Skinny Label Does Not Prevent Finding of Induced Infringement

In GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., Nos. 2018-1976, 2018-2023 (Fed. Cir. Oct. 2, 2020), the Federal Circuit reversed the district court’s grant of Teva’s motion for judgment of non-infringement as a matter of law.

GlaxoSmithKline sued Teva for induced infringement of Reissue Patent No. RE40,000, which is directed to a method of treating congestive heart failure with carvedilol. Teva sought to evade liability for induced infringement by marketing its product with a “skinny label” pursuant to 21 U.S.C. § 355(j)(2)(A)(viii).  “Skinny labeling” refers to the practice by which a drug manufacturer seeks approval for some, but not all, of the indications for which the branded drug has been approved. The district court granted Teva’s motion for judgment as a matter of law (“JMOL”) because it found no proof that Teva had actually caused physicians to prescribe generic carvedilol to treat congestive heart failure.  The Federal Circuit reversed the district court’s JMOL order, holding that the district court applied an incorrect standard.  The Court explained that induced infringement should be found when the provider of an identical product knows of and markets that product for intended direct infringing activity. At trial, GSK introduced promotional materials, press releases, product catalogs, FDA labels, and testimony of witnesses from both sides indicating that Teva marketed its generic product for the treatment of heart failure.  Thus, substantial evidence supported the jury’s finding of induced infringement and Teva’s JMOL motion should have been denied.

In dissent, Chief Judge Prost agreed with the district court’s JMOL analysis and argued that the majority’s holding nullified Congress’s statutory provision for skinny labels.