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The Highlights
- Supreme Court to Clarify Skinny‑Label Inducement: The Court took Hikma to decide when a generic drug maker can be liable for inducing infringement even after carving out a patented indication.
- Case Centers on Non‑Label Conduct:Because Hikma fully removed the patented use from its label, the issue is whether marketing statements and press releases alone can show inducement.
- Ruling Will Shape Generic Launch Strategies: The decision could redefine how brands and generics handle carve‑outs, marketing language, and early patent‑litigation risks.
Introduction
On January 16, 2026, the Supreme Court granted a petition for writ of certiorari in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.1 The case involves the issue of whether a generic drug maker can be found to have induced infringement of a pharmaceutical method-of-treatment patent where the generic drug maker "carves out" certain treatment indications in its proposed label (a so-called "skinny label").
The grant of certiorari comes after the Court invited the Solicitor General to submit his views — the second time that the Court has done so on a question of induced infringement for skinny labels.
The Solicitor General's brief urged the Court to take up Hikma and rule for the generic drug maker, mirroring the Solicitor General's position in 2023 in Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC ("GSK").2 In GSK, however, the Court denied certiorari over Justice Kavanaugh's dissent.
Hikma presents a different procedural posture from GSK. In Hikma, the U.S. Court of Appeals for the Federal Circuit reversed a district court's Rule 12(b)(6) dismissal of patent owner Amarin's complaint for failure to state a claim of induced infringement. By contrast, in GSK, the Federal Circuit reinstated a jury's verdict of induced infringement after the district court granted judgment as a matter of law of noninfringement.
This article explores the current state of induced infringement law and why the Supreme Court may have chosen Hikma as the vehicle to address induced infringement in the context of a generic drug maker's skinny label.
Pharmaceutical labeling
Under the Hatch-Waxman Act, a generic drug's label ordinarily must mirror the brand drug's label, ensuring that the generic drug carries the same essential information regarding safety, dosage, and use.
Congress nonetheless recognized that a brand drug may be approved for multiple indications over time, some of which remain protected by method-of-use patents. Under these circumstances, section viii of the Hatch-Waxman Act permits a generic drug maker to seek FDA approval while omitting or carving out the still-patented indication from its label.
Although the generic may carve out the patented use, certain portions of the brand label — e.g., clinical study descriptions or pharmacological background — may be difficult or impossible to remove without rendering the label incomplete or misleading. As a result, even a properly carved-out "skinny label" may still contain information that reflects the broader clinical profile of the branded drug.
Once a generic drug is approved and launched, it is widely understood that the generic drug will be substituted and prescribed across the full range of indications for which the brand drug is approved. That includes even those indications that were carved out from the brand label.
Hikma's path to the Supreme Court
Hikma launched a generic version of Amarin's Vascepa product in 2020. Hikma's label for its generic product did not list every indication for which Vascepa had received FDA approval.
Instead, Hikma's skinny label stated that its generic product was indicated for severe hypertriglyceridemia ("SH") but carved out Amarin's patented indication for reducing cardiovascular risk ("CV").
Hikma released several press releases that broadly referred to its generic product as the "generic version" or "generic equivalent" of Vascepa and provided sales data for all uses of Vascepa, including CV. Hikma also marketed the drug on its website as "AB" rated, meaning it was therapeutically equivalent to Vascepa when used as labeled.
Amarin sued Hikma for induced infringement of Amarin's CV patent under 35 U.S.C. § 271(b), citing Hikma's press releases, website, and product label as evidence of Hikma's specific intent to actively encourage physicians to prescribe the generic Vascepa product for the off-label CV indication. The district court dismissed Amarin's complaint under Rule 12(b)(6), concluding that Hikma did not plausibly allege induced infringement.
The Federal Circuit reversed the dismissal of Amarin's complaint. It held that Amarin plausibly alleged that Hikma actively induced healthcare providers to directly infringe. While the court acknowledged that Amarin's inducement allegations likely would have failed if they had been based on Hikma's label alone, it reasoned that Amarin's complaint also relied on Hikma's public statements and marketing materials.
Thus, at the pleadings stage, where the district court was required to accept the totality of Amarin's allegations as true, the Federal Circuit determined that Amarin's inducement allegations were at least sufficiently plausible to survive a motion to dismiss.
Factual differences from GSK
GSK's Coreg product has three indications of use: (1) treatment of hypertension; (2) treatment of congestive heart failure ("CHF"); and (3) reduction of cardiovascular mortality in patients suffering from left ventricular dysfunction following a myocardial infarction ("post-MI LVD").
Teva launched a generic version of Coreg that included a partial skinny label, which listed only the hypertension and post-MI LVD indications and carved out the CHF indication. Teva issued press releases and marketing materials describing its product as a "Generic version of [GSK's] cardiovascular agent Coreg®" and an "AB-rated generic equivalent" of GSK's Coreg® Tablets "indicated for treatment of heart failure and hypertension."
GSK sued Teva for induced infringement of a patent claiming a method of decreasing mortality caused by CHF by administering carvedilol. After a jury found Teva liable for induced infringement, the district court granted Teva's post-trial motion for judgment as a matter of law ("JMOL") of noninfringement, determining that GSK had failed to prove that Teva's alleged inducement actually caused physicians to directly infringe.
The Federal Circuit reversed, reinstating the jury's infringement verdict. The court relied on testimony and evidence showing that, despite Teva carving out the CHF indication, the remaining post-MI LVD indication, together with the clinical studies section of the label, overlapped with the patented CHF method and thus instructed infringement. Key to the Federal Circuit's determination was expert testimony that post-MI LVD is intertwined with heart failure.
The Federal Circuit also relied on Teva's marketing materials, which did not distinguish between CHF and post-MI LVD, and testimony that physicians rely on these marketing materials. Notably, the court stated it was not holding that simply calling a product a "generic version" or "generic equivalent" is enough to encourage infringement.
In all, the court determined that GSK had provided substantial evidence that Teva's partial skinny label, marketing materials, and press releases instructed and encouraged performance of the patented method.
Why the Supreme Court granted certiorari in Hikma but not GSK
Hikma and GSK differ both procedurally and factually, which may explain why the Supreme Court declined to grant certiorari in GSK but chose to take Hikma.
Procedurally, Hikma presented a unique posture compared to other recent skinny label inducement cases, including GSK.
Those cases came to the Federal Circuit either after post-trial motions (as in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.,3), after entry of judgment following a bench trial (as in H. Lundbeck A/S v. Lupin Ltd.4 and Grunenthal GmbH v. Alkem Laboratories Ltd.5) or after summary judgment (as in HZNP Medicines LLC v. Actavis Laboratories UT, Inc.6).
In GSK, the Federal Circuit's analysis of whether substantial evidence supported the jury's infringement verdict was based on a full evidentiary record, complete with expert testimony, prescribing data and the parties' internal documents. Hikma, conversely, is an appeal from a pleadings-stage dismissal, where Amarin's complaint needed to contain only plausible allegations.
Hikma and GSK also differ factually. Because Hikma's label fully carved out the patented CV indication, the Federal Circuit acknowledged that Hikma's label alone could not support induced-infringement allegations. Inducement instead would need to be inferred from non-label conduct, such as press releases and marketing statements.
This contrasts with GSK, where Teva launched its generic product with only a partial skinny label that, according to the jury, overlapped factually with the patented method. Thus, Teva's label itself was a key source of the induced-infringement finding and was further supported by non-label evidence.
Induced infringement at the Supreme Court
Section 271(b) states that "[w]hoever actively induces infringement of a patent shall be liable as an infringer." Liability for induced infringement requires three elements: (1) direct infringement by a third party; (2) specific intent by the alleged infringer to induce the direct infringement; and (3) knowledge that the induced acts constitute patent infringement.
Over the last 25 years, the Supreme Court has reaffirmed the importance of the specific-intent element to the inducement inquiry. In Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd.,7 for example, the Court stated that inducement liability is premised on "purposeful, culpable expression and conduct" and not "ordinary acts incident to product distribution."
Similarly, in Global-Tech Appliances, Inc. v. SEB S.A.,8 the Court reinforced that the specific-intent element requires the alleged infringer to have taken affirmative steps to encourage the direct infringement. These affirmative steps may be advertising an infringing use or instructing how to engage in an infringing use.
The Supreme Court also held in Global-Tech that inducement requires not only knowledge of the induced acts, but also that those acts constitute patent infringement. In reaching this holding, the Court rejected the Federal Circuit's previous standard, which allowed liability if the accused infringer showed deliberate indifference to a known risk that a patent exists.
The Supreme Court juxtaposed the "deliberate indifference" standard with willful blindness, which may be used to prove knowledge and requires an accused infringer to take a deliberate act to avoid knowledge of the infringing nature of the activities.
Current state of infringement in skinny label cases at the Federal Circuit
For induced infringement of method-of-treatment claims under the Hatch-Waxman Act, 35 U.S.C. § 271(e)(2), which relies on the generic drug maker's submission of an Abbreviated New Drug Application as the act of infringement, the specific-intent inquiry turns on whether the generic drug maker's proposed drug product label would encourage physicians or patients to directly infringe.9
Because infringement under § 271(e)(2) is reserved for generic products that have not yet received FDA approval for marketing, and because skinny labels by definition do not include at least one patented indication, patent owners must rely on statements in other sections of the proposed label to prove specific intent to induce infringement (e.g., clinical studies or dosage and administration sections).
Even though it is well known that a generic drug, once approved, may be prescribed for all the innovator drug's approved uses (even those that the generic drug maker carved out), the Federal Circuit has held that the generic drug's proposed label may be insufficient to prove specific intent where there is a true carve out of the patented indication.
Because Hikma received FDA approval to market and sell its generic Vascepa product, Amarin's complaint instead asserted induced infringement only under 35 U.S.C. § 271(b), which the Federal Circuit described as a "run-of-the-mill induced infringement case."10
In such circumstances, the Federal Circuit has applied traditional principles of induced infringement by allowing patent owners to rely on the totality of the evidence to prove inducement — i.e., not only the generic drug maker's proposed label but also other sources, including marketing materials and press releases.11
How the Supreme Court may decide Hikma
At least four of the nine justices (the minimum required to grant certiorari) — with Justice Kavanaugh likely among them — believe Hikma raises an important induced-infringement issue that warrants clarification. Based on the Supreme Court's Global-Tech and Grokster decisions, the Court will almost certainly reaffirm a rigorous standard for patent owners to establish the requisite intent for induced infringement.
The questions now are what sources of proof will suffice and how far the Court's reasoning in Hikma will extend. Based on the Court's past inducement cases, the Court could follow at least three possible routes in deciding Hikma.
First, the Court could endorse the "totality" approach that the Federal Circuit applied in Hikma and GSK. This outcome would allow branded companies to rely on not only a generic drug maker's label, but also on non-label evidence — such as marketing materials, press releases and physician prescribing behaviors — to support induced-infringement claims.
This approach would maintain the current scope of liability by maintaining the availability of evidence beyond the label to establish the requisite intent. It also would result in greater certainty for branded pharmaceutical companies that their induced-infringement claims will not be dismissed before discovery occurs.
Second, the Court could opt to narrow the categories of evidence and allegations that may be used to support induced infringement, limiting patent owners' possible proof to evidence of explicit and direct encouragement to infringe the patented use. For example, the Court could decide that only clear statements in a generic drug maker's label encouraging an infringing use could support a claim for induced infringement, excluding more general, non-instructional marketing statements.
This outcome would give generic drug manufacturers greater certainty when deciding to carve out indications for a skinny label by making it harder for innovator pharmaceutical companies to establish induced infringement based on a skinny label.
This could also give generic drug makers an out to remove patented indications from their labels while still marketing their products as a true "generic equivalent" to the branded product, without important qualifiers (as Hikma and GSK have done). This could be especially problematic for brand companies given that generic drugs are known to be prescribed off-label for both noninfringing and infringing uses, regardless of any carve-outs.
Finally, the Court could take a middle-ground approach. Instead of applying a bright-line rule that evidence beyond the label may not be considered, the Court could clarify exactly what non-label evidence is legally relevant to plausibly allege induced infringement. This approach would refine what qualifies as an "affirmative act," particularly at the pleadings stage.
For any of these routes, Hikma's impact on the pharmaceutical industry will also depend on whether and how the Court cabins its decision. For example, the Court could distinguish between cases arising from a motion to dismiss and those arising post-trial.
It could also differentiate between cases where a generic drug has been approved and marketed (as in Hikma) and cases arising under 35 U.S.C. § 271(e)(2)(A), where the generic product has not received FDA approval and the infringement allegations instead rely on evidence of how the generic drug would be used if approved.
Conclusion
Hikma presents the Supreme Court with a narrow but consequential opportunity to shape induced-infringement doctrine in the context of skinny labels.
Regardless of the outcome, it may result in a shift in the specific intent requirement for induced infringement by either substantially altering a brand company's ability to prove induced infringement or limiting generic drug makers from relying on carve outs as an absolute shield from inducement liability.
However the Court decides the case, Hikma is poised to shape not only induced-infringement jurisprudence but also the practical calculus surrounding generic launches, labeling strategies, and early-stage patent litigation in the pharmaceutical industry.
Footnotes
1. No. 24-889.
2. No. 22-37.
3. 7 F.4th 1320 (Fed. Cir. 2021).
4. 87 F.4th 1361 (Fed. Cir. 2023).
5. 919 F.3d 1333 (Fed. Cir. 2019).
6. 940 F.3d 680 (Fed. Cir. 2019).
9. See Grunenthal, 919 F.3d at 1339.
10. Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., 104 F.4th 1370, 1377 (Fed. Cir. 2024).
11. See GSK, 7 F.4th at 1338.
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