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

The early resolution mechanism for drug patent disputes refers to the system that links the approval procedures for the marketing of related drugs with the resolution procedures for related drug patent disputes. In October 2020, Article 76 of the newly revised Patent Law introduced relevant provisions for early settlement of drug patent disputes.    

In the framework of the newly revised Patent Law, the National Medical Products Administration and the CNIPA, together with relevant departments, formulated the Measures for the Implementation of Early Resolution Mechanism for Drug Patent Disputes (Trial) (hereinafter referred to as the Measures).

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

The Measures is designed to provide parties with a mechanism for resolving patent disputes during the review and approval links of relevant drugs, protect the legitimate rights and interests of drug patent holders, and reduce the risk of patent infringement after generic drugs going on the market. The main content of the Measures includes system of platform construction and information disclosure, system of patent right registration, system of generic drug patent declaration, system of judicial link and administrative link, approval waiting period system, system of drug review and approval as well as classification, and system of exclusive period of the first generic drug market, etc.

3. Which ways are there for early settlement of drug patent disputes?

The Measures stipulates that if the patent holders or interested parties have objections to the four kinds of patent declarations, they can file a lawsuit with the people's court or request the patent administration department of the State Council for administrative adjudication on whether the related technical solutions applying for marketed drugs fall within the protection scope of the relevant patent rights. That is, judicial way and administrative way. Within the regulated duration, the patentee may choose a way voluntarily. If the party chooses to request an administrative judgment from the Patent Administration Department of the State Council, and is not satisfied with the administrative adjudication, then files an administrative litigation 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 judgment within the stipulated time limit, the generic drug applicant may file a lawsuit or request an administrative judgment in accordance with relevant regulations to conform that the relevant drug technical solution dose not fall into the protection scope of related patent.

4. What are the relevant drug patents contained in the early resolution mechanism for drug patent disputes?

The specific drug patents that can be registered in the Chinese marketed drug patent information registration platform include: patent for pharmaceutical active ingredients of chemical drugs (excluding API), patent for pharmaceutical compositions containing active ingredients; patent for composition of traditional Chinese medicine, patent for extraction of traditional Chinese medicine and patent for medical application of traditional Chinese medicine; patent for the sequence structure of active ingredients of biological products, patent for medical application of biological products. Related patents do not include patents for 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 applicants for biological similar, when submitting applications for drug marketing authorization, should compare the patent information that has been public on the Chinese listed drug patent information registration platform, and make a declaration about each related generic drug. Within 10 working days after the generic drug application is accepted, the generic drug applicant should notify the marketing authorization holder of the corresponding statement and the statement basis. Wherein, if the declaration does not fall into the protection scope of the related patent rights, the basis of the statement shall include the comparison table of the generic drug technical solution and the relevant claims of the related patent and relevant technical data. In addition to the paper data, the generic drug applicant should also send the statement and its basis to the marketing license holder’s e-mail address registered on the Chinese listed drug patent information registration platform, and keep related records.

6. How to start the waiting period?

Patent holders or interested parties who have objections to the four categories of patent declarations applied for the registration of chemical generic drugs, within 45 days since the application date of the publication of the drug marketing authorization by the National Drug Evaluation Agency, may file a lawsuit with the people’s court or request an administrative judgment from the patent administration department of the State Council to determine whether the related technical solutions applying for marketed drugs have been involved in the protection scope of relevant patent rights. If patentees or interested parties file a lawsuit or request an administrative adjudication within the stipulated duration, they shall submit a copy of the case registration or acceptance notice to the National Drug Evaluation Agency within 15 working days from the date that the people’s court filed the case or the patent administration department accepted it, and notify the applicant of generic drugs. After receiving the copy of the case registration from the People's Court or acceptance notice of the Patent Administration Department of the State Council, the Drug Administration Department of the State Council will set a 9-month waiting period for the application for registration of chemical generic drugs.

For that a chemical generic drug applicant declares the related patent rights of the generic drug recorded in the Chinese listed drug patent information registration platform should be declared invalid, if the patentee or interested parties fail to file a lawsuit with the people's court or request an administrative judgment on whether the related technical solutions of the listed drugs fall into the protection scope of relevant patent rights, then the waiting period will not be launched.

7. If the patent disputes are not early resolved, how to deal with the related drugs after marketing?

The measures does not apply to those which have not registered relevant information on the Chinese listed drug patent information registration platform; the waiting period will not be launched in which the patentee or interested party has not filed a lawsuit or requested an administrative adjudication within the regulated time limit. For such cases where patent disputes have not been resolved early, after the related drugs are approved for marketing, if the patent holders believe 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 law shall not be revoked, and its effectiveness will not be affected.

From CNIPA

July 5th, 2021