Rehearing Requested: Hikma Challenges Federal Circuit’s Skinny Label Ruling
Patent – Patently-O 2024-08-27
Summary:
by Dennis Crouch
[A prior version of this article's title mistakenly stated that Amarin had filed the petition]
Hikma's recent petition for rehearing en banc against Amarin asks the Federal Circuit to reconsider its "skinny label" jurisprudence. Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc., 23-1169 (Fed. Cir. 2024)
These cases typically involve the following scenario:
- a drug formulation with multiple approved uses;
- the formulation/compound patents are all expired as are patents on one or more uses; but
- at least one method of use claim is still under patent (e.g., take 100 mg each day to treat hypertension...).
The FDA will approve a generic version of the formulation, but the approved label will only mention the non-patented uses. Thus, it is a "skinny label" because the patented uses listed on for the branded formulation have been "carved out."
Of course, everyone understands that it is the same drug and will be just as safe and effective as the branded. The generic manufacturer, along with doctors, patients, pharmacies, insurance companies, and hospitals, . . . they all understand the carveout as simply a patent legalese.