The introduction of substance patents in 1987 was viewed with apprehension as it was believed that the system would only reinforce the domination of the technology of advanced countries based on the trade agreement between Korea and the USA. However, substance patents provided the Korean pharmaceutical industry with the driving force required to develop new substances, and the Korean pharmaceutical industry has been constantly improving its research and development capability. The patent-approval linkage system was implemented according to the Korea-US Free Trade Agreement in 2015. The system comprises the following: registering the drugs in the Green List, notifying the listed patent and marketing approval holders about the application for generic marketing approval, patent holder's request for staying generic sales and first generic exclusivity. Korean generic companies are expected to have opportunities that enable them to challenge the global market by accumulating experience of designing of generic products, making patent challenges and strategically developing of new drugs or incrementally modified drugs through the linkage system.
Keywords: FTA; IMD; R&D; first generic exclusivity; generics; new drugs; patent trial; patent-approval linkage; stay of generic sales; substance patents.