The Localization of Drug Patent Linkage System in China: Where Should It Go?

The improvement of drug accessibility needs to be promoted by both drug innovation and drug imitation. Given the current situation in China where both the quantity of drug innovation and the quality of imitation need to be improved, China’s drug patent linkage system should primarily aim to promote competition in the drug market and take the elimination of potential competition-restricting effects as the basic orientation for improvement. NMPA and CNIPA can address the issue of “evergreen patents” by conducting substantive reviews of patent information and punishing deliberate improper registration of patent information. To prevent the abuse of the approval waiting period system, in substantive law, it is necessary to further clarify the constitutive elements of liability for damages caused by the abuse of the approval waiting period system; in procedural law, parties initiating litigation (or requesting an adjudication) may be required to provide guarantees. Regarding the issue of reverse payment settlement agreements, it is necessary to add provisions of the expiration of the exclusivity period for the first generic drug and the record review of reverse payment settlement agreements. For reverse payment settlement behaviors that harm social public interests, the people's procuratorate shall initiate civil public interest litigation.