Mylan v. FDA

The federal district court in Washington, D.C. filed an opinion dismissing generic drug manufacturers Matrix and Mylan’s lawsuit against the FDA and generic manufacturer Ranbaxy on Monday, May 2 for lack of standing and ripeness.

As we recently reported, the plaintiffs brought this suit to try to force a decision from the FDA rejecting Ranbaxy’s ANDA for generic Lipitor®. Co-plaintiff Mylan has a pending ANDA for generic Lipitor®, filed after Ranbaxy’s ANDA. The plaintiffs argued that the FDA should deny Ranbaxy’s ANDA, alleging that it contained false information about a generic Lipitor® manufacturing site in India. Further arguing that FDA delay in making a decision on Ranbaxy’s ANDA could have significant and adverse effects on subsequent ANDA filers and on generic drug consumers, the plaintiffs also demanded a quick decision from the FDA. The FDA and Ranbaxy filed separate motions to dismiss the suit, with the FDA arguing, inter alia, that the plaintiffs did not have standing to bring the suit and that the case was unripe for judicial review.

Courts have recently made several decisions regarding subsequent ANDA filers’ standing against various parties. We reported in October that the Federal Circuit in Teva v. Eisai found standing in for a subsequent ANDA filer to sue an NDA holder where the NDA holder’s actions kept the first ANDA filer’s 180-day generic exclusivity period from starting. The Federal Circuit has also found standing in Caraco Pharm. Labs, Ltd. v. Forest Labs, Inc., 527 F.3d 1278 (Fed. Cir. 2008) for ANDA applicants excluded from FDA approval to bring suit against an NDA holder listing a patent in the Orange Book. Conversely, the Federal Circuit found a lack of standing for a subsequent ANDA filer that would not have been able to obtain approval for its drug even if it prevailed in its suit against the NDA holder in Janssen Pharmaceutica, N.V. v. Apotex, Inc. However, the Mylan suit involves a subsequent ANDA filer instead suing the FDA and a first ANDA filer.

In its opinion in Mylan, the D.C. district court heeded the FDA’s argument that the plaintiffs do not have standing because the FDA has not yet given even tentative approval to the plaintiffs’ subsequently-filed ANDA. Even if the FDA were to decide in the plaintiffs’ favor, the plaintiffs would still be prohibited from marketing their drug until they could obtain approval for their ANDA. The court noted that Ranbaxy, the owner of the ANDA at issue, joined the suit as a defendant on the FDA’s side, so the suit challenged a pending first-filed ANDA not belonging to any of the plaintiffs.

The court also dismissed the case because it lacked ripeness, which requires fitness of litigated issues for judicial decision as well as any hardships that would result from withholding judicial consideration. The district court found that the issues here are not fit for review because plaintiffs cannot be certain as to the likelihood of approval for their pending ANDA and because the FDA has not taken any final action. Additionally, without even tentative ANDA approval, plaintiffs cannot show hardship resulting from the court’s decision to dismiss the case. The court noted that plaintiffs’ claims may ripen later after the FDA makes a final decision on the Ranbaxy ANDA.

This decision to dismiss Mylan, if it withstands appeal, requires that a subsequent ANDA filer have a more mature controversy before filing a complaint in the district court against a first ANDA filer. To bring suit against a first ANDA filer, a subsequent ANDA filer needs to have standing (which the plaintiffs here could have possibly had if their ANDA had received tentative approval) and ripeness (which the plaintiffs here could have possibly had after a final FDA decision on Ranbaxy’s ANDA). Under the reasoning of the Mylan dismissal, a subsequent ANDA filer must wait to meet these requirements before filing suit to force FDA action concerning a first-filed ANDA. This may pose some difficulty on subsequent ANDA filers dissatisfied with FDA ANDA procedures, but may also present courts with clearer issues to decide in ANDA litigation.