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Antitrust Concerns in Settlement of Pharmaceutical Patent Litigation

机译:药品专利诉讼和解中的反托拉斯关注

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摘要

To date, neither the FTC nor federal district court judges have shown a willingness to consider whether an unpredictable legal, legislative, or regulatory environment may have justified the litigants' desire to settle these cases. Consider the terazosin case, for example. Geneva could not have known how the FDA and the courts would resolve the successful-defense rule. Moreover, its agreement to stay off the market until all appeals had been exhausted has obvious business justification when considering what damages might flow from a reversal after Geneva had commenced marketing. Zenith, for its part, could not have known whether the Federal Circuit would reverse the District of New Jersey to permit Zenith's de-listing action. Is settlement unreasonable in the face of such uncertainties? As this article goes to print, the answer to that question is very much up in the air. However, litigants can and should be aware of the sorts of settlement provisions that led to all these challenges in the first place.
机译:迄今为止,联邦贸易委员会和联邦地方法院的法官都未表示愿意考虑不可预测的法律,立法或监管环境是否可能证明诉讼人有意愿解决这些案件。例如,考虑特拉唑嗪的情况。日内瓦不知道FDA和法院如何解决成功防御规则。此外,考虑到日内瓦开始销售后的逆转可能造成什么损害,它同意在所有上诉都用完之前不让其退出市场的协议具有明显的商业理由。就Zenith而言,它尚不知道联邦巡回法院是否会撤回新泽西州地区,以允许Zenith退市。面对这种不确定性,解决方案是否不合理?在本文付印之时,对该问题的答案悬而未决。但是,诉讼人可以而且应该知道首先导致所有这些挑战的和解条款。

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