SCOTUS To Hear Skinny Label Dispute
Jan 26, 2026
•1 minute read
Supreme Court will hear Hikma v. Amarin addressing whether generic drug "carve-out" labeling constitutes induced patent infringement. Amarin sued Hikma in 2022 claiming Hikma's generic Vascepa label inadequately carved out Amarin's cardiovascular method patents. Delaware District Court dismissed but Federal Circuit reversed, finding plausible induced infringement claim. Case centers on tension between FDA-permitted skinny labels and patent law, with Solicitor General supporting review, arguing Federal Circuit decision undermines congressional balance.
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