의약품 허가-특허 연계제도와 특허법의 조화

The approval-patent linkage system

The approval-patent linkage system was firstly introduced in the United States as a part of 'Hatch-Waxman Act'. so this paper analyses the process in the operation of this system and problems caused after the introduction of this system in the United States. and any possible problems brought about after the entry into force of the KORUS FTA. In this paper I examined articles of KORUS FTA concerning about medicines, and examined what should be prepared to satisfy these articles by Korean government. For this purpose I looked into the patent law containing the article 96 and the pharmaceutical affairs law containing the approval-patent linkage system. Finally I suggested some ideas which would be necessary for amendment to minimize the damage to Korean pharmaceutical industry caused by KORUS FTA and to support Korean pharmaceutical industry for the development.