#hatch-waxman

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#skinny-label
fromPatently-O
6 days ago
Intellectual property law

Supreme Court's January 2026 IP Docket: Hikma Leads a Small but Significant Field

Hikma v. Amarin questions whether a skinny-label generic can face induced infringement for calling its product a 'generic version' or citing branded sales.
fromPatently-O
4 weeks ago
Intellectual property law

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

The Solicitor General urges Supreme Court review to clarify that FDA-compliant skinny labels and basic commercial statements should not automatically constitute inducement of patent infringement.
fromPatently-O
6 days ago
Intellectual property law

Supreme Court's January 2026 IP Docket: Hikma Leads a Small but Significant Field

fromPatently-O
4 weeks ago
Intellectual property law

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

fromPatently-O
2 months ago

Supreme Court on Patents Fall 2025

The leading contender is Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889, which asks whether a generic drug manufacturer that fully carves patented uses out of its FDA-approved label can nonetheless face induced infringement liability simply by calling its product a "generic version" of the brand-name drug or referencing publicly available information about the branded product's sales. The
Intellectual property law
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