역지급 합의의 규제에 관한 연구

Reverse payment is a payment by original pharmaceutical firms to generic firms on conditions that the generic firms would delay their entry into market. Reverse payment has been a hot topic in antitrust because of the Hatch-Waxman Act. Because of the Korea-U.S. FTA, Korean government would adopt a similar approval-patent linkage system. It is unprecedented that there are many supporting opinions on applying the per se illegality or the standard of exclusiveness on patents on reverse payment, even though the anti-competitiveness of reverse payment is not clear. For applying rule of reason, we consider several market structure elements, by assessing the market power and the possibility of other generic medicine manufacturer entering. After the competition authority can prove that the anticompetitiveness is remarkable by assessing the objective elements such as the size of reverse payment, agreed entering time, and collateral transaction, firms can counter-argue by justifying their agreement based on legal costs and uncertainty in legal process. Finally, in legislating Korean approval-patent linkage system, in order to limit the anti-competitive effects of reverse payment, we could consider the followings:we give the exclusive right to a generic firm which first proves invalidity of a patent in the court, we deprive a firm of the exclusive right when the firm makes a reverse payment, we allow multiple firms share the right, or we might not adopt the 180-day exclusivity clause.