Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S
|Docket No.||Op. Below||Argument||Opinion||Vote||Author||Term|
Dec 5, 2011
|Apr 17, 2012||9-0||Kagan||OT 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 Justice Kagan on April 17, 2012. Justice Sotomayor filed a concurring opinion.
- In Plain English: Recent decisions (Amy Howe)
- Opinion analysis: Court’s purposive reading hands Federal Circuit second patent reversal of the Term (Ronald Mann)
- Argument recap: Justices fully engaged in latest generic/branded pharma case (Ronald Mann)
- Argument preview: Federal Circuit faces uphill battle in latest generics case (Ronald Mann)
Briefs and Documents
Merits Briefs for Petitioners
- Brief for Caraco Pharmaceutical Laboratories et al.
- Reply brief for Caraco Pharmaceutical Laboratories et al.
Amicus Briefs Supporting Petitioners
- Brief for the Generic Pharmaceutical Association
- Brief for Rep. Henry A. Waxman
- Brief for the United States of America
- Brief for Mylan Pharmaceuticals Inc.,
- Brief for AARP and U.S. PIRG
Merits Briefs for the Respondents
Amicus Briefs Supporting the Respondents
- Brief for Allergan, Inc. et al.
- Brief for the Pharmaceutical Research and Manufacturers of America
- Brief for the Washington Legal Foundation
- Opinion below (Fed. Cir.)
- Amicus brief of TEVA Pharmaceuticals USA, Inc.
- Amicus brief of Consumer Federation of America et al.
- Amicus brief of Mylan Pharmaceuticals, Inc.
- Amicus Generic Pharmaceutical Association