On February 9, 2021, the China National Intellectual Property Administration (CNIPA) released the Administrative Ruling Measures for the Early Resolution Mechanism for Drug Patent Disputes (Draft for Solicitation of Comments) (药品专利纠纷早期解决机制行政裁决办法（征求意见稿)). This follows on the drafts of the Supreme People’s Court Patent Linkage Litigation Regulations and the joint National Medical Products Administration and CNIPA’s Implementing Measures for Drug Patent Dispute Early Resolution Mechanism issued last year. Patent linkage was introduced in Article 76 of China’s amended Patent Law to take effect June 1, 2021.

Article 76 specifies two routes for challenging a market authorization filing for a patented drug: litigation or administrative adjudication. The above-mentioned Supreme People’s Court’s litigation regulations cover the litigation route and this draft covers the administrative adjudication route.  What is lacking from both though is a time limit to adjudicate these cases. The draft joint implementing measures set a 9-month deadline for challenging a marketing authorization and it is unlikely that a complex pharmaceutical litigation involving a foreign patentee could be completed within this timeframe.

An unofficial translation draft adjudication measures follows:

Article 1 In order to handle cases involving administrative rulings on patent disputes (hereinafter referred to as administrative rulings on drug patent disputes) in the process of review and approval of drug listings in accordance with the law, these Measures are formulated in accordance with the “Patent Law of the People’s Republic of China” and relevant laws, regulations and rules.

Article 2 The CNIPA is responsible for the administrative rulings referred to in Article 76 of the Patent Law.

Article 3 If a case handler has a direct interest relationship with the party concerned, he shall recuse himself. The parties also have the right to apply for withdrawal of the case handler. If a party applies for withdrawal, the reasons shall be explained. The withdrawal of case handling personnel shall be decided by the main person in charge of the case handling department.

Article 4 The parties requesting the CNIPA to make administrative rulings on drug patent disputes shall meet the following conditions:

(1) The requestor is the patentee or interested party of the relevant patent and the applicant for the drug marketing authorization as mentioned in Article 76 of the Patent Law, and the interested party refers to the licensee of the relevant patent and the registered drug Holders of marketing authorization;

(2) There is a clear respondent;

(3) There are clear requests and specific facts and reasons;

(4) Relevant patent information has been effectively registered on the Chinese listed drug patent information registration platform, and the patent type complies with the relevant provisions of the “Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes”;

(5) The parties concerned have not filed a lawsuit with the people’s court for the drug patent dispute before, or the people’s court has not accepted the case for filing.

Article 5 Anyone requesting the CNIPA to make an administrative ruling on a drug patent dispute shall submit a request and the following materials:

(1) Proof of subject qualification.

(2) Registration information of related patents on the China’s listed drug patent information registration platform, the drug marketing authorization application published by the National Medical Products Administration information platform, and the declaration that the application does not fall into the protection scope of the relevant patent rights.

(3) If the requestor is an applicant for a drug marketing authorization, it should also submit the drug-related technical plan for the registration application. If the technical plan involves confidential information, it needs to be submitted and declared separately.

Article 6 The request shall contain the following contents:

(1) The name or name and address of the requesting party, the name and contact number of the legal representative or the main person in charge, if an agent is appointed, the name of the agent and the name, address and contact number of the agency.

(2) The name or address of the respondent, the name of the legal representative, telephone number and other matters.

(3) Relevant patent information registered on China’s listed drug patent information registration platform, including patent number, patent type, patent status, patentee, expiry date of patent protection, and specific claims for determining whether it falls within the scope of protection.

(4) The relevant information and declaration types of the drug applied for registration published on the information platform of the National Medical Products Administration.

(5) The reasons for whether the drug technical plan applied for registration falls within the protection scope of the relevant patent right.

(6) List of evidence materials.

(7) The signature (natural person) or seal (legal person and other organization) of the requestor or the specially authorized agent. Relevant evidence and supporting materials can be submitted in the form of an attachment to the request.

Article 7 After receiving the request and related materials, the CNIPA shall register and review the request and other materials. If the request and related materials are incomplete, the requester shall be notified to fill in the missing information within the prescribed time limit.

Where a request for administrative adjudication of a drug patent dispute falls under any of the following circumstances, the request shall be deemed to have not been submitted:

(1) Failing to use the prescribed format or filling in that does not meet the requirements;

(2) Failure to submit certification materials in accordance with regulations.

Article 8 Where a request for administrative adjudication of a drug patent dispute falls under any of the following circumstances, the CNIPA shall not accept it and notify the requester:

(1) The request lacks basic information such as the name or name of the requester, contact address, etc., or lacks patent right information;

(2) The respondent is not clear;

(3) The patent involved in the case does not belong to the type of patent subject registered on the Chinese listed drug patent information registration platform, or the patent involved in the case is inconsistent with the patent in the fourth category of declaration;

(4) The claims involved in the patent involved are declared invalid.

Article 9 If the party’s request meets the conditions specified in Article 4 of these Measures, the CNIPA shall open the case within the prescribed time limit and notify the requester and the respondent.

Article 10 The CNIPA may verify relevant evidence with the National Medical Products Administration according to the processing needs.

Article 11 The CNIPA may decide to conduct a written trial or an oral trial based on the request of the parties and the circumstances of the case.

If the CNIPA  decides to conduct an oral hearing, it shall notify the parties of the time and place of the oral hearing at least 3 working days before the oral hearing. If the requester refuses to participate without proper reason or withdraws midway without permission, the request shall be deemed to have been withdrawn; if the requestee refuses to participate without proper reason or withdraws midway without permission, there will be a default judgement.

Article 12 During the handling of administrative adjudication of a drug patent dispute, if some of the claims involved in the patent involved are declared invalid, the CNIPA will make an administrative ruling on the basis of maintained valid claims; if all relevant claims are declared invalid, the CNIPA will reject the administrative ruling request.

Article 13 The CNIPA may conduct mediation in accordance with the wishes of the parties when handling administrative adjudication of drug patent disputes. After mediation, if the parties reach a consensus, the CNIPA may prepare a mediation statement at the request of the parties. If the mediation fails, the CNIPA shall make an administrative ruling in a timely manner.

Article 14 In any of the following circumstances, the party concerned may apply to suspend the handling of the case, and the CNIPA 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 process;

(2) One of the parties has lost the capacity to request an administrative ruling, and the legal representative has not been determined;

(3) The legal person or other organization as one of the parties terminates, and the successor to rights and obligations has not been determined;

(4) One party cannot participate in the trial due to force majeure;

(5) Other circumstances that the adjudication should be suspended.

Article 15 Before the CNIPA makes an administrative ruling, the requester may withdraw his request. If the requester withdraws his request after the conclusion of the administrative ruling with a decision having been announced or the written ruling has been issued, the effectiveness of the administrative ruling shall not be affected.

If the requester withdraws his request or his request is deemed to have been withdrawn, the administrative adjudication procedure for drug patent disputes shall be terminated.

Article 16 In the administrative ruling made by the CNIPA, it shall make a determination as to whether the technical plan of the drug applied for marketing falls within the protection scope of the relevant patent right, and explain the reasons and basis.

After an administrative ruling is made, it shall be disclosed to the public in accordance with relevant regulations.

Article 17 If a party is dissatisfied with the administrative ruling on a drug patent dispute made by the CNIPA, he may bring a suit in a people’s court within 15 days from the date of receipt of the administrative ruling.

Article 18 The parties are responsible for the authenticity of the evidence or certification materials they provide.

The parties are obliged to keep confidential the trade secrets they learned in the administrative adjudication procedure, and shall bear legal responsibility if they disclose, use or allow others to use the tradesecrets without authorization.

Article 19 Personnel handling administrative adjudication of drug patent disputes and other staff members who abuse their power, neglect their duties, practice favoritism, or disclose trade secrets learned during the handling process, if they do not constitute a crime, shall be given administrative sanctions in accordance with the law; if a crime is suspected, they shall be transferred to the judicial organ for handling.

Article 20 Anything not provided for in these Measures shall be implemented in accordance with the “Measures for Patent Administrative Enforcement” and the relevant provisions of the CNIPA on administrative rulings on patent infringement disputes.

Article 21 The CNIPA is responsible for the interpretation of these Measures.

Article 22 These Measures shall come into effect on June 1, 2021.

The original text is available here: 药品专利纠纷早期解决机制行政裁决办法（征求意见稿).  Comments are due March 27, 2021 and can be submitted via: 

1. Email: zhifa@cnipa.gov.cn

2. Fax: 010-62083319

3. Letter: Enforcement Guidance Office, Intellectual Property Protection Department, CNIPA, No. 6 Xitucheng Road, Haidian District, Beijing, 100088.