MYLAN LABORATORIES, INC. v. THOMPSON

No. 04-5296.

389 F.3d 1272 (2004)

MYLAN LABORATORIES, INC., et al., Appellants, v. Tommy G. THOMPSON, Secretary, United States Department of Health and Human Services, et al., Appellees.

United States Court of Appeals, District of Columbia Circuit.

Decided November 30, 2004.

Rehearing Denied January 21, 2005.


Attorney(s) appearing for the Case

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.

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.

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


Opinion for the court filed by Circuit Judge HENDERSON.

KAREN LeCRAFT HENDERSON, Circuit Judge:

Appellants Mylan Laboratories, Inc., Mylan Technologies, Inc. and Mylan Pharmaceuticals, Inc. (Mylan) appeal the district court's summary judgment upholding the decision of appellee Food and Drug Administration (FDA). The FDA decision granted appellees ALZA Corp. and Janssen Pharmaceutica, Inc., both subsidiaries of Johnson and Johnson, (collectively, ALZA) a six...

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