AAIPHARMA INCORPORATED, Plaintiff-Appellant,
v.
Tommy G. THOMPSON, Secretary of Health and Human Services; Bernard Schwetz, DVM, Ph.D., Acting Commissioner of the United States Food and Drug Administration; United States Food and Drug Administration, Defendants-Appellees,
Barr Laboratories, Incorporated; Pharmaceutical, Incorporated, Intervenors.
United States Court of Appeals, Fourth Circuit.https://leagle.com/images/logo.png
Argued February 25, 2002.
Decided July 10, 2002.
Attorney(s) appearing for the Case
ARGUED: James C. Burling, Hale & Dorr, L.L.P., Washington, D.C., for Appellant. Howard Stanley Scher, Appellate Staff, Civil Division, United States Department of Justice, Washington, D.C., for Appellees. ON BRIEF: Mark A. Heller, Hale & Dorr, L.L.P., Washington, D.C.; James D. Myers, Richard P. Vitek, Myers, Bigel, Sibley & Sajovec, P.A., Cary, North Carolina, for Appellant. Robert D. McCallum, Jr., Assistant Attorney General, Douglas N. Letter, Appellate Staff, Civil Division, United States Department of Justice, Washington, D.C.; Daniel E. Troy, Chief, Eric M. Blumberg, Deputy Chief for Litigation, Michael N. Druckman, Associate Chief for Enforcement, United States Food and Drug Administration, Rockville, Maryland, for Appellees. Dan Hartzog, Gregory Brown, Cranfill, Sumner & Hartzog, L.L.P., Raleigh, North Carolina; George C. Lombardi, Christine J. Siwik, James F. Hurst, Winston & Strawn, Chicago, Illinois; Robert W. Spearman, Parker, Poe, Adams & Bernstein, L.L.P., Raleigh, North Carolina; Edgar H. Haug, Daniel G. Brown, Frommer, Lawrence & Haug, L.L.P., New York, New York, for Intervenors.
Before MICHAEL, Circuit Judge, JACKSON, United States District Judge for the Eastern District of Virginia, sitting by designation, and FRIEDMAN, United States District Judge for the Eastern District of Virginia, sitting by designation.
United States Court of Appeals, Fourth Circuit.
Affirmed by published opinion. Judge MICHAEL wrote the opinion, in which Judge JACKSON and Judge FRIEDMAN joined.
OPINION
MICHAEL, Circuit Judge.
The Federal Food, Drug, and Cosmetic Act (FFDCA) requires the manufacturer of a brand name drug approved by the Food and Drug Administration (FDA) to provide the FDA with a listing of all patents that claim the approved drug or a method of using the drug. See 21 U.S.C. § 355(b)(1), (c)(2). The...
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