United States DC Circuit

The Food and Drug Administration properly granted defendants a six-month period of pediatric marketing exclusivity, pursuant to 21 U.S.C. section 355a, following the expiration of the final patent for its brand name transdermal fentanyl system, used to treat chronic pain.

Appellate Information

• Argued 11/08/2004
• Decided 12/01/2004
• Published 12/01/2004

Judges

• Before:  EDWARDS and HENDERSON, Circuit Judges, and WILLIAMS, Senior Circuit Judge.

Court

• United States DC Circuit

Counsel

• For Appellant:
  
• E. Anthony Figg argued the cause for the appellants.  Thomas C. Goldstein was on brief., Paul F. Brinkman, Amy S. Manning and Thomas J. Parker were on brief for amicus curiae Generic Pharmaceutical Association in support of appellants.


• For Appellees:
  
• Howard S. Scher, Attorney, United States Department of Justice, argued the cause for the appellees.  Peter D. Keisler, Assistant Attorney General, Kenneth L. Wainstein, United States Attorney, Douglas N. Letter, Counsel, United States Department of Justice, and Alex M. Azar, II, General Counsel, Daniel E. Troy, Chief Counsel, and Eric M. Blumberg, Deputy Chief Counsel, United States Department of Health & Human Services, were on brief for federal appellees.  Andrew E. Clark and Karen E. Schifter, Attorneys, United States Department of Justice, entered appearances., Anthony Herman, Peter O. Safir, Carolyn F. Corwin and Kelly M. Jaske were on brief for appellees Alza Corporation and Janssen Pharmaceutica, Inc., Bruce N. Kuhlik, David E. Korn and Donald O. Beers were on brief for amicus curiae Pharmaceutical Research and Manufacturers of America in support of the appellees., Gary W. Brown was on brief for amicus curiae Candlelighters Childhood Cancer Foundation National Office in support of the appellees.