Novo Nordisk A/s v. Caraco Pharmaceutical Laboratories, Ltd.
688 F.3d 766
Fed. Cir.2012Background
- Caraco moves for summary affirmance of a district court injunction under 21 U.S.C. § 355(j)(5)(C)(ii)(I) following Caraco v. Novo Nordisk.
- Supreme Court reversed this court and remanded for further proceedings in Caraco Pharm. Labs. v. Novo Nordisk A/S, 132 S. Ct. 1670 (2012).
- Novo Nordisk argues on remand that Novo’s use code may be correct and that the injunction should reinstate the prior use code.
- FDA regulations require branded company to draft and submit use codes; the district court ordered Novo to amend its use code to reinstate a narrower description.
- Majority holds Novo’s current use code is inaccurate and endorses a corrective injunction, but allows Novo to propose the exact language of a compliant use code within defined limits.
- Concurrence agrees Novo’s use code is incorrect and Caraco is entitled to correction, but would allow court to mandate a specific code rather than permit only a proposed code.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Is Novo’s use code correct under Caraco? | Novo argues its use code accurately describes all approved uses. | Caraco argues Novo’s code inaccurately claims two uses not covered by the '358 patent. | No; Novo’s use code is not correct. |
| Should the district court be allowed to dictate the precise wording of the corrected use code? | Novo should have control to draft the corrected code. | Caraco seeks a concrete, limited correction as described by court. | The injunction may permit Novo to propose language within limits; court may correct overbreadth. |
| Does the counterclaim remedy allow mandatory correction of the use code or only prohibitory relief? | Counterclaim permits a corrective order to change the use code. | The remedy should be limited to enjoining improper use codes unless properly corrected. | Remedy can include mandatory correction, with court guiding scope to avoid overbreadth. |
Key Cases Cited
- Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 132 S. Ct. 1670 (Supreme Court 2012) (counterclaim allows correction of use code that misdescribes patent scope)
- Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 601 F.3d 1359 (Fed. Cir. 2010) (FDA use codes and patent scope discussed in appeal)
- Joy Techs., Inc. v. Flakt, Inc., 6 F.3d 768 (Fed. Cir. 1993) (abuse of discretion standard for injunction scope)
- California v. American Stores Co., 495 U.S. 271 (U.S. 1990) (mandatory injunctions available under traditional equity)
- Morrison v. Work, 266 U.S. 481 (U.S. 1925) (mandatory injunction may be granted in exercise of sound judicial discretion)
- Weinberger v. Romero-Barcelo, 456 U.S. 305 (U.S. 1982) (equitable jurisdiction broad where not constrained by statute)