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Policy Interpretation of "Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial)"

Time:2021-12-16 Views:322

1. What is the background of the drafting of the "Measures for the Implementation of the Early Resolution Mechanism for Pharmaceutical Patent Disputes (Trial)"?

The early resolution mechanism for drug patent disputes refers to a system that links the approval procedures for the marketing of related drugs with the resolution procedures for related drug patent disputes. The "Opinions on Deepening the Reform of the Review 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 all 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 relevant provisions on early settlement of drug patent disputes, clarifying that the drug regulatory department of the State Council and the patent administration department of the State Council Formulate specific measures for the connection between the approval of drug marketing authorization and the resolution of patent disputes at the stage of drug marketing authorization application, which shall be implemented after the approval of the State Council.

In order to implement the decisions and deployments of the Party Central Committee and the State Council, and promote the establishment of an early resolution mechanism for drug patent disputes in my country, the State Food and Drug Administration and the State Intellectual Property Office, together with relevant departments, have settled drug patent disputes under the framework of the newly amended "Patent Law". The specific system of the early settlement mechanism was carefully studied, borrowed from international practices, and after extensive consultation and improvement of the opinions of the industry, associations, experts, etc., the "Implementation Measures for the Early Resolution Mechanism for Pharmaceutical Patent Disputes (Trial)" (hereinafter referred to as the "Measures") was formulated.

2. What is the purpose and main content of the "Measures"?

The "Measures" are designed to provide parties with a mechanism for resolving patent disputes during the review and approval of relevant drug listings, protect the legitimate rights and interests of drug patent holders, and reduce the risk of patent infringement after the listing of generic drugs. The main contents of the "Measures" include: platform construction and information disclosure system, patent right registration system, generic drug patent declaration system, judicial link and administrative link system, approval waiting period system, drug review and approval classification system, and the first generic drug market Exclusive period system, etc.

3. What are the ways for early settlement of drug patent disputes?

The "Measures" stipulate that if the patentee or interested parties have objections to the four types of patent declarations, they can file a lawsuit with the people's court or request the patent administration department of the State Council on whether the relevant technical solutions of the drug applied for listing fall within the scope of protection of the relevant patent rights. Administrative rulings, namely: judicial channels and administrative channels. Within the prescribed time limit, the patentee can choose the way by himself. If a party chooses to request an administrative ruling from the Patent Administration Department of the State Council, but is not satisfied with the administrative ruling and then initiates an administrative lawsuit in the People's Court, the waiting period will not be extended.

If the patentee or interested party fails to file a lawsuit or request an administrative ruling within the prescribed time limit, the generic drug applicant may file a lawsuit or request an administrative ruling in accordance with the relevant regulations to confirm that the relevant drug technical plan does not fall into the scope of the relevant patent protection. .

4. What are the relevant drug patents covered by the early resolution mechanism for drug patent disputes?

The specific drug patents that can be registered in the Chinese listed drug patent information registration platform include: patents for pharmaceutical active ingredients of chemical drugs (excluding bulk drugs), patents for pharmaceutical compositions containing active ingredients, and patents for medical purposes; Chinese medicine compositions for traditional Chinese medicines Patent, patent of Chinese medicine extract, patent for medical use; patent for sequence structure of active ingredients of biological products, patent for medical use. Related patents do not include patents on intermediates, metabolites, crystal forms, preparation methods, detection methods, etc.

5. How to make a patent declaration?

Applicants for chemical generic drugs, applicants for traditional Chinese medicines with the same name and same prescription, and biosimilars, when submitting drug marketing authorization applications, should compare the patent information that has been published on the Chinese drug patent information registration platform for each related generic drug. Pharmaceutical patents make a statement. Within 10 working days after the generic drug application is accepted, the generic drug applicant shall notify the marketing authorization holder of the corresponding statement and the basis for the statement. Among them, if the declaration does not fall into the protection scope of the relevant patent rights, the basis of the declaration shall include the comparison table of the generic drug technical solution and the relevant claims of the relevant patent and relevant technical information. In addition to the paper materials, the generic drug applicant should also send the statement and the basis for the statement to the e-mail address registered by the marketing license holder on the Chinese listed drug patent information registration platform, and keep relevant records.

6. How to start the waiting period?

If the patentee or interested party has objections to the four types of patent declarations applied for the registration of chemical generic drugs, they may, within 45 days from the date of publication of the drug marketing authorization application by the National Drug Evaluation Agency, determine whether the relevant technical solutions for the application for marketed drugs have been implemented. Involved in the scope of protection of relevant patent rights, file a lawsuit with the people’s court or request an administrative ruling from the patent administration department of the State Council. Patent holders or interested parties who file a lawsuit or request an administrative ruling within the prescribed time limit shall submit a copy of the case initiation or acceptance notice to the national drug review within 15 working days from the date of acceptance by the people’s court or the patent administration department of the State Council. Agency and notify the applicant of generic drugs. After receiving a copy of the acceptance notice from the People's Court or the Patent Administration Department of the State Council, the Drug Administration Department of the State Council sets a 9-month waiting period for the registration application of chemical generic drugs.

Where a chemical generic drug applicant declares that the patent rights related to the generic drug included in the Chinese listed drug patent information registration platform should be declared invalid, if the patentee or interested party fails to determine whether the related technical solution of the listed drug falls into the relevant patent right The scope of protection does not initiate a waiting period if a lawsuit is filed in the people's court or an administrative ruling is requested from the patent administration department of the State Council.

7. If patent disputes have not been resolved early, how should the relevant drugs be dealt with after they are on the market?

These measures do not apply to the relevant patent information that has not been registered on the Chinese marketed drug patent information registration platform; if the patentee or interested party has not filed a lawsuit or requested an administrative ruling within the prescribed time limit, no waiting period will be set. For such cases where patent disputes cannot be resolved early, after the relevant drugs are approved for marketing, if the patentee believes that the relevant drugs infringe their corresponding patent rights and cause disputes, they shall be resolved in accordance with the "Patent Law of the People's Republic of China" and other laws and regulations. The drug marketing authorization decision that has been approved in accordance with the law shall not be revoked, and its effectiveness will not be affected.


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