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TAKEDA PHARMACEUTICALS, U.S.A., INC. v. BURWELL

Civil Action No. 14-cv-1668 (KBJ), Civil Action No. 14-cv-1850 (KBJ).

78 F.Supp.3d 65 (2015)

TAKEDA PHARMACEUTICALS, U.S.A., INC., Plaintiff, v. Sylvia Mathews BURWELL, in her official capacity as Secretary, United States Department of Health and Human Services, et al., Defendants, and Hikma Pharmaceuticals PLC, et al., Intervenor-Defendants. and Elliott Associates, L.P., et al., Plaintiffs, v. Sylvia Mathews Burwell, in her official capacity as Secretary, United States Department of Health and Human Services, et al., Defendants, and Hikma Pharmaceuticals PLC, et al., Intervenor-Defendants.

United States District Court, District of Columbia.

Signed January 13, 2015.

Attorney(s) appearing for the Case

Jessica L. Ellsworth , Susan Margaret Cook , Catherine E. Stetson , Hogan Lovells US LLP, Matthew D. McGill , Lucas C. Townsend , Mithun Mansinghani , Gibson Dunn & Crutcher LLP, Washington, DC, Michael Sitzman , Gibson, Dunn & Crutcher LLP, San Francisco, CA, for Plaintiff.

Jessica R. Gunder , U.S. Department of Justice, Washington, DC, for Defendant.

UNDER SEAL

MEMORANDUM OPINION

Table Of Contents

I. BACKGROUND . . . 69

A. Colchicine: A Drug For The Treatment Of Gout . . . 69

B. FDA's Drug Approval Framework: The Hatch-Waxman Amendments . . . 71

1. NDAs, ANDAs, and 505(b...

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