Nos. 97-5082, 97-5111.

140 F.3d 1060 (1998)

MOVA PHARMACEUTICAL CORP., Appellee, v. Donna E. SHALALA, Secretary, U.S. Department of Health & Human Services and Michael A. Friedman, Acting Commissioner, U.S. Food and Drug Administration, Appellees, Mylan Pharmaceuticals, Inc., Appellant.

United States Court of Appeals, District of Columbia Circuit.

Decided April 14, 1998.

Attorney(s) appearing for the Case

Steven Lieberman, Washington, DC, argued the cause for appellant Mylan Pharmaceuticals, Inc., with whom E. Anthony Figg was on the briefs.

Howard S. Scher, Attorney, United States Department of Justice, Washington, DC, argued the cause for the federal appellants, with whom Frank W. Hunger, Assistant Attorney General, Mary Lou Leary, United States Attorney at the time the briefs were filed, and Douglas N. Letter, Litigation Counsel, were on the briefs.

Steven J. Glassman, New York City, argued the cause for appellant Pharmacia & Upjohn Company, with whom David O. Bickart, Washington, DC, was on the briefs.

Ronald L. Grudziecki, Alexandria, VA, argued the cause for appellee, with whom James S. Rubin was on the brief.

John F. Cooney, Washington, DC, filed the brief for amicus curiae Teva Pharmaceuticals, USA.

Before: WALD, SILBERMAN and TATEL, Circuit Judges.

WALD, Circuit Judge:

On December 19, 1996, the Food and Drug Administration ("FDA") approved an application by a drug manufacturer, Mylan Pharmaceuticals, Inc. ("Mylan") to market a generic version of micronized glyburide, a drug used to treat diabetes. Another drug manufacturer, Mova Pharmaceutical Corp. ("Mova"), had filed an earlier application to market a generic version of the same drug; however, Mova's application had not yet been approved, because of a patent...

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