Federal Circuit Sidesteps Determination of Generics’ Skinny Label as Protection Against Induced Infringement

In a per curiam order, GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., Nos. 2018-1976, 2018-2023 (Fed. Cir. Feb. 11, 2022), the Federal Circuit denied Teva’s petition for rehearing en banc of the panel decision, which found Teva’s induced infringement of GSK’s carvedilol patent based on its generic drug label.

The patent-in-suit is directed to a method of treating congestive heart failure with carvedilol.  Teva argued against inducement liability, citing its alleged compliance with the FDA-regulated practice of “skinny-labeling” its generic drug, which carved out the patented indication for heart failure based on GSK’s sworn statements.  In a 6-3 split decision, the Federal Circuit acknowledged potential fairness concerns in finding Teva liable for inducement despite the skinny label, but ultimately denied review because Teva’s un-adjudicated equitable estoppel defense could lead to the label’s exclusion as inducement evidence.  The Court explained that the focus on remand should be Teva’s reasonable reliance on GSK’s communications regarding enforceability of carvedilol’s patented indication, and whether GSK should be equitably estopped from using the skinny label as evidence.

In dissent, Judges Prost, Reyna, and Dyk concluded that Teva adhered to the FDA labelling mandate and its skinny label should not have been used as infringement evidence.