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Abstract

With the multi-billion dollar generic pharmaceutical industry growing annually, litigation under the Hatch-Waxman Act—the legislation that expedited the Food & Drug Administration’s (“FDA”) approval process for generic drugs—can have substantial economic implications on American consumers. Under the Hatch-Waxman Act, a generic drug company can challenge a brand-name pharmaceutical company’s pioneer drug patent(s) in an Abbreviated New Drug Application (“ANDA”) by filing a Paragraph IV certification with the FDA, and the patentee can—and usually does—sue for infringement. The court may find the pioneer drug patent(s) invalid or not infringed by the generic drug, which results in savings to American consumers when the affordable generic drug is eventually brought to market. The United States District Court for the District of Delaware’s four Article III judges hear the majority of cases arising under the Hatch-Waxman Act. However, unlike other patent-heavy dockets, the District of Delaware does not have uniform local patent rules and very rarely entertains motions for summary judgment in Hatch-Waxman litigation. This article evaluated the District of Delaware’s procedures in handling Hatch-Waxman cases and presents an empirical study of the district’s summary judgment practice in these cases. The empirical study shows that the District of Delaware’s practice is efficient and predictable and not contrary to the purpose behind the Hatch-Waxman Act: to bring more low-cost generic drugs to consumers. Because the district has a bench experienced in patent litigation, the District of Delaware does not need to adopt local patent rules and should continue its current practice of rarely hearing summary judgment motions in ANDA cases.

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