A Federal Circuit ruling in Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc. found that patent litigation over generic drugs is only permitted in districts where an act of infringement has already transpired, and specifically, only where certain FDA-directed regulatory activity took place.
While the Federal Circuit's decision in Valeant is impactful, questions remain about how long it will be the law of the land. Valeant filed a petition for rehearing en banc, and Mylan has filed a response. The case may ultimately see its way to the Supreme Court.
In a Law360 article, IP litigation attorneys examine consequences of the Federal Circuit decision and questions regarding what acts may be deemed relevant to being a submitter of the abbreviated new drug application, or ANDA, for venue purposes. The authors explain that there is the potential for congressional action this year, as the question of Hatch-Waxman Act venue is a discrete one that ought to find legislative support. Thus, the Federal Circuit panel's decision may not be the last word on the issue.
The article was co-authored by IP litigation partner Matt Rizzolo (Washington, D.C.).
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