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ANDRX PHARMACEUTICALS, INC. v. BIOVAIL CORP.

Nos. 01-1650, 02-1025.

276 F.3d 1368 (2002)

ANDRX PHARMACEUTICALS, INC., Plaintiff-Cross Appellant, v. BIOVAIL CORPORATION, Defendant-Appellant, v. Tommy G. Thompson, Secretary of Health and Human Services, Bernard A. Schwetz, Acting Principal Deputy Commissioner, U.S. Food and Drug Administration, and U.S. Food and Drug Administration, Defendants-Appellees. Biovail Laboratories, Inc., Plaintiff/Counterclaim Defendant, and Biovail Corporation, Counterclaim Defendant-Appellant, v. Andrx Pharmaceuticals, Inc., Defendant/Counterclaimant-Cross Appellant.

United States Court of Appeals, Federal Circuit.

January 17, 2002.

Attorney(s) appearing for the Case

Louis M. Solomon, Solomon, Zauderer, Ellenhorn, Frischer & Sharp, of New York, New York, argued for plaintiff-cross appellant 01-1650, and for defendant/counterclaimant-cross appellant in 02-1025, Andrx Pharmaceuticals, Inc. Of counsel were Colin A. Underwood, Teresa A. Consalves, and Jennifer R. Scullion. Also of counsel was Gerald J. Houlihan, Houlihan & Partners, P.A., of Miami, Florida.

Michael A. Cardozo, Proskauer Rose LLP, of New York, New York, argued for defendant-appellant in 01-1650, and plaintiff/counterclaim defendant, and counterclaim defendant-appellant in 02-1025, Biovail Corporation and Biovail Laboratories, Inc. Of counsel were Ronald S. Rauchberg, Nancy A. Kilson; and Alec W. Farr, Proskauer Rose LLP, of Washington, DC.

Howard S. Scher, Attorney, Appellate Staff, Civil Division, Department of Justice, of Washington, DC, argued for defendants-appellees, Tommy G. Thompson, Secretary of Health and Human Services, et al. Of counsel was Douglas N. Letter, Attorney.

Before BRYSON, LINN, and DYK, Circuit Judges.

DYK, Circuit Judge.

Biovail Corporation ("Biovail") appeals an order of the United States District Court for the Southern District of Florida. Pursuant to 21 U.S.C. § 355(j)(5)(B)(iii), the district court (1) shortened the statutory thirty-month delay of approval of Andrx Pharmaceuticals, Inc.'s ("Andrx") pending Abbreviated New Drug Application ("ANDA") by the Food and Drug Administration ("FDA") and (2) ordered that the ANDA be approved by the FDA. Andrx...

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