About 2 years ago, China implemented its patent linkage system. Geared towards helping foreign companies to bring new drugs to China and helping local Chinese generic companies promote their products, to date, about 30 patent linkage cases have been reviewed by the Chinese National IP Administration (CNIPA). Of these cases, about 10 supported the patent holder, seven supported the Chinese generic, and the remaining cases were pulled back.
Chinese generic manufacturers that submit for drug registration must report to the NMPA the status of the patented drug. Patent holders that think the generic application is not valid must appeal to the NMPA within 45 days. Normally, a contentious case leads to about a 9-month holding period. During this time, the NMPA will review the generic drugs technical file and try to come to a decision.