특허권자와 복제약 사업자의 역지불합의에 관한 연구 - 관련 미국판례와 공정거래위원회의 개정 심사지침을 중심으로 -

This article relates to study on reverse payment agreement between patent holders and generic drug manufacturers, especially focused on related American cases and revised guideline of Korean Fair Trade Commission. On December 13, 2011, Free Trade Agreement between the Republic of Korea and the United States of America(here in after, refer to as 'Korea-U.S. FTA') was ratified by the House of Representatives and the Senate of USA respectively, therefore, the only thing remained to be in effect of the agreement is ratification of Korean National Assembly. Among Korea-U.S. FTA, the most arguable issue is approval-patent linkage system. The Hatch-Waxman Act established a regulatory framework that sought to balance incentives for continued innovation by research based pharmaceutical companies and opportunities for market entry by generic drug manufacturers. However, because of reverse payment agreement between patent holders and generic drug manufacturers, approval-patent linkage system under Hatch-Waxman Act tend to not work effectively. Then, reverse payment agreement between patent holders and generic drug manufacturers are against Antitrust Law? We don't have any case about that question, but the courts of United States have lots of cases as to that question. For example, one court of appeals found that kind of agreement to constitute a per se antitrust violation. Other courts have found that kind of agreement to be legal, in part based on the reason that agreement as to patent fell within the patentees' exclusionary right. In this article, I set forth my thoughts on how to balance the role of Antitrust Law and the patent property right given to patentee by Patent Law, and suggested the way to practice 'approval-patent linkage system' more effectively in Korea without the same trial and error in States through studying of related American cases.