China National Intellectual Property Administration
Announcement No. 435
In order to conscientiously implement the decisions and deployments of the Party Central Committee and the State Council on comprehensively strengthening the protection of intellectual property rights, effectively safeguard the legitimate rights and interests of patentees, encourage drug research and development and innovation, and hear cases involving administrative adjudications on patent disputes in the process of review and approval of a drug for marketing in accordance with laws and regulations, the “Measures of Administrative Adjudication in Early Resolution Mechanism for Drug Patent Disputes”, formulated by China National Intellectual Property Administration in accordance with the "Patent Law of the People's Republic of China" and related laws, regulations and rules, as well as the related provisions of the “Measures for Implementation of Early Resolution Mechanisms for Drug Patent Disputes (For Trial Implementation)”, is hereby promulgated, and shall come into effect from the date of promulgation.
Announcement is hereby given.
China National Intellectual Property Administration
July 5, 2021
Measures of Administrative Adjudication in Early Resolution Mechanism for Drug Patent Disputes
Article 1 In order to hear cases involving administrative adjudication on patent disputes in the process of review and approval of a drug for marketing (hereinafter referred to as administrative adjudication on drug patent disputes) in accordance with the laws, these Measures are formulated in accordance with the Patent Law of the People's Republic of China (hereinafter referred to as the Patent Law) and related laws, regulations and rules.
Article 2 China National Intellectual Property Administration is responsible for the handling of administrative adjudication referred to in Article 76 of the Patent Law.
The China National Intellectual Property Administration establishes an administrative adjudication committee for the early resolution mechanisms for drug patent disputes, to organize and carry out work related to administrative adjudication in early resolution mechanisms for drug patent disputes.
Article 3 Where the case handling personnel has any of the following circumstances, he shall, on his own initiative, be recused from the case:
(1) Being a close relative of the party or its agent;
(2) Having an interest relationship with the patent application or patent right;
(3) Having other relationship with the party or its agent, which may affect the fair handling of the case.
The party also has the right to apply for recusal of the case handling personnel. Where the party applies for recusal, the reasons shall be explained.
The recusal of the case handling personnel shall be decided by the case handling department.
Article 4 Where a party requests China National Intellectual Property Administration to make an administrative adjudication on drug patent disputes, the following conditions shall be met:
(1) The requestor is the applicant for the drug marketing authorization or the relevant patentee or interested party as mentioned in Article 76 of the Patent Law, wherein the “interested party” refer to the licensee of the relevant patent or the registered drug marketing authorization holder;
(2) There is a clear respondent;
(3) There are clear requests and specific facts and reasons;
(4) The relevant patent information has been registered on the China's registration platform of marketed drug patent information, and complies with the relevant provisions of the “Measures for Implementation of Early Resolution Mechanisms for Drug Patent Disputes”;
(5) A People's Court has not accepted a case on the drug patent dispute before;
(6) Where the applicant for the drug marketing authorization files an administrative adjudication request, within 45 days from the date when the national drug evaluation agency publicizes the drug marketing authorization application, the patentee or interested party does not file a lawsuit with the people’s court or file an administrative adjudication request on the drug patent dispute;
(7) A request for administrative adjudication shall be limited to confirming whether a technical solution of a single drug applied for marketing authorization falls within the protection scope of a single patent right.
Article 5 Where a patentee or interested party requests confirmation that the technical solution related to the drug applied for marketing authorization falls within the protection scope of the relevant patent right, the applicant for drug marketing authorization shall be the respondent.
Where the patent right is co-owned by multiple patentees, a request shall be made by all the patentees, unless some of the joint patentees expressly waive the relevant substantive rights.
The drug marketing authorization holder or the licensee of exclusive patent license contract can make a request in his own name; the licensee of sole patent license contract can make a request in his own name in case that the patentee does not make a request.
Article 6 Where an applicant for the drug marketing authorization requests confirmation that the technical solution related to the drug applied for marketing authorization does not fall within the protection scope of the relevant patent right, the patentee shall be the respondent.
Article 7 Where China National Intellectual Property Administration is requested to make an administrative adjudication on drug patent disputes, a request and the following materials shall be submitted:
(1) Proof of a party’s standing.
(2) Registration information of the relevant patents on the China's registration platform of marketed drug patent information, the applications for the drug marketing authorization publicized on the information platform of the national drug evaluation agency and the certification that the drug does not fall within the protection scope of the relevant patent right as well as the basis of the certification.
(3) Where the requestor is an applicant for the drug marketing authorization, the technical solution relevant to the drug applied for registration shall also be submitted. Where the technical solution involves confidential information, a separate submission shall be made and a statement on the confidentiality shall be made accordingly.
Article 8 The request shall contain the following contents:
(1) The name and address of the requestor, the name of the legal representative or the principal person in charge, telephone number and where an agent is appointed, the name of the agent and the name, address and telephone number of the agency；
(2) The name and address of the respondent, the name of the legal representative, the telephone number and other matters；
(3) Information of relevant patents registered on the China's registration platform of marketed drug patent information, including patent number, patent type, patent status, patentee, expiration date of patent term, and specific claims requested for determining whether the drug falls within the protection scope；
(4) The relevant information of the drug applied for registration publicized on the information platform of the national drug evaluation agency and the certification type；
(5) Reasons on whether the technical solution of drug applied for registration falls within the protection scope of the relevant patent right；
(6) List of evidentiary materials；
(7) The signature (natural person) or seal (legal person and other organization) of the requestor or the authorized agent. Related evidence and evidentiary materials can be submitted in the form of an attachment to the request.
Article 9 After receiving the request and relevant materials, China National Intellectual Property Administration shall register and examine the request and other materials. Where the request and relevant materials are incomplete, the request does not use the prescribed format or the filling does not meet the requirements, the requestor shall be notified to make corrections within five working days. If no correction is made within the time limit or the same defect still exists after the correction, the administrative adjudication request will not be accepted.
Article 10 Where a request for administrative adjudication on drug patent disputes falls under any one of the following circumstances, China National Intellectual Property Administration shall not accept it and notify the requestor:
(1) The request lacks basic information such as the name and contact address of the requestor, etc., or lacks patent right information;
(2) The respondent is not clear;
(3) The party’s standing of the requester and the respondent do not meet the relevant conditions as stipulated in Articles 4, 5 and 6 of these Measures.
(4) The patent in suit does not belong to the types of patent subject matter registered on the China's registration platform of marketed drug patent information, or the patent in suit is inconsistent with the patent in the fourth type of certification;
(5) The involved claims of the patent in suit are declared invalid by China National Intellectual Property Administration.
(6) The request does not specify the patent claims involved and the specific matters of the request for administrative adjudication;
(7) The requester fails to specify the reasons for the administrative adjudication, or fails to specify the reasons for the administrative adjudication in combination with the evidence submitted;
(8) One request for administrative adjudication involves technical solution of more than one drugs applied for marketing authorization or more than one patent rights;
(9) The same drug patent dispute has been filed by the people's court.
Article 11 Where a party’s request meets the conditions as stipulated in Article 4 of these Measures, China National Intellectual Property Administration shall accept the case within five working days and notify the requestor and the respondent.
Article 12 China National Intellectual Property Administration may verify related evidence with the medical products administration department based on the application of the party or according to the needs of case handling.
Article 13 China National Intellectual Property Administration shall form a collegial panel to hear the case. The collegial panel may conduct an oral hearing or a written hearing based on the request of the parties and the circumstances of the case.
Where the same party files multiple administrative adjudication requests for multiple patent rights related to the same drug, China National Intellectual Property Administration may conduct joint hearings.
Where China National Intellectual Property Administration decides to conduct an oral hearing, the time and place of the oral hearing shall be notified to the parties at least five working days before the oral hearing. Where the requestor refuses to participate without justifiable reasons or withdraws midway without permission, the request shall be deemed to have been withdrawn; where the respondent refuses to participate without justifiable reasons or withdraws midway without permission, the hearing shall be held in default.
Article 14 During the handling of the cases for administrative adjudication on drug patent disputes, where some of the involved claims of the patent in suit are declared invalid by China National Intellectual Property Administration, an administrative adjudication will be made on the basis of the claims which are maintained valid; where all of the involved claims of the patent in suit are declared invalid, the request for administrative adjudication will be rejected.
Article 15 China National Intellectual Property Administration may conduct a mediation in accordance with the wishes of the parties when handling the cases for administrative adjudication on drug patent disputes. After the mediation, where the parties reach a consensus, China National Intellectual Property Administration may issue a mediation agreement at the request of the parties. Where the mediation fails, China National Intellectual Property Administration shall make an administrative adjudication in time.
Article 16 In any one of the following circumstances, the parties may apply to suspend the handling of the case, and China National Intellectual Property Administration may also decide to suspend the handling of the case ex officio:
(1) One party has died and needs to wait for the heir to indicate whether to participate in the case;
(2) One party has lost the active ability to request for administrative adjudication, and the legal representative has not been determined;
(3) The legal person or other organization as one party terminates, and the successor to its rights and obligations has not been determined;
(4) One party cannot participate in the hearing due to force majeure;
(5) Other circumstances that should suspend the handling.
Where a party requests invalidation of the patent in suit, China National Intellectual Property Administration may not suspend the handling of the case.
Article 17 Before China National Intellectual Property Administration makes an administrative adjudication, the requestor may withdraw his request. Where the requestor withdraws his request or his request is deemed to have been withdrawn, the procedure of administrative adjudication on drug patent disputes shall be terminated.
Where the requestor withdraws his request after the conclusion of the administrative adjudication has been made, the effectiveness of the administrative adjudication shall not be affected.
Article 18 Where China National Intellectual Property Administration makes an administrative adjudication, it shall make a determination on whether the technical solution of drug applied for marketing falls within the protection scope of the relevant patent right, and explain the reasons and basis.
After an administrative adjudication is made, it shall be delivered to the parties and copied to the medical products administration department under the State Council, and at the same time disclosed to the public in accordance with the "Regulations on Disclosure of Government Information" and relevant regulations. When an administrative adjudication is disclosed to the public, information involving trade secrets shall be deleted.
Article 19 Where a party is not satisfied with the administrative adjudication on drug patent disputes made by China National Intellectual Property Administration, he may take legal action before a people's court according to laws.
Article 20 The parties are responsible for the authenticity of the evidence or evidentiary materials provided by them.
The parties bear the obligation of confidentiality for the trade secrets that they learned in the procedure of administrative adjudication; where they disclose or use or allow others to use the trade secrets, they shall bear corresponding legal responsibility.
Article 21 The case handling personnel of administrative adjudication on drug patent disputes and other staffs abuse their powers, neglect their duties, practice favoritism, or disclose trade secrets that they learned in the handling process, where a criminal offence is not constituted, administrative sanctions shall be given in accordance with the laws; where a criminal offence is suspected, the handling shall be transferred to judicial authorities.
Article 22 For matters not covered in these Measures, the “Measures for Patent Administrative Enforcement” and the relevant provisions for administrative adjudications on patent infringement disputes issued by China National Intellectual Property Administration shall apply.
Article 23 China National Intellectual Property Administration is responsible for the interpretation of these Measures.
Article 24 These Measures shall come into effect from the date of promulgation.
