Supreme Court Decision Syllabus (SCOTUS Podcast)
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Supreme Court Decision Syllabus (SCOTUS Podcast)
Hikma Pharmaceuticals USA, Inc. v. Amarin Pharma Inc. (Patent infringement)
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In a unanimous opinion by Justice Jackson, the Supreme Court held that Amarin failed to plausibly allege that Hikma actively induced infringement of Amarin’s patented cardiovascular-use methods for Vascepa. Although Hikma marketed a generic version of the drug using an FDA-approved “skinny label” that omitted the patented cardiovascular indication, Amarin argued that various statements in Hikma’s labeling, website, patient materials, and press releases nevertheless encouraged doctors to prescribe the drug for the patented use. The Court rejected that theory, emphasizing that inducement under 35 U.S.C. §271(b) requires affirmative, purposeful steps designed to encourage infringement, not merely statements that could conceivably lead someone to infringe. Many of Hikma’s challenged statements reflected legal requirements or standard industry practices, while others were omissions or vague references that did not plausibly show an intent to promote infringing use. Because Amarin’s allegations relied on speculation and attenuated chains of inference rather than concrete acts encouraging infringement, the complaint failed to state a claim, and the Court reversed the Federal Circuit’s decision allowing the suit to proceed.
Hello, this is Jeff Barnum reading the Supreme Court syllabus in Hickma Pharmaceuticals USA Incorporated et al. versus Amarin Farman Incorporated et al. surcheroid to the United States Court of Appeals for the Federal Circuit. Argued April 29, 2026, decided June 4th, 2026. Once the Food and Drug Administration, FDA, has approved a new drug, federal law authorizes other manufacturers to seek approval for marketing generic versions so long as they do not infringe on any patented uses. All 50 states and the District of Columbia permit or require medical providers to substitute the brand name drug with the cheaper generic version. Still, generic manufacturers may be subject to liability under federal law if they actively induce infringement of the brand manufacturer's patent. Hamari Pharma Incorporated developed VACIPA, a drug containing the active ingredient icosapent ethyl. In 2012, the FDA approved VASIPA for the treatment of severe hypertriglycyridemia, the SH indication. In 2019, the FDA approved VACIPA for a second, more common use, reducing cardiovascular risk in hyperdriglycyridemia patients who already take statins, the CV indication. Amarin attained two method of use patents for this indication. HICMA Pharmaceuticals USA Incorporated, a generic drug manufacturer, submitted an abbreviated new drug application for generic icosapin ethyl in 2016. It initially filed a paragraph 4 certification asserting that Amarin's SH indication patents were invalid. After a district court invalidated Amarin's SH indication patents, HICMA supplemented its application with a Section 8 statement, seeking approval of a skinny label that included only the SH indication and carved out VACIPA's still patented CV indication method of use. In 2020, the FDA approved HICMA's application with the skinny label and assigned an AB rating indicating therapeutic equivalence to Vesipa when used according to its labeling. Amarin filed suit in the District of Delaware, alleging that HICMA actively induced others to infringe Amarin's CV indication patents based on the totality of Hickma's statements across the skinny label, the patient information leaflet, HICMA's website, and its press releases. The district court granted Hickma's motion to dismiss for failure to state a claim, explaining that none of these statements constituted active steps to encourage infringement. The Federal Circuit reversed, finding it at least plausible that a physician could read the relevant statements as an instruction or encouragement to infringe. Held, Amarin has failed to state a claim for active inducement in violation of Section 271B, so its complaint cannot withstand Hickma's motion to dismiss. The central question is whether Amarin plausibly alleged that Hickma actively encouraged infringing use, not merely whether doctors could plausibly read the alleged statements as instructions to infringe. A claim for active inducement of infringement under Section 271B requires three elements, direct infringement by a third party, knowledge that the induced acts constitute patent infringement, and active steps to encourage direct infringement. This case concerns the third element, active steps. Active steps involve purposeful, culpable expression and conduct, i.e. affirmative, as opposed to passive actions to bring about the desired result of patent infringement. We have defined active steps to exclude ordinary acts incident to product distribution. Those are insufficient to support liability. Given those standards, Amarin misses the mark in arguing that it need not do more than allege a plausible chain of events through which statements made by HICMA could lead a healthcare provider to prescribe or dispense HICMA's drug to reduce a patient's cardiovascular risk. Allegations of active steps cannot be based only on vague language combined with speculation about how others may act. Applying these standards, Amarin fails to allege more than a sheer possibility that Hickma actively induced infringement. Several of Hickma's statements have an obvious alternative explanation, compliance with the law or standard industry practice. Hickma's label retained information about a clinical study, but that is because by statute Hickma's label must be identical to Amarin's except for the carved out use. Further, describing a drug as the generic equivalent to the brand name comparator is normal industry practice. Because the court looks for affirmative statements or actions to induce liability, Amarin may not rely on mere omissions in actions or nonfeasance, such as the skinny label's omission of the CV limitation of use, or the press release's failure to mention that HICMA's approved use was limited to the far lesser known SH indication, to plausibly allege active inducement. HICMA's remaining statements are too vague to support inducement liability. The patient information leaflet's warning about side effects for people with cardiovascular disease and its disclaimer that medicines are sometimes prescribed for other purposes are implausibly roundabout ways to induce medical providers to infringe. The website's description of the therapeutic category as hyperdriglydemia and the indication that the drug is A-B-rated do not plausibly constitute statements designed to stimulate others to commit infringement, especially where the website clarifies that Hickma's generic is indicated for fewer than all approved indications of VACIPA. Finally, the sales figures in Hickma's press releases, the vaguest of the statements alleged, require a possible, but not plausible chain of events to occur for a medical provider to draw encouragement to infringe. Reversed and remanded, Justice Jackson delivered the opinion for a unanimous court. Thank you for listening. 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