United States DC Circuit

Under the Hatch-Waxman Amendments a new drug application patent holder's letter to FDA stating it was de-listing its drug patent to extent it was ordered to by a court does not justify a Paragraph IV certification of a generic drug maker.

Appellate Information

• Decided 11/06/2001
• Published 11/06/2001

Judges

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

Court

• United States DC Circuit

Counsel

• For Appellant:
  
• Jacqueline H. Eagle argued the cause for appellant.   With her on the briefs were Joseph F. Coyne, Jr., Carlton A. Varner, Arthur Y. Tsien, David F. Weeda, and Robert F. Green.


• For Appellees:
  
• Howard S. Scher, Attorney, United States Department of Justice, argued the cause for appellee.   With him on the brief were Kenneth L. Wainstein, United States Attorney, Douglas N. Letter, Litigation Counsel, Michael M. Landa, Acting Chief Counsel, Food & Drug Administration, and AnnaMarie Kempic, Associate Chief Counsel., Richard M. Cooper argued the cause for appellees Baker Norton Pharmaceuticals, Inc. and IVAX Pharmaceuticals, Inc.   With him on the brief was Philip A. Sechler.