United States Federal Circuit

In a case alleging patent infringement and Hatch-Waxman Act violations, judgment in favor of the defendant is affirmed with respect to holdings that, 1) the Act does not require the FDA to review patents substantively before listing them in the Orange Book, 2) an ANDA applicant must file a paragraph IV certification for each patent that claims a drug that is the subject of an approved NDA, and 3) the FDA's regulation requiring that patents submitted as part of an NDA supplement be listed in the Orange Book must be upheld.

Appellate Information

• Decided 10/27/2003
• Published 10/27/2003

Judges

• Before NEWMAN, Circuit Judge, PLAGER, Senior Circuit Judge, and BRYSON, Circuit Judge.

Court

• United States Federal Circuit

Counsel

• For Appellant:
  
• Hugh L. Moore, Lord, Bissell & Brook, of Chicago, IL, argued for plaintiff-appellant.   With him on the brief were Terrence P. Canade and Hugh S. Balsam.   Of counsel on the brief was Arthur Y. Tsien, Olsson, Frank and Weeda, P.C., of Washington, DC.


• For Appellees:
  
• Daniel E. Troy, Chief Counsel, Office of the Chief Counsel, Food and Drug Administration, of Rockville, MD, argued for defendants-appellees Tommy G. Thompson, Secretary of Health and Human Services, et al.   With him on the brief were Eric M. Blumberg, Deputy Chief Counsel for Litigation;  and Karen E. Schifter, Associate Chief Counsel, Food and Drug Administration, and Alex M. Azar II, General Counsel, Department of Health and Human Services, of Washington, DC. On the brief for defendants-appellees were Douglas N. Letter and Howard S. Scher, Attorneys, Appellate Staff, Civil Division, United States Department of Justice, of Washington, DC., E. Edward Bruce, Covington & Burling, of Washington, DC, argued for defendant-appellee Smithkline Beecham Corporation.   On the brief were Bruce N. Kuhlik, Christopher N. Sipes, and Elizabeth S. Weiswasser.   Of counsel was Stephen T. Kaminski.