Supreme Court Reins in Skinny Label Lawsuits

On June 4, 2026, the Supreme Court issued a unanimous decision in Hikma v. Amarin heightening the type of conduct that must be pleaded to maintain an induced infringement claim against a generic pharmaceutical company marketing a drug product under a skinny label. This is an important decision affecting all companies involved in Hatch-Waxman ANDA litigation.

When a drug is approved for both patented and non-patented uses, a generic company can seek FDA approval solely for the non-patented uses. In such cases, the generic drug label carves out (known as a section viii carve-out) the patented uses and indicates the drug only for the approved non-patented uses, resulting in a so-called “skinny label.” Nonetheless, generic drug manufacturers marketing their drugs under a skinny label know that their drugs ultimately will be prescribed for the patented use because all states permit and sometimes even require medical providers to substitute brand-name drugs with the cheaper approved generic. But knowledge of infringement has never been enough to establish inducement. Inducement also requires active steps that encourage infringement.

The Court’s decision sets a factual threshold for the type of conduct which must be alleged to bring an infringement suit against a drug approved under a skinny label and clearly delineates the types of conduct that do not qualify.

Relying on its precedent in the copyright context, the Court reaffirmed that ordinary acts incident to product distribution are not enough. Vague language combined with speculation about how others may act is also insufficient. The alleged inducement must be clear to the relevant audience and affirmative to promote the claim from a mere possibility into the realm of plausibility. Thus, statements that merely might cause others to infringe do not qualify as active encouragement. The statements must be designed to encourage infringement.

Under these standards, Amarin’s complaint failed.

What Acts Count and Do Not Count?

Statements With Obvious Alternative Explanations. Amarin contended that Hikma’s label induced infringement because even though it carved out the patented indication, it still contained results from a clinical study that included patients within the scope of the patented indication. Amarin also faulted Hikma for describing its product as the generic equivalent of the branded drug. The Court rejected both. Hikma’s product label was required to comply with federal law, and the statements regarding generic equivalence were standard industry practice. These alternative explanations were obvious and therefore negated any plausible inference of culpability.  

Omissions, Inaction, or Nonfeasance. Amarin also argued that when Hikma advertised its product as a generic equivalent, it should have advised the public that the generic was not approved for the patented use. The Court rejected this because inducement requires affirmative actions and does not attach to acts of omission.

Vague Statements and Speculation Versus Statements “Designed” to Encourage Infringement. Amarin was left with vague statements on Hikma’s website, statements relating to sales figures, and assumptions that medical professionals may have relied on certain statements in Hikma’s label in prescribing the drug for the patented use. But these types of vague and speculative statements were not “designed” to encourage infringement. The Court’s decision makes clear that only statements (such as those in advertisements, marketing materials, and the like) “designed” to cause others to infringe qualify as acts of encouragement to support a plausible inducement claim. Thus, it is no longer enough that medical professionals may interpret statements as encouraging infringement; the generic company’s statements must be specifically designed to do so.

What Does Hikma Mean for Pharmaceutical Companies?

Branded pharmaceutical companies have always faced an uphill battle in bringing patent infringement suits against skinny label products. The holding in Hikma v. Amarin raises the bar further and practically forecloses infringement actions against skinny labels except in rare circumstances. Brands will need to look for ways to differentiate their products from the skinny label generic versions in the marketplace, for example, by co-branding the drug for the patented and non-patented indications, if permissible under FDA regulations.

For generic pharmaceutical companies, the decision provides a clear roadmap for what commercial conduct they can now undertake when marketing their skinny label product without risking a lawsuit.