China Patent Linkage Update – The Patent Registration Platform Is Finally Launched!

25 May 2021

China patent linkage update – The patent registration platform is finally launched!
 

On 18 May 2021, the Center for Drug Evaluation (“CDE”) of the National Medical Products Administration (“NMPA”) formally launched the Chinese Marketed Drug Patent Information Registration Platform (https://zldj.cde.org.cn) (the “Patent Platform”).
 

The Patent Platform is a completely new website, and is available for public testing until 31 May 2021 (see an accompanying notice of CDE for the Patent Platform (the “Notice”)). The CDE is also seeking public consultation on the Patent Platform during the testing period.
 

According to the Notice, the CDE is encouraging market authorization holders (“MAHs”) to participate in the testing of the Patent Platform. The registered/recorded patent information for chemical, TCM, biologic drugs provided/uploaded during the testing period will be published after further confirmation from the MAH after 1 June 2021. MAHs are required to ensure the truthfulness, accuracy and completeness of the registered information.

The Patent Platform provides three modules – patent registration, patent information publicity, and patent certification. The patent registration module is used to register the patent information, and the public can search the registered patent information and the patent certifications of generic MA applications.
 

The Notice also contains the following templates:-
 

• Appendix I: Template Form for Chinese Marketed Drug Patent Information Registration (the “Patent Template Form”)

• Appendix II: Form Completion Guide for Chinese Marketed Drug Patent Information Registration (the “Form Completion Guide”)

• Appendix III: Patent Certification Publication Template
   

Patent Template Form and Form Completion Guide
 

The Patent Template Form contains the basic information to be completed, including the MAH, drug type, basic information of the drug (drug generic name, dosage form, specification and MA number), basic information of the patent/s (patent number, title, patentee, grant date, copies of patent certificate and grant document, the relationship of MAH and patentee, simple information on patent claims mapping to the drug), contact information of the MAH (contact person, phone number, email address and postal address), and a declaration (the “Declaration”).
 

It is important to note that more than one patent can be registered for a drug and more than one claim mapping to the drug can be included. For the simple claims mapping, only the claim no., patent type, expiry date, and status (valid, expired or invalid) have to be specified.
 

Please note that according to the Patent Template Form and Form Completion Guide, indication patents for biologics can also be registered on the Patent Platform. This had not been included in the previous draft Patent Linkage Implementation Measures issued by NMPA and China National Intellectual Property Administration (“CNIPA”) in September 2020.

The Form Completion Guide provides more information on the types of patents that can be registered and specifically states that intermediate, metabolites, crystal form/polymorph, manufacturing process, and detection method are NOT eligible for registration. The patents that can be registered on the Patent Platform are:
 

• Chemical drug – API compound patent, formulation patent, and medical use patent;

• Biologic – API sequence patent, and medical use patent; and

• TCM – formulation patent, extract patent, and medical use patent.
   

The Declaration states that the contact information of the MAH will be used for the service of court/administrative documents and the patent certification of generic drugs to be completed for ANDA. The MAH has to undertake to update the contact information on a timely basis, otherwise the service of documents to the original contact information contained on the Patent Platform will be deemed as good service. In addition, service on the MAH will be effective on the patentee and licensees (if applicable), and if the MAH and the patentee are not the same person, the MAH must have a written authorization from the patentee. The MAH is required to keep the served documents properly.
 

Patent Certification Publication Template

Patent Certification Publication Template contains a form to be published on the Patent Platform, containing information of a generic drug (drug name, acceptance date, drug type, registration classification and applicant), originator drug (MA number and MAH), the patent certification and acceptance date. It also attaches a Patent Certification Form, to be completed by a generic applicant.

The Patent Certification Form contains the information of a generic drug (drug name, drug type, dosage form, specification, applicant, postal address, contact person, contact number and email address) and the information of the originator drug (drug name, MA number, MAH, registration number on the Patent Platform, registered patent number, registered claim no., the category of patent certification, and remark).

The patent certification categories are:-:
 

• Category 1 – No “Originator Patent” (originator patent/s registered on the Patent Platform);

• Category 2 – The Originator Patent has expired or been invalidated, or the generic applicant has obtained a patent licence;

• Category 3 – The generic applicant undertakes not to sell the generic drug before the expiry of the Originator Patent;

• Category 4.1 – The Originator Patent should be invalidated;

• Category 4.2 – The generic drug does not fall within the scope of Originator Patent.
   

A significant change in the Patent Certification Form is that a generic applicant must notify the MAH of the patent certification within 10 working days upon the acceptance of the generic drug MA application. The generic applicant has to send and email the documents to the MAH as per the contact information contained on the Patent Platform. The generic applicant is required to keep the relevant documents properly.
 

Alison Wong, Partner, Bird & Bird