American Bioscience v. Bristol-Myers

Amicus brief before the U.S. District Court for the Central District of California regarding a proposed settlement between American Bioscience, Inc. (ABI) and Bristol-Myers Squibb Co. regarding the listing of a patent purportedly covering the cancer drug Taxol on the Food and Drug Administration’s Orange Book. The brief advises the court that, because the Commission had just initiated an investigation of the conduct of ABI and Bristol, the Commission was not taking a position with regard to appropriateness of listing the patent. The brief further explains the potential consequences of the proposed settlement on generic entry and the potential harm to consumers of delaying such entry. The brief expresses concern that the judicial finding that the settlement contemplates — that the patent meets the statutory requirements for listing in the Orange Book — will prejudice parties who may later challenge the listing. The brief requests the court to consider the ramifications for generic entry and the pendency of the Commission’s investigation before entering the order proposed by the parties.