제약시장에서의 역지급합의에 대한 경쟁법 적용에 관한 연구 = Regulating the Reverse Payment Agreement In the Pharmaceutical market

다국어 초록 (Multilingual 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 (Reference)

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