United States DC Circuit

Having assigned Warner-Lambert's gabapentin patent a use code corresponding to neurodegenerative diseases, the FDA acted arbitrarily and capriciously in rejecting plaintiff's section viii statement as though that patent covered a method for treating epilepsy. The district court properly sustained FDA's decisions to delist that patent and to award exclusivity to plaintiff.

Appellate Information

• Argued 11/25/2003
• Decided 01/20/2004
• Published 01/20/2004

Judges

• Before:  GINSBURG, Chief Judge, and EDWARDS and TATEL, Circuit Judges.

Court

• United States DC Circuit

Counsel

• For Appellant:
  
• William A. Rakoczy argued the cause for appellants.   With him on the briefs were Hugh S. Balsam and Arthur Y. Tsien.  Hugh L. Moore, Jacqueline H. Eagle, and Matthew O. Brady entered appearances.


• For Appellees:
  
• Andrew E. Clark, Attorney, U.S. Department of Justice, argued the cause for the federal appellees.   With him on the brief were Peter D. Keisler, Assistant Attorney General;  Eugene M. Thirolf, Director;  Alex M. Azar II, General Counsel, U.S. Department of Health & Human Services;  Daniel E. Troy, Chief Counsel;  and Karen E. Schifter, Associate Chief Counsel.   Christine N. Kohl, Attorney, U.S. Department of Justice;  Douglas N. Letter, Litigation Counsel;  and Howard S. Scher, Attorney, entered appearances., Charles J. Raubicheck argued the cause for appellee Purepac Pharmaceutical Company.   With him on the brief was Steven M. Amundson.  James M. Webster, Mark C. Hansen, and Richard H. Stern entered appearances.