The District of Delaware’s recent decision in Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. demonstrates that the U.S. Supreme Court’s decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. may apply beyond Rule 12(b)(6), including at summary judgment and that Hikma’s reasoning applies beyond “skinny label” carve-outs to other label language.
Hikma clarified the standard for pleading induced patent infringement under 35 U.S.C. § 271(b). 608 U.S. 580, 592 (2026) (“But implicit or explicit, the necessary inducement must be ‘clear’ to the relevant audience and ‘affirmative.’”)
Although Hikma arose from a pharmaceutical “skinny label” dispute, the Court’s reasoning is not limited to that context, and an early post-Hikma decision from the District of Delaware – Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., No. 1:23-cv-00152-JLH, Dkt. 387 (D. Del. Sept. 24, 2026) (slip op.) – suggests that the Court’s requirement of “clear” and “affirmative” encouragement can have broader implications for pharmaceutical labeling and inducement claims generally.
The developing case law remains limited—Hikma was decided in June 2026—but this early district court application suggests that patentees are likely to face a more demanding standard when the alleged inducement rests principally on labeling or other conduct that does not affirmatively promote the patented use.
The Supreme Court’s Decision in Hikma
Hikma concerned Amarin’s Vascepa® (icosapent ethyl), which was approved for two indications: (1) treatment of severe hypertriglyceridemia and (2) reducing cardiovascular risk in hypertriglyceridemia patients who already take statins. After Amarin obtained patents covering the latter use, Hikma sought approval for a generic product with a “skinny label” that carved out the patented cardiovascular indication.
Amarin alleged that Hikma induced infringement because its label and other communications encouraged physicians to prescribe the generic for the patented indication. The Federal Circuit held that Amarin had plausibly alleged inducement, reasoning that a physician could potentially read Hikma’s statements as an instruction or encouragement to practice the patented method. See Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., 104 F.4th 1370, 1380 (Fed. Cir. 2024).
The Supreme Court unanimously reversed. The Court held that inducement requires affirmative conduct that clearly encourages the infringing acts; it is not enough that a communication makes infringement foreseeable, possible, or inferable. Hikma, 608 U.S. at 590–95. Section 271(b), the Court explained, requires “‘affirmative steps to bring about the desired result’ of infringement.” Id., 608 U.S. at 594.
The Court identified several deficiencies in Amarin’s position. Some of Hikma’s statements had an “obvious alternative explanation,” such as compliance with federal law or ordinary industry practice. Id., 608 U.S. at 581. The Court also rejected theories based on omissions or inaction, explaining that inducement requires affirmative statements or actions rather than mere failures to act. Id., 608 U.S. at 582. And although active inducement need not be express, the relevant conduct must be sufficiently “clear” to the relevant audience and “affirmative.” Id., 608 U.S. at 592.
In sum, the decision sets specific parameters for alleging inducement based on labels, marketing materials, and other communications by requiring affirmative conduct that clearly encourages the infringing acts.
Vanda Pharmaceuticals: Early District Court Application
The Honorable Jennifer L. Hall’s recent decision in Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., No. 1:23-cv-00152-JLH, Dkt. 387 (D. Del. Sept. 24, 2026) (slip op.) may be instructive on how district courts will assess inducement claims in the wake of Hikma.
Vanda asserted method-of-treatment patents concerning the administration of tasimelteon to patients taking beta blockers. The asserted claims generally required discontinuing beta-blocker treatment before administering tasimelteon. Teva and Apotex marketed generic tasimelteon products whose labels were substantively identical to Vanda’s FDA-approved label. The relevant label stated that “[n]ighttime administration of beta-adrenergic receptor antagonists may reduce the efficacy of tasimelteon.” Vanda, Dkt. 387 at 5.
Following the Supreme Court’s decision in Hikma, Judge Hall invited supplemental briefing concerning its impact on Vanda’s inducement claim. See id. at 8, n. 6. The defendants argued that the record contained no evidence of active inducement beyond the generic labels themselves. See generally Vanda, Dkt. 375 at 5-7.
The district court agreed and granted summary judgment of non-infringement. Judge Hall concluded that, after Hikma, “no reasonable juror could find” that the defendants’ labels encouraged, recommended, or promoted the infringing use. Vanda, Dkt. 387 at 14. The court emphasized that active steps need not be express, but they must be “clear” to the relevant audience and “affirmative.” Id. at 8. The question, therefore, was not whether the label language could be understood to lead physicians toward the patented method, but whether the language constituted an affirmative step to commit infringement.
In the court’s view, it did not. According to Judge Hall, a statement that nighttime administration of beta blockers “may reduce the efficacy” of tasimelteon was not, as a matter of law, an affirmative step toward the patented method. Id. at 8.
The court rejected Vanda’s effort to distinguish Hikma on the ground that Hikma involved a Hatch-Waxman “skinny label” carve-out. Id. at 8. n.6 (“[t]he reasoning of Hikma is not limited to the context of carve-outs.”)
Why Vanda Matters
Vanda is significant for at least two reasons.
1. Hikma may apply beyond Rule 12(b)(6), including at summary judgment
Vanda demonstrates that Hikma is more than a pleading decision. The Supreme Court decided Hikma under Rule 12(b)(6), holding that the allegations did not plausibly establish active inducement. Vanda, by contrast, applied Hikma on summary judgment after discovery. The district court treated the “clear” and “affirmative” requirement as a substantive limitation on the evidence necessary to prove inducement, not simply as a heightened pleading standard.
2. Hikma’s reasoning applies beyond “skinny label” carve-outs to other label language
Vanda confirms that the reasoning of Hikma is not confined to skinny labels. The accused products in Vanda did not present the precise carve-out circumstances at issue in Hikma. Nevertheless, the court applied the Supreme Court’s affirmative-conduct requirement to the defendants’ labels and found the evidence insufficient as a matter of law.
That distinction could prove particularly important in future pharmaceutical patent infringement cases. Brand-name patentees may continue to rely on labels, prescribing information, regulatory submissions, sales materials, websites, and other communications as evidence of inducement. But Hikma and Vanda suggest that courts will focus on whether those materials affirmatively encourage the patented method. Labels that merely describe the drug, identify potential risks or interactions, or provide information from which an infringing use might be inferred may not be found to infringe under an inducement theory.
Practical Implications
Vanda extends Hikma in two respects. Hikma and Vanda suggest that compliance with FDA requirements, ordinary descriptions of a generic product, and neutral or cautionary statements may not constitute evidence of induced infringement. That physicians could use such information in practicing a patented method does not necessarily indicate infringement.
For patentees, the decisions underscore the importance of developing evidence of affirmative encouragement. Evidence that physicians had knowledge of the patent, actually practiced the patented method, or that a label made the use foreseeable, may not by itself establish inducement. Demonstrating that the defendant’s own communications or conduct directly led to the infringing use could be key to proving inducement.
Looking Ahead
Notwithstanding the Vanda decision, Amarin v. Hikma has not reached a final conclusion. Following the Supreme Court’s decision, the Federal Circuit recalled its mandate, vacated its prior opinion and judgment, and remanded the case to the District of Delaware for further proceedings consistent with Hikma. See Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., No. 2023-1169, 2026 WL 2056020, at *1 (Fed. Cir. July 15, 2026). The district court is expected to apply the Supreme Court’s clarified inducement standard to the underlying record and additional precent may be created to guide future litigants.
For now, however, Hikma and Vanda point in the same direction: (1) courts may apply the Supreme Court’s “clear” and “affirmative” requirement at the summary-judgment stage and not just in the specific skinny-label circumstances presented in Hikma; (2) § 271(b) requires affirmative encouragement of infringement, not merely conduct that makes infringement foreseeable or possible.
