October 26, 2026
Hikma Pharma. USA Inc. v. Amarin Pharma, Inc., 608 U.S. 580 (2026) (Jackson, J.)
Response by Jasper L. Tran
Geo. Wash. L. Rev. On the Docket (Oct. Term 2025)
Slip Opinion | SCOTUSblog
Tightening Patent Inducement
The 2025 Term was the first time in over a decade that the Supreme Court revisited inducement of patent infringement. In the decade prior, between 2005 and 2015, the Supreme Court quietly1 issued four decisions2 that have revolutionized active inducement of patent infringement under 35 U.S.C. § 271(b).3
This provision, which originated from the Patent Act of 1952, briefly states: “Whoever actively induces infringement of a patent shall be liable as an infringer.”4 This general, vague language (e.g., how does one define “actively”) left the courts to determine the statute’s contours, and the Supreme Court finally took up the question over fifty years later. Since the 2024 October Term, the Supreme Court has decided five patent cases interpreting § 271(b).
The Supreme Court added the fifth case in the 2025 October Term after a decade-long break. In Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (“Hikma”),5 the Court issued a unanimous decision holding that a generic drug6 manufacturer’s use of a skinny label (a term for when a generic excludes patented uses of a drug) alongside standard marketing statements does not automatically constitute inducement of patent infringement.7
I. Hikma v. Amarin
The dispute arises from the Hatch-Waxman Act, which permits a generic manufacturer to carve the branded drug’s patented uses out of the label (a “skinny label”) and seek approval only for the unpatented uses.8 In Hikma, the brand-name drug manufacturer, Amarin, developed the drug Vascepa, which contains the active ingredient icosapent ethyl, to treat severe hypertriglyceridemia (“SH indication”) and, more commonly, to reduce “cardiovascular risk in hypertriglyceridemia patients who already take statins” (“CV indication”).9 Amarin sued the generic manufacturer, Hikma, alleging that Hikma actively induced others to infringe Amarin’s CV-indication patents based on the totality of Hikma’s statements across the skinny label, the patient information leaflet, Hikma’s website, and its press releases.10
A claim for induced infringement under § 271(b) requires three elements: (1) a third party’s direct infringement, (2) “knowledge that ‘the induced acts constitute patent infringement,’” and (3) “active steps” towards infringement.11 Hikma turns on the third element. Active steps involve “affirmative” actions and “purposeful, culpable expression and conduct,” as opposed to passive actions, and exclude “ordinary acts incident to product distribution.”12 The issue, therefore, is whether Amarin plausibly alleged that Hikma actively encouraged infringing use, not merely whether doctors could plausibly read the alleged statements on Hikma’s generic drug as instructions to infringe.
Applying these standards, the Court found Amarin’s allegations insufficient. Amarin alleged “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.”13 But the Court clarified that allegations of inducement must rest on statements “designed to stimulate others,” which is “narrower” than statements that merely “could stimulate others.”14
All of Hikma’s public statements had an “obvious alternative explanation”15 other than encouraging infringement, as Hikma “was just complying with the law or with standard industry practice.”16 The skinny label raised no issue because, “by statute, Hikma’s label must be identical to Amarin’s except for the carved-out [patented] use.”17 Hikma’s press releases describing its product as “generic Vascepa” conform to the “normal industry practice” of truthfully describing “a generic drug as ‘equivalent’ to the brand-name competitor.”18 Nor could Amarin aggregate otherwise weak allegations, such as Hikma’s general therapeutic equivalence or Amarin’s total market sales, or rest on “‘vague’ language ‘combined with speculation about how [others] may act.’”19
II. Hikma’s Significance for the Induced Infringement Doctrine and Skinny Labeling
Hikma does more than decide a pharmaceutical dispute. It completes the Court’s two-decade clarification of induced patent infringement by filling in the contours of the statute’s requirement that inducement be active. First, Metro-Goldwyn-Mayer Studios v. Grokster20 supplied the doctrine’s common law foundation; then Global-Tech Appliances v. SEB S.A.21 and Commil USA v. Cisco Systems22 defined its knowledge requirement; and Limelight Networks v. Akamai Technologies23 tied it to a predicate act of direct infringement.
The remaining issue was that none of those cases explained what independent work the word “actively” performs in § 271(b). Hikma answers this last unresolved question. Encouragement must consist of voluntary, affirmative conduct designed to stimulate infringement, rather than conduct that the law compels or that merely allows infringement to occur.24
Although Hikma clarifies what does not constitute active encouragement, the decision leaves open what might: What statements could qualify as conduct “designed to stimulate others”?25 A generic drug manufacturer that “explicitly markets its drug to prescribers for a carved-out use” or “that takes promotional steps directed at the patented indication” would presumably qualify.26 The decision also notes that a generic’s use of implicit encouragement might qualify as induced infringement if it were “‘clear’ to the relevant audience and ‘affirmative.’”27 The harder question, left open by the Court, is what conduct could affirmatively induce patent infringement “when a generic manufacturer otherwise adheres to an FDA-approved skinny label.”28 That question is harder because, in skinny-label litigation, inducement is not one enforcement option among many; it is the only one. Patients and prescribers may directly infringe a method-of-use patent, yet no rational patentee will sue the patients and doctors who make up its market, leaving § 271(b) as the sole channel through which such a patent can be enforced.29
For a generic drug manufacturer’s day-to-day operations, Hikma converts the “section viii carve-out”30 and truthful statements about equivalence to the branded drug into a pleading-stage safe zone.31 A manufacturer that launches a generic drug behind a compliant skinny label may describe its product as the brand’s generic version, tout its therapeutic equivalence rating, and issue standard launch press releases without those acts alone supporting an induced infringement claim. Silence is equally safe: The Court held that Amarin could not rely on Hikma’s “mere omissions, inactions, or nonfeasance,” such as the skinny label’s omission of Amarin’s patented drug use.32 Hikma nevertheless indicates a line between compelled skinny label content and voluntary content. For example, when statutes, regulations, or standard industry practices may require or implicitly authorize comparison to the patented drug,33 content that exceeds those requirements and targets the carved-out use invites liability. Regulatory and marketing teams should accordingly scrub labels, leaflets, websites, and press materials for use-specific language the law did not compel because that additional language is now where active inducement exposure lives.
Additionally, Hikma is as much a pleading decision as a liability decision. The case reached the Court on a motion to dismiss, and the Court resolved it by tightening what a branded drug manufacturer’s complaint must plausibly allege. By narrowing the kinds of statements that can plausibly constitute active inducement, Hikma reduces not only ultimate liability but also access to discovery. Complaints that rest on aggregate marketing materials or generalized allegations of encouragement become vulnerable to dismissal before expensive document production begins.34 A branded drug manufacturer that wants discovery must now plead specific, voluntary conduct directed at a drug’s patented use at the outset. Litigators will feel this procedural shift long before any question of ultimate liability arises.
For pending and future disputes, the most pressing question is how much of GlaxoSmithKline v. Teva Pharmaceuticals (“GSK”)35 survives Hikma. In GSK, the Federal Circuit sustained a $235 million induced patent infringement verdict against a generic drug manufacturer that had marketed its drug under a partial label, a decision that alarmed the generic industry and set the stage for Hikma.36 Teva’s partial label allegedly retained language covering two out of three patented uses for the branded drug. Though the label omitted one patented use, the Court found the generic drug’s label induced infringement, based on the generic’s equivalence-rating press releases and general marketing.37 Hikma’s logic splits GSK in two, as these are the precise customary statements Hikma places on the safe side of the line. In Hikma, the Court disavowed the Federal Circuit’s drift toward asking whether a reader could take a statement as an instruction to infringe, a trend commentators criticized as “infringement by label.”38
One should ultimately measure Hikma by what it changes about the focus of inducement litigation rather than by the win-loss column. Hikma hands generic manufacturers a victory, one consistent with the post-COVID pressure to lower drug prices.39 The shift in focus is evidentiary. Before Hikma, plaintiffs invited courts to infer encouragement from marketplace effects, asking what a physician might foreseeably do after reading a label, a generic’s website, and a press release together. After Hikma, courts must ask if a defendant’s statements are voluntary acts designed to stimulate infringement. Future cases will turn less on whether physicians predictably prescribed the drug for patented uses and more on whether the manufacturer voluntarily chose to include in its label words or conduct directed toward those uses. The center of gravity of induced patent infringement litigation thus shifts from market consequences to affirmative promotional conduct.
Jasper L. Tran consults for OpenAI. He previously practiced IP litigation with Milbank and clerked in the District of Colorado.
References
[1] Timothy R. Holbrook, The Supreme Court’s Quiet Revolution in Induced Patent Infringement, 91 Notre Dame L. Rev. 1007, 1007 (2016).
[2] See Commil USA, LLC v. Cisco Sys., Inc., 575 U.S. 632 (2015); Limelight Networks, Inc. v. Akamai Techs., Inc., 572 U.S. 915 (2014); Global-Tech Appliances, Inc., v. SEB S.A., 563 U.S. 754 (2011); Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913 (2005).
[3] 35 U.S.C. § 271(b). For a history of § 271(b) since its inception in the Patent Act of 1952, see Mark A. Lemley, Inducing Patent Infringement, 39 UC Davis L. Rev. 225, 227–28 (2005).
[4] 35 U.S.C. § 271(b).
[5] 608 U.S. 580 (2026).
[6] A generic drug is the cheaper “biological[] equivalent to[] the brand-name drug.” Caraco Pharm. Lab’ys., Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 405 (2012).
[7] Hikma, 608 U.S. at 595–96.
[8] See 21 U.S.C. § 355(j)(2)(A)(viii); Caraco, 566 U.S. at 406 (describing the “section viii” carve-out mechanism).
[9] Hikma, 608 U.S. at 583.
[10] Id. at 583–84.
[11] Id. at 586–87 (first quoting Global-Tech Appliances, Inc., v. SEB S.A., 563 U.S. 754, 766 (2011), then quoting Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 936 (2005)). The Court relied on its three earlier inducement decisions from 2005, 2011, and 2014 to state this rule. See Limelight Networks, Inc. v. Akamai Techs., Inc., 572 U.S. 915, 920–21 (2014); Global-Tech Appliances, 563 U.S. at 766; Grokster, 545 U.S. at 936.
[12] Grokster, 545 U.S. at 937; see also Hikma, 608 U.S. at 590, 592 (citing Grokster).
[13] Hikma, 608 U.S. at 590 (alteration in original).
[14] Id. at 591 (emphasis in original).
[15] Id. at 592 (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 567 (2007)).
[16] Id.
[17] Id.
[18] Id. at 593 (quoting Inwood Lab’ys., Inc. v. Ives Lab’ys., Inc., 456 U.S. 844, 847–48 (1982)).
[19] Id. at 592, 594–95 (quoting Takeda Pharms. U.S.A., Inc. v. West-Ward Pharm. Corp., 785 F.3d 625, 632 (Fed. Cir. 2015).
[20] 545 U.S. 913 (2005).
[21] 563 U.S. 754 (2011).
[22] 575 U.S. 632 (2015).
[23] 572 U.S. 915 (2014).
[24] Hikma, 608 U.S. at 590; cases cited supra note 2.
[25] Id. at 591 (emphasis in original).
[26] Aydin Harston & Anh-Thu Lam, Supreme Court’s Unanimous Ruling in Hikma v. Amarin: A Game-Changer for Skinny Label Strategies, Rothwell Figg: Biosimilars L. Bull. (June 11, 2026), https://www.biosimilarsip.com/2026/06/11/supreme-courts-unanimous-ruling-in-hikma-v-amarin-a-game-changer-for-skinny-label-strategies/ [https://perma.cc/N2CB-9JGP].
[27] See Hikma, 608 U.S. at 592 (quoting Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 937 (2005)).
[28] Harston & Lam, supra note 26.
[29] See generally Rebecca S. Eisenberg, The Problem of New Uses, 5 Yale J. Health Pol’y L. & Ethics 717 (2005) (explaining that patents on new uses of known drugs are systematically difficult to enforce because the direct infringers are patients and physicians).
[30] See 21 U.S.C. § 355(j)(2)(A)(viii).
[31] See Hikma, 608 U.S. at 592–95.
[32] Id. at 593 (quoting Twitter, Inc. v. Taamneh, 598 U.S. 471, 489 (2023)).
[33] See id. 592–93.
[34] See id. at 589; cf. Bell Atl. Corp. v. Twombly, 550 U.S. 544, 567 (2007) (dismissing a complaint whose allegations had an “obvious alternative explanation”).
[35] 7 F.4th 1320 (Fed. Cir. 2021).
[36] See id. at 1327–35; see also id. at 1360 (Prost, J., dissenting) (warning that the majority’s approach nullifies the “section viii carve-out” pathway).
[37] Id. at 1335–38.
[38] Jacob S. Sherkow & Paul R. Gugliuzza, Infringement by Drug Label, 78 Stan. L. Rev. 131, 134–36 (2026); see Hikma, 608 U.S. at 590 n.3 (disavowing the approach exemplified by GSK, 7 F.4th at 1336–37).
[39] For example, Congress passed the landmark Inflation Reduction Act of 2022, which aimed to lower prescription drug prices. Inflation Reduction Act of 2022, Pub. L. 117-169, 136 Stat. 1818 (2022). Furthermore, polling from March 2026 shows that the public broadly supports policies to lower drug costs, with eighty-eight percent in favor of making it easier for generic drugs to come to market. Audrey Kearney, Julian Montalvo III, Ashley Kirzinger & Liz Hamel, Public Opinion on Prescription Drugs and Their Prices, KFF (Mar. 31, 2026), https://www.kff.org/health-costs/public-opinion-on-prescription-drugs-and-their-prices/ [https://perma.cc/4TWH-AXDF].
