Abstract
The equivalence of the US Orange Book in China, the "CN Orange Book" has been operating since 29 June 2021. This "CN Orange Book" is a mountain full of treasures, for example clear indication on what claim is covering which subject matter in a particular drug patent. This "unofficial" user guide aims to provide foreigners information on how to navigate this "CN Orange Book", which operates in Chinese.
* * * * * * * * * *
In the US, the Orange Book is a publication from the US FDA that identifies drug products with marketing approval from the FDA and related patent and exclusivity information. Information in the Orange Book could be used in actions under the Hatch-Waxman Act, which allows a patentee to file an artificial act of infringement that allows the drug innovator to file suit before the generic drug is commercialized, such that the drug marketing approval process of the generic drug at the US FDA could be suspended.
China is required to introduce a similar system under the Phase-I trade agreements signed with the US in January 2020. I have been following this since then, and have several articles and posts on this topic. Recently, this "CN Orange Book" (official name: China listed drugs patent information registration platform) has become officially online on 29 June 2021, with many developments thereafter, and I have received many questions on how to use this. This motivates me to write this "unofficial" user guide, mainly for foreign users. This user guide may need updates periodically as things are changing too fast in China.
The equivalence of the US FDA in China is the China National Medical Products Administration, the NMPA.
This is the October 2021 version of this guide, as there have been many developments shortly after my first July version was finished on 19 July 2021.
Click here to continue reading . . .
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.