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By Sophie Fulara and Andrew Wasson
On June 4, 2026, the Supreme Court held that Hikma Pharmaceuticals did not induce healthcare providers to infringe Amarin Pharma’s brand-name method-of-use patents.
Amarin Pharma, manufacturer of the brand-name icosapent ethyl (Vascepa), brought suit against Hikma Pharmaceuticals, manufacturer of generic icosapent ethyl, alleging that Hikma induced infringement of Amarin’s patents by virtue of its label, website, and press releases.1
Amarin obtained a method-of-use patent for using Vascepa to treat severe hypertriglyceridemia (“SH indication”).2 In response, Hikma filed an ANDA with a paragraph IV certification and successfully invalidated Amarin’s SH patents.3 In the meantime, Amarin received FDA approval for using Vascepa to reduce cardiovascular risk in hypertriglyceridemia patients who take statins (“CV indication”).4 Hikma amended its ANDA with a section viii statement to carve out the CV indication.5 It also removed certain labeling pertaining to the CV indication in order to match Vascepa’s (“CV Limitation of Use”).6
The Supreme Court held that Amarin failed to state a claim of active inducement under §271(b).7 Thus, Amarin cannot withstand Hikma’s motion to dismiss under Rule 12(b)(6).8
Inducement requires three elements: (1) direct infringement by a third party, (2) the inducer’s knowledge that the induced acts constitute patent infringement, and (3) active steps on the part of the inducer to encourage direct infringement.9 The third element was at issue in this case.10 The Court defined inducement in previous case law, stating that it “must involve the taking of affirmative steps.”11 Although it need not be express—i.e., it may be implicit—active inducement cannot be based solely on “vague” language “combined with speculation about how others may act.”12
Twombly and Iqbal require that for a claim to survive a motion to dismiss, a plaintiff must “state a claim to relief that is plausible on its face,” which “asks for more than a sheer possibility” that the defendant acted unlawfully.13 The Supreme Court said this does not compel the conclusion that Amarin should prevail because the inducement standard requires “active steps,” while Amarin merely argued that it need not do more than allege a plausible chain of events in which Hikma’s statements induce a healthcare provider to prescribe Hikma’s drug for the CV indication.14
The Court provided several reasons for its decision.15 First, Hikma’s statements have an obvious alternative explanation other than encouraging infringement, particularly complying with the law or standard industry practice.16 Hikma’s label matches Amarin’s by excluding the CV Limitation of Use while retaining information about a clinical study in which some patients took statins because Hikma’s label must be identical to Amarin’s except for the carved-out use under 21 USC §355(j)(2)(A)(v).17 Furthermore, Hikma’s description of its product as “generic Vascepa” in its press releases follows normal industry practice to truthfully describe a generic as equivalent to the brand-name product.18
Second, Amarin’s reliance on mere omissions, inactions, or nonfeasance does not constitute affirmative statements or actions that the Court requires for active inducement.19 Amarin may not rely on Hikma’s omission of the CV Limitation of Use on its skinny label and on Hikma’s press releases’ failure to mention that its product’s use was limited to the SH indication.20
Third, Hikma’s remaining statements on its label, website, and press releases are too vague to establish active inducement.21 For example, Hikma’s skinny label identifying potential side effects for people with cardiovascular diseases with a note that medication is sometimes prescribed for uses other than those specifically indicated does not induce infringement.22 Similarly, describing the drug’s therapeutic category on its website as “hypertriglyceridemia,” rather than “severe hypertriglyceridemia” is not an instruction to prescribe the drug for a patented use.23
Thus, the Court said Amarin improperly argued that it need not do more than allege a plausible chain of events where Hikma’s statements could lead a healthcare provider to prescribe Hikma’s drug to reduce a patient’s cardiovascular risk.24