Tamoxifen Ruling Eases Hatch-Waxman Settlements

By Marius Meland (November 11, 2005, 12:00 AM EST) -- On November 2, 2005, the United States Court of Appeals for the Second Circuit affirmed the dismissal of complaints filed by consumers and others in civil antitrust litigation relating to anti-cancer drug, Tamoxifen. In re Tamoxifen Citrate Antitrust Litigation, No. 03-7641 (2d Cir., November 2, 2005). The complaints asserted that AstraZeneca and Barr Laboratories violated federal and state antitrust laws when they settled Astra's patent litigation against Barr. That patent litigation was instituted under the Hatch-Waxman Act of 1984, 21 U.S.C. §355 (j)(5)(B)(iii), following Barr's filing of an ANDA (abbreviated new drug application) seeking FDA approval of a generic equivalent of Tamoxifen....

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