Pharmachemie B.V. v. Barr Laboratories, Inc.
Court of Appeals for the D.C. Circuit
1Opinion of the Court
Opinion for the Court filed by Circuit Judge ROGERS.
ROGERS, Circuit Judge:
Barr Laboratories, Inc. (“Barr”) appeals the district court’s grant of summary judgment, interpreting the Hatch-Waxman Amendments of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq., and regulations promulgated thereunder, 21 C.F.R. §§ 314.94, 314.107, to Pharma-chemie, B.V., a potential competitor of Barr’s. Barr contends that the district court erred in vacating an administrative ruling of the Food and Drug Administration (“FDA”) that Barr, as the first company to file a paragraph IV certification…
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