Skinny Labels at the Supreme Court: Carving Out Room for Generics to Breathe

Written by: Ari Feinstein and Zoe E. Vikstrom

HIKMA PHARMACEUTICALS USA INC. et al. v. AMARIN PHARMA, INC., et al.

Jackson, J., delivered the opinion for a unanimous Court.  Certiorari to the United States Court of Appeals for the Federal Circuit.

Summary: To be adequately pled, induced infringement claims must rest on affirmative acts encouraging infringement, not omissions, inactions, roundabout theories, or vague statements.

Amarin Pharma, Inc. (Amarin) obtained FDA approval for its drug Vascepa® (icosapent ethyl), which was originally indicated for the treatment of severe hypertriglyceridemia.  The original Vascepa® label included a use limitation stating that its effect “on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.”  The FDA later approved Vascepa® for a second, much more common treatment—to reduce cardiovascular risk in hypertriglyceridemia patients who already take statins.  Amarin then removed the use limitation from its label.  Though Amarin had obtained method-of-use patents for both indications, a district court invalidated the patents covering the original, narrower indication.  In response to these developments, drug manufacturer Hikma Pharmaceuticals USA, Inc. (Hikma), which had an Abbreviated New Drug Application (ANDA) for a generic version of Vascepa® pending with the FDA, supplemented its ANDA with a section viii statement, seeking a “skinny label” limited to the original, narrower, and no-longer-patented indication.  Hikma also removed the use limitation from its skinny label and, after obtaining FDA approval, began marketing its drug.  Amarin then sued Hikma under 35 U.S.C. § 271(b), alleging induced infringement of the method-of-use patent for the newer, broader indication.

The district court granted Hikma’s motion to dismiss for failure to state a claim.  The Federal Circuit reversed, however, holding that it was “at least plausible that a physician could read” Hikma’s label, website, and press releases as encouragement to prescribe Hikma’s drug for the still-patented use.  The Supreme Court granted certiorari.

The Supreme Court concluded that Amarin’s allegations failed to plausibly plead that Hikma took affirmative steps to encourage infringement.  First, Hikma’s removal of the use limitation and retention of information about a clinical study in which some patients were on statins was done to satisfy the statutory requirement that Hikma’s label be identical to the Vascepa® label except for the carved-out use.  Second, Amarin’s allegations based on a patient-information leaflet warning of possible side effects for people with cardiovascular disease was too “roundabout” to plausibly state a claim for inducement.  Third, Hikma’s categorization of its drug as a “hypertriglyceridemia” drug on its website was akin to describing a drug for leukemia as “a cancer drug”—a broad category, not an instruction to prescribe the drug for a specific type of cancer.  Fourth, though Hikma described its product as “generic Vascepa” or the “generic equivalent” of Vascepa® in its press releases, the Supreme Court found those statements to be truthful and consistent with normal industry practice.  Fifth, while Hikma did not specify in its investor-focused press releases that its drug was limited to the original, narrower indication, the Court explained that such an alleged omission or inaction does not plausibly state a claim for active inducement.

Thus, the Supreme Court reversed the judgment of the Federal Circuit and remanded the case for further proceedings consistent with the opinion.

Editor: Sean Murray