High Court Agrees to Hear ‘Skinny Label’ Dispute

The U.S. Supreme Court has agreed to hear a patent-infringement dispute between generic drugmaker Hikma Pharmaceuticals USA, Inc. and brand-name company Amarin to decide whether generic drugmakers may face liability for inducement of patent infringement when they market a drug under a so-called “skinny label” — i.e., a label that omits uses still under patent, even if the generic otherwise duplicates the brand-name drug.

The U.S. government recently urged the high court to review the case. In its brief, the Solicitor General argued that the lower court’s ruling — which found inducement liability based largely on the generic’s carve-out label plus public statements that described the drug as the “generic version” of Amarin’s product — “threatens to undermine” the carefully calibrated balance enacted by the 1984 Hatch‑Waxman Amendments.

In this case, Hikma followed a familiar path: its generic drug — a version of Amarin’s icosapent ethyl — is labeled only for severe hypertriglyceridemia (an unpatented use), excluding the cardiovascular-risk use that remains under patent. But the U.S. Court of Appeals for the Federal Circuit reversed a prior dismissal, holding that the combination of Hikma’s skinny label plus its public references (such as press releases and investor disclosures) about total sales and equivalence to the brand drug gave rise to a plausible claim that Hikma was “actively inducing” infringement.

In its brief, the Solicitor General warned that allowing such inducement claims based on innocuous marketing statements or truthful descriptions risks undermining the “skinny-label” pathway entirely. Regulated generic manufacturers may be deterred from using the carve-out — or may withdraw from the market altogether — out of fear that any public remark about their generic’s equivalence or total sales could expose them to patent-infringement liability. That, the brief argued, would upset the balance Congress struck: promoting affordable generics while preserving legitimate patents.

If the Supreme Court adopts the government’s reasoning, it could significantly curtail liability for generic makers who use skinny labels — reinforcing the carve-out pathway and protecting generic competition. On the other hand, a ruling upholding the Federal Circuit’s reasoning could give patent holders broader leverage over generics, even when the generics strictly comply with FDA labeling rules — potentially chilling market entry of generics for drugs with mixed patented and non-patented uses.