역지불 합의의 요건과 경쟁제한성 판단 : King drug Co. of Florence, Inc. v. Smithkline Beecham Corp., 791 F.3d 388 (3rd Cir. 2015) 판결

Pharmaceutical market is strongly related with public health. The hazard created by invalid patents in this market and its monopoly power might be serious. In this sense, the Hatch Waxman act seeks to solve this problem, by encouraging manufacturers of generic drugs to challenge weak or invalid patent on brand name drugs so consumers can enjoy lower drug prices. Particularly, filing a paragraph IV certification means provoking litigation, because the patent statute treats paragraph IV certification as a per se act of infringement. As a result, patentees have strong incentive to settle with challengers in the form of reverse payment settlements. The anticompetitive harm from such a payment appears not to be only that the patentee is reaping supracompetitive monopoly profits from decidely invalid or noninfringed patent. The payment likely seeks to prevent the risk of competition. Even though other settlement terms might allow a generic challenger to enter the market prior to patent expiration, and thus permit some competition benefiting consumers, a reverse payment including delay simply keeps prices at supracompetitive level while dividing that return between the challenged patentee and the patent challenger. In reverse payment situations the patentee likely possess the power to bring about this anticompetitive harm. An explained large reverse payment settlements itself would normally suggest that the patentee has serious doubts about the patent's survival. A reverse payment settlement is immune from antitrust attack so long as its anticompetitive effects fall within the scope of the exclusionary potential of the patent. In Actavis case, the U.S. Supreme Court held that patent and antitrust policy are both relevant in determining the scope of the patent monopoly. This case seems to be faithful to Actavis ruling. This Court rejected the near-irrebuttable presumption, known as the scope of the patent test. To the contrary, the Court declined to abandon the 'rule of reason' in favor of presumptive rule or a quick-look approach. Even exclusive licenses cannot avoid antitrust scrutiny where they are used in anticompetitive ways. In addition, this court held that a no-AG agteement, when it represents an unexplained large trasnfer of value from the patent holder to the alleged infringer, may be subject to antitrust scrutiny under the rule of reason. In Korean context, this ruling could be referred in deciding reverse payment settlement cases, because it is not the transfer of cash or the form of reverse payment that triggers antitrust concern, but the impact of that payment on consumer welfare.