Key Takeaways
- Supreme Court to decide if “generic version” marketing can support induced infringement claims. On Jan. 16, 2026, the Court granted Hikma’s petition for cert. in a closely watched case that could redefine the limits of skinny labeling and induced infringement law for generic drugs and biosimilars.
- Federal Circuit ruling puts skinny labeling strategy in the spotlight. By reviving Amarin’s induced infringement claims despite Hikma’s carved-out label, the appellate court raised new questions about the viability of long-standing generic and biosimilar defenses.
- Pharma and biosimilar companies should reassess labeling and marketing strategies. Companies are encouraged to join our Feb. 11, 2026, webinar, What’s the Skinny on Skinny Labeling?, for a deeper dive into what’s at stake and how to prepare.
In what is certainly one of the hottest cases to watch relating to skinny labeling and induced infringement for the pharmaceutical industry, the Supreme Court granted Hikma’s cert. petition on Jan. 16, 2026. At bottom, this case and the questions presented involve whether a generic company can induce infringement by making statements about its product being a “generic version” of a branded product and referencing total branded company sales when the generic label has carved out the indication covered by the brand company’s patents through a skinny label.
Skinny labeling has been a strategy used by generic and biosimilar companies for decades to avoid being held liable for induced infringement of method of use patents. In the case at issue, Hikma had obtained a dismissal of Amarin’s induced infringement complaint in the U.S. District Court for the District of Delaware based on Hikma’s skinny label that carved out the patented indication. But the Federal Circuit reversed, finding that Amarin’s allegations that Hikma’s public statements that it was selling a “generic version” of the branded product and referencing total brand sales (not limited to the indication for which Hikma was seeking approval) was sufficient to state a claim and survive a motion to dismiss.
While the case involves a unique instance where pleading standards are at issue, the Supreme Court’s review could have significant ramifications for the pharma and biologics industry.
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