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According to news on the website of the State Drug Administration on the 4th, the State Drug Administration and the State Intellectual Property Office issued the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" (hereinafter referred to as 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 content of the "Measures" includes: 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.

Source: State Drug Administration website

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 for 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 brings an administrative lawsuit to 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 relevant regulations to confirm that the relevant drug technical solution does not fall into the scope of the relevant patent protection. .

What are the relevant drug patents covered by the early settlement mechanism for drug patent disputes?

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

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 applications for drug marketing authorization, should compare the patent information that has been published on the patent information registration platform for listed drugs in China, and target 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.

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 the 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 registration or acceptance notice to the national drug review within 15 working days from the day the people’s court filed the case or the patent administration department of the State Council accepted it. Organization 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 application for registration 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 invalidated, if the patentee or interested parties fail to determine whether the related technical solutions of the listed drugs fall into the relevant patent rights 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.

If patent disputes are not resolved early, how should the relevant drugs be handled after they are marketed?

These Measures do not apply to the relevant patent information that has not been registered on the Chinese listed 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.