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首页> 外文期刊>The Antitrust Bulletin >A short-run welfare analysis of FTC antitrust oversight of patent litigation settlements under the Hatch-Waxman Act
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A short-run welfare analysis of FTC antitrust oversight of patent litigation settlements under the Hatch-Waxman Act

机译：《哈奇-沃克斯曼法》下联邦贸易委员会对专利诉讼和解的反托拉斯监督的短期福利分析

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摘要

The Hatch-Waxman Act's principal provisions grant incumbent pharmaceutical drug manufacturers an injunction against competitive entry pending the outcome of patent infringement litigation and a 180-day exclusivity period for the generic manufacturer beyond the initial 30 months. These provisions are commonly seen as the basis for anticompetitive settlement agreements, in which monopoly profits are used to elicit voluntary entry forbearance from potential generic drug competitors. Antitrust enforcement by the FTC has been applied to prohibit these alleged anticompetitive settlements. The analysis herein compares the total welfare (and consumer welfare) associated with two cases: Hatch-Waxman entry injunctions with and without restrictions on "reverse payments" in settlements of patent infringement suits brought by incumbent, branded drug manufacturers. I find that FTC enforcement to prohibit or to deter "anticompetitive" settlements may―only may―increase welfare, if the total cost of FTC antitrust enforcement is ignored. However, considering the latter, no FTC intervention is likely to be best. These results are driven by the fact that with an entry injunction, as provided by the Hatch-Waxman Act, potential entrants may be injured substantially by frivolous patent infringement actions, and remedies in successful private antitrust counter-suits provides for treble damages to redress this harm. The prospect of treble damages provides a substantial deterrent, for infringement suits without significant merit.
机译：《哈奇-瓦克斯曼法案》的主要条款授予在职专利药品制造商禁止竞争进入的禁令，以等待专利侵权诉讼的结果，以及仿制药生产商在最初30个月后的180天独占期。这些规定通常被视为反竞争和解协议的基础，在该协议中，垄断利润被用来从潜在的仿制药竞争对手那里获得自愿入境的宽容。 FTC已执行反托拉斯法来禁止这些所谓的反竞争和解。本文中的分析比较了与以下两种情况相关的总福利（和消费者福利）：在由现有品牌药物制造商提起的专利侵权诉讼的和解中，对“逆向付款”有和没有限制的“哈奇-沃克斯曼入境禁令”。我发现，如果FTC反托拉斯执法的总成本被忽略，禁止或阻止“反竞争”和解的FTC执法可能（仅可能）增加福利。但是，考虑到后者，没有FTC干预可能是最好的。这些结果是由以下事实驱动的：根据《哈奇-瓦克斯曼法案》的规定，实施准入禁令可能会导致轻而易举的专利侵权行为严重损害潜在进入者，而成功的私人反托拉斯反诉讼中的补救措施则可提供三倍的赔偿以弥补这一缺陷。危害。对于没有明显优点的侵权诉讼，三倍损害的可能性提供了很大的威慑力。

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