On August 21, 2017, the Third Circuit reversed dismissal of the direct purchaser plaintiffs’ complaint, reviving the direct purchaser plaintiffs’ patent fraud, sham Orange Book listing, sham litigation, sham citizen petition, and reverse-payment claims to continue. The Court sent the case back to the trial court for further proceedings.
First, the Third Circuit overturned the district court’s dismissal of the reverse payment claims, finding that the direct purchaser plaintiffs had plausibly alleged that Pfizer made a “large” and “unjustified” reverse payment in exchange for Ranbaxy’s promise to stall generic competition. The Court held that the district court erred by imposing a “heightened” pleading standard – requiring the complaint to set forth in detail a “reliable monetary estimate” of the direct purchaser plaintiffs’ overcharges and to “come up with possible explanations for the reverse payment and then rebut those explanations in response to a motion to dismiss.
Second, the Third Circuit held the district court committed reversible error by finding the direct purchaser plaintiffs’ patent fraud allegations implausible, just because Pfizer had prevailed in some prior litigations – which “functionally amounted to the application of collateral estoppel and was therefore improper because Lipitor plaintiffs were not parties” in those prior cases.
Third, because the district court’s dismissal of the direct purchaser plaintiffs’ sham Orange Book and sham litigation claims turned on its errant dismissal of the patent fraud claims, the Third Circuit reversed those dismissals as well.
And fourth, the Third Circuit held the direct purchasers had plausibly alleged that Pfizer’s citizen petition, submitted to the FDA, was a sham. The Court found that the district court’s conclusion to the contrary rested on inappropriate fact finding and inferences at the motion-to-dismiss stage.
Hagens Berman is co-lead counsel in this action alleging that drug manufacturer Pfizer delayed market entry of generic versions of the cholesterol drug Lipitor. Plaintiffs allege Pfizer accomplished the generic block by fraudulently procuring a follow-on patent for Lipitor, knowingly listing that patent in the FDA Orange Book without any lawful basis to do so, suing generic pharmaceutical companies that challenged that patent’s blocking ability, and then leveraging those meritless lawsuits into reverse payment settlements with the generic manufacturers.
As a result of this wrongdoing, the plaintiffs’ allege, purchasers who needed to buy Lipitor were forced to pay monopoly prices for the medication for longer than they should have.
"Although the original compound patent for Lipitor expired March 24, 2010, generics were foreclosed from entering the market until November 30, 2011, over 20 months later. Pfizer, at first acting alone and then later with Ranbaxy, illegally caused this delay by implementing an overarching anticompetitive scheme," the suit states. The scheme worked as planned. Generic Lipitor was not sold until on or about Nov. 30, 2011, far later than it would have been sold absent the defendants‘ illegal, anticompetitive conduct.
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