Patent Law, applies for suspension of the suit on the ground that the patent administration department under the State Council has accepted the request for invalidation of the relevant patent, the People’s Court generally shall not support it.
Article 7 Where an applicant for drug marketing authorization claims that any of the circumstances prescribed in such as Article 67 or Article 75(2) of the Patent Law exists, the People’s Court may, upon examination and verification, make a judgment to confirm that the technical scheme related to the drug under registration does not fall within the scope of protection of the relevant patent.
Article 8 A party has the obligation to keep confidential the trade secret that is obtained in the course of litigation or other business information that needs to be kept confidential, and if the party discloses it without authorization or uses it outside the litigation activity or allows others to use it, the party shall bear civil liability according to law. Where the circumstances prescribed in Article 111 of the Civil Procedure Law are constituted, the People’s Court shall handle them according to law.
Article 9 Where the technical scheme related to a drug under registration submitted by the applicant for drug marketing authorization to the People’s Court is obviously inconsistent with the technical data declared to the State drug evaluation institution and impedes the People’s Court from trying the case, the People’s Court shall deal with the case in accordance with the provisions of Article 111 of the Civil Procedure Law.
Article 10 Where the patentee or an interested party applies for act preservation in the litigation referred to in Article 76 of the Patent Law and requests to prohibit the applicant for drug marketing authorization from performing any act prescribed in Article 11 of the Patent Law within the validity period of the relevant patent, the People’s Court shall handle the matter in accordance with the relevant provisions of the Patent Law and the Civil Procedure Law; the People’s Court shall not support a request for prohibition of an application for the marketing of a drug or the review and approval of the marketing of a drug.
Article 11 In the litigation for patent infringement or patent declaratory judgment involving the same patent and the drug under registration, if the party claims to determine whether the technical scheme of the drug involved falls within the protection scope of the relevant patent based on the effective judgment of the lawsuit referred to in Article 76 of the Patent Law, the People’s Court shall generally support it, unless there is evidence to prove that the technical scheme of the sued infringing drug is inconsistent with the technical scheme of the drug under registration or a new claim is validly established.
Article 12 If the patentee or interested party knows or should have known that the patent it claimed shall be declared invalid or the technical scheme related to the drug under registration does not fall into the scope of protection of the patent, but still files a lawsuit or requests an administrative rulingas referred to in Article 76 of the Patent Law, the applicant for the drug marketing authorization may institute a suit for damages to the Beijing Intellectual Property Court.
Article 13 Services made by the People’s Court according to the law on a party via the contact person, mailing address, email, etc. published on the platform established by the relevant administrative department under the State Council in accordance with the coordination measures shall be deemed as valid services. After a party submits to the People’s Court a confirmation of the address for service, the People’s Court may also serve to the address for service specified in the confirmation.
Article 14 These provisions shall come into force on July 05, 2021. If the relevant judicial interpretations previously issued by this Court are inconsistent with these provisions, these provisions shall prevail.
