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Pharmachemie B.V. v. Barr Laboratories, Inc.

Drug company's appeal in action for enforcement of generic exclusivity was moot and subject to dismissal where competitor lost patent suit against original manufacturer and thus could not challenge exclusivity period.

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Argued December 5, 2001

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. ss 301 et seq., and regulations promulgated thereunder, 21 C.F.R. ss 314.94, 314.107, to Pharmachemie, 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 for tamoxifen, a breast cancer drug, as part of its application for FDA review and approval of its generic version of tamoxifen, had a statutory right to 180 days of generic exclusivity. After the district court granted summary judgment, Pharmachemie lost its court challenge to the underlying patent of the pioneer drug manufacturer’s tamoxifen. As a result, Pharmachemie cannot market its generic version of tamoxifen until the patent expires. Because the FDA’s ruling no longer causes any redressible harm to Pharmachemie, we conclude that the case is moot and, accordingly, we dismiss the appeal for lack of jurisdiction, vacate the judgment of the district court, and remand the case to the district court with instructions to dismiss the complaint.

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