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GENUS LIFESCIENCES, INC. v. AZAR

Case No. 1:20-cv-00211 (TNM).

486 F.Supp.3d 450 (2020)

GENUS LIFESCIENCES, INC., Plaintiff, v. Alex M. AZAR II, et al., Defendants, Lannett Co., Inc., Intervenor-Defendant.

United States District Court, District of Columbia.

Signed September 15, 2020.

Attorney(s) appearing for the Case

Andrew D. Prins, John Richard Manthei, Philip Jonathan Perry, Ryan S. Baasch, Latham & Watkins LLP, Washington, DC, for Plaintiff.

Kathleen Braun Gilchrist, U.S. Department of Justice, Washington, DC, for Defendants.

David A. Hickerson, Lori Allison Rubin, Foley & Lardner LLP, Washington, DC, for Intervenor-Defendant.

MEMORANDUM OPINION

In the pharmaceutical development arena, Congress created a "winner-take-all" prize. Under the Federal Food, Drug, and Cosmetic Act ("FDCA"), the first developer of a "new chemical entity" ("NCE")—a drug approved for the first time in the United States—...

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