This was opened on 18 May 2021 (http://www.cde.org.cn/news.do?method=largeInfo&id=464a59511b09ddfc). The test is to be ended on 31 May 2021.

This is related to the drug patent linkage system, which was reported in my article below:

https://www.linkedin.com/pulse/chinas-draft-patent-linkage-implementation-method-public-toby-mak/?lipi=urn%3Ali%3Apage%3Ad_flagship3_profile_view_base_post_details%3BvA97KIhJQ2%2BoXaoS0dosSA%3D%3D

This is similar to the Orange Book in the US.

I have tried https://zldj.cde.org.cn, but it seems there is no option to register as a new user for trying the system…… I am not sure how the test, which would finish testing on 31 May 2021, could be done.

I also have the following observations, which are from the explanatory notes (“中国上市药品专利信息登记填表说明.pdf”):

1)    Drugs are divided into three types (as already specified in the draft resolution mechanism in Sep 2020, and see my article above for details), Chinese medicine, chemical drug, and biological drug, with the following registrable matters:

  • Chinese medicine – Chinese medicine composition, Chinese medicine extraction, and medical use
  • chemical drug – active ingredient chemical compound, pharmaceutical composition comprising chemical active ingredient, and medical use
  • biological drug – sequence structure of active ingredient, and medical use.

While it is encouraging to see that medical use patent (in Swiss type claim format, as the CNIPA does not allow method of treatment claims) is now opened for registration for biological drugs, it is disappointing to see that biological drug pharmaceutical composition is still out.

2)    The notes specify that “not including patents directed to intermediates, metabolite, crystal form, method of manufacturing”. It is unclear whether a patent is excluded from the registration by merely containing such subject matters. It is typical that, for example, a patent directed to the crystal form also has claims directed to pharmaceutical compositions.

3)    Licensees could be registered. However, it is unclear whether a simple registration (recording the licensee's name) is sufficient, or further proving document/information is required.

4)    Patents that could be registered include those that have lapsed and declared invalid. As mentioned before, I believe these refer to those with their status announced by the CNIPA (the CNIPA will only do so after the status become final). While it is understandable that the user (drug registrant) should update the status of their patents in the database in good time after registration, it is unclear whether such lapsed and invalid patents must be registered when doing a new entry.

 I have emailed the NMPA to ask for clarification on points 2) to 4) above. Let's stay tuned.

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