U.S. Supreme Court Holds Generic Manufacturer’s “Skinny Label” and Marketing Did Not Induce Patent Infringement
06/09/2026
On June 4, 2026, Justice Ketanji Brown Jackson, writing for a unanimous Supreme Court of the United States, reversed a decision by the United States Court of Appeals for the Federal Circuit and held that Amarin Pharma, Inc. failed to plausibly allege that Hikma Pharmaceuticals USA Inc. actively induced patent infringement through its generic version of Vascepa under 35 U.S.C. § 271(b). Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889 (U.S. June 4, 2026). Plaintiff alleged that the totality of defendant’s statements across its “skinny label,” website, patient leaflet, and press releases induced physicians to prescribe defendant’s generic drug for plaintiff’s patented cardiovascular use.
Plaintiff markets Vascepa, containing the active ingredient icosapent ethyl, which the U.S. Food and Drug Administration approved in 2012 to treat severe hypertriglyceridemia (the “SH Indication”) and, in 2019, to reduce cardiovascular risk in certain patients taking statins (the “CV Indication”), for which plaintiff obtained method-of-use patents. Defendant later obtained FDA approval for a generic version by using a “skinny label” that carved out the patented CV Indication and covered only the off-patent SH Indication. The district court dismissed plaintiff’s complaint for failure to plausibly allege active inducement, but the Federal Circuit reversed, concluding it was “at least plausible” that physicians could interpret defendant’s statements as encouraging use of the generic for the patented CV Indication.
The Court explained that the central question is whether defendant plausibly took “active steps” to encourage infringement, not whether its statements could be read as instructions to infringe. Reaffirming that induced infringement requires “purposeful, culpable expression and conduct,” the Court held that “ordinary acts incident to product distribution” are insufficient. Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 937 (2005).
Applying that standard, the Court first concluded that several of defendant’s challenged statements had “obvious alternative explanation[s],” including compliance with federal law and standard industry practice. Generally, a generic label must mirror the branded label except for carved-out uses. The Court further held that plaintiff could not rely on “mere omissions,” such as the label’s omission of the CV Indication or the press releases’ failure to mention that defendant’s approved use was limited to the SH Indication. Finally, the Court held that defendant’s remaining statements, including information in the patient leaflet, website descriptions, AB-rating references, and sales figures contained in investor-focused press releases, were too vague and speculative to plausibly constitute affirmative encouragement of infringement. Because plaintiff failed to plausibly allege affirmative steps, the Court reversed and remanded for further proceedings.
