In order to further improve the quality of judicial interpretation, according to the work arrangement, the Supreme People's Court decided to publish the Provisions on Several Issues Concerning the Application of Law to Civil Cases Involving the Review and Approval of Patent for the Listing of Drugs (draft for comment) to the public through the official website and official wechat of the Supreme People's Court to solicit suggestions for amendment.

Supreme People's Court on trial

Patent civil cases involving drug listing review and approval

The provisions of the applicable law on certain issues

(Draft for comment)

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, and in light of the actual trial of intellectual property rights.

Article 1 A civil case of first instance involving the examination and approval of a drug for listing as provided for in Article 76 of the Patent Law shall be under the jurisdiction of the Beijing Intellectual Property Court.

Article 2 The term "relevant patent" as mentioned in Article 76 of the Patent Law refers to the relevant patent of a generic drug registered in China on the patent information registration platform for Listed drugs.

The interested party mentioned in Article 76 of the Patent Law refers to the licensee of the relevant patent and the registered holder of the marketing authorization of the drug as mentioned in the preceding paragraph; The relevant parties refer to the right holders, interested parties and drug marketing authorization applicants of the relevant patents mentioned in the preceding paragraph.

Article 3 Where a party brings a lawsuit referred to in Article 76 of the Patent Law, it shall comply with the provisions of the Civil Procedure Law on the conditions for prosecution, and submit the following evidence materials at the time of prosecution:

(1) Information about patents registered on the patent information registration platform for listed drugs in China;

(2) The relevant information of the application for registration of the drug published on the information platform of the national drug evaluation agency and the statement that the drug has not fallen into the scope of protection of the relevant patent right;

(3) prima facie evidence on whether the technical scheme of the drug applied for registration falls within the scope of protection of the relevant patent right.

The applicant for a drug marketing authorization shall submit to the people's court, within the period of first instance of defense or at the time of filing a lawsuit, a copy of the technical data that it has declared to the national drug evaluation agency and which corresponds to the determination of whether it falls within the scope of protection of the relevant patent right.

Article 4 Where a patentee or an interested party brings a claim referred to as the basis for action in Article 76 of the Patent Law, which does not belong to the type of patent that can be registered on the patent information registration platform for the declared drug listed in China, the people's court shall not accept it; If the case has been accepted, an order shall be made to reject the lawsuit.

Where the patentee or an interested party brings a part of the claim on which the lawsuit is based as mentioned in Article 76 of the Patent Law falls under the circumstances provided for in the preceding paragraph, the people's court may rule that the lawsuit in that part shall not be accepted; Those that have already been accepted shall not be included in the scope of trial.

Article 5 Where, after a party has filed an action referred to in Article 76 of the Patent Law, other parties file another action referred to in Article 76 of the Patent Law against the same patent right and the drug for which registration has been applied, the people's court may jointly try the case according to law. Where the patentee or an interested party applies to participate in the proceedings as a third party, in conformity with the relevant provisions of the Civil Procedure Law, the people's court shall grant permission.

Article 6 Where a party claims that the litigation referred to in Article 76 of the Patent Law should not be accepted or applies for suspension of the litigation on the ground that the patent administration department under The State Council has accepted the application for administrative ruling referred to in Article 76 of the Patent Law, the people's court shall not support it.

Article 7 Where a party applies for suspension of the litigation referred to in Article 76 of the Patent Law on the ground that the patent administration department under The State Council has accepted the request for invalidation of the relevant patent right, the people's court generally does not support it.

Article 8 Where the patent administration department under The State Council invalidates the claim on which the litigation basis is referred to in Article 76 of the Patent Law, or where an administrative judgment of first instance determines that the claim should be declared invalid, the people's court may rule to reject the lawsuit brought by the patentee or an interested party, or at the request of the applicant for the marketing authorization of a drug. The judgment confirmed that the drug related technical solutions applied for registration did not fall within the scope of protection of the relevant patent rights.

Article 9 Where an applicant for a drug marketing authorization claims a prior art defense in the proceedings referred to in Article 76 of the Patent Law or there are statutory circumstances that are not regarded as infringing the patent right, the people's court, upon examination and establishment, may make a judgment to reject the claim of the patentee or interested party, or at the request of the applicant for a drug marketing authorization. The judgment confirmed that the drug related technical solutions applied for registration did not fall within the scope of protection of the relevant patent rights.

Where the applicant for a drug marketing authorization claims in defense that the relevant patent right obviously belongs to the situation that should be declared invalid, the people's court may, upon examination and verification, make a judgment to reject the claim of the patentee or interested party, or, at the request of the applicant for a drug marketing authorization, make a judgment to confirm that the drug-related technical scheme applied for registration does not fall within the scope of protection of the relevant patent right.

Article 10 Where the patentee or an interested party applies for act preservation in the proceedings referred to in Article 76 of the Patent Law, requesting that the applicant for the marketing authorization of a drug be prohibited from carrying out or about to carry out acts of manufacturing, use, offering to sell, sell or import for the purposes of production or business within the validity period of the relevant patent right, it shall provide a guarantee, or if it does not, it shall provide a guarantee. Order dismissal of the application.

Where the patentee or an interested party applies for act preservation in the proceedings referred to in Article 76 of the Patent Law, requesting prohibition of the act of applying for the listing of a drug or the act of reviewing and approving it, the people's court shall not support it.

Article 11 Where a party has the obligation to keep confidential the trade secrets of other parties that it obtains in litigation, and arbitrarily discloses or uses or allows others to use the trade secrets outside the litigation activities, it shall bear civil liability according to law. If the case constitutes a circumstance as provided for in Article 111 of the Civil Procedure Law, the people's court may take compulsory measures according to law. If the case constitutes a crime, criminal responsibility shall be investigated according to law.

Article 12 Where part of the technical scheme for the drug applied for registration falls within the scope of protection of the relevant patent right or part does not fall within the scope of protection of the relevant patent right, the people's court shall make a determination respectively in the main text of the judgment.

Article 13 Where the relevant technical scheme of a drug submitted to the people's court for registration by an applicant for a drug marketing authorization is obviously inconsistent with the technical information declared to the national drug evaluation agency, which is sufficient to affect the normal trial of the case, the people's court may handle the case in accordance with the provisions of Article 111 of the Civil Procedure Law.

Article 14 For the same patent right and a drug applied for registration, before the drug is approved for marketing, the party to file a lawsuit of infringement of the patent right or confirmation of non-infringement of the patent right after the filing time of the lawsuit referred to in Article 76 of the Patent Law, shall be transferred to the Beijing Intellectual Property Court, and the previous case shall not be transferred.

After the drug regulatory department under The State Council has approved the application for registration of the drug according to law, where the party concerned files a lawsuit for infringement of the patent right or confirms that the patent right is not infringed, the drug shall not be transferred.

Article 15 Where, after the drug applied for registration has been approved for listing in accordance with law, the people's court hearing the litigation referred to in Article 76 of the Patent Law makes an effective judgment and finds that the technical scheme related to the drug applied for registration falls within the scope of protection of the relevant patent right, The patentee or an interested party may bring a separate lawsuit for infringement of the patent right against the exploitation of the patent by the party concerned.

Article 16 In a lawsuit of patent infringement or confirmation of non-infringement against the same patent right and a drug applied for registration, where the parties claim to determine whether the technical scheme of the accused infringing drug falls within the scope of protection of the relevant patent right according to the effective judgment of the lawsuit referred to in Article 76 of the Patent Law, the people's court generally supports it. However, unless there is evidence to prove that the technical scheme of the accused infringing drug is inconsistent with the relevant technical scheme of the drug applied for registration or the cause of the new claim is established.

Article 17 Where the patentee or an interested party abuses its rights, brings a lawsuit referred to in Article 76 of the Patent Law and withdraws the lawsuit without proper reason, or all the claims for litigation are not supported, and the applicant for a drug marketing authorization brings a lawsuit for compensation for the losses suffered by suspending the approval of the drug listing and reasonable litigation expenses, the people's court may accept the lawsuit according to law. The above cases of first instance shall be under the jurisdiction of the Beijing Intellectual Property Court.

Article 18 The service made by the people's court to the contact person, correspondence address, E-mail, etc. listed on the patent information registration platform of listed drugs in China or the information platform of the national drug evaluation agency shall be deemed to be effective service. After the parties have submitted a confirmation of the address for service to the people's court, the people's court shall deliver the service to the address specified in the confirmation.

Article 19 These Provisions shall come into force as of June 1, 2021. If the relevant judicial interpretations previously issued by the Court are inconsistent with these Provisions, these Provisions shall prevail.