TRI-BIO LABORATORIES, INC. v. U.S.

No. 87-5123.

836 F.2d 135 (1987)

TRI-BIO LABORATORIES, INC., Appellant, v. UNITED STATES of America and Food and Drug Administration, Appellees.

United States Court of Appeals, Third Circuit.

Decided December 29, 1987.

Rehearing and Rehearing Denied February 1, 1988.


Attorney(s) appearing for the Case

Delbert J. McQuaide, Steven S. Hurvitz, Darryl R. Slimak, McQuaide, Blasko, Schwartz, Fleming & Faulkner, Inc., State College, Pa., for appellant Tri-Bio Laboratories, Inc.

Richard K. Willard, Asst. Atty. Gen., James J. West, U.S. Atty., Margaret A. Cotter, Asst. Director, Office of Consumer Litigation, Gerald C. Kell, Office of Consumer Litigation, Civ. Div., U.S. Dept. of Justice, Washington, D.C. (Thomas Scarlett, Chief Counsel, Eric M. Blumberg, Associate Chief Counsel for Enforcement Food and Drug Admin., Rockville, of counsel), for appellees U.S. and Food and Drug Admin.

Before GIBBONS, Chief Judge, and WEIS, Circuit Judge, and KELLY, District Judge.


Submitted Pursuant To Third Circuit Rule 12(6) August 19, 1987.

Rehearing and Rehearing En Banc Denied February 1, 1988.

OPINION OF THE COURT

WEIS, Circuit Judge.

A pharmaceutical manufacturer filed for Food and Drug Administration approval of a generic animal drug, incorporating in its application the research and testing data submitted by another manufacturer that earlier had obtained approval to market the predecessor brand name drug....

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