In Eli Lilly & Co. v. Actavis Elizabeth, 435 Fed. App’x 917, 927 (Fed. Cir. 2011), the U.S. Court of Appeals for the Federal Circuit held that substantial, noninfringing “off-label” uses of an approved drug cannot defeat a claim of contributory infringement in an action brought under the Hatch-Waxman Act. This decision, along with its underlying rationale, took away from generic drug manufactures a bona fide and potent defense against contributory infringement claims in Hatch-Waxman litigation. Unfortunately for generic companies, this decision still stands—despite contravening U.S. Supreme Court precedent—allowing branded companies to continue pursuing otherwise spurious claims for contributory infringement.
This article discusses how Supreme Court precedent conflicts with the Federal Circuit’s decision in Eli Lilly, and why the Federal Circuit’s decision should be overturned.
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