In two recent cases involving antitrust claims against branded manufacturers for alleged attempts to delay and prevent generic entry, plaintiffs alleged that each branded manufacturer filed a frivolous citizen petition with the U.S. Food and Drug Administration (FDA), which delayed FDA approval of generic products. In each case, a threshold question was whether the plaintiff could even show that the citizen petition actually delayed the Abbreviated New Drug Application (ANDA) approval – which one plaintiff could not.
In Aventis Pharma S.A. v. Amphastar Pharms., Inc. (C.D. Cal. 2009), Amphastar Pharmaceuticals Inc. had filed counterclaims against Aventis Pharmaceutical in response to Aventis’ patent suits against Amphastar in relation to a generic form of its anti-clotting drug, Lovenox. The counterclaims alleged, among other things, that Aventis’ affiliate had engaged in sham litigation, obtained and enforced its patents by fraud, and submitted a frivolous citizen petition to the FDA. On May 18, 2009, the court dismissed the counterclaims.
In its decision, the district court ruled that there was insufficient evidence to indicate that the delay in approval of Amphastar’s generic Lovenox, and that of other Lovenox generics, was due to Aventis’ patent suit and petitioning before the FDA. Critical to the court’s decision was the fact that the Amphastar ANDA was filed in 2002 and had yet to be either approved or rejected by the FDA, in spite of Amphastar’s repeated indications to the court that such a decision was imminent.
In Roxane Laboratories v. GlaxoSmithKline PLC, Civ. 01638 (E.D. Pa. 2009), the court also considered an allegation that a brand manufacturer violated Section 2 of the Sherman Act through the filing of citizen petitions with FDA. The district court in this case denied the brand manufacturer’s motion to dismiss. Roxane Laboratories filed antitrust claims against GSK relating to citizen petitions regarding Roxane’s ANDA for a generic version of GSK’s Flonase. GSK asserted that Roxane failed to support its claim that the petitions caused a delay in generic approval by failing to assert that it was prepared to enter the market upon approval. The court allowed Roxane to amend its complaint and in doing so, Roxane stated that it had consulted with FDA in preparing its ANDA submission and had, in anticipation of approval, manufactured approximately four million units of generic product for shipment upon approval. In light of the amended complaint, the court denied GSK’s motion to dismiss.
In 2007, Congress passed legislation specifically addressing the FDA citizen petition process for petitions that relate to pending ANDAs.