제약사업자 간 분쟁종결합의의 위법성 판단기준

The pharmaceutical patent linkage system means that the approvalor delay system for generic version of a drugs containing the sameactive pharmaceutical ingredient (API) as that of a registered brand drugin the orange book. It has been adopted to promote the innovation inpharmaceutical industry and pharmaceutical patent protection byensuring the profitability of its innovative products. However, its’incentive method for a generic patent challenger, like the exclusivityforfeiture provisions, has been said to allow reverse payments by patentholders to generic challengers to delay other generic competitors’market entry. In Korea, the small size of a pharmaceutical market could leadpatent infringement settlements between a brand pharmaceutical partyand a generic business to foreclose the patent drug market. For thisreason, these settlements should be supervised in detail not to allow abrand patent proprietors to avoid competition by sharing theirmonopoly profits with generic challengers. Actually, the reverse payments could be found to establish theviolation of antitrust laws because of their objective anticompetitiveeffect of excluding or delaying entry of generics, and subjective intentto accept the anticompetitive effect. However, the patent infringement settlements should be legal if it based on the valid patent and if partiesactually intended the termination of the patent infringement suits in itsearly stages. As a result, the patent infringement settlements involvingso-called “reverse payments” should be investigated seriously to preventsuch payments effectively from allowing the brand patent owners toavoid competition by sharing their monopoly profits with genericchallengers.