Tag Archives: Patent 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 …

Are purposes of the patent-approval linkage system achieved?

The linkage between patent status and drug approval process consists of two elements: notification and prohibition. The notification element refers to a mechanism in which a patentee is notified of the application of marketing approval of a generic product. The prohibition element refers to a mechanism in which a marketing approval of a generic product …

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 …

US Ambassador confirmed patent linkage under FTA includes biologics

One of the controversies in implementing the KorUS FTA is whether biological products are subject to the patent linkage obligation of the KorUS FTA. The debate was provoked by the Korean government’s proposal which applies the patent linkage to biologics. But it is unclear if the FTA text imposes such an obligation.  Chapter 18 (IPRs) has no definition …