의약품 특허분쟁상 역지급합의에 대한 경쟁법상 문제

Recently, reverse payment agreement that appeared as part of the settlement agreement in the pharmaceutical patent litigation has been studied on the important issues of competition law in such Europe and the United States including the Korea. Reverse payment patent settlements are situations where patent holders agree to make a payment to potential competitors who have threatened to enter the market and challenge the patent holders' right to the patent, thereby delaying the point at which the competitor enters the market. If there are elements that restrict competition in reverse payment agreements, regulations on competition law against this is an important problem. Competition law issues of reverse payment agreement after all, is one of the problems of the relationship setting and competition law and patent rights. Basically patent's right to have the exclusivity. However, although the exercise of these patent rights there is a limit of the implicit right, but that it is very legitimate exercise of the rights. In other words, in the case of legitimate exercise of patent rights, there is no application of the competition law. Competition law must be applied to this in the case of exercise departing from the true scope of the rights that are granted on a law. However, regulations on competition law against this must be careful because the case of reverse payment agreement are a new law issues that arise recently. In principle reverse payment agreement must determine the presence or absence of its illegality by rule of reason. However, reverse payment agreement as a matter of law on patent rights is considered to be divided into three category. First, it is an act corresponding to the exercise of legitimate patent. Secondly, it is of course illegally appropriate action. Third, specifically illegality, that is, it is action that must review the propriety of the competition restrictive. At least ① such reverse payment agreement if the competition restriction content was out of the range of apparently patent rights (for example, even after the expiration duration of a patent, the generics promise not to enter the market) is clearly violation of competition law. And, ② If patent owner aware their patent rights are an invalid, such reverse payment agreement is clearly violation of competition law. There is a need for a detailed guidance for the reverse payment agreement. Guidance for the reverse payment agreement must be able to determine its competitive restrictive more easily when determining the reverse payment agreement by the Fair Trade Commission or by the lower court.