The Supreme People’s Court
Source: The Supreme People’s Court
Published: 2021-07-05 06:00:00
The “Provisions on Several Issues Concerning the Application of Law in the Trial of Civil Cases Involving Patent Right Disputes Related to the Drug Applied for Registration”, formulated by the Supreme People’s Court and adopted at the 1839th meeting of the Judicial Committee of the Supreme People’s Court on May 24, 2021, is hereby promulgated and shall come into effect on July 5, 2021.
The Supreme People’s Court
July 4, 2021
FASHI (2021) No. 13
The Supreme People’s Court
(it, adopted at the 1839th meeting of the Judicial Committee of the Supreme People’s Court on May 24, 2021, shall come into effect on July 5, 2021)
In order to correctly hear civil cases involving patent right disputes related to the drug applied for 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 legal provisions, combined with the reality of intellectual property right trials.
Article 1 Beijing Intellectual Property Court shall have jurisdiction over the first-instance cases involving the dispute filed by a party about the determination of whether to fall within the protection scope of the related patent right in accordance with the provisions of Article 76 of the Patent Law.
Article 2 The “related patents” mentioned in Article 76 of the Patent Law shall mean the patents to which the specific measures for the linkage between drug marketing license approval and patent right dispute resolution at the drug marketing license application stage (hereinafter referred to as the linkage measures) formulated by the relevant administrative department of the State Council are applicable.
The “interested parties” mentioned in Article 76 of the Patent Law shall mean the licensees of the patents mentioned in the preceding paragraph, and the related drug marketing authorization holders.
Article 3 Where a patentee or interested party takes legal action in accordance with Article 76 of the Patent Law, he or it shall submit the following materials in accordance with the provisions of Article 119 Item 3 of the Civil Procedure Law:
(I) The relevant patent information registered in the platform established by the relevant administrative department of the State Council in accordance with the linkage measures, including the patent name, patent number, related claims, etc.;
(II) The relevant information of the drug applied for registration published on the platform established by the relevant administrative department of the State Council in accordance with the linkage measures, including the drug name, drug type, registration category, and the correspondence between the drug applied for registration and the marketed drug involved, etc.;
(III) The fourth type of certification made by the applicant for drug marketing authorization in accordance with the linkage measures, and the bases of the certification.
The applicant for drug marketing authorization shall submit to the people’s court, within the period for submission of defense of the first instance, a duplicate copy of essential technical materials submitted to the national drug evaluation agency corresponding to the determination of whether it falls within the protection scope of the related patent right.
Article 4 Where the patentee or interested party fails to take legal action with the people’s court within the time limit specified in the linkage measures, the applicant for drug marketing authorization may take legal action with the people’s court for confirmation that the drug applied for registration does not fall into the protection scope of the related patent right.
Article 5 Where a party moves to dismiss the action mentioned in Article 76 of the Patent Law or applies for suspension of the action on the grounds that the patent administration department under the State Council has accepted a request for administrative adjudication mentioned in Article 76 of the Patent Law, the people’s court shall not support.
Article 6 Where a party applies for suspension of an action filed in accordance with Article 76 of the Patent Law on the grounds that the patent administration department under the State Council has accepted the request for invalidation of the related patent right, the people’s court generally shall not support.
Article 7 Where an applicant for drug marketing authorization asserts that there exists a circumstance stipulated in Article 67, Article 75 Item 2 of the Patent Law and so on, the people’s court upon examination and verification may decide that the technical solution relevant to the drug applied for registration does not fall within the protection scope of the related patent right.
Article 8 The parties bear the obligation of confidentiality for the trade secrets or other business information that needs to be kept confidential that has been obtained in the litigation; where they disclose or use or allow others to use it outside the litigation, they shall bear civil liability according to the laws. Where the circumstances stipulated in Article 111 of the Civil Procedure Law are constituted, the people’s court shall deal with it according to the laws.
Article 9 Where the technical solution relevant to the drug applied for registration submitted to the people’s court by the applicant for drug marketing authorization is obviously inconsistent with the technical materials submitted to the national drug evaluation agency, which hinders the people’s court from hearing 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 a patentee or an interested party applies for act preservation in the action mentioned in Article 76 of the Patent Law, requesting that the applicant for drug marketing authorization be prohibited from committing an act stipulated in Article 11 of the Patent Law, the people’s court shall deal with the matter in accordance with the relevant provisions of the Patent Law and the Civil Procedure Law; where a patentee or an interested party requests prohibition of the act of application for drug marketing or the act of review and approval thereof, the people’s court shall not support.
Article 11 In a lawsuit for infringement of patent rights or confirmation of non-infringement of patent rights regarding the same patent right and drug applied for registration, where a party asserts to determine whether the technical solutions of the accused drug falls within the protection scope of the related patent rights according to the effective judgment of the action mentioned in Article 76 of the Patent Law, the people’s court generally shall support, except where there is evidence that the technical solutions of the accused drug are inconsistent with the technical solutions relevant to the drug applied for registration or the reason that is newly asserted is justified.
Article 12 Where the patentee or interested party, who is aware or should be aware that the patent right claimed shall be declared invalid or the relevant technical solution of the drug applied for registration does not fall into the protection scope of the patent right, still files an action referred to in Article 76 of the Patent Law or requests for administrative adjudication, the applicant for drug marketing authorization may file a lawsuit for damage compensation to the Beijing Intellectual Property Court.
Article 13 The service of documents by the people’s court to a party’s contact person, mailing address, email and the like posted on the platform established by the relevant administrative department of the State Council in accordance with the linkage measures according to the laws, shall be considered effective. After the party submits the letter of confirmation of the address for service of documents to the people’s court, the people’s court can also serve it to the address for service specified in the letter of confirmation.
Article 14 This provision shall come into effect on July 5, 2021. In case of any discrepancy between the judicial interpretations previously issued by this court and the present Provisions, the present Provisions shall prevail.
