China’s Patent Linkage System - Patent information registration platform now available for testing

On 18 May 2021, China’s Centre for Drug Evaluation (CDE) issued a Notice on the Public Testing of the Early Resolution Mechanism of Drug Patent Dispute Related Patent Information Registration Platform (Notice). This official launch of the testing of the patent information registration platform for drugs marketed in China marks another substantial step forward in the implementation of a patent linkage system in the China.

The testing period for the patent information registration platform will take place from 18 May 2021 to 31 May 2021. Feedback should be sent to: [email protected], cc [email protected].

The platform, available at https://zldj.cde.org.cn/home, offers three search options: searches conducted by drug name, patent number, and company name. In addition, the platform also allows brand-name drug companies to register the relevant patents of drugs marketed in China, and also provides comprehensive search engines for registered patent-information and patent declarations.

Importantly, the Notice has three appendices providing a “patent information registration template”, “instructions on filling the form for registration of patent information of drugs marketed in China” (Instructions), and a “patent declaration disclosure template and format” (Template and Format).

According to the Instructions, the information to be filled in by brand-name companies includes:

• The name of the drug marketing authorisation holder;
• Drug type (e.g. Traditional Chinese Medicine (TCM), chemical drug, biological product);
• Common name of drug;
• Dosage form;
• Specification;
• Approval document number / registration certificate number;
• Patent information (can include information of multiple patents):
  • Relevant patent number;
  • Patent name;
  • Patent right holder;
  • Licensee (optional);
  • Grant date of the patent;
  • Patent right certification; and
  • Relationship between the drug marketing authorisation holder and the patent right holder;
• The corresponding relationship between the relevant patent claims and the drug. For one patent, multiple claims for the drug can be specified:
  • Claim number;
  • Type – for a TCM, the options are TCM composition patent, TCM extraction patent, medical use patent; for a chemical drug, the options are active pharmaceutical ingredient (API) compound patent, composition patent comprising the API, and medical use claims; for a biological product, the options are the active ingredient sequence structure patent, and medical use patent. The relevant patent does not include patents such as intermediate products, metabolites, crystal forms, preparation methods, and test methods;
  • Patent protection expiration date;
  • Status (valid, expired, invalid);
  • Note (optional);
• Contact person;
• Contact phone number;
• Email address; and
• Declaration that the information uploaded to the platform is true and accurate; acknowledgment that the contact information can be used in legal or administrative proceedings, and that the registration will be updated if there are any changes in contact information, etc.

The Template and Format further clarifies that in the patent declaration category, Category 4.1 indicates that the relevant patent has been invalidated. Category 4.2 indicates the generic drug does not fall within the protection scope of the relevant patent. Also, a new drug applicant has a duty to inform the brand-name drug marketing authorisation holder of the declaration and the supporting evidence within ten business days after the acceptance of an application of a Generic/TCM with the same name and prescription/Biosimilar. In addition to mailing the paper copy of the declaration and the supporting evidence, the applicant is also required to deliver the declaration and the supporting evidence to the brand-name drug marketing authorisation holder via the email address on the patent information registration platform.

Link to the Notice here.

For more information on the Notice, contact your regular CMS adviser or local CMS experts.