중국 의약품 허가특허연계제도의 구축과 시사점

Establishment and Implications of Drug approval-Patent Linkage System in China

The introduction of China s drug approval-patent linkage system will have a significant impact on Korean companies from a long-term perspective. The pharmaceutical industry is an industry that cannot exist without protection from intellectual property rights. With the growing demand for geriatric care due to aging and the growth of the emerging markets for pharmaceuticals, the U.S., Europe and Japan are trying to strengthen the competitiveness of their industries by strongly protecting drug inventions. The largest drug market is by far the United States, but China is emerging as a new market. However, despite the various efforts, it is still difficult to implement the drug approval-patent linkage system in China, so it is difficult to realize the goal of fully resolving patent disputes in advance. Through the analysis of the Chinese drug approval-patent linkage system, this paper seeks to examine the problems of the current Chinese drug approval-patent linkage system and explore ways to resolve and prevent patent disputes related to medicine in advance before the release of generic drugs in China.