Facts of the Case

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Amarin Pharma markets icosapent ethyl under the brand name Vascepa. In 2012, the FDA approved Vascepa for treating severe hypertriglyceridemia (the SH indication), which affects patients with blood triglyceride levels of at least 500 mg/dL. In 2019, following additional research and clinical trials, the FDA approved Vascepa for a second use: reducing cardiovascular risk in patients with triglyceride levels of at least 150 mg/dL (the CV indication). Amarin listed two patents covering the CV indication in the FDA’s Orange Book.

In 2016, Hikma Pharmaceuticals submitted an Abbreviated New Drug Application seeking approval for a generic version of icosapent ethyl. When the CV indication was approved in 2019, Hikma filed a “section viii statement” seeking FDA approval only for the SH indication by “carving out” the patented CV indication from its label—creating a “skinny label.” The FDA approved Hikma’s ANDA in May 2020. Throughout 2020, Hikma issued press releases referring to its product as the “generic version” or “generic equivalent” of Vascepa, describing Vascepa as indicated “in part” for the SH indication, and citing Vascepa sales figures (over $1 billion annually) that were attributable primarily to the CV indication. Hikma also marketed its product on its website under the therapeutic category “Hypertriglyceridemia” and as “AB” rated, though with a disclaimer that it was approved for fewer indications than Vascepa.

In November 2020, Amarin sued Hikma for induced infringement of its CV indication patents. The U.S. District Court for the District of Delaware granted Hikma’s motion to dismiss. The U.S. Court of Appeals for the Federal Circuit reversed, finding that Amarin’s allegations—based on Hikma’s skinny label combined with its press releases and marketing materials—plausibly stated a claim for induced infringement.

Questions

  1. 1. When a generic drug manufacturer excludes a patented use from its label, can it still be liable for inducing infringement if it calls its product a “generic version” of the brand-name drug and cites publicly available information about the brand-name drug’s sales?

    2. Can a patent infringement complaint survive dismissal if it does not allege that the defendant made any statement specifically instructing or encouraging the patented use?

Conclusions

  1. A generic drug manufacturer does not actively induce patent infringement under 35 U.S.C. §271(b) when its communications consist only of legally required labeling, standard industry language, omissions, and vague statements that lack any affirmative purpose of encouraging the patented use. Justice Ketanji Brown Jackson authored the 9-0 unanimous opinion of the Court.

    Proving "active inducement" of patent infringement—meaning a company deliberately encouraged someone else to violate a patent—requires three things: an actual act of infringement by a third party, knowledge that those acts infringe a patent, and, most critically, affirmative steps taken to encourage that infringement. The third element is the crux of this case. "Active steps" means purposeful, culpable conduct designed to bring about infringement—not just ordinary business activity that happens to accompany a product's sale. A company's mere knowledge that its product will end up used in a way that infringes a patent is not enough to create liability. Federal law gives generic manufacturers room to operate without every routine communication becoming evidence of wrongdoing.

    Applying that standard, none of Hikma's communications qualify as active inducement. Hikma's drug label retained certain clinical study information and omitted a limitation-of-use statement, but federal law actually required the generic label to mirror the brand-name label. Describing the generic as the "equivalent" of the brand-name drug is standard industry practice, not a scheme to induce infringement. Omissions and failures to clarify the scope of a generic's approved uses are passive conduct, not the affirmative action the law demands. The remaining statements—a patient leaflet warning, a broad therapeutic category description on a website, an equivalence rating, and investor-facing sales figures—are too vague and too many inferential steps removed from any act of infringement to plausibly suggest Hikma designed them to push doctors toward a patented use. Because Amarin could only show that infringement was possible through a speculative chain of events, not that Hikma plausibly acted to bring it about, the complaint fails to state a valid legal claim.