## Facts

- Novo Nordisk marketed repaglinide (Prandin) and held a method-of-use patent covering only one FDA-approved use: repaglinide in combination with metformin.
- The FDA had approved three uses for repaglinide, including non-patented uses not covered by Novo’s patent.
- Caraco sought FDA approval to market generic repaglinide through an ANDA using the § viii pathway, proposing labeling that carved out the patented combination use.
- While patent litigation between the parties was pending, Novo amended its Orange Book use code to describe its patent in broader terms that effectively suggested coverage of all approved uses.
- The broadened use code prevented FDA approval of Caraco’s § viii ANDA because the proposed carved-out label necessarily overlapped with the listed use code.
- Caraco asserted a statutory counterclaim seeking an order requiring Novo to correct the use code to match the patent’s actual scope.
- The district court granted relief and ordered Novo to modify the use code; the Federal Circuit reversed, reading the counterclaim narrowly.

## Issues

1. Whether 21 U.S.C. § 355(j)(5)(C)(ii)(I) permits a generic manufacturer, when sued for infringement, to counterclaim for correction of an overly broad use code that misdescribes the scope of a method-of-use patent.
2. Whether an Orange Book use code is “patent information submitted” under 21 U.S.C. § 355(b) and (c) that may be corrected or deleted via the counterclaim provision.
3. Whether the counterclaim is available only when the listed patent claims no approved method of using the drug, or also when it claims some approved method but the listing overstates what it claims.

## Decision

- The Supreme Court unanimously reversed the Federal Circuit and remanded.
- The counterclaim provision authorizes an order requiring correction of an inaccurate use code that misstates a patent as covering a particular approved method of use.
- “Patent information” subject to correction or deletion includes the method-of-use description (use code) submitted for Orange Book listing.
- The remedy is not limited to cases in which the patent claims no approved method of use; it also reaches overbroad listings that inaccurately attribute additional approved uses to the patent.

## Legal Principles

- Under 21 U.S.C. § 355(j)(5)(C)(ii)(I), an ANDA applicant sued for infringement may seek judicial relief requiring the NDA holder to “correct or delete” inaccurately submitted Orange Book patent information.
- “Correct” has independent meaning from “delete”; the statute provides a correction remedy for misdescriptions of patent scope, not merely a mechanism to remove improperly listed patents.
- The Orange Book use code is “patent information” submitted under § 355(b) and (c) because it is part of the information required for method-of-use patent listings and is used by the FDA in administering § viii carve-outs.
- The counterclaim applies when the listing represents that a patent claims a particular approved method of using the drug, but the patent does not claim that method, even if the patent validly claims some other approved method.
- The statutory scheme assumes the FDA will publish submitted listings without independently verifying their accuracy, making the counterclaim a key mechanism to address inaccurate use codes that can block lawful § viii approvals.

## Conclusion

The Court held that Hatch-Waxman’s counterclaim provision permits a generic manufacturer sued for infringement to obtain an order correcting an inaccurate Orange Book use code that overstates a method-of-use patent’s coverage and prevents approval of a proper § viii carved-out label.


Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399 (2012)