China launches test run of its new patent linkage registration platform: what you need to know

Following amendments to China's Patent Law in October 2020, China will shortly launch a new patent linkage system for pharmaceutical patents.  In order to use the system, holders of existing marketing approvals in China will need to register relevant patent information for their products on a drug patent registration platform.  On 18 May 2021, the China Center of Drug Evaluation ("CDE") released details regarding the drug patent registration platform and invited owners of marketing approvals for originator drugs to test the platform by registering their drug-related patent information on the platform.  The test run period is open until 31 May.  It is expected that the test platform will be transferred to the official registration platform as soon as, or shortly after, the patent linkage mechanism prescribed under the amended PRC Patent Law enters into effect on 1 June 2021.  The CDE has confirmed that those who participate in the testing can choose to have their test registrations published on the official registration platform after the system is officially launched.

Further information

The official website for the test run of the China Marketed Drug Patent Information Registration Platform is: https://zldj.cde.org.cn.  

Further comments and questions on the test platform can be sent to the CDE via email at: zhangxx@cde.org.cn, copying yjjdc@nmpa.gov.cn.  Email subject lines should be marked “China Marketed Drug Patent Information Registration Platform” for ease of recognition.

To be eligible for registering a drug-related patent for patent linkage, the originator drug needs to have obtained a marketing approval in China.  The eligible types of patents must be one of the following types:

  • chemical drugs: active ingredients, medical composition containing active ingredients, medical use;
  • biological products: sequence structure; and
  • Chinese herbal drugs: Chinese herbal extractions, Chinese herbal compositions, medical use.

The test platform and registration documents are provided in Chinese only, but the website contents and template forms are relatively easy to complete and are self-explanatory.  

Please find attached our unofficial in-house English translations of the template documents and registration instructions.  If you are interested in further exploring the test platform, would like us to assist you with this or have more questions regarding the forthcoming patent linkage system in China, please get in touch with our Hogan Lovells lawyers listed in this article.

Attachments:

Notice on matters related to the public testing of the patent information registration platform related to the early settlement mechanism of drug patent disputes

Instructions for filling out the registration form for patent information of listed drugs in China

Template for Patent information registration

Patent declaration disclosure template

Authored by Julia Peng and Andrew Cobden.

 

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