[U.S.] Skinny Labels and “Induced Infringement,” June 2024 <CAFC> Amarin v. Hikma
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Article information
Article type: Case note
Category: United States
Topics: —
First published on this website: 2026-11-01
Display and classification checked: November 2, 2026
Originally published on Ameblo: 2024-08-04 (Japan time). Full English translation.
[U.S.] Skinny Labels and “Induced Infringement,” June 2024 <CAFC> Amarin v. Hikma
Motion to Dismiss ⇒ Remanded to the district court
Skinny labels for generic drugs and “induced infringement”: for a generic drug approved with a carve-out and therefore without an express statement of the CV indication on its label, the following circumstances indicate the possibility of both noninfringing and infringing uses.
<1> The patient population described in the label's “Clinical Studies” section overlaps with the patented invention.
<2> In a statement concerning the generic drug, the defendant mentioned that most sales derived from the CV indication.
<3> It was advertised in a broad category.
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