역지불합의에 대한 경쟁당국의 제재 현황 및 시사점 - 미국 제약산업에 대한 규제 사례를 중심으로 한 비교법적 고찰 - = Current Regulation Trends and Implications on Pay-for-Delay - Comparative Legal Study based on U.S. Law and Cases -

다국어 초록 (Multilingual Abstract)

The expanding trends of active investment on innovative industries require strong intellectual property rights. In the same time, the market status where intellectual property rights are emphasized also raise questions on whether this market calls for anticompetitive regulations to acquire market fairness and to remove restraints on fair competition. Pay-for-delay settlement - or reverse payment settlement - could be referenced as a typical category of agreement between market players where strong rights of intellectual property rights are required and simultaneously, need for anti-competitive regulations are raised. The original pharmaceutical companies tend to willingly invest astronomical amount of R&D cost to invent original drug because this invention guarantees strong rights based on patent rights and discretionary authority to determine the market price and the amount of supply. Therefore, the original pharmaceutical companies are strongly attracted to expedient method to expand such exclusionary rights and decision-making power. These desires are realized as pay-for-delay settlement between original and generic pharmaceutical companies and actually prevent generic pharmaceutical companies from entering the pharmaceutical market by inventing generics. In the end, it effects end-customers by prohibiting them from purchasing cheaper medicines.
Therefore, the questions rises here, that whether the competition law and relevant regulations are appliable to the patent rights. This questions were actually traditional in the U.S. and EU authorities and they have been deciding on pay-for-delay practices based on certain standards of decision. Moreover, Korean competition authority and court also followed these regulation trend of the U.S. and EU on GSK&Dong-a case.
The first premise before responding above question should be whether the intellectual property rights and anti-competitive regulations can coexist in the same market. These two arena are easily being understood contradictory and incompatible. However, these two simultaneously pursue innovations and effectiveness of customers in the market. If this common purposes and goals are seriously considered, competition law and its relevant regulations are also applied to the area of intellectual property rights. As a result, unlawful - or anticompetitive- execution of intellectual property rights are not allowed to actually promote fair, active and valid competition, leading to follow-up and new innovations in the market.