의약품 허가-특허 연계제도에 도입에 따른 시사점: KORUS FTA를 중심으로

Since the KORUS FTA re-negotiation was concluded on December 2010, the introduction of Drug Approval-Patent Linkage system has become the centre of public interest. The approval-patent linkage system was originally designed in order to protect patents' right. The patent owner shall be notified of the identity of any other person who requests marketing approval to entre the market during the term of patent. Consequently, this provision indicates that any pharmaceutical company which makes generics cannot have the permission of marketing its generics without approval of patent owner. WTO TRIPs does not include this provision, which means it is WTO TRIPs plus. The approval-patent linkage system was firstly introduced in the United States as a part of 'Hatch-Waxman Act', and Canada also adopted this system when joining NAFTA. This article analyses the process in the operation of this system and problems caused after the introduction of this system in the United States and Canada. In addition, any possible problems beought about after the entry into force of the KORUS FTA and the introduction of the approval-patent linkage system are discussed based upon the analysis of related provisions in the KORUS FTA to this system in chapter IV. Most of all, the structure of domestic pharmaceutical industry which mainly produce generics eventually leads to the loss on sale because of the delay of marketing approval. The introduction of the approval-patent linkage system is also sure to increase legal exposure to domestic generic producers. Therefore, this article suggests that the reform of domestic pharmaceutical industry, the establishment of data management system of the patent of material and an exhaustive and detailed enactment and amendment of the relevant law in order to effectively respond to any possible problems caused by the introduction of the approval-patent linkage system.