Justices to Side with Generic Drugmakers in Patent Spat, Attorneys Predict

The U.S. Supreme Court heard arguments on April 29 in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma Inc., a closely watched patent case examining when a generic drugmaker using a “skinny label” may be liable for induced infringement under the Hatch‑Waxman Act. 

The dispute stems from claims by Amarin Pharma that Hikma induced infringement of patents covering a cardiovascular use of Amarin’s drug Vascepa, even though Hikma sold its generic version under a label limited to non‑patented uses. Amarin alleges Hikma’s marketing materials and press releases encouraged physicians to prescribe the drug for patented indications. 

Finnegan attorney Charles Collins‑Chase said the justices appear unlikely to revise longstanding pleading law and are likely to side with Amarin. “The justices seemed unlikely to issue a ruling that would alter the pleading standards under Twombly and Iqbal,” he said. 

Even without a change to pleading standards, Charles said the ruling could still meaningfully affect future cases. “The case could still have huge implications by changing the type and amount of evidence required to plausibly plead inducement in skinny‑label cases,” he said. 

A Delaware district court dismissed Amarin’s suit in 2022, but the Federal Circuit reversed in 2024, finding the allegations sufficient to proceed. The Supreme Court’s decision could influence how lower courts evaluate marketing conduct in induced infringement claims going forward.