On October 2, 2020, the U.S. Court of Appeals for the Federal Circuit vacated a district court’s judgment in favor of defendant Teva in a case involving “skinny labels.” GlaxoSmithKline LLC v. Teva Pharm. USA, Inc., 976 F.3d 1347 (Fed. Cir. 2020). When a drug can be used to treat multiple conditions, a generic can “carve out” the patented indications from its label. 21 U.S.C. § 355(j)(2)(A)(viii) (“section viii”). The resulting “skinny label” allows the generic to launch its product for uses not covered by the patent. GlaxoSmithKline LLC and SmithKline Beecham (Cork) Ltd. (together, “GSK”) sued Teva Pharmaceuticals USA, Inc. (Teva) for patent infringement. After a trial in the U.S. District Court for the District of Delaware, the jury found the patent valid and infringed, and assessed damages.
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The US Court of Appeals for the Federal Circuit reverses a judgment that upheld “skinny labels” and allowed a generic to launch on uses not covered by a patent (GlaxoSmithKline / Teva)
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