"Unofficial" CN Orange Book User Guide For Pharmaceutical Patents

Abstract

The equivalence of the US Orange Book in China, the "CN Orange Book" has been operating since 29 June 2021. This "CN Orang 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.