News flash - Patent Linkage Implementing Measures came into force in China on 4 July 2021
On 4 July 2021, the National Medical Products Administration (the “NMPA”) and the China Intellectual Property Administration (the “CNIPA”) published the “Implementing Measures for Drug Patent Dispute Early Resolution Mechanism (Trial for Implementation)” (the “Patent Linkage Implementing Measures”), which came into effect immediately. On the same day, the NMPA issued the “Notice for the Implementation of the Patent Linkage Implementing Measures (No.46 of 2021)” (the “Notice No.46”), confirming that on 4 July 2021, the China Marketed Drug Patent Information Registration Platform (the “Patent Platform”) was fully operational.
The Patent Linkage Implementing Measures apply to chemical drugs, biologics and Traditional Chinese Medicine (the “TCM”). The key provisions in the final Patent Linkage Implementing Measures are set out below:
1. Patent registration
A marketing authorisation holder (the “MAH”) must register the patent information on the Patent Platform within 30 days upon obtaining the marketing authorisation (“MA”) certificate in China. The registered patent information must be kept up-to-date and any changes to the patent information must be recorded within 30 days. The registered patent information includes the drug name, dosage form, drug specification, MAH, patent number, patent title, patentee, licensee, patent grant date, patent expiry date, patent status, patent type, claim mapping and contact information, etc.
Only granted patents can be registered on the Patent Platform. The following types of patents are registrable:
- Chemical drugs – API compound patent, composition (containing API) patent, and medical use patent;
- Biologics – sequence patent, and medical use patent;
- TCMs – composition patent, extract patent, and medical use patent.
Medical use patents must be consistent with the indications in the approved drug monograph. Patents for intermediates, metabolites, crystal forms/polymorphs, manufacturing processes, and detection methods are NOT eligible for registration. The MAH is responsible for the truthfulness, accuracy and completeness of the registration information, i.e. the information should be consistent with the MA approval, patent certificate and the patent scope should cover the approved drug.
The public can view the registration information on the Patent Platform (and any changes thereto). It appears that the registered information can be opposed, though the Patent Linkage Implementing Measures do not state how such opposition will be presented. The MAH must deal with the opposition promptly.
The Patent Linkage Implementing Measures have not expressly addressed the timing for filing of the patent information for drugs approved before 4 July 2021. However, according to the Center for Drug Evaluation (“CDE”) of NMPA’s “Notice on the Testing of the Patent Platform” (18 May 2021) and “Advance Notice on Ending the Testing of the Patent Platform” (25 June 2021), and NMPA’s Notice No.46, the patent information of approved drugs can be registered on the Patent Platform (some have already been registered and…
