Hatch-Waxman And Copying: An Exception To The Exception?

Partner Jonathan Bachand and Associate Ashley Morales co-authored, "Hatch-Waxman And Copying: An Exception To The Exception?" which was published in Law360.

Excerpt: Over a year ago, in a Law360 Expert Analysis article, we set forth the reasons why, in our opinion, evidence of copying is irrelevant as a secondary consideration of nonobviousness in Hatch-Waxman abbreviated new drug application cases. We also urged district courts to preclude costly discovery into these issued based on revised Rule 26 of the Federal Rules of Civil Procedure. Recently, the Federal Circuit issued an opinion that could be read to conflict with the court’s own precedent regarding the relevance of copying in ANDA cases. In this article we analyze the Federal Circuit’s recent decision in Merck Sharp & Dohme Corp. v. Hospira Inc. in an attempt to discern the potential basis for this holding.

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