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

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.

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

• Brief for  Novo Nordisk A/S and Novo Nordisk Inc. 

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

Certiorari-stage documents

• 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

• Petition for certiorari 
• Brief in opposition
• Petitioners’ supplemental brief
• Respondents’ supplemental brief
• Petitioners’ reply
• Amicus brief of Apotex, Inc.