Mylan Pharmaceuticals Inc. has lost its bid in Washington federal court to force a U.S. Food and Drug Administration decision on whether a rival company can have exclusive rights to sell the generic version of Lipitor.
In a written opinion (PDF) issued yesterday afternoon, U.S. District Court Judge James Boasberg dismissed Mylan's lawsuit against the FDA, ruling that the suit was premature and that Mylan lacked standing.
Pfizer has held exclusive rights to Lipitor for 15 years, according to Boasberg’s opinion. Seeking to tap into the lucrative Lipitor market – in one filing (PDF), the FDA calls it “one of the most prescribed drugs in the world” – Mylan and Ranbaxy Pharmaceuticals Inc. have been developing generic versions of the drug for almost a decade.
Ranbaxy was the first to challenge Pfizer’s exclusive right to the Lipitor-related patents starting in 2002. According to the terms of a settlement with Pfizer, Ranbaxy was given permission to begin marketing its generic drug as of Nov. 30, 2011.
As the first to throw its hat in the ring, Ranbaxy became eligible for an exclusivity arrangement that would prevent any competitors from marketing a generic version of the drug for 180 days after November 30. This arrangement, as approved by Congress as a reward for bringing generic drugs onto the market, is subject to FDA approval.
In 2009, the FDA notified Ranbaxy that it was launching an investigation into data produced from one of its facilities in India, but has not released publicly whether the data is related to the generic Lipitor drug. Mylan’s complaint is filed under seal, but according to Boasberg’s opinion the company is claiming that if the investigation involves the generic Lipitor, Ranbaxy will have to withdraw and re-file its application, in the process losing its “first” place spot and eligibility for exclusivity.
Mylan sued the FDA on March 18, seeking a preliminary injunction from the court to force the agency to issue a decision on whether the investigation into Ranbaxy involves the generic Lipitor and, if it does, to then make a decision on whether Ranbaxy should still be entitled to the 180-day exclusivity.
In the injunction order Mylan had proposed (PDF) to the court, the company alleged that the FDA “has arbitrarily, capriciously and unlawfully failed to make a decision or other determination.” Mylan claimed that it was at risk of losing millions if it manufactured the drug and then Ranbaxy was granted exclusivity, or if it waited and missed out on potential business if the FDA denied the exclusivity.
Both the FDA and Ranbaxy filed motions to dismiss. Ranbaxy, in its motion to dismiss (PDF), accused Mylan of pushing the agency to make a decision prematurely “so that they can enter the generic atorvastatin market free from the constraints of Ranbayd’s hard-earned exclusivity.”
Boasberg wrote in his opinion that he was granting the dismissal on two fronts – first, that Mylan lacks standing to sue and second, that the suit is premature. Noting that Mylan has yet to receive approval of its own version of generic Lipitor, Boasberg wrote that there is no previous case law that allows a company awaiting approval of its own drug to force the FDA to take action on a competitor’s application.
Mylan was represented by Douglas Farquhar of Washington’s Hyman, Phelps & McNamara, who declined to comment when reached Monday evening. The U.S. Department of Justice, which represented the FDA, and the FDA both declined to comment.
In an earnings call this morning, Mylan CEO Robert Coury spoke about the decision.
“We are disappointed in the court’s ruling granting the FDA's motion to dismiss our complaint, even though we did not incorporate any financial benefit from generic Lipitor into our 2011 guidance,” Coury said during the call, according to a Mylan spokeswoman. “We fully intend to evaluate all available options to help facilitate timely consumer access to generic versions of Lipitor."
Ranbaxy was represented by Carmen Shepard and Carlos Angulo of Washington’s Zuckerman Spaeder, who referred questions to Ranbaxy. A Ranbaxy spokesman said in a written statement this morning that “we concur with Judge Boasberg’s decision.”