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# Lawyers Say Federal Circuit Strattera Decision Missed Mark
- URL: https://www.fdaweb.com/lawyers-say-federal-circuit-strattera-decision-missed-mark/
- Published: 2018-05-17T12:00:00.000Z
- Updated: 2026-09-15T00:05:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141473

Three Alston Bird patent lawyers say a Federal Circuit Court of Appeals decision in *Lilly v. Actavis Elizabeth* conflicts with Supreme Court precedent and should be overturned. Writing in the *New York Law Journal*, the attorneys [say](https://www.law.com/newyorklawjournal/2018/05/17/lawful-but-never-substantial-off-label-use-and-contributory-infringement-in-hatch-waxman-litigation/?slreturn=20180417161152&ref=fdaweb.com) the appeals court held that substantial non-infringing off-label uses of an approved drug (Strattera) cannot defeat a claim of contributory infringement in an action brought under Waxman-Hatch. “The decision, along with its underlying rationale, took away from generic drug manufacturers a bona fide and potent defense against contributory infringement claims in Waxman-Hatch litigation,” the article says. “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.”

The attorneys say the doctrine of contributory infringement was never meant to impose liability on a generic drug manufacturer simply because it is restricted from promoting approved drugs off-label, and is no reason to delay the availability of cheaper drugs to patients. “With *Lilly*, the federal circuit missed an opportunity to set the proper legal standard for contributory infringement in a Waxman-Hatch litigation,” the attorneys conclude. “Hopefully, it will have another opportunity in the very near future to overturn its decision in *Lilly* and limit the reach of contributory infringement in the pharmaceutical context such that significant off-label uses may constitute substantial non-infringing uses sufficient to rebuff contrived claims of contributory infringement brought against generic drug manufacturers by branded drug makers.”