Update November 2010: The court has certified a class of direct purchasers.
Eastern District of Pennsylvania Judge Anita B. Brody rejected Glaxo-SmithKline’s (GSK) motion to dismiss a case alleging that it anticompetitively delayed the entry of generic Flonase into the market by filing citizens petitions before the FDA. GSK argued that its conduct was protected by the Noerr-PenningtonDoctrine, but plaintiff direct and indirect purchases argued that the conduct fell within the sham exception. Plaintiffs allege that just days before the FDA would have approves an abbreviated new drug application for generic Flonase, GSK filed citizen petitions that delayed approval of any ANDAs for Flonase until the agency established guidelines to determine the bioequivalency of nasal spray products. After the FDA rejected GSK’s petition and approved an ANDA for generic Flonase filed byRoxane, the company sued Roxane and the FDA in an effort to block the launch of a generic version of the nasal spray.