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.
This drug patent linkage system is the only tool available to a new drug owner to delay approval of the corresponding generic drugs marketing approval process, as China does not provide new drug exclusivity (5 years for chemical, and 12 years for biologic) as in the US.
The equivalence of the US FDA in China is the China National Medical Products Administration, the NMPA.
This is the December 2021 version of this guide, as there have been many developments after my first July 2021 version that was finished on 19 July 2021, and my second October 2021 version finished on 14 October 2021.
This version has the following updates:
- Emphasis of non-existence of drug exclusivity in China.
- Inclusion of data in Dec 2021, including the number of entries in the "CN Orange Book", and patent linkage declarations filed.
- Drug patent linkage complaint situation in Dec 2021.
- A table showing differences between the US and China drug patent linkage systems in the appendix (special thanks to Carol Nielsen of Nielsen IP for providing the idea, and the review by Corey Salsberg of Novartis).
It is available at the link below:
UNOFFICIAL-CN-Orange-Book-user-guide-Dec-2021.pdf
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.