Announcement of National Medical Products Administration and China National Intellectual Property Administration on Promulgation of the Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial)
[2021] No.89
The National Medical Products Administration (NMPA) in conjunction with the China National Intellectual Property Administration (CNIPA) have organized the formulation of the Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial) in accordance with the Chinese Patent Law, which are hereby promulgated upon approval by the State Council, effective as of the date of promulgation.
This Announcement is hereby made.
Annex:
1. Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial)
2. Policy Interpretation of the Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial)
NMPA CNIPA
July 4, 2021
Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial)
Article 1 These Measures are formulated for the purposes of protecting the legitimate rights and interests of drug patentees, encouraging research and development of new drugs and promoting development of high-level generic drugs, and establishing an early resolution mechanisms for drug patent disputes.
Article 2 The drug supervision and administrative department of the State Council shall organize and establish a China Patent Information Registration Platform for marketed drugs for Drug Marketing Authorization Holder (MAH) to register the patent information relating to drugs registered and marketed in China.
These Measures shall not apply to drugs of which relevant patent information is not registered in China Patent Information Registration Platform for Marketed Drugs.
Article 3 The State Drug Evaluation Agency shall be responsible for establishment and maintenance of the China Patent Information Registration Platform for Marketed Drugs in China and disclose relevant patent information of drugs approved for marketing.
Article 4 A marketing authorization holder shall, within 30 days from obtaining the drug registration certificate, register the drug name on its own, dosage form, specifications, marketing authorization holder, relevant patent number, patent title, patentee, patent licensee, date of patent granting and expiry date of protection period, patent status, patent type, corresponding relationship between the drug and the relevant patent claims, correspondence address, contact person, contact information and the like. Where there is any change in the relevant information, the drug marketing authorization holder shall complete update within 30 days from the effective date of the change in information.
A drug marketing authorization holder shall be responsible for the authenticity, accuracy and integrity of the relevant information registered, and shall promptly verify and deal with the relevant objections received and record the same. The registration information shall be consistent with the relevant information in the patent register, patent gazette and the drug registration certificate; patent rights for medical purposes shall be consistent with the indications or main functions of the drug instructions approved for marketing; the relevant patent protection scope shall cover the corresponding technical solution of the approved drugs marketed. The reason for amendments to the relevant information shall be stated and announced.
Article 5 A chemical drug marketing authorization holder may register a patent of active pharmaceutical ingredients, a patent of pharmaceutical composition containing active ingredients, and a patent of pharmaceutical use on the China Patent Information Registration Platform for Marketed Drugs.
Article 6 When submitting an application for drug marketing authorization, an applicant of chemical generic drugs shall, with reference to the patent information disclosed on the China Patent Information Registration Platform for Marketed Drugs, make a declaration for each relevant drug patent of the generic drugs. The declaration shall be divided into four categories:
Classification I declaration: there is no relevant patent information of the generic drugs on the China Patent Information Registration Platform for Marketed Drugs;
Classification II declaration: the relevant patent rights of the generic drugs recorded on the China Patent Information Registration Platform for Marketed Drugs have been terminated or declared invalid, or the applicant for generic drugs has obtained the relevant patent implementation license from the patentee;
Classification III declaration: the patent rights of the generic drugs are recorded on the China Patent Information Registration Platform for Marketed Drugs, and the applicant for generic drugs undertakes that the generic drugs applied for will not be marketed temporarily before the expiration of the corresponding patent rights; and
Classification IV declaration: the patent rights of the generic drugs recorded on the China Patent Information Registration Platform for Marketed Drugs shall be declared invalid, or their generic drugs do not fall within the scope of protection of the relevant patent rights.
The applicant for generic drugs shall be responsible for the authenticity and accuracy of the relevant declaration. The State Drug Evaluation Agency shall, within ten working days after an application for generic drugs is accepted, make the application information and corresponding declaration available to the public on the information platform; the applicant for generic drugs shall notify the marketing authorization holder of the corresponding declaration and basis for the declaration. If the marketing authorization holder is not the patentee, the marketing authorization holder shall notify the patentee. If the declaration is made that the generic drugs do not fall within the scope of protection of the relevant patent rights, the basis for the declaration shall include a comparison table between the technical solution of the generic drugs and the relevant claims of the relevant patent and relevant technical materials. In addition to paper materials, the applicant for generic drugs shall also send a declaration and basis for the declaration to the email address registered by the marketing authorization holder on the China Patent Information Registration Platform for Marketed Drugs and keep relevant records.
Article 7 Any patentee or interested party who has any objection to the four categories of patent declaration may, within 45 days from the date on which the application for marketing is made public by the State Drug Evaluation Agency, institute legal proceedings in the People’s Court or request an administrative adjudication from the patent administrative department under the State Council regarding whether the relevant technical solution of the drug applied for marketing falls within the scope of protection of the relevant patent rights. Where a party concerned refuses to accept the administrative adjudication rendered by the patent administrative department under the State Council, it may institute legal proceedings in the People’s Court in accordance with the law upon receipt of the administrative adjudication.
Where a patentee or interested party institutes legal proceedings or requests an administrative adjudication within the specified time limit, it shall, within 15 working days from the date on which the case is filed by the People’s Court or accepted by the patent administrative department under the State Council, submit a copy of the notice of filing or acceptance to the State Drug Evaluation Agency and notify the applicant for generic drugs.
Article 8 Upon receipt of the copy of the notice of filing a case by the People’s Court or acceptance by the patent administrative department under the State Council, the drug administrative department under the State Council shall set a waiting period of nine months for the registration application of chemical generic drugs. The waiting period shall only be set once from the date on which the case is filed by the People’s Court or accepted by the patent administrative department under the State Council. The State Drug Evaluation Agency shall not stop technical evaluation during the waiting period.
Where the patentee or interested party fails to institute legal proceedings or request an administrative adjudication within the specified time limit, the drug administrative department under the State Council shall, based on the technical evaluation conclusion and the statement submitted by the applicant for generic drugs, directly decide whether to approve the drug to be marketed; the applicant for generic drugs may institute legal proceedings or request an administrative adjudication in accordance with the relevant provisions.
Article 9 For a registration application of chemical generic drugs which causes a waiting period, the patentee or interested party or the applicant for chemical generic drugs shall, within 10 working days upon receipt of the judgment or decision, submit the relevant documents to the State Drug Evaluation Agency.
For a registration application of chemical generic drugs which has passed the technical evaluation, the State Drug Evaluation Agency shall deal with the application accordingly in light of the effective judgment of the People’s Court or the administrative adjudication of the patent administrative department under the State Council:
1) where it is confirmed that the application falls within the scope of relevant protection of patent rights, the application for registration of chemical generic drugs shall be transferred to the administrative examination and approval stage before the expiration of the patent rights;
2) where it is confirmed that the application does not fall within the scope of relevant protection of patent rights or both parties reach a settlement, the application for registration of chemical generic drugs shall be transferred to the administrative examination and approval stage according to the procedures;
3) where the relevant patent rights are invalidated according to the law, the application for registration of chemical generic drugs shall be transferred to the administrative examination and approval stage according to the procedures;
4) where, after the waiting period has expired, the drug administrative department under the State Council has not received the effective judgment or mediation document of the People’s Court or the administrative adjudication of the patent administrative department under the State Council, the application for registration of chemical generic drugs shall be transferred to the administrative examination and approval stage according to the procedures;
5) where the drug administrative department under the State Council receives the effective judgment of the People’s Court or the administrative adjudication of the patent administrative department under the State Council confirming that the application falls within the scope of relevant protection of patent rights, the application for registration of chemical generic drugs shall be transferred to the State Drug Evaluation Agency to be handled according to Item (1), Paragraph 2 of this Article.
Where, after the drug administrative department under the State Council makes a decision to suspend the approval, the People’s Court overturns the original administrative adjudication, the parties reach a settlement, the related patent rights are declared invalid, or the patentee or interested party withdraws the request for litigation or administrative adjudication, the generic drug applicant may apply to the drug administrative department under the State Council for approval of the marketing of the generic drug, and the drug administrative department under the State Council may make a decision of approval or disapproval.
Article 10 For an application for registration of a Classification I or Classification II chemical generic drug, the drug administrative department under the State Council shall make a decision on whether or not to approve the drug to be marketed based on the technical evaluation conclusion; for an application for registration of a Classification III chemical generic drug, a decision on approval of the drug to be marketed shall be made if it passes the technical evaluation, and the relevant drug shall be marketed only after the expiry of effective period of the corresponding patent rights and the market exclusivity period.
Article 11 For a chemical generic drug that succeeds in patent challenge and obtains approval for marketing for the first time, a market exclusivity period shall be granted. The drug administrative department under the State Council will not approve a generic drug of the same kind to be marketed within 12 months from the date of approval of the drug, unless it succeeds in patent challenge jointly. The market exclusivity period shall not exceed the original patent period of the challenged drug. During the market exclusivity period, the State Drug Evaluation Agency will not cease technical evaluation. For an application for registration of a chemical generic drug that passes the technical evaluation, the application shall be transferred to the administrative evaluation and approval stage before the market exclusivity period expires.
The successful patent challenge means that an applicant of a chemical generic drug submits four categories of declarations, and relevant patent rights are declared invalid according to its request for patent invalidation, and the drug can be approved for marketing.
Article 12 Marketing authorization holders of traditional Chinese medicine and biological products shall register relevant patent information according to Articles 2, 3, 4 and 7 hereof. Traditional Chinese medicine may be registered as a traditional Chinese medicine composition patent, traditional Chinese medicine extract patent, pharmaceutical use patent, and biological products may be registered as sequence structure patent or pharmaceutical use patent of active ingredients.
Applicants for traditional Chinese medicine of the same name and prescription and biosimilar drugs shall make relevant patent declaration according to Article 6 hereof.
Article 13 For an application for registration of a traditional Chinese medicine of the same name and prescription and biosimilar drugs, the drug supervision and administrative department of the State Council shall directly make a decision on whether or not to approve the drug to be marketed based on the technical evaluation conclusion. Where the People’s Court or the patent administrative department under the State Council confirms that the relevant technical solution falls within the scope of protection of relevant patent rights, the relevant drug may only be marketed after the expiry of the corresponding patent rights.
Article 14 After a chemical generic drug, traditional Chinese medicine of the same name and prescription, biosimilar drugs and the like approved for marketing, if a patentee or an interested party believes that the relevant drug infringes upon its/his corresponding patent rights and a dispute arises therefrom, it shall be settled according to the Patent Law of the People’s Republic of China and other relevant laws and regulations. Where a legally approved drug marketing authorization decision is not revoked, its effectiveness shall not be affected.
Article 15 Where a patent party submits a false statement or commits other fraudulent acts, intentionally registers a patent whose scope of protection is unrelated to the approved drugs to be marketed, or does not fall under a patent type that should be registered with the China Patent Information Registration Platform for Marketed Drugs, infringes upon the relevant patent rights of the patentee or causes a party concerned to suffer losses, the corresponding liability shall be borne pursuant to the law.
Article 16 These Measures shall come into force as of the date of promulgation.
Interpretation of Policies for the Implementing Measures for the Mechanism for Early Resolution of Drug Patent Disputes (Trial)
I. What is the background for the drafting of the Implementing Measures for the Mechanism for Early Resolution of Drug Patent Disputes (Trial)?
The mechanism for early resolution of drug patent disputes refers to the system to link the procedures for approval of marketing of the relevant drugs with the procedures for resolving drug patent disputes. The Opinions on Deepening the Reform of the Evaluation and Approval System and Encouraging Innovation in Drugs and Medical Devices and the Opinions on Strengthening Intellectual Property Protection issued by the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council both propose to explore the establishment of a drug patent linkage system. In October 2020, Article 76 of the newly amended Patent Law of the People’s Republic of China (hereinafter referred to as the “Patent Law”) introduced the relevant provisions on early resolution of drug patent disputes, clarifying that the drug administration under the State Council shall, in concert with the patent administration under the State Council, formulate specific transition measures for resolving patent disputes during the stages of drug marketing authorization approval and drug marketing authorization application, which shall come into force upon approval by the State Council.
In order to implement the decisions and arrangements of the Central Committee of the Communist Party of China and the State Council and promote the establishment of an early resolution mechanisms for drug patent disputes in China, the Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial) (hereinafter referred to as the “Measures”) are formulated by the National Medical Products Administration (NMPA) in conjunction with the China National Intellectual Property Administration (CNIPA) in concert with the relevant departments under the framework of the relevant provisions of the newly amended Chinese Patent Law and after extensive solicitation of opinions and improvement from the industry, associations and experts.
II. What is the purpose and main content of the Measures?
The Measures aim to provide the parties concerned with a mechanism to resolve relevant patent disputes in the process of evaluating and approving relevant drugs to be launched into the market, to protect the legitimate rights and interests of drug patent right holders, and to reduce the risk of patent infringement after generic drugs have been launched into the market. The Measures mainly include: platform development and information disclosure system, patent registration system, generic drug patent declaration system, judicial and administrative linkage system, approval waiting period system, drug evaluation and approval classification system, and first generic drug market exclusivity period system.
III. What are the ways to solve the drug patent disputes at an early stage?
The Measures provide that, if a patent right holder or interested party raises an objection to the four categories of patent declaration, it may file a lawsuit with the People’s Court or request an administrative adjudication from the patent administrative department under the State Council regarding whether the relevant technical solution of the drug applied for marketing falls within the protection scope of relevant patent rights, namely, judicial and administrative channels. The patent right holder may choose other ways by itself within the specified time limit. If the party concerned chooses to request an administrative adjudication from the patent administrative department under the State Council but refuses to accept the administrative adjudication and files an administrative lawsuit with the People’s Court, the waiting period shall not be extended.
If the patent right holder or interested party fails to file a lawsuit or request an administrative adjudication within the specified time limit, the generic drug applicant may file a lawsuit or request an administrative adjudication in accordance with the relevant provisions so as to confirm that the relevant technical solution of the drug does not fall within the protection scope of relevant patent rights.
IV. What are the relevant drug patents to be covered by the early resolution mechanisms for drug patent disputes?
The specific drug patents that may be registered on the China Patent Information Registration Platform for Marketed Drugs include pharmaceutical active ingredient compound patents of chemical drugs (excluding APIs), pharmaceutical composition patents containing active ingredients, and patents for pharmaceutical use; patents for TCM composition, patents for TCM extract, and patents for pharmaceutical use; sequence structure patents of active ingredients of biological products, and patents for pharmaceutical use. Relevant patents do not include patents for intermediates, metabolites, crystal forms, preparation methods, detection methods, etc.
V. How to make a patent declaration?
When filing an application for drug marketing authorization, applicants of chemical generic drugs, applicants of TCM drugs of the same name and prescription, and applicants of bio-similar drugs shall, by reference to the patent information published on the China Patent Information Registration Platform for Marketed Drugs, make a declaration for each relevant drug patent of the generic drugs. Within ten working days after an application for generic drugs is accepted, the generic drug applicant shall notify the marketing authorization holder of the corresponding declaration and the basis for the declaration. In particular, if the declaration does not fall within the protection scope of the relevant patent right, the basis for the declaration shall include a table showing comparisons between the technical solution of the generic drug and the involved claims of the relevant patent as well as relevant technical materials. In addition to paper materials, applicants for generic drugs shall also send a declaration and basis for the declaration to the email address registered by the marketing authorization holder on the China Patent Information Registration Platform for Marketed Drugs and keep relevant records.
VI. How to activate the waiting period?
Any patentee or interested party who objects to the four categories of patent declaration made for an application for registration of chemical generic drugs may, within 45 days from the date on which the application for drug marketing authorization is made public by the national drug evaluation institution, institute a lawsuit with the People’s Court or request an administrative adjudication from the patent administration department under the State Council regarding whether the relevant technical solution of the drug applied for marketing falls within the protection scope of the relevant patent right. Where a patentee or interested party files a lawsuit or requests an administrative adjudication within the specified time limit, it shall, within 15 working days from the date on which the case is filed by the People’s Court or accepted by the patent administration department under the State Council, submit a copy of the notice of filing the case or acceptance to the national drug evaluation institution and notify the applicant of the generic drugs. Upon receipt of the copy of the notice of filing the case by the People’s Court or acceptance by the patent administration department under the State Council, the drug administration department under the State Council shall set a waiting period of nine months for the application for registration of chemical generic drugs.
Where an applicant of chemical generic drugs declares that the relevant patent rights of the generic drugs recorded in the China Patent Information Registration Platform for Marketed Drugs shall be declared invalid, if the patentee or interested party has not filed a lawsuit with the People’s Court or requested an administrative adjudication from the patent administration department under the State Council on whether the relevant technical solution of the drug marketed falls within the scope of protection of the relevant patent rights, the waiting period shall not be activated.
VII. Where a patent dispute is not settled at an early stage, how to handle the case after the relevant drug is marketed?
These Measures shall not apply to the patent information which is not registered with the China Patent Information Registration Platform for Marketed Drugs; where the patentee or interested party fails to file a lawsuit or request an administrative adjudication within the specified time limit, no waiting period shall be set. Where a patent dispute is not settled at an early stage, after the relevant drug is approved for marketing, if the patentee believes that the relevant drug infringes its or his corresponding patent right and causes a dispute, the dispute shall be settled in accordance with the provisions of the Patent Law of the People’s Republic of China and other laws and regulations. Where a legally approved drug marketing authorization decision is not revoked, its effectiveness shall not be affected.
Date: July 4, 2021
Source: CNIPA
