Caraco Pharmaceutical Laboratories v. Novo Nordisk A/S
In brief
The Supreme Court sided with Caraco, allowing a generic maker to use the counterclaim to correct an inaccurate use code and overturning the Federal Circuit’s ruling.
- Where it stands
- Decided
Decided 9-0 · April 17, 2012 · Opinion by Justice Kagan
- What it’s about
- Caraco challenged Novo Nordisk’s description of which uses its Prandin patent covered while seeking approval for a generic drug.
- Who it affects
- Generic drug makers may use the counterclaim to challenge a brand’s use code when it inaccurately says a patent covers a particular way to use the drug.
Summary: written with AI from the case record.
What it's about
The Supreme Court overturned the Federal Circuit and sent the case back (reversed and remanded), deciding that a generic maker may use the Hatch-Waxman Act’s counterclaim provision to correct a description that inaccurately says a patent covers a particular use.
Caraco sought approval for a generic version of Novo Nordisk’s Prandin and challenged Novo’s description of which uses its patent covered. Novo’s patent did not claim an approved method of use.
The Hatch-Waxman Act provides a path for generic drug approval, including for unpatented uses even when other approved uses remain under patent.
Question presented
1. Does the counterclaim provision of the Hatch-Waxman Act only apply if Novo's Prandin patent does not claim any approved method of use? 2. Does Novo's use code for Prandin qualify as "patent information submitted under subsections (b) and (c)" for the purposes of the act?
What the Court decided
Holding
A generic manufacturer may employ the counterclaim provision to force correction of a use code that inaccurately describes the brand’s patent as covering a particular method of using a drug. 601 F. 3d 1359, reversed and remanded.
- Result
- Reversed
The vote
What's next
The Federal Circuit will take up the case again under the Supreme Court’s ruling.
Documents
Opinions
Audio
Docket activity
New analysis added
AI analysis generated: Case Briefing
New analysis added
AI analysis generated: Impact Analysis
AI analysis generated: Decision Record
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AI analysis generated: Opinion Summary
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Audio Recording added: Oral Arguments - Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S
Opinion added: Caraco Pharm.
More questions
- What does a use code describe?
- It describes which uses of a drug the brand company says its patent covers.
Sources
Primary materials plus reporting. Best-effort analysis: this explainer relies on a mix of primary materials and trusted secondary sources. Official filings and opinions remain authoritative.