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Decided

Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S

Docket No.10-844
Op. BelowFed. Cir.
ArgumentDec 5, 2011

Holding

A generic drug manufacturer may employ the counterclaim provision of the Hatch-Waxman Act to force correction of a use code that inaccurately describes the brand"s patent as covering a particular method of using a drug.

Judgment

Reversed and remanded, 9-0, in an opinion by Elena Kagan on Apr 17, 2012. Justice Sotomayor filed a concurring opinion.

Proceedings & orders timeline

Oct 15, 2010
Application (10A380) to extend the time to file a petition for a writ of certiorari from October 27, 2010 to December 26, 2010, submitted to The Chief Justice.
Oct 18, 2010
Application (10A380) granted by The Chief Justice extending the time to file until December 23, 2010.
Dec 23, 2010
Petition for a writ of certiorari filed. (Response due January 27, 2011)
Jan 10, 2011
Order extending time to file response to petition to and including February 25, 2011.
Jan 27, 2011
Brief amicus curiae of Teva Pharmaceuticals USA, Inc. filed.
Jan 27, 2011
Brief amicus curiae of Generic Pharmaceutical Association filed.
Jan 27, 2011
Brief amici curiae of Consumer Federation of America and U.S. PIRG filed.
Jan 27, 2011
Brief amicus curiae of Mylan Pharmaceuticals, Inc. filed.
Jan 27, 2011
Brief amicus curiae of Apotex, Inc. filed.
Feb 25, 2011
Brief of respondents Novo Nordisk A/S, and Novo Nordisk Inc. in opposition filed.
Mar 7, 2011
Reply of petitioners Caraco Pharmaceutical Laboratories, Ltd., et al. filed.
Mar 9, 2011
DISTRIBUTED for Conference of March 25, 2011.
Mar 28, 2011
The Acting Solicitor General is invited to file a brief in this case expressing the views of the United States.
May 26, 2011
Brief amicus curiae of United States filed.
Jun 3, 2011
Supplemental brief of respondents Novo Nordisk A/S, and Novo Nordisk Inc. filed.
Jun 7, 2011
DISTRIBUTED for Conference of June 23, 2011.
Jun 7, 2011
Supplemental brief of petitioners Caraco Pharmaceutical Laboratories, Ltd., et al. filed. (Distributed)
Jun 27, 2011
Petition GRANTED.
Jul 13, 2011
The time to file the joint appendix and petitioners' brief on the merits is extended to and including August 29, 2011.
Jul 13, 2011
The time to file respondents' brief on the merits is extended to and including October 17, 2011.
Aug 16, 2011
Consent to the filing of amicus curiae briefs, in support of either party or of neither party, received from counsel for the respondents.
Aug 29, 2011
Joint appendix filed (two volumes). (Statement of costs filed)
Aug 29, 2011
Brief of petitioners Caraco Pharmaceutical Laboratories, Ltd., et al. filed.
Sep 6, 2011
Brief amicus curiae of United States filed.
Sep 6, 2011
Brief amicus curiae of Generic Pharmaceutical Association filed.
Sep 6, 2011
Brief amicus curiae of Rep. Henry A. Waxman filed.
Sep 6, 2011
Brief amici curiae of AARP and U.S. PIRG filed.
Sep 6, 2011
Brief amicus curiae of Mylan Pharmaceuticals, Inc. filed.
Sep 12, 2011
SET FOR ARGUMENT ON Monday, December 5, 2011.
Sep 19, 2011
CIRCULATED
Sep 26, 2011
Record received from U.S.C.A. for Federal Circuit. (1 box)
Sep 27, 2011
Motion of the Solicitor General for leave to participate in oral argument as amicus curiae and for divided argument filed.
Oct 17, 2011
Brief of respondents Novo Nordisk A/S, and Novo Nordisk Inc. filed. (Distributed)
Oct 24, 2011
Brief amici curiae of Allergan, Inc., et al. filed. (Distributed)
Oct 24, 2011
Brief amicus curiae of Pharmaceutical Research and Manufacturers of America filed. (Distributed)
Oct 24, 2011
Brief amicus curiae of Washington Legal Foundation filed. (Distributed)
Nov 7, 2011
Motion of the Solicitor General for leave to participate in oral argument as amicus curiae and for divided argument GRANTED.
Nov 16, 2011
Reply of petitioners Caraco Pharmaceutical Laboratories, Ltd., et al. filed. (Distributed)
Dec 5, 2011
Argued. For petitioners: James F. Hurst, Chicago, Ill.; and Benjamin J. Horwich, Assistant to the Solicitor General, Department of Justice, Washington, D. C. (for United States, as amicus curiae.) For respondents: Mark A. Perry, Washington, D. C.
Dec 13, 2011
Record from U.S.D.C. for Eastern District of Michigan is electronic.
Apr 17, 2012
Judgment REVERSED and case REMANDED. Kagan, J., delivered the opinion for a unanimous Court. Sotomayor, J., filed a concurring opinion.
May 21, 2012
JUDGMENT ISSUED.
May 31, 2012
Record returned to U.S.C.A. for Fedral Circuit.

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