China Drafts Patent Linkages Regulations, Seeks to Boost Protections for Patent Holders

Moving to better its system for settling patent disputes while also providing generic drugs a market pathway, Chinese authorities in September issued a draft policy addressing the relationship between market approval of generic drugs and the patent status of branded equivalents.

The draft Patent Linkage Measures issued by the National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA) would delay approval for a generic until the patent term on the branded equivalent has expired, or until the relevant authority has determined the branded drug’s patent will not be infringed or is invalid.

The draft regulations would cover chemical drugs, biologics, and traditional Chinese medicines. They would codify in regulatory language and bolster protections rarely enforced by Chinese authorities in the past.