What happened
The U.S. Supreme Court handed Hikma Pharmaceuticals USA Inc. a unanimous win, reversing a Federal Circuit ruling that had allowed Amarin Pharma Inc. to press claims that Hikma induced infringement of patents covering a cardiovascular-risk use of Vascepa.
Justice Ketanji Brown Jackson wrote that Amarin's complaint failed because the relevant question was not whether doctors could read Hikma's label, website and press releases as encouraging infringement, but whether Hikma itself actively encouraged infringing use. The Federal Circuit had found it plausible that physicians could read the challenged statements as instructions or encouragement to infringe. "That was error."
The case arose from Hikma's generic icosapent ethyl product. Amarin developed Vascepa, first approved for severe hypertriglyceridemia and later approved for reducing cardiovascular risk in hypertriglyceridemia patients already taking statins. After Amarin obtained method-of-use patents for the cardiovascular indication, Hikma sought approval for a skinny label covering only the nonpatented severe-hypertriglyceridemia indication, and the FDA approved the generic with an AB rating.
Amarin sued in Delaware, alleging Hikma induced infringement based on the combined effect of its skinny label, patient information leaflet, website and press releases. The district court dismissed the case, but the Federal Circuit revived it, concluding that a physician could plausibly read Hikma's statements as encouraging patented cardiovascular use.
The Supreme Court said active inducement under Section 271(b) requires affirmative steps, not speculation that others may infer an infringing use from vague or ordinary commercial statements. The opinion said Hikma's label largely reflected statutory sameness requirements, its generic-equivalence language reflected normal industry practice, and Amarin could not rely on omissions or inaction to plead active inducement.
The court also rejected Amarin's reliance on Hikma's patient leaflet, website and sales-related press releases. The opinion said the leaflet's warning and disclaimer were too roundabout to amount to inducement, the website's hypertriglyceridemia category and AB-rating statements did not plausibly invite patented use, and investor-directed sales figures required too many inferential steps to support liability.
The ruling reverses the Federal Circuit and sends the case back for further proceedings consistent with the opinion, after the justices concluded Amarin failed to state a claim that could survive Hikma's Rule 12(b)(6) motion.