United States Federal Circuit

Under 21 USC 355(j)(5)(B)(iii), a district court has no authority in a drug patent infringement action to shorten the FDA's thirty-month stay of approval because of alleged improper conduct before the FDA.

Appellate Information

• Decided 01/17/2002
• Published 01/18/2002

Judges

• DYK, Circuit Judge., Before BRYSON, LINN, and DYK, Circuit Judges.

Court

• United States Federal Circuit

Counsel

• For Appellees:
  
• 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.