Ineffective Skinny Label Leaves Generic Liable Despite Effort to Carve-Out the Patented Indication

| Makoto Tsunozaki, Ph.D.


Before Moore, Newman, Prost (dissent). Panel rehearing of an appeal from the U.S. District Court for the District of Delaware

Summary: Substantial evidence supported the jury verdict of induced infringement when testimony indicated that a generic failed to carve out a potentially infringing use from a label and the generic’s advertisements provided further evidence of an intent to encourage the patented use.

GlaxoSmithKline (GSK) sued Teva for inducing patent infringement based on Teva’s sale of generic carvedilol. GSK’s carvedilol product is approved, inter alia, for treating congestive heart failure (CHF) and left ventricle dysfunction (LVD). The patent at issue related to the use of carvedilol to treat CHF and GSK represented to the FDA that this patent covered the treatment of CHF. Teva’s label for generic carvedilol included the LVD indication but it excluded the CHF indication by seeking a “skinny label” that carved the CHF indication from the label. The jury returned a verdict for GSK, finding that Teva’s skinny label induced infringement of the patented treatment of CHF. The district court, however, granted Teva’s JMOL motion of no inducement based on a lack of evidence that Teva actually caused physicians to directly infringe the patented use for treating CHF. On appeal, the Federal Circuit reversed, finding that there was substantial evidence to support the jury’s verdict on infringement. Teva filed a motion for en banc review, which the original panel construed as a request for panel rehearing that it granted.

On panel rehearing, the Federal Circuit again reinstated the jury’s verdict. The Federal Circuit held that substantial evidence supported the jury’s factual finding that Teva’s attempt to carve-out the patented use with a skinny label was ineffective. In particular, the court found that the jury was entitled to credit expert testimony explaining that the LVD indication along with additional sections of Teva’s label disclosed each of the claim limitations, and that Teva’s label, marketing materials, and press releases constituted substantial evidence from which the jury could reasonably infer an intent to encourage infringement. The Federal Circuit further noted that GSK’s representations to the FDA concerning the scope of the patent were not fully dispositive of infringement. However, the court indicated that issues of fact remained regarding Teva’s contention that these representations were at odds with GSK’s infringement allegations and remanded to the district court to consider Teva’s arguments concerning equitable estoppel.

Judge Prost dissented, arguing that the majority weakened the intentional-encouragement requirement of induced infringement, eviscerated the requirement to prove causation for inducement, and has created confusion as to the “skinny label” practice for generic drugs.

Editor: Paul Stewart