Pfizer Can't Hide Records on Generic Drug Suits
(CN) - Discovery concerning Pfizer's alleged monopoly power over Lipitor and its generic equivalents can proceed without interference from another drugmaker, a federal judge ruled.
Chimes Pharmacy and RP Healthcare sued pharmaceutical giant Pfizer and generic drugmaker Ranbaxy for illegally keeping a generic version of the blockbuster cholesterol drug Lipitor off the U.S. market in November 2011.
Related cases were filed around the country in December 2011, at which point the Judicial Panel on Multidistrict Litigation centralized the matters in New Jersey.
Pfizer had wanted to stay the case pending Supreme Court review of antitrust litigation regarding K-Dur, a drug used to treat low blood levels of potassium, but U.S. District Judge Peter Sheridan refused last year.
In light of that order, two groups of plaintiffs, the so-called direct purchasers and end-payors, moved to compel document production by the defendants. The direct purchaser plaintiffs sought documents related to the Pfizer/Ranbaxy litigation on blood pressure drug Accupril; documents from the litigation in Canada and Australia concerning Lipitor; and an agreement between Ranbaxy and Teva.
They claim that Ranbaxy's launch of a generic version of Accupril in late 2004 led Pfizer to obtain a preliminary injunction and posted a $200 million bond in March 2005. Pfizer then allegedly signed a reverse-payment agreement to have Ranbaxy delay marketing its generic Lipitor.
The direct purchasers further allege that when the Pfizer/Ranbaxy litigation ended in the District of Delaware in 2005, the Patent Trademark Office may have not had access to all of the facts developed in the two foreign proceedings, whose dispositions did not occur until 2006.
To ensure that it had a back-up manufacturing site for its generic product, Ranbaxy allegedly entered into an agreement with Teva Pharmaceuticals.
The end-payor plaintiffs meanwhile seek records related to six domestic suits filed between 2007 and 2010 concerning Pfizer's alleged attempts to thwart generic manufacturers from obtaining judgments of invalidity and/or noninfringement.
Mylan Pharmaceuticals, headquartered in Cecil Township, Pa., is not a party to the Lipitor multidistrict litigation, but moved to intervene to protect its interests in discovery.
U.S. Magistrate Judge Douglas Arpert said last week, however, that it would be "superfluous" to let Mylan intervene. In a separate ruling, he partially denied the direct purchasers' motion and granted the motion of the end-payors.
Producing foreign litigation records would be burdensome and potentially irrelevant if Judge Sheridan were to dismiss the plaintiffs' fraud claims, the unpublished ruling states.
"While the court might otherwise accept direct purchaser plaintiffs' position, the fact remains that defendants' motions to dismiss are pending," Arpert wrote. "And, to be sure, production of the foreign litigation documents appears to require a significant undertaking."
The court tossed aside the defendants' claim that the need for Accupril documents would be obviated should it apply a "scope of the patent" test, noting that the Supreme Court recently held that antitrust and patent principles are not "mutually exclusive."
"Here, the Accupril litigation documents are relevant because they may shed light on the nature of the alleged reverse payment agreement between Pfizer and Ranbaxy," Arpert wrote.
The judge also threw out the defendants' claim that the Ranbaxy/Teva agreement is irrelevant as it was negotiated nearly two years after the Ranbaxy/Pfizer settlement and alleged reverse payment agreement.
"Even if the court were to accept defendants' position that the Pfizer/Ranbaxy agreement must be evaluated at the time of its execution, the Ranbaxy/Teva agreement would still be relevant," Arpert wrote. "For example, the agreement would be relevant to Ranbaxy's state of mind regarding what it stood to lose by delaying its generic entry. At a minimum, the Ranbaxy/Teva agreement is likely to lead to the discovery of admissible evidence. And there is no demonstrable burden on defendants to produce these materials."
The court agreed that the domestic settlement agreements are relevant, as well.
"Defendants' position that these requests amount to an 'impermissible fishing expedition' is undermined by the fact that Pfizer has already agreed to produce documents from the underlying litigations which preceded each of the requested settlement agreements," Arpert wrote.
The defendants must produce the responsive documents within 30 days, the ruling states.