한·중 FTA와 의약품 허가특허연계제도: 비교법적 고찰을 중심으로

Currently, China is the world's third largest phamaceutical market and it is expected that this will be World's No. 1 in 2015. The pharmaceutical industry in China is growing rapidly especially focusing on generics where there is no particular global phamaceutical company. While favorable policies to promote its domestic enterprises, China has been increasing regulatory barriers to foreign companies. This happens in generic market as well. The system has been established, however, it is not properly working in the light of the purpose of the implementation. In order to target the China's generic phamaceutical market, in the wake of Korea-China FTA, it may be one of the possible ways to gurarntee the enforceability by aligning China's systemic level with Korea's level. In such a process, there is in need of a Korea-China FTA negotiations with regard to patent linkage system by analyzing the pros and cons thoroughly which has been already reflected on the Pharmaceutical Affairs Law. However, there is no sufficient research and analysis of 'patent linkage system' included in China's pharmaceutical legislation. Therefore, this paper analyzes the relationship between generic pharmaceutical products approval and articles related to Patent, and also examines current operating satus. Especially after comparing judicial review of 'patent linkage system' that is introduced in the Pharmaceutical Affairs Law via Korea-US FTA, it draws some implication for the negotiation of Korea-China FTA.