United States DC Circuit

The exclusivity provision period provided by the Drug Price Competition and Patent Term Restoration Act does not apply to the holder of an approved New Drug Application.

Appellate Information

• Argued 05/09/2005
• Decided 06/03/2005
• Published 06/07/2005

Judges

• GINSBURG, Chief Judge., Before:  GINSBURG, Chief Judge, and SENTELLE and ROGERS, Circuit Judges.

Court

• United States DC Circuit

Counsel

• For Appellant:
  
• William H. Rooney argued the cause for appellants.   With him on the briefs were Theodore C. Whitehouse and James N. Czaban., William A. Rakoczy, Christine J. Siwik, Amy D. Brody, and Lara E. Monroe-Sampson were on the brief for amicus curiae Mylan Pharmaceuticals, Inc. in support of appellants.


• For Appellees:
  
• Jeffrey S. Bucholtz, Deputy Assistant Attorney General, U.S. Department of Justice, argued the cause for federal appellees.   With him on the brief were Peter D. Keisler, Assistant Attorney General, Eugene M. Thirolf, Director, Andrew E. Clark, Attorney, Alex M. Azar, II, General Counsel, Food & Drug Administration, and Eric M. Blumberg, Deputy Chief Counsel., Bert W. Rein argued the cause for appellees Pfizer Inc., et al.   With him on the brief were Karyn K. Ablin and Jeffrey B. Chasnow.