NMPA and CNPIA promulgated the Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial Implementation)
In accordance with the Patent Law of the People's Republic of China, the National Medical Products Administration (NMPA) and the National Intellectual Property Administration (CNIPA) formulated the Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial Implementation), which are hereby promulgated with the approval of the State Council and will be implemented from the date of promulgation.
It is hereby announced.
NMPA and CNIPA
July 4th, 2021
Implementation Measures for the Early Resolution Mechanism for
Drug Patent Disputes (Trial Implementation)
Article 1 These Implementation Measures are formulated for the purposes of protecting the legitimate rights and interests of drug patentees, encouraging research on new drugs, promoting the development of high-level generic drugs, and establishing an early resolution mechanism for drug patent disputes.
Article 2 The medical products administration of the State Council shall organize the establishment of the China’s Patent Information Registration Platform for Marketed Drugs so that marketing authorization holders for drugs may register patent information on drugs registered and marketed in China.
These Implementation Measures shall not apply to drugs for which relevant patent information has not been registered on the China’s Patent Information Registration Platform for Marketed Drugs.
Article 3 The national drug evaluation institution shall be responsible for establishing and maintaining the China’s Patent Information Registration Platform for Marketed Drugs, and for disclosing the patent information on drugs that have been approved for marketing.
Article 4 A marketing authorization holder for drugs shall, within 30 days of obtaining the drug registration certificate, independently register the drug name, dosage form, specifications, marketing authorization holder, relevant patent number, patent title, patentee, patent licensee, patent grant date, and patent term expiration date, patent status, patent type, correspondence between the drug and relevant patent claims, mailing address, contact person, and contact information, etc. Where the relevant information changes, the marketing authorization holder shall complete the update within 30 days after the change takes effect.
The marketing authorization holder for drugs shall be responsible for the authenticity, accuracy, and completeness of the relevant information registered by it, and shall verify and handle in a timely manner the relevant oppositions received and record them. The registration information shall be consistent with the information in the patent register, patent gazette, and drug registration certificate. The patent for medical use shall be consistent with the indications or functions in the instructions of the approved drug. The protection scope of the relevant patent shall cover the corresponding technical solutions of the approved drug. For a modification of relevant information, the reasons thereof shall be explained, and such modification shall be made public.
Article 5 A marketing authorization holder for chemical drugs may register patents for active pharmaceutical ingredient compounds, patents for pharmaceutical compositions containing active ingredients, and patents for medical uses on the China’s Patent Information Registration Platform for Marketed Drugs.
Article 6 When a chemical generic drug applicant submits an application for marketing authorization, it shall refer to the patent information disclosed on the China’s Patent Information Registration Platform for Marketed Drugs and make a declaration for each drug patent related to the reference listed drug. The declaration falls into four types:
Type I: There is no relevant patent information about the reference listed drug on the China’s Patent Information Registration Platform for Marketed Drugs;
Type II: The patent related to the reference listed drug included in the China’s Patent Information Registration Platform for Marketed Drugs has been terminated or declared invalid, or the generic drug applicant has obtained a license from the patentee to exploit the relevant patent;
Type III: The patent related to the reference listed drug has been included in the China’s Patent Information Registration Platform for Marketed Drugs, and the generic drug applicant undertakes not to market the generic drug applied for before the expiration of the corresponding patent term;
Type IV: The patent related to the reference listed drugs included in the China’s Patent Information Registration Platform for Marketed Drugs shall be declared invalid, or its generic drug does not fall into the protection scope of the relevant patent.
The generic drug applicant shall be responsible for the authenticity and accuracy of the relevant declaration. Within ten working days after the application for the generic drug is accepted, the national drug evaluation institution shall disclose the application information and the corresponding declaration on the information platform to the public. The generic drug applicant shall notify the marketing authorization holder of the corresponding declaration and the basis therefor. Where the marketing authorization holder is not the patentee, the marketing authorization holder shall notify the patentee. Where a declaration does not fall within the protection scope of the relevant patent, the basis for the declaration shall include a comparison table of the technical solutions of the generic drug and the relevant claims of the relevant patent as well as relevant technical materials. In addition to the paper materials, the generic drug applicant shall also send the declaration and the basis therefor to the email address registered by the marketing authorization holder on the China’s Patent Information Registration Platform for Marketed Drugs, and keep relevant records.
Article 7 Where the patentee or any interested party has objections to any of the four types of patent declarations, it or he or she may, within 45 days from the date when the national drug evaluation institution discloses the application for marketing authorization, file a lawsuit with a people's court or request the patent administrative department under the State Council for administrative adjudication in relation to whether the relevant technical solutions of the drug for which marketing authorization is sought fall within the protection scope of the relevant patent. Where a party is dissatisfied with the administrative adjudication made by the patent administrative department under the State Council, it or he or she may file a lawsuit in a people's court according to law after receiving the administrative adjudication order.
Where the patentee or any interested party files a lawsuit or requests administrative adjudication within the prescribed time limit, it or he or she shall, within 15 working days from the date on which the people's court dockets the case or the patent administrative department under the State Council accepts the case, submit a copy of the notice of case filing or case acceptance to the national drug evaluation institution, and notify the generic drug applicant.
Article 8 Upon receipt of the copy of the notice of case filing issued by the people's court or notice of case acceptance issued by the patent administrative department under the State Council, the medical products administration under the State Council shall set a nine-month waiting period for the application for registration of the chemical generic drug. The waiting period shall start from the date when the people's court dockets the case or the patent administrative department under the State Council accepts the case and shall be set only once. During the waiting period, the national drug evaluation institution shall not stop technical evaluation.
Where the patentee or any interested party fails to file a lawsuit or request administrative adjudication within the prescribed time limit, the medical products administration under the State Council shall directly decide whether to approve the marketing of the generic drug based on the conclusions of the technical evaluation and the declaration submitted by the generic drug applicant. The generic drug applicant may file a lawsuit or request administrative adjudication in accordance with relevant regulations.
Article 9 With respect to any chemical generic drug registration application that triggers a waiting period, the patentee or any interested party and the chemical generic drug applicant shall, within ten working days of receipt of the judgment or written decision, submit the relevant documents to the national drug evaluation institution.
With respect to any chemical generic drug registration application that has passed the technical evaluation, the national drug evaluation institution shall handle it accordingly in light of the effective judgment of the people's court or the administrative adjudication order of the patent administrative department under the State Council:
(1) If the chemical generic drug is confirmed to fall within the protection scope of the relevant patent, the relevant chemical generic drug registration application shall be transferred to the administrative examination process before the expiration of the patent;
(2) If the chemical generic drug is confirmed not to fall within the protection scope of the relevant patent or the two parties reconcile, the relevant chemical generic drug registration application shall be transferred to the administrative examination process according to the procedures;
(3) If the relevant patent is invalidated according to law, the relevant chemical generic drug registration application shall be transferred to the administrative examination process according to the procedures;
(4) If, after the waiting period, the medical products administration under the State Council has not received the effective judgment or mediation statement from the people's court or the administrative adjudication order of the patent administrative department under the State Council, the relevant chemical generic drug registration application shall be transferred to the administrative examination process according to the procedures; and
(5) If, during the period of administrative examination, the medical products administration under the State Council receives the effective judgment of the people's court or the administrative adjudication order of the patent administrative department under the State Council, which confirms that the chemical generic drug falls within the protection scope of the relevant patent, the relevant chemical generic drug registration application shall be submitted to the national drug evaluation institution, which will handle it in accordance with the provisions of paragraph 2 (1) of this Article.
Where, after the medical products administration under the State Council decides to suspend the approval, the people's court reverses the original administrative adjudication order, the two parties reconcile, the relevant patent is declared invalid, or the patentee or any interested party withdraws the lawsuit or the request for administrative adjudication, the generic drug applicant may apply to the medical products administration under the State Council for marketing approval of the generic drug, and the medical products administration under the State Council may decide whether to grant the approval or not.
Article 10 For chemical generic drug registration applications with Type I or II declarations, the medical products administration under the State Council shall directly make a decision on whether to grant marketing approval based on the conclusion of the technical evaluation. For chemical generic drug registration applications with a Type III declaration, if the technical evaluation is passed, a marketing approval decision shall be made, and the relevant drugs shall not be marketed until the expiration of the relevant patent term and market exclusivity period.
Article 11 The first chemical generic drug that successfully challenges a patent and is approved for marketing shall be granted a market exclusivity period. Within 12 months of the date of approval of the drug, the medical products administration under the State Council shall no longer approve the marketing of generic drugs of the same variety, except those that jointly challenge a patent successfully. The market exclusivity period shall not exceed the original patent term of the challenged drug. Within the market exclusivity period, the national drug evaluation institution shall not stop the technical evaluation. For a chemical generic drug registration application that has passed the technical evaluation, the application shall be transferred to the administrative examination process before the market exclusivity period expires.
Successfully challenging a patent means that a chemical generic drug applicant submits a Type IV declaration, and that the relevant patent is declared invalid according to the applicant's request for invalidation of the patent, so that the generic drug may be approved for marketing.
Article 12 Marketing authorization holders for traditional Chinese medicines and biological products shall register relevant patent information in accordance with Articles 2, 3, 4, and 7 of these Implementation Measures. For traditional Chinese medicines, patents for traditional Chinese medicine compositions, patents for traditional Chinese medicine extracts, and patents for medical use may be registered; for biological products, patents for the sequence structure of active ingredients and patents for medicinal use may be registered.
An applicant for a traditional Chinese medicine of the same name and formula or a biosimilar shall make a patent declaration in accordance with Article 6 of these Implementation Measures.
Article 13 For an application for registration of a traditional Chinese medicine of the same name and formula or a biosimilar, the medical products administration under the State Council shall directly make a decision on whether to grant marketing approval based on the conclusion of the technical evaluation. Where the people's court or the patent administrative department under the State Council confirms that the relevant technical solutions fall within the protection scope of the relevant patent, the relevant drug may be marketed only after the expiration of the corresponding patent term.
Article 14 Where, after a chemical generic drug, a traditional Chinese medicine of the same name and formula, or a biosimilar is approved for marketing, the patentee or any interested party considers that the relevant drug infringes on the corresponding patent and a dispute arises, the dispute shall be resolved in accordance with the Patent Law of the People's Republic of China and other relevant laws and regulations. A marketing authorization decision for a drug already approved according to law shall not be cancelled, nor shall its effectiveness be affected.
Article 15 Where an individual or entity commits fraud by submitting false declarations, or intentionally registers on the China’s Patent Information Registration Platform for Marketed Drugs a patent whose protection scope is not related to the drug approved for marketing or which does not belong to the types of patents that should be registered, infringing on the relevant patent of the patentee or otherwise causing losses to the party, the individual or entity shall bear corresponding liabilities according to law.
Article 16 These Implementation Measures take effect as of the date of promulgation.
