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ARTICLE · 04 NOVEMBER 2020

Skinny Label Doesn't Prevent Infringement Liability

The Federal Circuit decision in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., is getting attention for potentially "endangering" the practice of skinny labelling.

United StatesIntellectual Property

The Federal Circuit decision in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., is getting attention for potentially "endangering" the practice of skinny labelling. Indeed, the Federal Circuit held that Teva's skinny label did not shield it from liability for inducing infringement of an Orange Book-listed method of use patent. Chief Judge Prost's dissenting opinion argues the majority decision upsets the "critical balance" between promoting innovation in the pharmaceutical space and permitting low-cost generic drugs to enter the market, but the realities of prescription drug practices make it hard to pick a side when an innovator develops and patents a new use for a known drug.

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