Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/s
132 S. Ct. 1670
SCOTUS2012Background
- FDA requires brand use codes in the Orange Book; FDA does not verify use-code accuracy and relies on the codes to gate generic approvals.
- Hatch-Waxman allows ANDAs to proceed via section viii carve-outs or paragraph IV certifications, influencing timing of generic entry.
- Congress added a counterclaim in 2003 allowing an ANDA infringer to seek correction or deletion of patent information if the patent does not claim an approved method of use or the drug.
- Caraco sought to use the counterclaim to force correction of Novo’s use code for the ’358 method-of-use patent after Novo’s code broadened.
- Novo held a use code that initially described a limited use then broadened to cover all three approved uses; Caraco sought to carve out unpatented uses.
- The Federal Circuit held the counterclaim unavailable, prompting Supreme Court review (holding the counterclaim is available).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the counterclaim covers correcting a use code. | Caraco: not an means not any; covers disputed scope | Novo: not an means any; covers no uses if patent claims all | Yes; can correct overbroad use code |
| What counts as “patent information submitted under subsection (b) or (c)”? | Caraco: use codes fall within broader “patent information” | Novo: only patent numbers and expiration dates | Use codes fall within the counterclaim’s scope; “submitted under” is broad |
| Meaning of “the patent does not claim ... an approved method of using the drug” | Caraco: not a particular one; excludes at least two uses | Novo: requires no claimed method at all except one | Not an exact “not any”; context supports ability to challenge specific uses |
| Remedial scope of the counterclaim | Caraco: remedies include correcting use codes | Novo: should be delisting or no effect | Remedies include correcting the listing to permit approval for non-infringing uses |
Key Cases Cited
- Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990) (submission of information under a regulatory scheme contemplated by statute)
- Mylan Pharmaceuticals, Inc. v. Thompson, 268 F.3d 1323 (Fed. Cir. 2001) (delisting/invalid information context; use of counterclaims referenced)
- Ardestani v. INS, 502 U.S. 129 (1991) (regulatory proceedings governed by a statutory provision)
- TRW Inc. v. Andrews, 534 U.S. 19 (2001) (statutory interpretation avoiding superfluous provisions)
- Johnson v. United States, 559 U.S. 133 (2010) (context governs the meaning of statutory terms)