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December 28, 2012

Mylan Lab's challenge to the FDA's decision on Ranbaxy's marketing period is denied

By Suzanne Szymonik, JD

A generic competitor's preliminary injunction motion to set aside the FDA's decision that a first-to-file generic manufacturer did not forfeit its 180-day marketing exclusivity period was denied (Mylan Laboratories, Ltd. v FDA, December 27, 2012, Bates, J). The agency's decision was supported by the administrative record and was not arbitrary, capricious, or an abuse of discretion, and thus, the competitor's challenge under the Administrative Procedure Act (APA) was denied and summary judgment for the agency was appropriate.

Background. Under provisions of the Hatch-Waxman Act, the first generic applicant to file a drug application is eligible for a 180-day period of marketing exclusivity. The exclusivity period may be forfeited, however, if the first generic applicant fails to obtain tentative approval of the application from the FDA within 30 months of the application date, unless the failure is caused by a change in, or a review of, the requirements for approval of the application imposed after the application filing date (21 U.S.C. sec. 355(j)(5)(D)(i)(IV)).

Facts. Ranbaxy Laboratories Limited, the first-to-file generic firm, filed its application to market valsartan, an angiotensin receptor blocker used mainly to treat high blood pressure, in 2004. The FDA tentatively approved its application in 2007, four months after the expiration of the 30-month approval period, noting that a 2007 change in the United States Pharmacopeia (USP) monograph for the drug was a change in requirements for approval of the application. In 2008, the generic competitor, Mylan Laboratories, filed its application to market valsartan. In 2012, an FDA memorandum set forth the agency's seven reasons for deciding that Ranbaxy had not forfeited its exclusivity period.

Mylan's main argument. Mylan complained that the FDA did not address the consistency of the new/changed USP monograph with pre-existing approval requirements, rendering the agency's memorandum arbitrary and capricious under the APA. The FDA responded that there was no final USP monograph before 2007, and thus, the final monograph represented a change in requirements for Ranbaxy.

Opinion. The imposition of USP standards for the first time, and the specific sequence of events that took place thereafter, properly led the FDA to conclude that the publication of the USP monograph was a cause of the delay in tentative approval, according to the court. Furthermore, Ranbaxy was not required to comply with a proposed USP monograph. Mylan's second argument that Congressional intent to ensure that the 180—day exclusivity period enjoyed by the first generic firm cannot be used as a bottleneck to prevent additional generic competition was not persuasive. Nor was its third argument, that Ranbaxy was not actively pursuing approval. Mylan waived this argument because it was raised too late in the proceedings.

The district court also found that Mylan was not irreparably harmed by its inability to market the drug because first-year sales would be less than one percent of its annual revenues. Finally, it found that there is no statutory entitlement to marketing exclusivity for runner-up generic firms.

The case number is 12-1637 (JDB).

Edward Anthony Figg and Sharon Lynch Davis (Rothwell, Figg, Ernst & Manbeck, PC); Eric R. Hunt, Lara E. FitzSimmons, and William A. Rakoczy (Rakoczy Molino Mazzochi Siwik LLP), for Mylan Laboratories Limited and Mylan Pharmaceuticals, Inc. Andrew E. Clark, U.S. D.O.J., for the FDA, HHS Secretary Kathleen Sebelius and FDA Commissioner Margaret A. Hamburg.

MainStory: TopStory HatchWaxmanNews GenericDrugNews PrescriptionDrugNews

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