The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) launched a patent information registration platform for public testing of drugs approved in the People’s Republic of China (PRC).[1] The CDE further specified 1) patents eligible for the registration; 2) the deadline for generic applicants to submit a patent declaration; and 3) the four types of patent declarations.
The platform allows registration of compound patents, composition patents, and use patents of a drug marketed in the PRC. However, patents claiming intermediates, metabolites, crystalline forms, preparation methods, or detection methods are not eligible for the platform registration.[2]
A generic applicant will have 10 days from the receipt of their marketing approval application to provide a notice of patent declaration to the marketing approval holder of the relevant innovative drug.[3]
The four types of patent declarations specified by the CDE are similar to the corresponding paragraph I-IV certifications to the Food and Drug Administration (FDA) in the United States, as summarized below.
| Type | CDE Patent Declaration[4] | FDA Patent Certification[5] |
| 1 | That the relevant patent information has not been registered. | That the patent information has not been submitted to the FDA. |
| 2 | That the relevant patent has expired or been invalidated, or the generic applicant has a license for the relevant patent. | That the patent has expired. |
| 3 | That the relevant patent information has been registered, but the generic applicant promises that the generic drug will not be marketed before the date that the relevant patent will expire. | The date on which the patent will expire. |
| 4 | Type 4.1: That the relevant patent should be invalidated. | That the patent is invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of the drug product for which the abbreviated new drug application (ANDA) is submitted. |
| Type 4.2: That the relevant patent will not be infringed by the generic drug. |
[1] The CDE of the NMPA issued the Notice on the public testing of the platform for registration of patent information related to the mechanisms for early resolution of drug patent disputes and other related matters (the Notice) on May 18, 2021. The Notice includes 1) an instruction for the form of registration of patent information of approved drugs in the PRC (the Instruction); 2) a template of patent information registration; and 3) a template of patent declaration, http://www.cde.org.cn/news.do?method=largeInfo&id=464a59511b09ddfc. See https://zldj.cde.org.cn/home for the official website of the platform.
[2] The Instruction, § 8.
[3] The template of patent declaration.
[4] Id.
[5] 21 C.F.R. 314.94.