China update: “Orange Book”- type patent register established as trial version. A start into the new Patent Linkage System


We have recently reported on the major upcoming changes for pharmaceutical patent owners in accordance with the 4th amendment of the patent law which establishes a patent linkage system and patent term extensions (PTEs) in China.

Now a further step has been taken by the responsible authority to establish the necessary Drug Patent Information Record Platform. On May 18 the Center for Drug Evaluation (“CDE”) of the National Medical Products Administration (“NMPA”) made a trial version available. The database in trial version can be evaluated until May 31.

While this is a preliminary version and opened for public comments first, it can be expected that the final database will not be much different. Further details can be found below.

On the CDE website link marketing authorisation holders can enter the respective patent information using a Patent Information Registration Form. The also published Instructions for Filling out the Registration Form for Patent Information of Listed Drugs in China provide valuable information on the newly created system, such as:

  • Types of patents that can be registered:
    1. for chemical drugs: Active pharmaceutical ingredient (API) compound patents; composition/formulation patents and medical use patents;
    2. for biologics: API patents (relating to sequences) and medical use patents; and
    3. for traditional Chinese medicines (TCM): composition/formulation patents, TCM extract patents and medical use patents

(note: other patents are specifically mentioned to be excluded from registration, such as patents for intermediates, metabolites, crystal forms, preparation methods or detection methods which are specifically mentioned.)

  • Numbers of patents registrable per drug:

There is no limitation on the number of patents that can be registered for each drug. The information needs to be consistent with the relevant information in the patent register and pdf documents need to be uploaded.

(note: Where the marketing authorisation holder (MAH) and patentee are not the same the relationship between the two needs to be stated and authorisation from the patentee be provided. In this regard it is important to note that all legally relevant documents from courts or administrative enforcement authorities will be send to the registering MAH and not the patentee. It is therefore a must to keep the contact information updated and ensure fast cooperation between MAH and patentee to utilise the new patent linkage system.)

As can be seen from the above it may be important to gather all relevant information timely, consider the status and authorisation of the MAH with regard to the patents and to establish new procedures within regulatory and legal functions in China.

Besides the module to register patent information corresponding to existing originator marketing authorisations, it also includes modules for the public to view registered patent information as well as patent relevant declarations of generic marketing authorisation applicants.

In this regard it is important to recognise that generic marketing authorisation applicants need to provide a Generic Applicant Declaration Form which is also provided by CDE as a template on the website.

As can be seen generic applicants need to state the category of the patent declaration status under which they apply, such as:

Category 1: Patent information related to originator drugs is not included in the Patent Information Record Platform for listed drugs in China.
Category 2: Patent information for listed drugs in China identify the patent rights related to the originator drugs included in the Patent Information Record Platform have been terminated or declared invalid, or the applicant of the generic drug has obtained a patent license from the patentee.
Category 3: The Patent Information Record Platform contains patents related to the originator drugs, and the generic drug applicant undertakes that the generic drugs applied for will not be marketed before the expiration of the corresponding patent rights.
Category 4.1: Patent rights related to the originator drugs included in the Patent Information Record Platform for listed drugs in China shall be declared invalid; or
Category 4.2: the generic drugs do not fall into the scope of protection of patent rights related to originator drugs included in the Patent Information Record Platform for listed drugs in China.

It is important to note that the generic applicant undertakes to be responsible for the authenticity and accuracy of the relevant statement. Within 10 working days after the generic application for chemical drugs, TCMs with the same name and the same prescription or biosimilar drugs are accepted, the applicant is obliged to notify the marketing authorisation holder of the statement on the category and the grounds for the statement.

In view of short deadlines the originator that has registered the relevant patent information must ensure to be quickly and spurred into action by the MAH once a generic applicant makes a statement under category 4. As the generic applicant needs to provide its statement additionally by email, the MAH’s registered email address needs to be updated at all times.

We will keep you posted on further developments on the patent law reform details in this field as they come along noting that June 1, 2021 is the effective date of the revised patent law. Please reach out to us if you have further questions.

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