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Explore the latest in patent, trademark, and copyright cases on the Merchant & Gould LLP blog. Stay informed with expert insights on intellectual property law updates.

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Last week, the Supreme Court issued a decision in <a href="https://www.supremecourt.gov/opinions/25pdf/24-889_5i36.pdf"><em>Hikma Pharmaceuticals USA Inc. v. Amarin Pharma Inc.</em></a>, No. 24-889 (Jun. 4, 2026), reversing and remanding a Federal Circuit ruling that Amarin Pharma had sufficiently stated a claim for induced infringement of its hypertriglyceridemia drug, Vascepa, by Hikma Pharmaceuticals.&nbsp;

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Vascepa’s main active ingredient is icosapent ethyl, which is commonly used to lower high blood triglycerides. The FDA originally approved Vascepa for treatment of severe hypertriglyceridemia (the “SH indication”), and later approved it to treat hypertriglyceridemia-associated cardiovascular risks (the “CV indication”). Amarin submitted U.S. Patent 9,700,537 and U.S. Patent 10,568,861 to the FDA, both of which claimed the CV indication method of use. Hikma sought approval of a Hatch-Waxman “skinny label” for its generic icosapent ethyl drug. The skinny label included the SH indication but carved out the CV indication protected by the ’537 and ’861 patents. Hikma’s skinny label was approved in 2020.

Amarin filed suit in the District of Delaware alleging Hikma actively induced prescribers to infringe the ’537 and ’861 patents based on the drug’s label and statements in Hikma’s marketing materials and on its website. The district court granted Hikma’s motion to dismiss for failure to state a claim of inducement. The Federal Circuit reversed, holding it was “at least plausible” that Hikma’s statements could be seen as instructions to prescribe its generic drug for the CV indication protected by the asserted patents.

A unanimous Supreme Court reversed and remanded. The Court explained that § 271(b) requires inducement that is clear to the relevant audience and active, not passive. Evaluating Amarin’s allegations under this standard, the Court concluded that Amarin’s pleading failed to state a plausible claim for relief under <em>Twombly/Iqbal</em>. First, the Court determined that several of Hikma’s statements, including those on the skinny label, had “obvious alternative explanations,” including compliance with federal labeling regulations. Second, the Court held that Amarin could not rely on mere omissions or inaction to allege inducement because affirmative statements or actions are required. Third, the Court explained that Amarin’s speculative allegations about how prescribers would interpret vague language in the label’s patent information leaflet and marketing materials were insufficient to show that Hikma took affirmative steps encouraging infringement.

SCOTUS Rejects Inducement Claim on Skinny Label Generic Drug

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