United States DC Circuit

A determination by the FDA as to the date that an exclusivity period for drug marketing for a generic drug manufacturer began is vacated where the FDA mistakenly thought itself bound by certain decisions, rendering its own decision arbitrary and capricious.

Appellate Information

• Argued 03/09/2006
• Decided 03/16/2006
• Published 03/16/2006

Judges

• Before:  RANDOLPH and TATEL, Circuit Judges, and WILLIAMS, Senior Circuit Judge.

Court

• United States DC Circuit

Counsel

• For Appellant:
  
• Jeffrey S. Bucholtz, Deputy Assistant Attorney General, U.S. Department of Justice, argued the cause for federal appellants.   With him on the briefs were Peter D. Keisler, Assistant Attorney General, Eugene M. Thirolf, Director, and Andrew E. Clark, Attorney., William A. Rakoczy argued the cause for appellant Apotex Inc. With him on the briefs were Christine J. Siwik, Lara E. Monroe-Sampson, and Arthur Y. Tsien.


• For Appellees:
  
• Jay P. Lefkowitz argued the cause for appellee.   With him on the brief was Steven A. Engel, John C. O'Quinn, and Michael D. Shumsky.