Drug patent litigation settlements specify a date for generic entry and typically include so-called “acceleration clauses” allowing the settling generic to enter earlier in certain circumstances, such as a third party winning the patent litigation. Agreed-upon dates in settlements between a brand and a generic with “first-filer” status affect the entire market because this date affects the date other generics may enter as well. This paper documents the entry outcome after a first filer-brand settlement by tracking how often the “acceleration clauses” in these settlements in fact accelerate entry. In total, the first filer entered prior to the original settlement date ten times in the 99 settlements included in our data. In four of these ten, the first filer failed to retain its 180-day exclusivity period — awarded by the FDA to the first generic to challenge the brand’s patents — which allowed other later filing generics to enter and trigger the acceleration clause. In two cases, the first filer’s entry was accelerated by another first-filer generic with shared rights to the 180-day exclusivity period. In the other four cases, the first filer’s earlier entry was due to some special clause in the settlement (e.g., because of a shrinking brand market). In no case was a first filer’s intact 180-day exclusivity period accelerated because of a later filing generic winning the patent litigation or settling for an earlier entry date.

中文翻译：

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药品专利和解协议的约定日期之前的通用条目

药品专利诉讼和解协议规定了仿制药进入的日期，通常包括所谓的“加速条款”，允许在某些情况下（如第三方赢得专利诉讼）和解仿制药可以更早进入。品牌与具有“第一申请人”身份的仿制药之间的和解协议中的约定日期会影响整个市场，因为该日期也会影响其他仿制药可能会进入的日期。本文通过追踪文件中的“加速条款”实际上加速入境的频率，记录了首次商标商和解后的入境结果。总共，第一位申报人在原始结算日期之前十次进入了我们数据中包含的99个结算中。在这十个中的四个中，第一位提交人未能保留其180天的独占期-由FDA授予挑战该品牌专利的第一个仿制药-允许其他后来提交的仿制药进入并触发加速条款。在两种情况下，另一名具有共享180天独占期限的通用权利的第一申请人加快了第一申请人的进入。在其他四种情况下，第一位申报人的较早进入是由于和解协议中的某些特殊条款（例如，由于品牌市场萎缩）。在任何情况下，第一申请人的完整180天独占期都不会得到加速，因为后来的仿制药获得了专利诉讼或解决了较早的进入日期。另一位具有180天独占期共享权的通用公司加快了第一名提交人的进入。在其他四种情况下，第一位申报人的较早进入是由于和解协议中的某些特殊条款（例如，由于品牌市场萎缩）。在任何情况下，第一申请人的完整180天独占期都不会得到加速，因为后来的仿制药获得了专利诉讼或解决了较早的进入日期。另一位具有180天独占期共享权的通用公司加快了第一名提交人的进入。在其他四种情况下，第一位申报人的较早进入是由于和解协议中的某些特殊条款（例如，由于品牌市场萎缩）。在任何情况下，第一申请人的完整180天独占期都不会得到加速，因为后来的仿制药获得了专利诉讼或解决了较早的进入日期。