역지불합의에 대한 공정거래법의 적용에 관한 연구- 우리나라와 미국의 판결례 분석을 중심으로 -

A Study on Criteria for Evaluating Legality of a Reverse Payment Settlement under the Korea Monopoly Regulation Act

초록

The reverse payment settlement partly induced by a unique drug approval-patent linkage scheme under the Hatch-Waxman Act (1984) has been a hotly debated topic in the American antitrust jurisprudence. Both the Korea Supreme Court and the United States Supreme Court recently rendered a decision on criteria for evaluating the legality of a reverse payment settlement under their competition law regime. The United States Supreme Court in Actavis made it clear that the rule of reason, not the scope-of-the-patent test, is the proper standard to review reverse payment settlements under the United States antitrust law. The Korea Supreme Court seemed to be influenced by Actavis and also adopted a similar approach to the reverse payment settlement between GSK and Dong-Ah Pharmaceutical Company. Those decisions can provide a useful guidance with regard not only to law enforcement against reverse payment settlements but also to broader issue of the interplay between the intellectual property right and the competition law. Also, in light of the fact that a drug approval-patent linkage system is scheduled to be put in force in 2015 in accordance with the Korea-US Free Trade Agreement, a great amount of care should be given to the policy rationale underlying the decisions in designing the system. Lastly, the section 59 of the Korea Monopoly Regulation Act should be on a careful review to be deleted, since it causes unnecessary ambiguity in the course of competition law enforcement against anti-competitive practices involving intellectual property rights including patents.

키워드

reverse payment settlementHatch-Waxman Actintellectual property right and competition lawdrug approval-patent linkagegeneric drug competitionActavis decisionSection 59 of the Monopoly Regulation Actjust exercise of intellectual property rights역지불합의해치왁스만법지식재산권과 경쟁법의약품 허가-특허연계제복제약경쟁Actavis 판결공정거래법 제59조지식재산권의 정당한 행사
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역지불합의에 대한 공정거래법의 적용에 관한 연구- 우리나라와 미국의 판결례 분석을 중심으로 -
제목 (타언어)
A Study on Criteria for Evaluating Legality of a Reverse Payment Settlement under the Korea Monopoly Regulation Act
저자
이호영
발행일
2014-00
저널명
경영법률
24
4
페이지
399 ~ 432