한미 FTA 의약품 허가 - 특허 연계제도 도입으로 인한 관련법 개정 및 그 영향에 관한 고찰 -

Because the patent register listing of patented medicines with Korea-US FTA compulsory effectuation affects the marketing and sale prevention system and incentives on the drugs challenging patents, the patented drugs must be registered list due to the consistent review criteria for the listing. It is very important to refer to the case of the United States and Canada with experience in the implementation of this system. The protection of intellectual property in the pharmaceutical industry is being used as an important tool for the recovery of huge R&D funds because of needing huge R&D funding and long-term investment concerning drug development by comparison with other business sectors. In that regard, the United States as a distinguished country with development of original drugs will try to get the most out of patent-drug approval linkage system to elevate the highest market share. Also the controversial debates on the evergreening strategy of dominant pharmaceutical producers may be spread widely and highly. Although the patent-drug approval linkage system is at a level to be a threat to our domestic pharmaceutical industry, we'll have to make systematic efforts to minimize the damages that can occur as a result of the introduction of patent-drug approval linkage into the domestic market.