Reforming Patent Approval Linkage

Reforming proposals for the existing patent-approval linkage system

Abstract In order to implement the Korea-US FTA, the drug approval-patent linking system was introduced in the Pharmaceutical Affairs Act on March 15, 2015. Five-years implementation experience has provoked discussion for reforming the linkage system, and the government-led discussion focuses on procedural reform and the problems revealed in the operation of the system. However, since …

Patent Linkage and its Reform

The US has disseminated TRIPS-plus rules through FTAs. One of them is a so-called drug approval and patent linkage system. South Korea imported the linkage system in 2012, and the Korean model was fully implemented from March 15, 2015. After four-year experience, the Korean government, specifically the Ministry of Food and Drug Safety, tries to revise the linkage system. Still we don’t …