Source: National Medical Products Administration
Published: 2021-07-04

According to the "Patent Law of the People's Republic of China", the “Measures for Implementation of Early Resolution Mechanisms for Drug Patent Disputes (For Trial Implementation)”, formulated by the National Medical Products Administration and the China National Intellectual Property Administration, is hereby promulgated with the consent of the State Council, and shall come into effect from the date of promulgation.
Announcement is hereby given.

National Medical Products Administration
China National Intellectual Property Administration
July 4, 2021

Measures for Implementation of Early Resolution Mechanisms for Drug Patent Disputes (For Trial Implementation)

Article 1 In order to protect the legitimate rights and interests of drug patentee, encourage new drug research and promote the development of high-level generic drugs, and establish an early resolution mechanism for drug patent disputes, these Measures are formulated.

Article 2 The medical products administration department under the State Council shall organize to establish the China's registration platform of marketed drug patent information for marketing authorization holders to register patent information related to drugs registered for marketing in China.
Where related patent information has not been registered on the China's registration platform of marketed drug patent information, these Measures do not apply.

Article 3 The national drug evaluation agency is responsible for establishing and maintaining the China's registration platform of marketed drug patent information, and publicizing patent information related to drugs that have been approved for marketing.

Article 4 Marketing authorization holder shall register the drug name, dosage form, strength, marketing authorization holder, related patent number, patent name, patentee, patent licensee, issue date of the patent and expiry date of patent term, patent status, patent type, correspondence between drugs and related patent claims, correspondence address, contact person, contact information, etc. within 30 days after obtaining the drug registration certificate. Where the related information changes, the marketing authorization holder shall update it within 30 days after the information change takes effect.
The marketing authorization holder shall be responsible for the authenticity, accuracy and completeness of the related information registered by him or it, and shall verify, deal with and record in time the related objections received. The registration information shall be consistent with the related information in the patent register, patent gazette, and drug registration certificate; the medical use patent shall be consistent with the indications or functional indications on the package insert of the approved drug; the related patent protection scope covers the corresponding technical solutions of the approved drug. Reasons for related information change shall be explained and publicized.

Article 5 A chemical drug marketing authorization holder may register a patent to pharmaceutical active ingredient compounds, a patent to a pharmaceutical composition comprising an active ingredient, and a patent to medical use on the China's registration platform of marketed drug patent information.

Article 6 When a chemical generic drug applicant submits an application for a drug marketing license, he shall make a certification regarding each of the related drug patents of the reference listed drug in accordance with the patent information already publicized on the China's registration platform of marketed drug patent information. There are four types of certifications:
The first type of certification: There is no patent information related to reference listed drug in the China's registration platform of marketed drug patent information;
The second type of certification: The patents related to the reference listed drug included in the China's registration platform of marketed drug patent information have been terminated or declared invalid, or the generic drug applicant has obtained the related patent license of the patentee;
The third type of certification: The China's registration platform of marketed drug patent information includes patents related to the reference listed drug, and the generic drug applicant promises that the generic drug applied for is temporarily not marketed before the expiration of the related patent;
The fourth type of certification: The patents related to the reference listed drugs included in the China's registration platform of marketed drug patent information shall be declared invalid, or the generic drugs are not covered by the protection scope of the related patents.
The generic drug applicant shall be responsible for the authenticity and accuracy of the related certification. Within 10 working days after the generic drug application is accepted, the national drug evaluation agency shall publicize the application information and corresponding certification on the information platform; the generic drug applicant shall notify the marketing authorization holder of the corresponding certification and the basis of the certification, and where the marketing authorization holder is other than the patentee, the marketing authorization holder shall notify the patentee. Where the certification indicates that the drug is not covered by the protection scope of the related patent, the basis of the certification shall include a comparison table of the generic drug technical solution and the related claims of the related patent as well as the related technical materials. In addition to the paper materials, the generic drug applicant shall also send the certification and the basis of the certification to the email address registered by the marketing authorization holder on the China's registration platform of marketed drug patent information, and keep related records.

Article 7 Where a patentee or interested party has objection to the fourth type of patent certifications, he or it may take legal action before a people's court or file a request for administrative adjudication with the patent administration department under the State Council about whether the technical solution associated with a drug for which marketing approval is being sought is covered by the protection scope of a related patent right, within 45 days from the date when the national drug evaluation agency publicizes the application for drug marketing license. Where the party does not satisfy with the administrative adjudication made by the patent administration department under the State Council, he or it may take legal action before a people's court after receiving the administrative adjudication.
Where the patentee or interested party takes legal action or files a request for administrative adjudication within the prescribed time limit, he or it shall submit a copy of the notification of acceptance of the case or request to the national drug evaluation agency within 15 working days from the date when the people's court accepts the case or the patent administration department under the State Council accepts the request, and notify the generic drug applicant.

Article 8 After receiving the copy of the notification that the people's court accepts the case or the patent administration department under the State Council accepts the request, the medical products administration department under the State Council shall set a 9-month waiting period for the registration application of chemical generic drugs. The waiting period is from the date when the people's court accepts the case or the patent administration department under the State Council accepts the request and is set once only. During the waiting period, the national drug evaluation agency shall not stop technical review.
Where the patentee or interested party fails to take legal action or request for administrative adjudication within the prescribed time limit, the medical products administration department under the State Council may directly make a decision as to whether the marketing of the drug is approved, according to the technical review conclusion and the certification submitted by the generic drug applicant; The generic drug applicant may take legal action or request for administrative adjudication in accordance with related regulations.

Article 9 For chemical generic drug registration application that triggers a waiting period, the patentee or interested party, and chemical generic drug applicant shall, within 10 working days from the date of receipt of the judgment or decision, etc, submit the related instruments to the national drug evaluation agency.
For an application for the registration of chemical generic drug that has passed the technical review, the national drug evaluation agency shall, in accordance with the effective judgment of the people's court or the administrative adjudication of the patent administration department under the State Council, proceed as follows:
(1) where it is confirmed that it is covered by the protection scope of the related patent right, the registration application for the related chemical generic drug shall not be transferred to the administrative examination and approval step until the patent right is soon to expire;
(2) where it is confirmed that it is not covered by the protection scope of the related patent right or the two parties have settled, the related chemical generic drug registration application shall be transferred to the administrative examination and approval step according to the procedure;
(3) where the related patent right is declared invalid according to law, the related chemical generic drug registration application shall be transferred to the administrative examination and approval step according to the procedure;
(4) where the medical products administration department under the State Council fails to receive an effective judgment or mediation certification from a people's court or administrative adjudication from the patent administration department under the State Council after the waiting period, the related chemical generic drug registration application shall be transferred to the administrative examination and approval step according to the procedure.
(5) where the medical products administration department under the State Council receives an effective judgment from a people's court or administrative adjudication from the patent administration department under the State Council during the administrative examination and approval period, confirming that it is covered by protection scope of the related patent rights, the related chemical generic drug registration application shall be transferred to the national drug evaluation agency in accordance with the first item of the second paragraph of this Article.
After the medical products administration department under the State Council makes a decision to suspend approval, where the people's court overturns the original administrative adjudication, the two parties have settled, the related patent right is declared invalid, or the patentee or interested party withdraws the legal action or administrative adjudication request, the generic drugs applicant may apply to the medical products administration department under the State Council for approval of the marketing of generic drugs, and the medical products administration department under the State Council shall make a decision on whether to approve it.

Article 10 For the registration application of chemical generic drugs involved in the first or second type of certification, the medical products administration department under the State Council shall make a decision as to whether the marketing of the drug is approved according to the technical review conclusions; for the registration application of chemical generic drugs involved in the third type of certification, where the technical review is passed, a decision to approve the marketing shall be made, and related drugs can only be marketed after the expiration of the corresponding patent right and the market exclusivity period.

Article 11 For the chemical generic drug that is the first to have successful challenge to the patent and is the first to have been approved for marketing, the market exclusivity period shall be granted. The medical products administration department under the State Council shall not approve the marketing of generic drugs of the same variety within 12 months from the date of approval of the drug, except for those who successfully jointly challenge the patent. The market exclusivity period does not exceed the original patent right term of the challenged drug. During the market exclusivity period, the national drug evaluation agency shall not stop technical review. For applications for registration of chemical generic drugs that have passed the technical review, the application for chemical generic drugs shall not be transferred to the administrative examination and approval step until the market exclusivity period is soon to expire.
“Successful challenge to the patent” or “successfully challenge the patent” means that the chemical generic drug applicant submits the fourth type of certification, and, according to his or its request for invalidation of the patent right, the related patent right is declared invalid, thus allowing the generic drug to be approved for marketing.

Article 12 Marketing authorization holders of traditional Chinese medicines and biological products shall register the related patent information and so on in accordance with Articles 2, 3, 4 and 7 of these Measures. Patents to traditional Chinese medicine composition, traditional Chinese medicine extracts and medical uses may be listed for traditional Chinese medicine, and patents to sequence structure of active ingredients and medical uses may be listed for biological products.
For traditional Chinese medicines with the same name and same prescription and biosimilar drugs, the applicant shall make related patent certification in accordance with Article 6 of these Measures.

Article 13 For the registration application of traditional Chinese medicines with the same name and same prescription and biosimilar drugs, the medical products administration department under the State Council shall directly make a decision on whether to approve the marketing according to the technical review conclusion. Where a people's court or the patent administration department under the State Council has confirmed that the related technical solution is covered by protection scope of a related patent right, the related drug cannot be marketed until the expiration of the related patent right.

Article 14 After a chemical generic drug, a traditional Chinese medicine with the same name and same prescription, biosimilar drug and so on is approved for marketing, where the patentee or interested party believes that the related drug infringes its corresponding patent rights and a dispute rises, it shall be resolved in accordance with the related provisions of the Patent Law of the People's Republic of China and other laws and regulations. The drug marketing license decision that has been approved in accordance with the law shall not be revoked and its effectiveness will not be affected.

Article 15 For those who conduct falsifications such as submit false certifications, deliberately register patents whose protection scope is irrelevant to the approved marketed drugs or which do not belong to the patent type that shall be registered on the China's registration platform of marketed drug patent information, infringe the related patent rights of the patentee or cause other losses to the parties, the corresponding legal liability shall be borne in accordance with the law.

Article 16 These Measures shall come into effect from the date of promulgation.