USV PHARMACEUTICAL CORPORATION v. RICHARDSON

No. 71-1596.

461 F.2d 223 (1972)

USV PHARMACEUTICAL CORPORATION, Appellee, v. Elliot L. RICHARDSON, Secretary of Health, Education, and Welfare, and Herbert L. Ley, Jr., Commissioner of Food and Drugs, Food and Drug Administration, Appellants.

United States Court of Appeals, Fourth Circuit.

Decided May 24, 1972.


Attorney(s) appearing for the Case

Howard S. Epstein, Atty., Dept. of Justice (Richard W. McLaren, Asst. Atty. Gen., Bruce B. Wilson, C. Coleman Bird, and Cheryl S. Karner, Attys., Dept. of Justice, and Peter Barton Hutt, Asst. Gen. Counsel, Joanne S. Sisk, Richard S. Silverman, Attys., Food, Drugs, and Environmental Health Div., Dept. of Health, Education, and Welfare, on brief), for appellants.

Joel E. Hoffman, Washington, D. C., (Robert L. Wald, Selma M. Levine, and Wald, Harkrader & Ross, Washington, D. C. on brief), for appellee.

Before WINTER, RUSSELL and FIELD, Circuit Judges.


RUSSELL, Circuit Judge:

Unlike the drug manufacturers in Bentex,1 this plaintiff markets a line of citrus bioflavonoid drugs,2 of which all but two were covered by NDAs issued at various times in 1955 and 1956. Like the plaintiffs in Bentex, however, it seeks by an action for declaratory judgment to secure the benefit of the exemption available under the "grandfather clause"3...

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