On July 4, 2021, National Medical Products Administration (NMPA) and China National Intellectual Property Administration (CNIPA) jointly issued the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" (No. 89 Announcement of 2021). On July 5, 2021, the CNIPA issued "Administrative Adjudication Measures for Early Resolution Mechanism for Drug Patent Disputes" (No.435 Announcement) and "Matters Concerning the Acceptance of Administrative Adjudication Measures for Early Resolution Mechanism for Drug Patent Disputes" (No.436 Announcement). The above announcements shall come into effect on the day of promulgation.

According to the relevant regulations of Early Resolution Mechanism for Drug Patent Disputes introduced in Article 76 of the newly amended "Patent Law of the People's Republic of China", the NMPA in conjunction with the CNIPA shall develop specific connection methods on patent dispute resolution during new drug review and approval stage, and application authorization stage. Based on this, the "Implementation Measures for Early Resolution Mechanism for Drug Patent Disputes (Trial)" is formulated and will be implemented with the approval of the State Council.

The Early Resolution Mechanism for Drug Patent Disputes refers to a system that links the related new drug approval procedures with the resolution procedures for related drug patent disputes. The Regulations are intended to provide parties with a mechanism for resolving related patent disputes, protect the legitimate rights and interests of drug patent holders, and reduce the risk of patent infringement after the post-marketing of generic drugs during the review of new drug marketing.

According to the regulations, the Chinese Post-marketing Drug Patent Information Registration Platform is officially launched. The holder of the relevant post-marketing drug authorization shall complete the registration and active disclosure of relevant drug patent information on the Chinese Post-marketing Drug Patent Information Registration Platform in advance as needed within 30 days after obtaining the drug registration certificate.

When the applicant submits an application for the marketing registration of chemical generic drugs, traditional Chinese medicines with the same name and same prescription, and biosimilar, they should make a statement for each related drug patent of the generic drug, comparing the relevant drug patent information disclosed on the Chinese Post-marketing Drug Patent Information Registration Platform. 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.

If the patentee or interested party has objections to the four types of patent statements, they can file a lawsuit with the people’s court or file a request for administrative ruling with the Patent Administration Department of the State Council (namely judicial and administrative channels) within 45 days from the date of the publication of the drug marketing authorization on whether the relevant technical solutions of the drugs applying for marketing fall within the protection scope of the relevant patent rights. Within the prescribed time limit, the patentee can choose the judicial channel or the administrative channel by himself. Any party, who is dissatisfied with the administrative ruling made by the Patent Administration Department of the State Council, may file a lawsuit with the people’s court in accordance with the law after receiving the administrative ruling. The plaintiff shall submit duplicate copy of notice of filing or acceptance to the National Drug Evaluation Agency and notify the generic drug applicant within 15 working days from the date of acceptance.

After receiving the notice of filing or acceptance, the Drug Administration Department of the State Council sets a 9-month waiting period (only once) for the registration application of chemical generic drugs. For registration applications of chemical generic drugs that trigger a waiting period, the patentee or interested party, or applicant for chemical generic drugs shall submit relevant documents to the National Drug Evaluation Agency within 10 working days upon receipt of the Judgement or Decision.

For the first chemical generic drug that successfully challenged the patent and was approved for marketing, a 12-month period of market exclusivity will be granted.

For chemical generic drugs, traditional Chinese medicines with the same name and same prescription, and biosimilar that have been approved for marketing, even if a dispute arises, they will not be cancelled, and the effectiveness will not be affected.