우리나라 제약산업 실정에 부합하는 한국형 허가-특허연계제도의 시행방안

Abstract

This article relates to study on the background of accepting Approval- Patent Linkage System in Korea and its enforcement plan coincide with Korean pharmaceutical industry. With the effectuation of the Korea-US FTA, so called Approval-Patent Linkage System became effective in Korea. In the early negotiation stage of Korea-US FTA, Korean government refused to accept the Approval-Patent Linkage System but the U.S. Government insisted to accept that system very strongly so Korea reluctantly accepted that system. As to Approval-Patent Linkage System, there are too many different view points. Someone says that Approval-Patent Linkage System will provoke the price hike of pharmaceuticals and resulted in a burden of medical insurance. On the other hands, another says that Korean Approval-Patent Linkage System will help generic drug manufacturers to enter the market more easily with Invalidation Trial of a Patent and Trial to Confirm the Scope of a Patent Right and, he expects, as a result the marketing penetration of generic drug will be accelerated. There could be different expectations on that system but unchangeable thing is the Approval-Patent Linkage System is already set up in our law in part and has to be brought into effect wholly by March 2015. This paper studied Hatch-Waxman Act which is the origin of Approval-Patent Linkage System and suggested desirable method to carry out this system in Korea.