October Term 2011 · Docket 10-844
Can a generic drug maker sue a brand-name company over FDA use codes?
Caraco argues the law bars its patent suit. Novo Nordisk claims the statute allows the challenge.
Verified source milestones
- — An official oral-argument transcript was verified.
- — An official oral-argument transcript was verified.
The arguments, in order
This case may have been argued more than once. Each entry below uses that session's official transcript. Later arguments do not erase earlier ones.
Argument 1 ·
What happened at the argument
Mr. Hurst argued that a statutory path exists for generic drugs since 1984.
Mr. Perry argued the core issue is an administrative law challenge to the FDA.
Mr. Horwich discussed the FDA's role in writing use codes for drugs.
Read the official transcript for this argument · Official argument details
Sources used for this argument breakdown
- Official Supreme Court Transcript — file page 10, lines 20-20 — Transcript, file page 10, lines 20-20
- Official Supreme Court Transcript — file page 10, lines 4-16 — Transcript, file page 10, lines 4-16
- Official Supreme Court Transcript — file page 11, lines 20-32 — Transcript, file page 11, lines 20-32
- Official Supreme Court Transcript — file page 12, lines 16-20 — Transcript, file page 12, lines 16-20
- Official Supreme Court Transcript — file page 16, lines 24-4 — Transcript, file page 16, lines 24-4
- Official Supreme Court Transcript — file page 27, lines 36-10 — Transcript, file page 27, lines 36-10
- Official Supreme Court Transcript — file page 3, lines 20-44 — Transcript, file page 3, lines 20-44
- Official Supreme Court Transcript — file page 3, lines 46-1 — Transcript, file page 3, lines 46-1
- Official Supreme Court Transcript — file page 3, lines 8-18 — Transcript, file page 3, lines 8-18
- Official Supreme Court Transcript — file page 4, lines 22-26 — Transcript, file page 4, lines 22-26
- Official Supreme Court Transcript — file page 5, lines 36-42 — Transcript, file page 5, lines 36-42
- Official Supreme Court Transcript — file page 5, lines 46-50 — Transcript, file page 5, lines 46-50
- Official Supreme Court Transcript — file page 56, lines 44-44 — Transcript, file page 56, lines 44-44
- Official Supreme Court Transcript — file page 59, lines 10-14 — Transcript, file page 59, lines 10-14
- Official Supreme Court Transcript — file page 59, lines 18-20 — Transcript, file page 59, lines 18-20
- Official Supreme Court Transcript — file page 59, lines 30-32 — Transcript, file page 59, lines 30-32
- Official Supreme Court Transcript — file page 6, lines 14-24 — Transcript, file page 6, lines 14-24
- Official Supreme Court Transcript — file page 6, lines 42-4 — Transcript, file page 6, lines 42-4
- Official Supreme Court Transcript — file page 7, lines 14-30 — Transcript, file page 7, lines 14-30
- Official Supreme Court Transcript — file page 8, lines 48-6 — Transcript, file page 8, lines 48-6
A citizen's guide to the whole case
What this case is about
This case tests whether a generic drug maker can sue a brand-name company over FDA use codes. Caraco seeks to dismiss the patent claim. Novo Nordisk wants the court to allow the suit to proceed.
Official sources for this section
- Official Supreme Court Transcript — file page 16, lines 24-4 — Transcript, file page 16, lines 24-4
- Official Supreme Court Transcript — file page 27, lines 36-10 — Transcript, file page 27, lines 36-10
- Official Supreme Court Transcript — file page 3, lines 20-44 — Transcript, file page 3, lines 20-44
- Official Supreme Court Transcript — file page 56, lines 44-44 — Transcript, file page 56, lines 44-44
How the case got here
The Supreme Court heard oral argument in this case on December 5, 2011.
Official sources for this section
- Official Supreme Court Transcript — file page 3, lines 8-18 — Transcript, file page 3, lines 8-18
- Official Supreme Court Transcript — file page 59, lines 30-32 — Transcript, file page 59, lines 30-32
What each side wants
Caraco wants the court to dismiss the patent claim against it.
Novo Nordisk wants the court to allow the patent claim to proceed.
Official sources for this section
- Official Supreme Court Transcript — file page 16, lines 24-4 — Transcript, file page 16, lines 24-4
- Official Supreme Court Transcript — file page 27, lines 36-10 — Transcript, file page 27, lines 36-10
- Official Supreme Court Transcript — file page 3, lines 20-44 — Transcript, file page 3, lines 20-44
- Official Supreme Court Transcript — file page 56, lines 44-44 — Transcript, file page 56, lines 44-44
What each side says
Caraco argues the statute does not cover this specific FDA use code scenario.
Novo Nordisk argues the statute permits a challenge to the FDA's administration.
Official sources for this section
- Official Supreme Court Transcript — file page 16, lines 24-4 — Transcript, file page 16, lines 24-4
- Official Supreme Court Transcript — file page 27, lines 36-10 — Transcript, file page 27, lines 36-10
- Official Supreme Court Transcript — file page 3, lines 20-44 — Transcript, file page 3, lines 20-44
- Official Supreme Court Transcript — file page 56, lines 44-44 — Transcript, file page 56, lines 44-44
What the justices asked
Justice Ginsburg asked if the original drug patent had already expired.
Justice Scalia asked if the statute explicitly excludes generic use claims.
Official sources for this section
- Official Supreme Court Transcript — file page 10, lines 20-20 — Transcript, file page 10, lines 20-20
- Official Supreme Court Transcript — file page 10, lines 4-16 — Transcript, file page 10, lines 4-16
- Official Supreme Court Transcript — file page 11, lines 20-32 — Transcript, file page 11, lines 20-32
- Official Supreme Court Transcript — file page 12, lines 16-20 — Transcript, file page 12, lines 16-20
- Official Supreme Court Transcript — file page 3, lines 46-1 — Transcript, file page 3, lines 46-1
- Official Supreme Court Transcript — file page 4, lines 22-26 — Transcript, file page 4, lines 22-26
- Official Supreme Court Transcript — file page 5, lines 36-42 — Transcript, file page 5, lines 36-42
- Official Supreme Court Transcript — file page 5, lines 46-50 — Transcript, file page 5, lines 46-50
- Official Supreme Court Transcript — file page 59, lines 10-14 — Transcript, file page 59, lines 10-14
- Official Supreme Court Transcript — file page 59, lines 18-20 — Transcript, file page 59, lines 18-20
- Official Supreme Court Transcript — file page 59, lines 30-32 — Transcript, file page 59, lines 30-32
- Official Supreme Court Transcript — file page 6, lines 14-24 — Transcript, file page 6, lines 14-24
- Official Supreme Court Transcript — file page 6, lines 42-4 — Transcript, file page 6, lines 42-4
- Official Supreme Court Transcript — file page 7, lines 14-30 — Transcript, file page 7, lines 14-30
- Official Supreme Court Transcript — file page 8, lines 48-6 — Transcript, file page 8, lines 48-6
Why it matters
This dispute determines how generic drug makers challenge brand-name patents. It affects the speed of generic drug entry into the market. It shapes the balance between patent rights and public access to medicine.
Official sources for this section
- Official Supreme Court Transcript — file page 16, lines 24-4 — Transcript, file page 16, lines 24-4
- Official Supreme Court Transcript — file page 27, lines 36-10 — Transcript, file page 27, lines 36-10
- Official Supreme Court Transcript — file page 3, lines 20-44 — Transcript, file page 3, lines 20-44
- Official Supreme Court Transcript — file page 56, lines 44-44 — Transcript, file page 56, lines 44-44
What happens next
This article currently covers the argument record. Use the official docket link for later case activity.
Official sources for this section
- Official Supreme Court Transcript — file page 10, lines 20-20 — Transcript, file page 10, lines 20-20
- Official Supreme Court Transcript — file page 10, lines 4-16 — Transcript, file page 10, lines 4-16
- Official Supreme Court Transcript — file page 11, lines 20-32 — Transcript, file page 11, lines 20-32
- Official Supreme Court Transcript — file page 12, lines 16-20 — Transcript, file page 12, lines 16-20
- Official Supreme Court Transcript — file page 3, lines 46-1 — Transcript, file page 3, lines 46-1
- Official Supreme Court Transcript — file page 3, lines 8-18 — Transcript, file page 3, lines 8-18
- Official Supreme Court Transcript — file page 4, lines 22-26 — Transcript, file page 4, lines 22-26
- Official Supreme Court Transcript — file page 5, lines 36-42 — Transcript, file page 5, lines 36-42
- Official Supreme Court Transcript — file page 5, lines 46-50 — Transcript, file page 5, lines 46-50
- Official Supreme Court Transcript — file page 59, lines 10-14 — Transcript, file page 59, lines 10-14
- Official Supreme Court Transcript — file page 59, lines 18-20 — Transcript, file page 59, lines 18-20
- Official Supreme Court Transcript — file page 59, lines 30-32 — Transcript, file page 59, lines 30-32
- Official Supreme Court Transcript — file page 6, lines 14-24 — Transcript, file page 6, lines 14-24
- Official Supreme Court Transcript — file page 6, lines 42-4 — Transcript, file page 6, lines 42-4
- Official Supreme Court Transcript — file page 7, lines 14-30 — Transcript, file page 7, lines 14-30
- Official Supreme Court Transcript — file page 8, lines 48-6 — Transcript, file page 8, lines 48-6
Official Court provenance
Official docket and case history · Official Supreme Court oral-argument detail page
Title and summary sources
- Official Supreme Court Transcript — file page 16, lines 24-4 — Transcript, file page 16, lines 24-4
- Official Supreme Court Transcript — file page 27, lines 36-10 — Transcript, file page 27, lines 36-10
- Official Supreme Court Transcript — file page 3, lines 20-44 — Transcript, file page 3, lines 20-44
- Official Supreme Court Transcript — file page 56, lines 44-44 — Transcript, file page 56, lines 44-44
- Official Supreme Court Transcript — file page 16, lines 24-4 — Transcript, file page 16, lines 24-4
- Official Supreme Court Transcript — file page 27, lines 36-10 — Transcript, file page 27, lines 36-10
- Official Supreme Court Transcript — file page 3, lines 20-44 — Transcript, file page 3, lines 20-44
- Official Supreme Court Transcript — file page 56, lines 44-44 — Transcript, file page 56, lines 44-44
Revision history
- Revision 1 · Official Transcript ·
Correction: Rewritten to the concise citizen-facing editorial standard.
- Revision 2 · Official Transcript ·
Correction: Migrated to the dated official Court activity contract without model use.