Bristol-Myers Squibb Co. v. IVAX Corp.

Bristol-Myers Squibb Company (BMS) (plaintiff), a paclitaxel drug manufacturer and pioneer patent holder for brand-name Taxol, sued generic paclitaxel drug manufacturers Baker Norton (BN), a subsidiary of IVAX Corp., and Zenith Goldline (ZG) (defendants) for patent infringement when BN and ZG filed an abbreviated new drug application (ANDA) with the Food and Drug Administration (FDA) to approve and market paclitaxel to treat Kaposi’s sarcoma, a rare AIDS-related cancer. BMS filed a competing application for orphan-drug approval after exercising its exclusive license for Taxol that it had licensed from the National Cancer Institute (NCI) with whom it had entered into a cooperative research and development agreement (CRADA). BN and ZG asserted numerous counterclaims based on federal antitrust and state tort laws. BN and ZG specifically alleged that BMS only sought to exercise its right to get an exclusive license and competing application for orphan-drug approval after it discovered confidential information about BN and ZG’s plans and that BMS made misrepresentations during congressional hearings about its pricing plans. BN alleged immunity under the Noerr-Pennington doctrine that provides private parties with immunity from antitrust liability when petitioning for government action. BN and ZG argued that the doctrine does not apply if the government has a commercial interest at stake and acts in a commercial role as opposed to a political or regulatory role, and that a commercial exception to the Noerr-Pennington doctrine should apply.