$536 Million Settlement of IN RE BUSPIRONE Patent and Antitrust Litigations

On November 21, 2000, the day before its patent-derived exclusivity on buspirone was to expire, Bristol listed in the FDA's Orange Book a patent (that had issued that day) claiming the administration of a buspirone metabolite, alleging that the patent covered the administration of buspirone as well. That listing had the immediate effect of preventing the FDA from approving any buspirone ANDAs. This firm, representing Mylan Pharmaceuticals, brought suit against Bristol and the FDA, winning a preliminary injunction compelling Bristol to request that the patent be de-listed. Mylan also brought suit for a declaratory judgment of noninfringement and/or invalidity and violation of the antitrust laws arising from the improper Orange Book listing and an infringement suit Bristol subsequently brought against Mylan. After Mylan obtained the preliminary injunction compelling the de-listing of the patent, 29 State Attorneys General and several class action plaintiffs groups joined Mylan's suit. On January 7, 2003, Bristol announced a settlement in principle of all those actions for under which Bristol would pay a total of $535 million. The settlement followed two rulings in Mylan's favor: (1) summary judgment of noninfringement or, in the alternative, invalidity granted by U.S. District Court for the Southern District of New York ("S.D.N.Y"); and (2) an order by the S.D.N.Y. denying Bristol’s motion to dismiss antitrust counterclaims and holding that Bristol had acted in an objectively unreasonable fashion in listing the metabolite patent for buspirone in the Orange Book and suing Mylan on it. Those decisions may be found at 185 F. Supp.2d 340 and 185 F. Supp.2d 363.