Hikma Pharmaceuticals v Amarin Pharma (U.S., June 4, 2026) 2024-889

This episode concerns the case of Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., the Supreme Court addressed whether a generic drug manufacturer can be held liable for active inducement of patent infringement through its marketing and labeling. Amarin alleged that Hikma's "skinny label" and promotional materials encouraged doctors to prescribe its generic drug for a still-patented cardiovascular use, even though the label was only approved for a non-patented indication. The Court unanimously ruled in favor of Hikma, clarifying that active inducement requires affirmative and purposeful steps to promote infringement rather than passive omissions or vague statements. Justice Jackson emphasized that the legal standard for a motion to dismiss requires a plaintiff to show more than a mere possibility that a physician might misunderstand a generic’s intended use. Consequently, the Court found that standard industry practices, such as describing a product as a generic equivalent or citing total market sales, do not constitute illegal encouragement. This decision provides significant protection for generic manufacturers using section viii "carve-outs" to bring cheaper medications to market without facing speculative litigation.

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