Originally published on March 3, 2026, by Law360.

In 2024, the U.S. Court of Appeals for the Federal Circuit ruled in Amarin v. Hikma that Amarin had plausibly alleged that Hikma induced infringement of its patents. Now that the U.S. Supreme Court has granted certiorari, we present an update and some practice tips.

The fight in Hikma is not really about one omega‑3 drug. It is about whether a generic that follows the U.S. Food and Drug Administration‘s Section viii pathway can still get haled into prolonged inducement litigation because it calls its product a generic version of the brand and cites public sales data.

With the Supreme Court now set to decide Hikma v. Amarin, this case has the potential to elucidate for how far induced infringement under Title 35 of the U.S. Code, Section 271(b), can reach in the so-called skinny label setting.[2]

Statutory Background

Title 21 of the U.S. Code, Section 355(j)(2)(A)(viii), known as Section viii of the Hatch‑Waxman Act, allows an abbreviated new drug application filer to omit, or carve out, patented methods of use from its label and seek FDA approval only for unpatented indications.[3] The statute is in place to permit earlier generic entry for nonpatented uses, without forcing a full label match or automatically triggering infringement on method‑of‑use patents.[4]

Inducement under Section 271(b) requires two things: intent to cause infringement and affirmative acts that encourage or cause others to practice the patented method.[5]

In the skinny label context, the question has been whether the label itself crosses the line from describing indications and safety information into telling doctors to infringe.

GlaxoSmithKline LLC v. Teva Pharmaceuticals USA Inc., decided by the Federal Circuit in 2021, pushed that debate by reading seemingly neutral label language as actionable inducement at a post‑trial stage.[6]

Amarin v. Hikma takes the next step. There, the Hikma label fully carved out the patented cardiovascular risk‑reduction indication, and the dispute turned on what Hikma said in press releases, websites and other public communications.[7]

Regulatory Background

Amarin’s Vascepa drug originally was approved with an indication for severe hypertriglyceridemia in 2012.[8] From 2012 to 2019, the label contained a limitation regarding cardiovascular use.[9] In December 2019, the FDA approved a new cardiovascular risk‑reduction indication, and Amarin listed method‑of‑use patents for that indication in the Orange Book.[10]

Hikma filed its ANDA in 2016 and, after the cardiovascular approval, submitted a Section viii carveout to omit the patented cardiovascular indication, leaving only the unpatented severe hypertriglyceridemia indication.[11]

The FDA approved Hikma’s skinny label in May 2020.[12] Although Hikma carved out the cardiovascular indication, some cardiovascular‑related warnings and clinical study context remained in other sections of the label.[13] Hikma launched its generic product in November 2020,[14] and shortly thereafter Amarin sued Hikma.

Amarin’s inducement theory did not rest on the label alone. In the U.S. District Court for the District of Delaware, Amarin alleged that Hikma

• Issued press releases that repeatedly described its product as a generic equivalent or generic version of Vascepa without clarifying that the cardiovascular indication was carved out;[15]
• Cited total Vascepa sales figures of more than $1.1 billion in those releases, although more than 75% of those sales were tied to the patented cardiovascular use;[16] and
• Maintained a website that identified its product as AB-rated to Vascepa and placed it in a hypertriglyceridemia therapeutic category broad enough to encompass both the severe hypertriglyceridemia and cardiovascular indications.[17]

Critically, there was no allegation that Hikma explicitly instructed physicians to prescribe its product for cardiovascular risk reduction, nor any language on its label’s indications‑and‑usage section reciting the cardiovascular indication.[18]

District Court Ruling

Hikma moved to dismiss Amarin’s complaint under Rule 12(b)(6) of the Federal Rules of Civil Procedure, arguing that the allegations in Amarin’s complaint, taken as true, did not plausibly state a claim on which relief can be granted.

Hikma’s motion was first addressed in the District of Delaware by Magistrate Judge Jennifer Hall, who recommended denying the motion.

Reviewing the report and recommendation on a de novo standard of review, U.S. District Judge Richard Andrews did not adopt Judge Hall’s recommendation, but instead granted Hikma’s motion to dismiss.[19] He accepted that press releases and public statements could be probative of intent, but he drew a sharp line between intent and an affirmative act of encouragement under Section 271(b).[20]

Judge Andrews explained that the complaint did not plead any statement that rises to the level of encouraging, recommending or promoting taking Hikma’s generic for the reduction of cardiovascular risk.[21] Marketing a fully carved out product as a generic equivalent or generic version of the brand, without more, did not qualify as an inducing act.[22] According to Judge Andrews, merely describing an infringing mode of use without specifically encouraging the use for patented uses is not the same thing as recommending or promoting it.[23]

The decision held that though the allegations might show that Hikma knew about off‑label cardiovascular indication, the complaint did not plausibly plead the required affirmative step under Section 271(b).[24] The court entered a Rule 54(b) judgment as to Hikma, allowing an immediate appeal to the Federal Circuit while claims against an insurer proceeded.

Federal Circuit Ruling

In a precedential opinion, the Federal Circuit reversed, holding that the totality of the allegations plausibly stated a claim for induced infringement and that dismissal at the pleadings stage was error.[25] The Federal Circuit pointed to three key issues.

At the Rule 12(b)(6) stage, the court must accept well‑pled facts as true and draw reasonable inferences in the plaintiff’s favor.[26] The Federal Circuit reasoned that what the label and public statements would communicate to physicians and the marketplace was a factual question, poorly suited to resolution on a motion to dismiss.[27]

Second, the Federal Circuit emphasized that this was not a label‑only case. While the carved out label did not itself recite the cardiovascular indication, the court focused on what the label, combined with Hikma’s public messaging and marketing statements, would plausibly communicate to physicians and the marketplace.[28]

Finally, the court reasoned that it was at least plausible that a physician could read Hikma’s press releases — “touting sales figures attributable largely to an infringing use, and calling Hikma’s product the ‘generic version'” of Vascepa — as an instruction or encouragement to prescribe the drug across any of the approved uses of icosapent ethyl.[29]

The court likewise found it plausible that marketing the product in a broad hypertriglyceridemia therapeutic category on Hikma’s website could be understood as encouragement to prescribe for the off‑label cardiovascular use.[30]

Hikma had argued that its AB‑rating statement and disclaimer stating that its product was approved for fewer than all Vascepa indications negated any inference of inducement.[31]

The Federal Circuit rejected that argument, noting that a single AB‑rating line and a generic disclaimer did not insulate Hikma from an inducement claim at the pleading stage when set against the broader allegations about label context and public statements.[32]

In other words, the Federal Circuit did not hold that “generic version of X” language is always inducing; rather, it held that, given the alleged sales mix, with over 75% attributable to the cardiovascular indication, the label’s residual cardiovascular context, and the way Hikma marketed the product, a factfinder could eventually view that messaging as purposeful encouragement of the patented use and that Amarin had done enough to get past Rule 12(b)(6).[33]

The Supreme Court’s Questions

Hikma petitioned the Supreme Court for certiorari, arguing that it had fully complied with Section viii and that the Federal Circuit’s plausibility framework undermines Congress’s carveout bargain.[34] The petition framed two questions:

1. When a generic drug label fully carves out a patented use, are allegations that the generic drugmaker calls its product a “generic version” and cites public information about the brand (such as sales figures) sufficient to state a claim for inducement?[35]
2. Must a complaint allege some instruction or statement that encourages, or even mentions, the patented use to satisfy Section 271(b) at the pleading stage?[36]

The Supreme Court granted Hikma’s petition for certiorari on Jan. 16, making Hikma v. Amarin the court’s central patent case on Hatch‑Waxman inducement this term.[37]

At the Supreme Court’s request, U.S. Solicitor General D. John Sauer filed an amicus brief. Sauer generally agreed with Hikma that inducement requires purposeful encouragement of the patented use and that a skinny label that omits that use is a significant fact cutting against inducement.[38]

Public statements must meaningfully promote the patented use; generic version language is not automatically enough, though context may still matter.[39]

Sauer also recognized that generic manufacturers may need to reference overall market size and sales figures to attract investors and justify the costs of developing their products.[40] In other words, the complaint must plausibly allege intent to encourage infringement, not mere awareness that some off‑label use may occur.

Amicus briefs from generic industry groups and scholars underscore the stakes. The Association for Accessible Medicines warned that allowing routine generic equivalence references to trigger inducement claims will increase launch uncertainty, raise costs and chill the use of the Section viii pathway.[41] Academic amici stressed that inducement historically requires affirmative acts, and that attaching liability to ambiguous speech would dilute the intent requirement, especially at the pleading stage.[42]

At the heart of the case are two very different narratives about what “generic version of Vascepa” means in the real world.

Hikma argues that a full carveout should protect generic entry for nonpatented uses and preserve the statutory promise of Section viii; calling the product a generic version is accurate equivalence speech, not an instruction to practice the patented cardiovascular risk‑reduction method; and inducement must require a clear affirmative step toward infringement, not standard commercial marketing materials that has accompanied generic launches for decades.[43]

Amarin, on the other hand, leaned heavily on market realities: Pharmacists and payors often treat “generic Vascepa” messaging as a cue for automatic substitution across all of Vascepa’s approved uses, not just the severe hypertriglyceridemia indication that remained.

According to Amarin, when the sales figures highlighted in press releases are overwhelmingly tied to the patented cardiovascular indication, it is at least plausible to infer that the marketing is aimed at that infringing use of cardiovascular indication. Furthermore, under the U.S. Supreme Court’s decisions in Bell Atlantic Corp. v. Twombly in 2007 and Ashcroft v. Iqbal in 2009, the question at the pleadings stage is plausibility, not which interpretation ultimately wins.[44]

How the Supreme Court addresses these issues will determine not only this case, but the usable boundaries of Section viii going forward. In the meantime, for abbreviated new drug application filers and brand companies, the case is already shaping behavior, as it should.

Generics must treat press releases and websites as potential inducement evidence, not just regulatory or investor relations material. If “generic version of X” is used, generics would be wise to pair that language with a clear, prominent statement of the FDA‑approved indication or indications for the generic product.

Generics must also be careful with sales and market‑size references, especially if branded sales are dominated by carved out patented uses. For statements related to AB‑rating, those statements must be coupled with the point that bioequivalence is for labeled uses only.

For brands, the pleading must include label context, press releases, website content, payer policies and substitution pathways. Brands should consider using public statements to the patented use with concrete allegations — for example, share of sales from the infringing indication, formulary structures or internal marketing strategies.

The allegations must also focus on whether any statement actually encourages the patented use, as opposed to merely describing equivalence. Supporting documented evidence, including prints from the website, investor pitch and other marketing materials, may play an important role in pleading infringement under Section 271(b).

The underlying message is straightforward: In the current uncertainty, marketing and communications around a skinny label launch should be drafted with Section 271(b) in mind from day one.

Practitioners should pay close attention to how the parties and amici frame the affirmative act requirement. Is it enough that a statement can reasonably be read as encouraging the patented use, or must it be designed to do so?

It is possible that the court may lean on GSK v. Teva as a template and categorize it as a fact-specific outcome.

Finally, the court may also weigh in on Section viii framework and to the government’s warning that overbroad inducement standards could destabilize generic competition.

In sum, skinny labels are no longer just a regulatory drafting exercise. They are now at the center of debate over how far inducement can reach in a carveout label case. Until the court draws clearer lines, both sides in Hatch‑Waxman litigation need to treat every word surrounding a generic launch as potential evidence in an inducement case.

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[1] Amarin Pharma, Inc. v. Hikma Pharms. USA Inc. , 104 F.4th 1370, 1374-75 (Fed. Cir. 2024) (describing Hikma’s Section viii carve‑out and framing the inducement issue).

[2] Hikma Pharms. v. Amarin Pharma, Inc., No. 24-889, 2026 WL 120677, at *1 (U.S. Jan. 16, 2026); Petition for Writ of Certiorari at i-iii, Hikma Pharms. USA Inc. v. Amarin Pharma, Inc. , No. 24‑889 (U.S. Feb. 14, 2025).

[3] 21 U.S.C. § 355(j)(2)(A)(viii); see also Petition for Writ of Certiorari, supra note 2, at 4-5.

[4] See Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S , 566 U.S. 399, 415 (2012).

[5] 35 U.S.C. § 271(b); MGM Studios Inc. v. Grokster, Ltd. , 545 U.S. 913, 936-37 & n.11 (2005).

[6] See GlaxoSmithKline LLC v. Teva Pharms. USA, Inc. , 7 F.4th 1320, 1327(Fed. Cir. 2021), cert. denied, 143 S. Ct. 244 (2022).​

[7] Amarin, 104 F.4th at 1375-76.

[8] Id. at 1372-73.

[9] Id.

[10] Id.

[11] Id.

[12] Id.

[13] Id. at 1376-78 (discussing clinical‑study and warning sections).

[14] Id. at 1374.

[15] Id. at 1373-74.

[16] Id.

[17] Id. at 1377.

[18] Id.

[19] Id. at 1375 (summarizing dismissal); see also Amarin Pharma, Inc. v. Hikma Pharms. USA Inc. , 578 F.Supp.3d 642, 642-43 (D. Del. 2022).

[20] Amarin, 578 F.Supp.at 646.

[21] Id. at 647.

[22] Id.

[23] Id.

[24] Id.

[25] Amarin, 104 F.4th at 1378-79.

[26] Id. at 1377 (citing Ashcroft v. Iqbal , 556 U.S. 662 (2009), and Bell Atl. Corp. v. Twombly , 550 U.S. 544 (2007)).​

[27] Id. at 1379.

[28] Id. at 1378-79.

[29] Id. at 1380.

[30] Id.

[31] Id. at 1374, 1380.

[32] Id. at 1380.

[33] Id. at 1380; see also Law360, “Fed. Circ. Skinny Label Ruling Guides On Infringement Claims,” at 3-4 (July 5, 2024).

[34] Petition for Writ of Certiorari, supra note 2, at 1-3, 14-18

[35] Id.

[36] Id.

[37] Hikma Pharms. v. Amarin Pharma, Inc., No. 24-889, 2026 WL 120677, at *1 (U.S. Jan. 16, 2026).

[38] Brief for the United States as Amicus Curiae at 10 14,Hikma, No. 24‑889 (U.S. Dec. 5, 2025).

[39] Id. at 21.

[40] Id. at 17-18.

[41] Hikma Pharms. v. Amarin Pharma, Inc., Brief for the Brief for the Association for Accessible Medicines as

2025 WL 920821, at *7 (Mar. 21, 2025).

[42] Hikma Pharms. v. Amarin Pharma, Inc., Brief of 30 Scholars of Law, Economics, and Medicine as Amici Curiae in Support of the Petition, 2025 WL 905474, at *6 (Mar. 20, 2025).

[43] See Amarin, 104 F.4th at 1378; Petition for Writ of Certiorari, supra note 2, at 18-21.

[44] Hikma Pharms. v. Amarin Pharma, Inc., Brief for Respondents in Opposition, 2025 WL 1435277, at *20 (May 15, 2025).