Mylan Pharms. v. FDA and Ranbaxy Labs., No. 11-566-JEB (D.D.C. 2011)
In an Opinion released earlier today, the U.S. District Court for the District of Columbia dismissed Mylan's lawsuit that sought to force FDA to act on Ranbaxy's ANDA for generic Lipitor (atorvastatin) and determine whether Ranbaxy forfeited its 180-day exclusivity for the product. The court granted FDA's motion to dismiss for lack of subject matter jurisdiction and denied Mylan's motion for a preliminary injunction.
In granting FDA's motion to dismiss, the court concluded that Mylan lacks standing to sue and that Mylan's claims are not ripe. With respect to standing, the court found it important that Mylan does not have tentative approval of its own ANDA for atorvastatin, and therefore Mylan's injury is not imminent. In addition, according to the court, Mylan's task of establishing standing was made "substantially more difficult because they allege the FDA unlawfully delayed acting on Ranbaxy's ANDA rather than their own." The court further found that Mylan's lack of tentative approval made its claims unripe, since they "rest upon contingent future events that may not occur as anticipated or may not occur at all."
The court, however, left open the possibility that Mylan could refile its claims at a later date:
By dismissing Plaintiffs' claims now, the Court does not foreclose the possibility that Plaintiffs may seek a judicial remedy at a future date -- e.g., when Plaintiffs' claims are truly fit for review. As the FDA points out, "Nothing prevents Mylan from seeking judicial recourse if and when FDA renders a final exclusivity decision that is not to Mylan's liking."
Under the terms of a settlement with Pfizer, Ranbaxy will launch its generic Lipitor on November 30, 2011 (provided that its ANDA has been approved by then). By filing this lawsuit, Mylan had sought to launch its own generic Lipitor as early as June 28, 2011.