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
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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.
Abstract
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.
참고문헌 (33)
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