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MYLAN PHARMACEUTICALS, INC. v. SEBELIUS

Civil Action No. 12-524 (ESH).

856 F.Supp.2d 196 (2012)

MYLAN PHARMACEUTICALS, INC., Plaintiff, v. Kathleen SEBELIUS, in her official capacity as Secretary of Health and Human Services, et al., Defendant, and Teva Pharmaceuticals USA, Inc., Defendant-Intervenor, and Cephalon, Inc., Defendant-Intervenor.

United States District Court, District of Columbia.

April 23, 2012.

Attorney(s) appearing for the Case

Edward Anthony Figg, Mark S. Willis, Glenn E. Karta, Randy Elizabeth Brenner-Leifer, Rothwell, Figg, Ernst & Manbeck, PC, Washington, DC, for Plaintiff.

Roger Joseph Gural, U.S. Department of Justice, Washington, DC, for Defendant.

Michael D. Shumsky, Kirkland & Ellis, LLP, Washington, DC, Andrew C. Phillips, Jay P. Lefkowitz, John Kevin Dolan Crisham, Kirkland & Ellis, LLP, New York, NY, for Defendant-Intervenor.

MEMORANDUM OPINION

ELLEN SEGAL HUVELLE, District Judge.

On April 4, 2012, two days before Mylan Pharmaceuticals Inc.'s ("Mylan") anticipated launch, the Food and Drug Administration ("FDA") decided that Teva Pharmaceuticals U.S.A. Inc. ("Teva USA") was entitled to a 180-day period of exclusivity to market modafinil, the generic version of Provigil. The FDA rejected Mylan's request for final approval to sell modafinil and indicated that it would consider...

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