Mylan v. FDA

The U.S. District Court for the District of Columbia will hold a hearing on motions for preliminary injunction and for dismissal in Mylan v. FDA on Thursday, April 28. Plaintiffs Mylan and Matrix brought this suit against the FDA to try to force the agency to enforce its Application Integrity Policy (“AIP”) against competing generic drug manufacturer Ranbaxy. Ranbaxy was the first ANDA filer for a generic version of Pfizer’s cholesterol-lowering drug Lipitor®. Co-plaintiff Matrix filed a subsequent ANDA for a generic version of Lipitor®, and co-plaintiff Mylan planned to distribute Matrix’s generic version of Lipitor®.

Ranbaxy’s ANDA could be eligible for approval as early as November 2011, which would trigger an 180-day exclusivity period for Ranbaxy’s generic version, to the exclusion of other generics, extending at least until May 2012. Mylan and Matrix allege that Ranbaxy has a practice of submitting false information to the FDA regarding a manufacturing site in India where it manufactures its generic version of Lipitor®. Therefore, Mylan and Matrix argue that the FDA should deny Ranbaxy’s ANDA under the Food, Drug, and Cosmetic Act (“FCDA”) and the AIP. Were the FDA to do so, Mylan and Matrix argue, other manufacturers’ generic versions of Lipitor® would be allowed to reach the market as early as June 2011. However, the FDA has not announced whether it will enforce the AIP against Ranbaxy’s ANDA. Mylan and Matrix argue that they suffer injury without this information because they cannot prepare to launch their version if allowed to do so. They therefore brought suit for unreasonable delay under the Administrative Procedure Act (“APA”) and for improperly granting a 180-day exclusivity period under the Hatch-Waxman Act.

With their complaint, Mylan and Matrix filed a motion for a preliminary injunction. They argued that they were likely to succeed on the merits of their case because, among other reasons, the FDA is not authorized to approve an ANDA containing an untrue statement of material fact. For the FDA to approve Ranbaxy’s ANDA, the plaintiffs argued, contradicts law, regulations, policies, and long-practiced procedures. Mylan and Matrix further alleged that they would suffer irreparable harm from approval of Ranbaxy’s ANDA and that the public interest would benefit if the FDA had to make a public decision on Ranbaxy’s ANDA.

Both the FDA and Ranbaxy moved to dismiss the suit and opposed the plaintiffs’ motion for a preliminary injunction. In support of dismissal, the FDA argued that the plaintiffs lack standing, that their claims are unripe, that any decision as to if or when to enforce the AIP against Ranbaxy would be subject to FDA discretion and therefore not judicially reviewable, and that the plaintiffs fail to adequately state a claim for unreasonable delay under the APA. Ranbaxy argued that the plaintiffs’ claims were not subject to judicial review, that the plaintiffs suffered no irreparable harm, and that the balance of harms favored Ranbaxy.

The ultimate decisions on these motions may have an impact on the usefulness of lawsuits for subsequent ANDA filers. This past October, the Federal Circuit held in Teva v. Eisai (on which we previously reported) that subsequent ANDA filers may in some cases have standing against an NDA holder. In Teva, the plaintiff could not obtain approval for its ANDA because an earlier ANDA filer’s 180-day exclusivity period had not even begun. The Federal Circuit found that the subsequent ANDA filer could challenge the NDA holder regarding validity, infringement, and enforceability of its Orange Book-listed patent. In doing so, the court cited Caraco Pharm. Labs, Ltd. v. Forest Labs, Inc., 527 F.3d 1278 (Fed. Cir. 2008), which states that an NDA holder listing a patent in the Orange Book can give rise to injury-in-fact for ANDA applicants excluded from FDA approval. The Federal Circuit also drew a distinction in Teva from Janssen Pharmaceutica, N.V. v. Apotex, Inc., 540 F.3d 1353 (Fed. Cir. 2008), in which the court affirmed summary judgment against a plaintiff because the plaintiff, a subsequent ANDA filer, would not have been able to obtain approval for its drug even if it prevailed in its suit against the NDA holder. However, in Mylan, Mylan and Matrix seek relief against the FDA and the first ANDA filer. If the court ultimately dismisses the case (especially if after appellate review), subsequent ANDA filers may have future difficulty bringing suit where they believe the FDA is not timely or adequately enforcing the law against earlier ANDA filers. However, if the preliminary injunction is ultimately granted, courts may see more viability in subsequent ANDA filers’ claims against the FDA or against first ANDA filers, which could result in increased litigation by and among ANDA applicants.