Actavis, Authorized Generics, and the Future of Antitrust Law

Marc G. Schildkraut
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Abstract

Abstract The Supreme Court’s decision in Federal Trade Commission v. Actavis, Inc. is a challenge to conventional antitrust analysis. Conventional civil antitrust cases are decided by a preponderance of the evidence. This means that conduct challenged under the rule of reason is only condemned if the conduct resulted in more competitive harm in the actual world than a world without the alleged violation. Under conventional analysis, the intent of the parties also plays only a supporting role in determining whether the conduct was anticompetitive. A holder of a valid patent has a right to exclude others practicing the patented technology. And, the patent holder is not assumed to have market power because it expended resources in maintaining exclusionary rights. Actavis creates doubts about these propositions in circumstances beyond the “reverse” payment settlement of a patent suit that may have delayed an alleged infringer market entry. This chapter explores whether applying Actavis logic to antitrust litigation can result in condemnation of practices where there is little chance of an anticompetitive effect, where the patent holder likely has a valid and infringed patent, where there is little reason to believe that the patent holder has market power, and where only one party, or no parties, to an agreement have an anticompetitive intent. This chapter also investigates whether Actavis creates new problems with standing analysis, damages calculations, and the balancing of efficiencies against anticompetitive effects. Nevertheless, the lower courts have begun to extend the logic of Actavis. This is apparent in the condemnation of no-Authorized-generic settlements.
Actavis,授权仿制药和反垄断法的未来
美国最高法院在联邦贸易委员会诉阿特维斯公司案中的判决是对传统反垄断分析的挑战。传统的民事反垄断案件是由证据优势决定的。这意味着,在理性规则下受到质疑的行为,只有在这种行为在现实世界中造成的竞争性损害大于没有指称的违反行为的世界时,才受到谴责。在传统分析中,当事人的意图在确定行为是否反竞争方面也只起辅助作用。有效专利的权利人有权排斥他人实施其专利技术。而且,专利权人不被认为具有市场支配力,因为它在维护排他性权利方面耗费了资源。Actavis在专利诉讼的“反向”付款解决方案之外的情况下对这些主张提出了质疑,这可能会推迟被指控的侵权人进入市场。本章探讨了将Actavis逻辑应用于反垄断诉讼是否会导致对以下情况的谴责:反竞争效果的可能性很小,专利持有人可能拥有有效且被侵权的专利,几乎没有理由相信专利持有人拥有市场力量,以及协议中只有一方或没有一方具有反竞争意图。本章还调查了Actavis是否在立项分析、损害赔偿计算以及效率与反竞争效应的平衡方面产生了新的问题。然而,下级法院已经开始扩展Actavis的逻辑。这一点在对未经批准的非专利定居点的谴责中是显而易见的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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