Key Points

• In a unanimous decision authored by Justice Jackson, the Supreme Court held that Amarin's complaint failed to state a claim for induced infringement under 35 U.S.C. § 271(b), reversing the Federal Circuit.
• The Court drew a critical distinction: the relevant question is whether a defendant actively encouraged infringement through its statements and conduct, not merely whether third parties could read those statements as encouragement to infringe.
• The Court assessed only whether Hikma's statements and actions objectively constituted active encouragement. It did not examine Hikma's reasoning or strategic thinking behind those actions.

The U.S. Supreme Court recently reversed the Federal Circuit in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., holding that a generic drug manufacturer's use of a "skinny label" and related promotional statements did not constitute induced patent infringement under 35 U.S.C. § 271(b).

The unanimous decision, authored by Justice Ketanji Brown Jackson and issued June 4, 2026, clarifies the standard for what constitutes "active steps to encourage direct infringement." In the process, it significantly narrows the pathway for brand-name pharmaceutical companies to bring inducement claims against generic competitors.

Companies on both sides of the generic-brand divide should reassess their labeling and litigation strategies in light of this decision.

What Is a "Skinny Label"?

Under the Hatch-Waxman Amendments, a generic drug manufacturer seeking FDA approval may submit a "section viii statement" asserting that it will market the drug for methods of use not covered by the brand manufacturer's active patents. When it does so, the generic manufacturer proposes a "skinny label" that carves out the patented methods of use from the brand-name drug's approved labeling, seeking approval only for unpatented indications not covered by an active patent. Nationwide, laws permit or require pharmacists to substitute the cheaper generic version for the brand-name product, whether or not the prescriber intends a patented or unpatented use, often resulting in generic substitution for the carved-out patented indications.

Background

Amarin Pharma, Inc. developed Vascepa, a drug containing the active ingredient icosapent ethyl. The FDA first approved Vascepa in 2012 to treat severe hypertriglyceridemia (the "SH indication"). In 2019, the FDA approved Vascepa for a second, more common use: reducing cardiovascular risk in patients with hypertriglyceridemia who already take statins (the "CV indication"). Amarin obtained two method-of-use patents for the CV indication.

Hikma Pharmaceuticals USA Inc., a generic drug manufacturer, filed an abbreviated new drug application for generic icosapent ethyl. After Amarin's SH-indication patents were invalidated, Hikma supplemented its application with a section viii statement and sought approval of a skinny label limited to the SH indication, carving out the patented CV-indication method of use. In 2020, the FDA approved Hikma's application with the skinny label and assigned it an "AB" rating indicating therapeutic equivalence to Vascepa when used according to its labeling.

Amarin filed suit in the District of Delaware, alleging that the totality of Hikma's statements across several documents: its skinny label, patient information leaflet, website and press releases encouraged health care providers to use Hikma's generic for the patented CV indication. The District Court granted Hikma's motion to dismiss for failure to state a claim. The Federal Circuit reversed, finding it "at least plausible that a physician could read" the relevant statements "as an instruction or encouragement to" infringe. The Supreme Court granted certiorari.

The Court's Analysis

The "Active Steps" Standard

A claim for induced infringement under § 271(b) 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 turned entirely on the third element. Hikma did not dispute before the Court that Amarin plausibly pleaded both direct infringement and the requisite knowledge.

The Court held that "active steps" require "purposeful, culpable expression and conduct" —affirmative actions that objectively constitute encouragement of infringement. The inquiry focuses on what the defendant's statements and actions are, not on the defendant's internal decision-making or motivations for taking them. Notably, the Court rejected Hikma's argument that active inducement must be "express," recognizing that implicit encouragement may also give rise to liability, but only where it is "clear" to the relevant audience and "affirmative." "Ordinary acts incident to product distribution" are insufficient, as are vague statements combined with speculation about how others may respond.

Application to Hikma's Conduct

The Court evaluated Amarin's allegations both individually and as a whole, concluding that "whether viewed together or separately, (they) fail to establish that Hikma took any affirmative steps to encourage infringement." The Court found that several of Hikma's challenged statements had an "obvious alternative explanation," including compliance with the law or standard industry practice. Hikma's label was required by statute to be identical to Amarin's except for the carved-out use and describing a generic drug as the "generic equivalent" of the brand-name comparator is normal industry practice. The Court accepted these explanations at face value without probing Hikma's purpose in making them.

The Court also held that omissions cannot establish active inducement. The skinny label's omission of the CV Limitation of Use and the press releases' failure to mention that Hikma's approved use was limited to the SH indication did not constitute affirmative encouragement, regardless of why Hikma chose to omit them.

Finally, the remaining statements, the patient information leaflet's warnings about cardiovascular side effects, the website's description of the therapeutic category as "hypertriglyceridemia," and sales figures in press releases were too vague or required too speculative a chain of events to plausibly constitute active encouragement.

Takeaways

The decision establishes that the "active steps" inquiry looks at whether statements and actions objectively amount to encouragement of infringement. Courts need not examine the defendant's subjective motivations or internal reasoning behind those actions. Generic manufacturers using skinny labels and complying with FDA labeling requirements have substantial protection from inducement claims where the challenged conduct has an obvious lawful explanation. Brand-name manufacturers alleging inducement will need to identify specific affirmative conduct that objectively constitutes encouragement, beyond standard labeling, omissions or vague promotional statements.

For more information, please contact Pejman F. Sharifi at 646.601.7673 or psharifi@foxrothschild.com, or another member of our national Intellectual Property Department.

This information is intended to inform firm clients and friends about legal developments, including the decisions of courts and administrative bodies. Nothing in this alert should be construed as legal advice or a legal opinion. Readers should not act upon the information contained in this alert without seeking the advice of legal counsel. Views expressed are those of the authors and not necessarily this law firm or its clients.