Opinion for the Court filed by Circuit Judge ROGERS.
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 Pharmachemie, B.V., a potential competitor...
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