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[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.



Update history

The first-published date remains unchanged. Display maintenance, classification changes, related-article updates, and text corrections are recorded separately.

November 1, 2026: First published on this website.

November 2, 2026: Added article information, classification, topics, language navigation, related articles where the same case was confirmed, consultation guidance, and SEO. The original text and first-published date were preserved.

 
 
 
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