A Blog About Intellectual Property Litigation and the District of Delaware

Entries for tag: Skinny Labels

On Tuesday, Judge Andrews issued what I believe is the first opinion in the district regarding "skinny labels" since the Federal Circuit issued its decision in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 7 F.4th 1320 (Fed. Cir. 2021).

As anyone immersed enough in patent law to read this blog will know, skinny labeling is the practice of excluding certain indications from the generic drug's label and associated inserts, so as to avoid inducing infringement of method of treatment patents listed in the orange book. In Amarin Pharma, Inc. et al v. Hikma Pharmaceuticals USA Inc., C.A. No. 20-1630-RGA, D.I. 97 (D. Del. Jan. 4, 2022), for instance, the branded drug was indicated for treatment of severe …