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Interpretation of Administrative Adjudication Measures on Early Settlement Mechanism for Drug Patent Disputes
 Last update:2021-09-27  browse:281 viewed

A few days ago, the State Intellectual Property Office of the people’s Republic of China issued the Administrative Adjudication Measures on the Early Settlement Mechanism for Drug Patent Disputes, and the relevant policies are now interpreted as follows.

 

 

The Formulating Background 

In October 2017, the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council issued the Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices, requesting to explore the establishment of a drug patent linkage system. In November 2019, the General Office of the Central Committee and the General Office of the State Council issued the Opinions on Strengthening the Protection of Intellectual Property Rights, proposing to explore the establishment of a drug patent linkage system again. In October 2020, the 22nd Session of the Standing Committee of the 13th National People's Congress passed the decision on amending the Patent Law of the People's Republic of China (hereinafter referred to as the Patent Law). Article 76 of the revised the Patent Law stipulates that during the process of drug marketing review and approval, if drug marketing authorization applicant and relevant patentee or interested party have disputes over the patent rights related to the drug applied for registration, they can file a suit in the People's Court, or request an administrative adjudication from the Patent Administration Department of the State Council.

 

In order to implement the decision and deployment of the Party Central Committee and the State Council, and to promote the establishment of an early settlement mechanism for drug patent disputes in our country, in accordance with the relevant provisions of the Patent Law and the Measures on Early Settlement Mechanisms for Drug Patent Disputes (for Trial Implementation) which is jointly formulated by the State Drug Administration and the State Intellectual Property Office, the State Intellectual Property Office conducted a serious study on the specific system of the early settlement mechanism for drug patent disputes, learning from relevant international practices and combining the national conditions of our country and the development characteristics of current pharmaceutical industry, and formulated the Administrative Adjudication Measures on Early Settlement Mechanisms for Drug Patent Disputes (hereinafter referred to as "Adjudication Measures").

 

The Formulating Progress

The State Intellectual Property Office actively promotes the formulation of the " Adjudication Measures " from the following three aspects.

 

The first aspect is to conduct extensive research to be realistic. Comprehensively sort out the drug patent linkage system in the United States and South Korea, etc. and carry out comparative analysis and case analysis. Through investigation and research, the State Intellectual Property Office can understand the attitudes of domestic and foreign pharmaceutical companies on the early settlement mechanism for pharmaceutical patent disputes to be implemented in my country and the expectations and demands of the domestic pharmaceutical industry on this system.

 

The second aspect is to do in-depth research to consolidate the theoretical foundation. Strengthen the theoretical research on early settlement mechanism for drug patent disputes. Entrust research institutions and colleges and universities to carry out works on relevant system analysis, policy recommendations and other research, to assist in the demonstration of the early settlement mechanism for drug patent disputes in China, and to study the impact of this mechanism on country's pharmaceutical industry. Based on the above work, the State Intellectual Property Office drafted the Administrative Adjudication Measures on the Early Settlement Mechanism for Drug Patent Disputes (Draft for Solicitation of Comments).

 

The third aspect is to actively solicit opinions from all parties. The State Intellectual Property Office has solicited the opinions of the Legislative Affairs Committee of the Standing Committee of the National People’s Congress, the Supreme People’s Court, the Ministry of Finance, the Ministry of Commerce, the Ministry of Justice, the National Medical Products Administration and other relevant departments in writing; It also publicly solicited opinions of all walks of life through official website, official micro-channels and other channels, and received a total of 16 pieces of 102 opinions from relevant chambers of commerce, associations, enterprises, law firms and related experts. Representatives of enterprises, intellectual property service organizations, experts and scholars were invited, respectively, to participate the symposium to listen their opinions and suggestions. After sorting out and analyzing the relevant opinions one by one, the State Intellectual Property Office further revised and improved the Draft for Solicitation of Comments

 

On May 14, 2021, after deliberation by the State Intellectual Property Office, the State Intellectual Property Office promulgated the Adjudication Measures on July 5. The Adjudication Measures shall enter into force on the date of promulgation.

 

Main Purpose and Contents

The formulation of the Adjudication Measures aims to further protect the legal rights and interests of drug patentee, reduce the risk of patent infringement in the pharmaceutical field, encourage drug R&D and innovation, promote the high-quality development of the pharmaceutical industry, and clarify and stipulate the relevant work of the implementation of administrative adjudication on the early settlement for drug patent disputes. 

The Adjudication Measures has 24 articles, covering and stipulating the content of the subject of administration adjudication, the scope of drug patents that can be adjudicated, the coordination with judicial channels, the relationship between administration adjudication and invalidation procedures, the enforcement and disclosure of administration adjudication, the judicial remedy for administration adjudication, and other case handling procedures. 

 

(1) Subjects that can request administration adjudication

The subject of the administrative adjudication is the petitioner. According to Article 76 of the Patent Law, the petitioner can be the patentee, interested party or the drug marketing authorization applicant of the relevant patent, of which the interested party refers to the licensee of the relevant patent or the registered drug marketing authorization holder.

 

(2) Time limit for requesting administration adjudication

According to the relevant provisions of the Measures on the Implementation of the Early Settlement Mechanism for Drug Patent Disputes (Trial), the patentee or interested party can make a request for the confirmation of the drug-related technical solutions applied for marketing authorization fall into the protection scope of the relevant patent rights, within 45 days from the date when the National Drug Evaluation Agency discloses the application for drug marketing authorization. 

 

Within 45 days from the date when the National Drug Evaluation Agency discloses the application for drug marketing authorization, if the patentee or interested party fails to sue the drug patent dispute to the people’s court or file a request for administrative adjudication, the drug marketing authorization applicant can make a request for the confirmation of the drug-related technical solutions applied for marketing authorization do not fall into the protection scope of the relevant patent rights.

 

(3) The Scope of drug patents that can be adjudicated administratively

The Adjudication Measures stipulate that drug patents that can be adjudicated must meet the following conditions, that are, the relevant patent information has been registered and disclosed on Chinese listed drug patent information registration platform, and the type of patent is in compliance with the relevant provisions of the Implementation Measures on the Early Settlement Mechanism for Drug Patent Disputes (Trial). 

 

According to the policy interpretation of the Implementation Measures on the Early Settlement Mechanism for Drug Patent Disputes (Trial) made by the National Medical Products Administration, the specific drug patents that can be registered in Chinese listed drug patent information registration platform include: patents for Pharmaceutical active ingredient compound of chemical drugs (excluding raw materials), patents for pharmaceutical composition containing active ingredients, patents for medicinal application; patents for Chinese medicinal compositions of traditional Chinese medicines, patents for Chinese medicinal extracts, patents for medicinal application; patents for sequence structures of active ingredients of biological products and patents for medicinal application. Related patents do not include patents on intermediates, metabolites, crystal forms, preparation methods, and detection methods, etc.

 

(4) Coordination between administrative adjudication and judicial ways

   According to the provisions of Article 4 of the Adjudication Measures, the administrative adjudication procedure requires that the related patent disputes in the process of drug review and approval have not been filed by the people's court. If the same patent dispute has been filed by the People's Court, the State Intellectual Property Office will not accept the administrative adjudication request submitted by the parties to ensure that the relevant dispute is settled through either administrative or judicial channel to avoid waste and conflict of dispute settlement procedures. 

 

(5) The relationship between administration adjudication and invalidation procedures

According to Article 14 of the Adjudication Measures, during the administrative adjudication of a drug patent dispute, if some of the claims involved in the patent are declared invalid, the State Intellectual Property Office will make an administrative adjudication on the basis of maintaining the patent claims valid; If all the claims involved in the patent are declared invalid, the State Intellectual Property Office will reject the request for administrative adjudication. In addition, if a party requests an invalidation of the patent involved in the case, Article 16 of the Adjudication Measures clarifies that the State Intellectual Property Office may not suspend the case.

 

(6) Enforcement and disclosure of administration adjudication

   The Adjudication Measures stipulates that the once the administrative adjudication is made, it shall be served to the parties and its copy shall be sent to the drug regulatory department of the State Council, and at the same time it shall be disclosed to the public in accordance with relevant regulations. When an administrative adjudication is made public, information involving trade secrets should be deleted.

 

At the same time, in accordance with the relevant provisions of the Implementation Measures on the Early Settlement Mechanism for Drug Patent Disputes (Trial), the patentee or interested party should submit the administrative adjudication to the National Drug Evaluation Agency within 10 workdays from receipt of the administrative adjudication.

  

(7) Judicial remedy for administration adjudication

   Article 19 of the Adjudication Measures stipulates that if parties are dissatisfied with the administrative adjudication on the drug patent dispute made by the State Intellectual Property Office, they may file a lawsuit to the People's Court in accordance with the law. According to Article 46 of the Administrative Procedure Law of the People's Republic of China, administrative proceeding can be brought within 6 months as of the date of service of the administrative adjudication.