In re Tamoxifen Citrate Antitrust Litigation

Date:
Citation Number: 03-7641

An amicus brief in support of plaintiffs-appellants’ petition for panel rehearing and rehearing en banc. The case concerns a decision by a divided panel of the appeals court upholding the dismissal, pursuant to FRCP 12(b)(6), of an antitrust challenge to a Hatch-Waxman patent settlement between AstraZeneca, the manufacturer of a branded drug, and Barr Labs., an FDA applicant for a generic counterpart. The Commission argues that the panel did not properly consider the Hatch-Waxman Act, which encourages challenges to pharmaceutical patents to facilitate the early entry of generic drugs, and that, if not corrected, the panel decision would permit the holder of a challenged drug patent to harm competition, and thus consumers, substantially by impermissibly paying a would-be generic rival to stay off the market.