Mylan Laboratories Ltd., v. U.S. Food and Drug Administration

January 07, 2013

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Mylan Laboratories Ltd., v. U.S. Food and Drug Administration, Civ. No. 12-1637, 2012 U.S. Dist. LEXIS 182148 (D.D.C., Dec. 27, 2012) (Bates, J.)

Drug Product and Patent(s)-in-Suit: Diovan® (valsartan); U.S. Pat. Nos. 5,399,578 (“the ’578 patent”), 5,972,990 (“the ’990 patent”), and 6,294,197 (“the ’197 patent”) 

Nature of the Case and Issue(s) Presented: The issue here concerns whether the intervening defendant Ranbaxy Laboratories Limited (“Ranbaxy”) forfeited its 180-day market exclusivity period when it failed to obtain tentative approval within thirty months of filing its valsartan ANDA. Approximately one year after Ranbaxy received tentative approval of its ANDA, plaintiff Mylan Laboratories Limited (“Mylan”) filed an ANDA seeking FDA permission to manufacture valsartan tablets. Mylan also sent several letters to the FDA seeking confirmation that Ranbaxy’s failure to obtain tentative approval of its ANDA within the thirty-month period resulted in forfeiture of its 180-day exclusivity period. On September 28, 2012, FDA issued a memorandum confirming that Ranbaxy did not forfeit the exclusivity period because the failure to obtain tentative approval within thirty months was a result of Ranbaxy’s efforts to comply with a USP monograph that had issued after Ranbaxy filed its ANDA, and the FDA’s subsequent review of those efforts. Accordingly, the FDA informed Mylan that it could not approve its ANDA until the expiry of Ranbaxy’s 180-day exclusivity period. In response to the FDA’s determination, Mylan filed suit against the FDA seeking a preliminary injunction. FDA moved to dismiss the suit, or in the alternative, summary judgment against Mylan. Ranbaxy intervened in the suit and also moved for summary judgment against Mylan. The court denied Mylan’s motion for a preliminary injunction, and granted the FDA and Ranbaxy’s motions for summary judgment.

Why the FDA and Ranbaxy Prevailed:  The court first addressed Mylan’s request for a preliminary injunction and the FDA’s motion to dismiss. Because the Administrative Procedure Act (“APA”) governed the FDA’s decision, the standard of dismissal under Federal Rule of Civil Procedure Rule 12(b)(6) did not apply.  Instead, rather than de novo review, the APA required the court to sit as an appellate tribunal to decide questions of law based on deference to the administrative record. The FDA’s determination was that a May 1, 2007 publication of the USP monograph for valsartan constituted a change in the requirements for approval of Ranbaxy’s ANDA, and that change was the cause of Ranbaxy’s failure to obtain tentative approval of its ANDA within the thirty-month forfeiture period. Mylan argued that the FDA had given no reasoned explanation for its determination that the publication of the USP monograph caused the delay in approval. The threshold issue was to determine whether the FDA had a reasoned basis to conclude that the USP monograph delayed approval.

The court found that the FDA’s decision that Ranbaxy had not forfeited its market exclusivity period was well-reasoned and supported by the available administrative record.  The court concluded that the FDA highlighted the following clear analysis in coming to its conclusion: it published a new, final USP monograph; Ranbaxy made an initial effort to comply with the new monograph; the FDA asked for more data from Ranbaxy; Ranbaxy provided the requested data; and the FDA had to review Ranbaxy’s amendments and additional data to ensure that its drug substance specifications and test methods met the standards set forth in the monograph, and that this additional review resulted in the delay.

Mylan also argued that allowing Ranbaxy to retain its marketing exclusivity period despite failing to obtain tentative approval within the thirty-month period was contrary to the congressional intent of the Hatch-Waxman Act. The court disagreed with Mylan’s position, noting that the act contained an express provision that created an exception to the forfeiture rule when delays in approval were caused by changes in approval requirements beyond an ANDA applicant’s control. The court determined that the FDA was correct in its determination that Ranbaxy could avail itself of the exception in this instance. The court also rejected Mylan’s argument that Ranbaxy had failed to actively pursue approval of its ANDA, finding that Mylan had failed to address this issue in its letters to the FDA, and brought it before the court for the first time in a reply memorandum in support of its motion for a preliminary injunction.

Last, the court found that Mylan could not demonstrate a likelihood of irreparable harm in the event that its preliminary injunction was denied.  The court held that the harms that Mylan complained of—loss of actual sales, sales opportunities, long-term contracts, and other market advantages—were purely economic in nature, and did not rise to the level of irreparable harm that it was required to demonstrate.

Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

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