Article 1    These measures are formulated to protect the legitimate rights and interests of drug patentee, to encourage the research of new drug as well as the development of high-quality generic drugs, and to establish an early settlement mechanism for drug patent disputes.

 

Article 2    A platform for listed drugs in China to register patent information which is established by the Drug Regulatory Department of the State Council, allows marketing authorization holders of drugs to register relevant patent information of listed drugs that registered in China.

 

These measures shall not apply to the drugs that register no relevant patent information in the platform.

 

Article 3   The right of establishing and maintaining the platform for listed drugs in China to register patent information is vested in the National Drug Evaluation Institution. It shall make a public disclosure of relevant patent information of approved listed drugs.

Article 4  The marketing authorization holder of drugs shall, within 30 days after obtaining the drug registration certificate, register the information of drug name, dosage form, specification, marketing authorization holder, relevant patent number, patent name, patentee, patent licensee, the date of patent authorization and the expiration date of the protection period, patent status, patent type, the correspondence between medicine and relevant patent claims, correspondence address, contact person, and contact information, etc. If relevant information changes, the marketing authorization holder of drugs shall perform the update within 30 days after the change takes effect.

 

The marketing authorization holder of drugs shall be responsible for the authenticity, accuracy and completeness of the relevant information registered, as well as verify, handle, and record the relevant objections received in time. The registration information should be consistent with that in patent register, patent gazette, and drug registration certificate; the medical use patent rights should be in line with the indications or functions of the approved listed drug directions; the relevant patent protection scope should cover the corresponding technical protocols of the approved drugs. If you want to change the relevant information, you should explain the reasons and make it public.

 

Article 5  The marketing authorization holders of chemical drug may register the patents of active ingredients in drugs, patents of pharmaceutical compositions that contains active ingredients, and patents of medical application on the China Listed Drug Patent Information Registration Platform.

 

Article 6   When a chemical generic drug applicant applies for a drug marketing license, he shall make a statement regarding each related drug patent of the generic drug in accordance with the patent information that has been published on the China Listed Drug Patent Information Registration Platform. There are four types of statement:

1. The first type: there is no information related to generic drugs in the China Listed Drug Patent Information Registration Platform.
2. The second type: the patent right of the generic drug included in the China Listed Drug Patent Information Registration Platform has been terminated or declared avoidance, or the applicant for the generic drug has been permitted the relevant patent implementation license by the patentee.
3. The third type: The patents related to the generic drugs is included in China Listed Drug Patent Information Registration Platform. The generic drug applicant shall promise that the applied generic drugs will not be listed before the expiration of the corresponding patent rights.
4. The fourth type: The patents related to the generic drugs included in the China Listed Drug Patent Information Registration Platform shall be declared avoidance. Or the applied generic drug is not covered in the protection scope of the related patents.

The generic drug applicant is responsible for the authenticity and accuracy of the relevant statement. China National Drug Evaluation Agency shall disclose the application information and corresponding statements on the information platform within 10 workdays after the application for generic drugs is accepted. The applicant for generic drugs shall inform the marketing authorization holders of the corresponding statements and statement basis. The same information shall inform the patentee if the holder is not the patentee. For the statement that is not covered in the protection scope of the relevant patent rights, the comparison table between generic drug technical protocol and relevant claims of the relevant patents, as well as the relevant technical information should be included in the statement. In addition to the paper materials, the generic drug applicant should also send the statement and statement basis to the e-mail address registered on China Listed Drug Patent Information Registration Platform by the marketing license holder and keep relevant records.

 

Article 7  If the patentee or stakeholders have objections to the four types of patent statements, they may file suit to people’s court or request administration adjudication to the Patent administration Department of the State Council in 45 days as of the date of the China National Drug Evaluation Agency publishes the drug marketing authorization application for the dispute whether the relevant technical protocols of the applied listed drugs are covered by the protection of relevant patent rights. If the party is dissatisfied with the administrative adjudication of the Patent Administration Department of the State Council, he may, after receiving the award, file a suit to people's court in accordance with the law.

 

If the patentee or stakeholder files a lawsuit or requests an administrative adjudication within time limit, they shall submit a copy of the case registration or acceptance notice to the China National Drug Evaluation Agency within 15 workdays as of the date of acceptance by the People’s Court or the Patent Administration Department of the State Council. Evaluation, and notify the generic drug applicant.

 

Article 8  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 shall set a 9-month waiting period registration and application of chemical generic drugs. The waiting period shall only be set once from the day when the people's court files the case, or the patent administration department of the State Council accepts it. The China National Drug Evaluation Agency will not stop the technical review during the waiting period.

 

If patentee or stakeholder fails to file a lawsuit or request an administrative adjudication within time limit, the Drug Administration Department of the State Council shall directly decide whether the drug is to be approved for marketing based on the technical review conclusion and the statement submitted by the generic drug applicant; The applicant can file a lawsuit or request an administrative adjudication in accordance with relevant regulations.

 

Article 9  For applications for registration of chemical generic drugs that trigger a waiting period, the patentee or stakeholder, and chemical generic drugs applicant shall submit the relevant documents to the China National Drug Evaluation Agency within 10 workdays as the date of receipt of the judgment or decision.

 

For applications for registration of chemical generic drugs that have passed the technical review, the China National Drug Evaluation Agency shall make treatment correspondingly in conjunction with the effective judgment of the people’s court or the administrative adjudication of the Patent Administration Department of the State Council.

(1) If the application is confirmed to be covered by the protection scope of relevant patent rights, it shall be transferred to the proceeding of administrative approval before the expiration of the patent right.

(2) If the application is confirmed not to be covered by the protection scope of relevant patent rights or the two parties have settled, the application for registration of the relevant chemical generic drugs shall be transferred to the proceeding of administrative approval in accordance with the procedures.

(3) If the relevant patent right is invalidated on the basis of the law, the relevant chemical generic drug registration applications shall be transferred to the proceeding of administrative approval in accordance with the procedures.

(4) If the Drug Administration Department of the State Council has not received the effective judgment or mediation document of the people's court, or the administrative adjudication of the patent administration department of the State Council after the waiting period, the relevant chemical generic drug registration applications shall be transferred to the proceeding of administrative approval in accordance with the procedures.

(5) If the Drug Administration Department of the State Council has received the effective judgment or mediation document of the people's court, or the administrative adjudication of the patent administration department of the State Council during the period of administrative approval, and confirms that the application is covered by the protection scope of the relevant patent rights, the relevant chemical generic drug registration applications shall be transferred to the China National Drug Evaluation Agency, and handled in accordance with the first term of the second paragraph of this article.

After the patent administration department of the State Council decides to suspend approval, the generic drug applicant can apply to the patent administration department of the State Council for approval of generic drugs for marketing if the people’s court overturns its original administrative adjudication, or the two parties have settled, or the relevant patent rights are declared invalid, or the patentee and stakeholder withdraw the lawsuit or administrative adjudication request. The patent administration department of the State Council can decide on whether to approve it or not. 

 

Article 10  For registration applications of chemical generic drugs that make the first and second statements, the patent administration department of the State Council shall make a decision on whether to approve of marketing based on the conclusions of the technical review; for applications that make the third statement and pass the technical review, the drugs shall not be listed until the expiration of the corresponding patent rights and the period of market exclusivity after they are approved for marketing. 

 

Article 11  A period of market exclusivity will be granted to the chemical generic drug that first succeeds in challenging the patent and is the first one to be approved for marketing. The Drug Administration Department of the State Council will no longer approve the marketing of generic drugs of the same variety within 12 months from the date of approval of that drug, except for the drug that successfully challenge together. The term of market exclusivity shall not exceed the term of the original patent right of the challenged drug, during which the China National Drug Evaluation Agency will not stop the technical review. The registration application for chemical generic drugs that has passed the technical review shall be transferred to the proceeding of administrative approval before the expiration of the market exclusivity.

 

Successful patent challenge means that applicants for chemical generic drugs submit the fourth statement. The relevant patent rights are declared invalid based on the applicant’s request for invalidation of patent rights, therefore the generic drugs are approved for marketing.

 

Article 12  Marketing authorization holders of traditional Chinese medicines and biological products shall register relevant patent information in accordance with Articles 2, 3, 4, and 7 of these Measures. Chinese medicine can register for Chinese medicine composition patent, Chinese medicine extract patent, and medical application patent. While biological products can register for sequence structure patent of active ingredients and medical application patent. 

 

Applicants for traditional Chinese medicines with the same name and same prescription, as well as biosimilars shall make relevant patent statement in accordance with the Article 6 of these Measures.

 

Article 13  For registration applications for traditional Chinese medicines with the same name and same prescription, and biosimilars, the patent administration department of the State Council shall make a decision on whether to approve of marketing based on the conclusions of the technical review. For applications that are confirmed to be covered in the protection scope of the relevant patent right by the People's Court or the Patent Administration Department of the State Council, the relevant drugs shall not be marketed until the expiration of the corresponding patent right.

 

Article 14  If the patentee or stakeholder believe that the chemical generic drugs, Chinese medicines with the same name and same prescription, and biosimilar drugs infringe their corresponding patent rights and cause disputes after they are approved of marketing, they shall follow the relevant provisions and regulations of Patent Law of the People’s Republic of China to address it. The marketing authorization of drugs hat has been approved in accordance with the law shall not be revoked, and its effectiveness will not be affected.

 

Article 15  Those who submit false statement and other fraudulent documents, deliberately register patents whose protection scope has nothing to do with the approved listed drugs, or which do not belong to the types that should be registered as patents to the Chinese listed drug patent information registration platform, infringing and damaging the patent rights of the patentee shall bear the corresponding liabilities according to the law.

 

Article 16  These measures shall come into forces as of the date of promulgation.