July 2009: In a case brought by Roxane Laboratories, Judge Anita Brody, Eastern District of Pennsylvania, denied SKB’s motion to dismiss after the plaintiff amended the complaint to allege specific reasons to believe that it’s ANDA would have been approved for generic Flonase were it not for SKB’s strategically filed consumer complaints. Roxane alleged that it had been working closely with the FDA and was very experienced in bringing genetic versions of drugs to market.
A group of indirect purchases have filed a class action in the Eastern District of Pennsylvania alleging that SmithKline Beecham filed sham citizens petitions with the FDA designed to delay the approval of a generic version of Flonase. Sham cases are difficult to pursue because petitioning a government body is generally permitted by the antitrust laws. Demonstrating that a petition is a mere sham requires proof that the petitioning activity was subjectively groundless. The allegations in this case suggest that a large part of the problem was caused by SmithKline Beecham’s strategically delayed filing. The case may thus pose the interesting question as to whether a strategically delayed, but not utterly groundless, petition may be characterized as a sham.