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Provisions of the Supreme People’s Court on Several Issues Concerning the Application of Law in the Trial of Civil Cases Concerning Patent Disputes Related to Drugs Applied for Registration
On July 5, 2021, the Supreme People’s Court released “Provisions of the Supreme People’s Court on Several Issues Concerning the Application of Law in the Trial of Civil Cases Concerning Patent Disputes Related to Drugs Applied for Registration”. The judicial interpretation came into force on the same day.
It is understood that the introduction of the judicial interpretation is an important initiative for the Supreme People’s Court to implement decisions and arrangements of the CPC Central Committee, serve the innovation and development of China's pharmaceutical industry and respond to social concerns actively. The early resolution mechanisms for drug patent disputes is a new legal system added to the Patent Law of the People’s Republic of China amended in 2020. The promulgation and implementation of the judicial interpretation plays an important role in guaranteeing a correct implementation of the Patent Law of the People’s Republic of China, improving the linkage between judicial proceedings and drug evaluation and approval procedures and administrative adjudication procedures, and promoting the unification of administrative enforcement standards and judicial adjudication standards of intellectual property rights.
The Regulations of the Supreme People’s Court on Several Issues Concerning the Application of Law in the Trial of Civil Cases Concerning Patent Disputes Related to Drugs Applied for Registration was Adopted at the 1839th Meeting of the Judicial Committee of the Supreme People’s Court on May 24, 2021, and now is promulgated. It shall take effect as of July 5, 2021.
Supreme People’s Court
July 4, 2021
Interpretation No. 13 [2021] Provisions of the Supreme People’s Court on Several Issues Concerning the Application of Law in the Trial of Civil Cases Concerning Patent Disputes Related to Drugs Applied for Registration
(Adopted at the 1839th meeting of the Judicial Committee of the Supreme People’s Court on May 24, 2021 and came into force as of July 5, 2021)
For a proper trial of civil cases concerning patent disputes related to drugs applied for registration, these provisions are formulated in accordance with the Patent Law of the People’s Republic of China (hereinafter referred to as the Patent Law), the Civil Procedure Law of the People’s Republic of China (hereinafter referred to as the Civil Procedure Law) and other relevant laws and regulations, taking into account actual practices of intellectual property adjudication.
Article 1 First instance cases filed by the parties in accordance with Article 76 of the Patent Law to confirm whether a dispute falls within the scope of protection of patent rights shall be under the jurisdiction of the Beijing Intellectual Property Court.
Article 2 Relevant patent referred to in Article 76 of the Patent Law refers to the patent adapted to the measures during the handover period regarding the settlement concerning patent disputes at the stages of drug marketing authorization approval and drug marketing authorization application (hereinafter referred to as the measures during the handover period) are applicable to the relevant administrative department under the State Council.
Interested parties referred to in Article 76 of the Patent Law refer to the licensee of the patent referred to in the preceding paragraph and the holder of the relevant drug marketing authorization.
Article 3 The patentee or interested party to sue under Article 76 of the Patent Law shall submit the following materials in accordance with the provisions of Article 119(3) of the Civil Procedure Law.
1) the relevant patent information registered by the relevant administrative departments under the State Council in the platform set up in accordance with the measures during the handover period, including patent name, patent number, relevant claims, etc.;
2) the relevant information of the drugs applied for registration announced by the relevant administrative departments under the State Council in the platform set up in accordance with the measures during the handover period, including the name of the drug, the category of the drug, the category of registration and the corresponding relationship between the drugs applied for registration and the marketed drugs involved;
3) the four categories of declarations and the basis for the declarations made by the applicant for a drug marketing authorization in accordance with the measures during the handover period.
The applicant for a drug marketing authorization shall, within the first instance defense period, submit to the People’s Court a copy of necessary technical materials declared to the National Drug Evaluation Agency corresponding to the determination of whether it falls within the scope of protection of the relevant patent rights involved.
Article 4 If a patentee or interested party fails to file a lawsuit before the People’s court within the time limit specified by the Measures during the handover period, the applicant for a drug marketing authorization shall file a lawsuit before the People’s court to request confirmation whether the applied drug registration does not fall within the scope of protection of the patent rights involved.
Article 5 The People’s Court shall not support the claim that the patent administrative department under the State Council has accepted the request for administrative adjudication referred to in Article 76 of the Patent Law and shall not accept the lawsuit referred to in Article 76 of the Patent Law or apply for suspension of the lawsuit.
Article 6 After the party filed a lawsuit in accordance with Article 76 of the Patent Law, the People’s Court usually does not support the application for suspension of proceedings on the grounds that the patent administrative department under the State Council has accepted the request for declaring invalidation of the patent rights involved.
Article 7 The applicant for drug marketing authorization claims to have circumstances such as Article 67, Article 75(2) of the Patent Law, the People’s court, after a verification, may decide to confirm the techncial solutions involved in the drug applied for registration do not fall within the scope of protection of the patent rights involved.
Article 8 Parties shall assume the obligation of confidentiality for business information obtained in the lawsuit or other commercial information that requires confidentiality and anyone who makes a disclosure or use outside of the lawsuit activities, allows others to use shall bear civil liability in accordance with the law. The People’s Court shall deal with the circumstances prescribed in Article 111 of the Civil Procedure Law according to law.
Article 9 Where the technical solutions related to drugs applied for registration filed by the applicant for drug marketing authorization to the People’s Court is obviously inconsistent with the technical materials declared to the National Drug Evaluation Agency and hinder the People’s Court to hear the case, the People’s court shall deal with it in accordance with Article 111 of the Civil Procedure Law.
Article 10 Patentees or interested parties apply for behavior preservation in the lawsuit referred to Article 76 of the Patent Law, requesting to prohibit the drug marketing authorization applicant in the patent rights involved during the validity of the implementation of the Patent Law, the People’s Court shall deal with it in accordance with the Patent Law and the relevant provisions of the Civil Procedure Law; the People’s Court shall not support request to prohibit the drug marketing application behaviors or review and approval behaviors.
Article 11 In the infringement of patent rights or confirmation of non-infringement of patent rights for the same patent right and application for registration of drugs, the people’s court shall generally support the claim of the parties to determine whether the technical solution of the drug involved falls within the scope of protection of the relevant patent rights according to the effective judgment of the lawsuit referred to in Article 76 of the Patent Law, with the exception that there is evidence to prove that the technical solution of the infringing drug is inconsistent with the technical solution of the drug applied for registration or the newly claimed cause is valid.
Article 12 The patentees or interested parties know or should know that the patent right claimed shall be declared invalid or the technical solution involved in the drug applied for registration does not fall within the scope of protection of the patent right, but still files a lawsuit or requests an administrative adjudication as referred to in Article 76 of the Patent Law, the applicant of the drug marketing authorization may file a lawsuit for damages to the Beijing Intellectual Property Court.
Article 13 Services made by the People’s Court to the parties on contact person, correspondence address, email, etc, published on the plastform set by the relevant administrative departments under the State Council in accordance with the measures during the handover period shall be deemed valid services. After the parties submit a confirmation of the address for services to the People’s Court, the People’s Court may also serve the service address stated in the confirmation.
Article 14 These provisions shall come into force as of July 5, 2021. The relevant judicial interpretation previously issued by the Court is inconsistent with these provisions, these provisions shall prevail.
