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Federal Circuit IP Blog

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

February 23, 2022

By Jason Y. Zhang, M.D.

Edited by Christina Ji-Hye Yang; Esther H. Lim; Elizabeth D. Ferrill

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.

Tags

drugs, infringement, estoppel, United States Court of Appeals for the Federal Circuit (CAFC), generic drug

Related Practices

Patent Litigation

Branded Hatch-Waxman (ANDA)

Appeals

Related Industries

Life Sciences

Pharmaceutical

Related Offices

Washington, DC

Contacts

Jason Y. Zhang, M.D.
Associate
Palo Alto, CA
+1 650 849 6732
Email
Christina_Yang
Christina Ji-Hye Yang
Associate
Washington, DC
+1 202 408 4465
Email
Esther_Lim
Esther H. Lim
Partner & Chief Diversity and Inclusion Officer
Washington, DC
+1 202 408 4121
Email
Elizabeth D. Ferrill
Partner
Washington, DC
+1 202 408 4445
Email

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