Amendments to Chinese Patents Law for the Life Sciences
On June 1, 2021, the fourth amendment of the Chinese patent law went into effect. The amendment contains generally applicable provisions and makes specific changes to design patent law and Life Science-related patents.
Alongside this, the Chinese National Intellectual Property Administration (CNIPA) issued revised patentability guidelines in January 2021 directed to patent prosecution in the Life Sciences.
Fourth amendment – linkage system
The fourth amendment creates a linkage system for patent listing and pre-approval adjudication of patent claims, similar to the Hatch Waxman system in the US, and involving the National Medical Products Administration (NMPA) and CNIPA. The law also creates a patent information platform for marketed drugs, similar to the US orange book, and introduces patent term extension for regulated drugs.
Marketing authorisation (MA) holders, typically the patent owner or licensee, can now list patents in the platform for chemical drugs including patents directed to the active ingredient, formulations containing the active, and medical uses.
The platform also allows for listing of patents related to biologics and traditional Chinese medicines. Listed patents can include the active ingredients and medical uses for biologics; and new formulations, methods of extraction, and medical uses for traditional medicines. The MA holder is responsible for authenticity, accuracy and completeness. While the law implies an ability to challenge listings, there is no particular mechanism in place for doing so.
“China continues to adopt patent laws more consistent with other countries to create more confidence in its IP system.”
Applicants for approval of generic chemical drugs (but not biologics and traditional medicines) must certify that:
