제약시장에서의 역지급합의에 대한 경쟁법 적용에 관한 연구
Regulating the Reverse Payment Agreement In the Pharmaceutical market
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초록
역지급합의와 관련하여 만일 우리나라에서 미국과 같은 제도가 도입되고, 이에 따라 사업자들이 전략적 행위로서 역지급합의를 하는 경우에는 공동행위로 파악될 것이라고 보았다. 그리고 공동행위심사기준이 경성공동행위와 연성공동행위를 구분하고 있는 바, 이중 경성공동행위에 해당될 것이라고 보았다. 부당성의 판단을 하는 것과 관련하여 특허법이 관여되어 있고, 특허권의 속성을 감안하면 마치 미국에서 기술시장의 경우 당연위법의 원칙을 적용하는 판례인 사안에서도 예외적으로 합리의 원칙을 적용하는 예가 있는 것처럼 달리 판단할 여지가 없는지를 살펴보는 것은 향후 입법이 이루어진다면 입법과정에서 사전적으로 검토하여 이러한 공정거래법상 문제를 최소화하는 방향으로 입법이 이루어져야 할 것이다.
Abstract
In the event KORUS FTA will be approved by each countries Congress, Korea has to revise the Drug Act for the purpose of implementing the FTA, a bilateral treaty between Korea and United States. If then, same problem in US re reverse payment agreement will be a legal issue in Korea based upon the same provision on the 180 days exclusivity for the protection of the first filer of the ANDA to KFDA. The standard of the Court re reverse payment agreement is not decisive even in United States whether rule of reason or per se illegal scrutiny has to be applied as of today. In case of Korea reverse payment agreement will be classified as a sort of hardcore cartel behavior, considering the context of the Korean FTC's guideline looks like and the nature of the reverse payment agreement thinking of how it works between the original drug manufacturer, the patent holder and generic drug manufacturer, the first ANDA applicant. In accordance with the Korean FTC's guideline, once reverse payment agreement decided as a part of hardcore cartel, then no market analysis has to done by Korean FTC. This situation means it will be hard to be justified in Korea to reach an reverse payment agreement. However any special treatment for the protection of the patent holder in order to facilitate the new drug innovation has to considered in the process of legislation for both ends meet as was the same case when Hatch-Waxman Act was made.
참고문헌 (14)
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