Label-Plus Liability: The Government Warns the Federal Circuit Misread Hatch-Waxman

by Dennis Crouch

The Solicitor General has recommended that the Supreme Court grant certiorari in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889, to resolve whether a generic manufacturer's FDA-compliant carved-out labeling and basic commercial statements can constitute active inducement of patent infringement. The government's December 2025 brief argues that the Federal Circuit's decision threatens to undermine the Hatch-Waxman Amendments' balance between promoting generic competition and protecting patent rights. Although the statute does not create immunity per se, the brief argues that the appellate panel erred by treating communications integral to the section viii skinny label pathway as evidence of culpable inducement -- and thus created a substantial disincentive for generic manufacturers to invoke a mechanism that Congress explicitly designed to prevent method-of-use patents from creating de facto monopolies on entire drug compounds.

• Read the Gov't Brief Supporting Certiorari
• Dennis Crouch, Label-Plus Infringement: The Tinderbox Theory of Generic Inducement, Patently-O (July 7, 2025)
• Dennis Crouch, Supreme Court Preview: Will “Skinny Labels” Get a Weight Check?, Patently-O (Jan. 1, 2025)​
• Dennis Crouch, Generic Drugs, Skinny Labels, and Liability for Off Label (Infringing) Uses, Patently-O (Feb. 17, 2025)
• Dennis Crouch, Amarin v. Hikma: Federal Circuit reverses Inducement Dismissal in Skinny-Label Case, Patently-O (Sept. 6, 2024)
• Dennis Crouch, Hikma Challenges Federal Circuit’s Skinny Label Ruling, Patently-O (Aug. 26 2024)

The case involves Hikma's generic version of Amarin's Vascepa (icosapent ethyl).  The drug compound is no longer patented and the method-of-use patents covering severe hypertriglyceridemia treatment were held invalid in prior litigation between Amarin and Hikma.  But, using the drug to treat cardiovascular risk is still patented.  This is the exact situation for a "skinny label" carveout FDA approval - where a generic receives approval to market generic versions of a drug, but only for the unpatented purposes.  Hikma obtained FDA approval carving out Amarin's patented cardiovascular risk reduction indication while retaining only the non-patented severe hypertriglyceridemia indication.

The problem with the skinny label approach is that everyone knows that its the same generic drug and so folks are bound to use the generic version for the patented purpose.  Doctors may prescribe generic drugs for any indication, and pharmacists often cannot determine why a particular drug is prescribed. Moreover, all fifty states and the District of Columbia either permit or mandate generic substitution when therapeutically equivalent generics are available, and this substitution occurs without regard to whether the generic is labeled for the specific use for which the brand-name drug is prescribed.  What this means is that we have a situation where Congress designed the Skinny Label system in a way that inevitably leads to off-label infringement.