IP Law Daily, PATENT—U.S.: Promotional statements about generic drug not ‘active steps’ required for inducement liability, (Jun 4, 2026)

By Thomas Long, J.D.

Brand-name manufacturer failed to plausibly allege that maker of generic drug for severe hypertriglyceridemia actively encouraged doctors to prescribe the generic for a patented cardiovascular use.

Statements by pharmaceuticals maker Hikma Pharmaceuticals USA Inc. that its generic drug for treatment of severely high triglycerides were the “generic equivalent” of the brand-name drug Vascepa could not support claims that Hikma actively induced doctors to infringe patents owned by Vascepa maker Amarin Pharma, Inc., the Supreme Court has held. In a unanimous decision written by Justice Ketanji Brown Jackson, the Court determined that Amarin failed to plausibly assert that Hikma engaged in active inducement in violation of 35 U.S.C. § 271(b). Amarin did not allege sufficient “active steps” by Hikma. The Court rejected Amarin’s contention that it only had to allege “a plausible chain of events through which statements made by [Hikma] could lead a healthcare provider … to prescribe or dispense Hikma’s drug to reduce a patient’s cardiovascular risk.” Dismissal of the claims was warranted because Amarin failed to allege “more than a sheer possibility” that Hikma actively induced infringement. Statements in Hikma’s promotional leaflet for its drug were deemed too vague to support inducement liability. The Court reversed a decision of the U.S. Court of Appeals for the Federal Circuit, which had held that that Amarin plausibly alleged that Hikma engaged in conduct that could show specific intent to induce infringement (Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889 (U.S. Jun. 4, 2026)).

Hikma’s generic drug. Amarin Pharma, Inc., manufactured icosapent ethyl and sold a brand-name drug containing the compound, named Vascepa. The drug was initially indicated for treatment of severely high triglycerides, but it was later patented for use in reduction of cardiovascular disease risk. Hikma developed a generic version of icosapent ethyl. It obtained Food and Drug Administration approval for the non-patented triglyceride indication and carved out (that is, omitted) the patented cardiovascular indication from the label, pursuant to 21 U.S.C. § 355(j)(2)(A)(viii) (“section viii”). Section viii states that an applicant for a new generic drug that has uses covered by a patent does not infringe that patent if the applicant carves out the patented uses from its labeling.

Infringement dispute. Despite Hikma’s compliance with section viii, Amarin filed a lawsuit accusing Hikma of infringing Amarin’s patent on use of the drug for prevention of cardiovascular problems. The issue was whether Hikma could be liable for “actively inducing” doctors to infringe Amarin’s patent in violation of 35 U.S.C. § 271(b).

As the Court described the dispute, “Amarin relied on a combination of Hikma’s statements across its skinny label (an abbreviated label used for generic drugs), its website, and its press releases to allege that Hikma took ‘active steps’ to induce infringement of Amarin’s patented uses. The district court dismissed of the case, concluding that Hikma did not engage in active inducement because its FDA-approved labeling did not instruct or encourage the patented use. The Federal Circuit reversed, finding it “at least plausible that a physician could read” the relevant statements “as an instruction or encouragement to” infringe.

Active inducement. “That was error,” said the Court. “The central question is whether Amarin plausibly alleged that Hikma actively encouraged infringing uses, not merely whether doctors could plausibly read the alleged statements as instructions to infringe” (emphasis added). The Court noted that it was well-known that doctors routinely prescribe generics for unlabeled, patented indications—and, in fact, are either permitted or required to do so under state generic substitution laws—so Hikma knew or possibly expected that its product would be put to infringing use. However, as the Court held in Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U. S. 913, 937 (2005)—a copyright case—“mere knowledge of infringing potential or of actual infringing uses [is] not … enough … to subject a distributor to liability.” Nonetheless, the Court explained, “a generic manufacturer can cross the line into liability if it ‘actively induces infringement of [the brand manufacturer’s] patent’” pursuant to Section 271(b).

The Court listed the required elements of an induced-infringement claim: (1) direct infringement by a third party; (2) knowledge by the inducer that the induced acts constitute patent infringement; and (3) active steps by the inducer to encourage direct infringement. The third element was the one most relevant to this case.

Alleged encouragement of infringement. Amarin alleged that Hikma’s statements in several documents added up to encouragement of infringing uses. While Hikma’s label omitted the patented cardiovascular indication, it retained information about a clinical study in which some patients took statins (which was a component of Amarin’s patented method). In addition, the patient information leaflet that accompanied the label warned against possible side effects for “people who have heart (cardiovascular) disease.” It also noted that medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Hikma’s website described its generic drug as “AB” rated (a code indicating that a generic drug is pharmaceutically and therapeutically equivalent to a brand-name reference drug), and listed the drug’s therapeutic category as “Hypertriglyceridemia,” a category that includes but is broader than severe hypertriglyceridemia. Finally, before releasing its drug, Hikma issued press releases describing its product as “generic Vascepa” without mentioning the limitations on the approved uses of its product. The releases also touted U.S. sales figures for Vascepa that were attributable to both the patented and unpatented indications.

Plausibility of “active steps” allegations. The Supreme Court explained that “inducement liability must be based on affirmative, as opposed to passive, steps to bring about patent infringement. Ordinary acts incidental to product distribution are not sufficient because basing liability on them would risk “trenching on regular commerce.” Accordingly, the Court concluded that Amarin “missed the mark” in arguing that it only had to plead a plausible chain of events through which Hikma’s statements could lead a healthcare provider to prescribe Hikma’s drug to treat cardiovascular risk. Citing the Grokster case, the Court said that “statements designed to stimulate others form a narrower category than statements that could stimulate others” (emphasis in original). The required active inducement can be indirect as well as direct, the Court noted, explaining that Hikma “overshot” by arguing that active inducement must be “express.” However, whether implicit or explicit, “the necessary inducement must be ‘clear’ to the relevant audience and ‘affirmative,’” said the Court.

Under these standards, Amarin failed to allege “more than a sheer possibility” that Hikma actively induced infringement of Amarin’s cardiovascular-indication patents, the Court determined. “Amarin’s allegations, whether viewed together or separately, fail to establish that Hikma took any affirmative steps to encourage infringement,” it said. In the Court’s view, several of the statements had an obvious alternative explanation—“Hikma was just complying with the law or with standard industry practice.” Retention of the clinical study information was mandated by statute, and it was a normal industry practice to truthfully describe a generic drug as equivalent to a brand-name comparator in prelaunch press releases. “We decline to put generic manufacturers between a rock and a hard place by turning adherence to the law and industry standards into building blocks for illegal conduct,” the Court stated.

Furthermore, Amarin could not rely on mere omissions or inactions. “With a healthy stretch of the imagination,” reasoned the Court, “one might believe that some medical providers could read between the lines and draw improper conclusions” from the skinny label’s omission of the cardiovascular limitation of use and the failure of the press releases to mention that Hikma’s drug was limited to severe hypertriglyceridemia. But these would not constitute affirmative statements or actions that would justify imposing liability.

Amarin also fell short in basing its inducement claim on “vague” statements mixed with speculation as to how medical providers might act. These statements were too passive to violate Section 271(b). “Treating them otherwise would turn any statement extraneous to the unpatented method of use—even one warning people against the patented method of use—into active inducement of infringement,” the Court explained. “Our case law leaves generic manufacturers more breathing room than that.”

With respect to the website statements, in the Court’s view it was not plausible that Hikma “designed” the statements “to stimulate others to commit” infringement. Moreover, Hikma’s website clarified that “Hikma’s generic version is indicated for fewer than all approved indications of the Reference Listed Drug,” Vascepa.

“Finally, the sales figures in Hikma’s press releases are the vaguest of ‘vague’ statements alleged in Amarin’s complaint,” the Court said, taking the position that there were “myriad steps between those statements and induced infringement.” Although the chain of events suggested by Amarin might be plausible, that was not enough to establish liability for inducement of infringement under Section 271(b).

Accordingly, the Supreme Court reversed the judgment of the Federal Circuit and remanded the case for further proceedings.

The Case is No. 24-889.

Judge: Jackson, K.

Attorneys: Charles Bennett Klein (Winston Taylor International LLP) for Hikma Pharmaceuticals USA Inc. Michael Robert Huston (Perkins Coie LLP) for Amarin Pharma, Inc.

Companies: Hikma Pharmaceuticals USA Inc.; Amarin Pharma, Inc.

MainStory: TopStory Patent GCNNews