CATALYST PHARMACEUTICALS, INC. v. BECERRA

No. 20-13922.

14 F.4th 1299 (2021)

CATALYST PHARMACEUTICALS, INC., Plaintiff-Appellant, v. Xavier BECERRA, Secretary of Health and Human Services, U.S. Department of Health and Human Services, Janet Woodcock, Acting Commissioner of the Food and Drug Administration, U.S. Food and Drug Administration, Defendants-Appellees, Jacobus Pharmaceutical Company, Inc., Intervenor-Defendant-Appellee.

United States Court of Appeals, Eleventh Circuit.

September 30, 2021.


Attorney(s) appearing for the Case

Philip Perry , Ryan Baasch , Cherish Alise Drain , Monica C. Groat , John R. Manthei , Andrew Prins , Latham & Watkins, LLP, Washington, DC, Michael Constantine Marsh , Attorney, Ryan Alan Roman , Akerman, LLP, Fort Lauderdale, FL, for Plaintiff-Appellant.

Brian James Springer , Scott R. McIntosh , U.S. Attorney General's Office, Washington, DC, Ann F. Entwistle , U.S. Department of Justice, Civil Division, Washington, DC, for Defendants-Appellees Alex Azar, Secretary of Health and Human Services.

Brian James Springer , Scott R. McIntosh , U.S. Attorney General's Office, Washington, DC, for Defendants-Appellees U.S. Department of Health and Human Services, Norman Sharpless, Acting Commissioner of Food and Drugs, U.S. Food and Drug Administration.

Marisa Maleck , Joel L. McElvain , Gabriel Krimm , King & Spalding, LLP, Washington, DC, Jarred Lee Reiling , King & Spalding, LLP, Chicago, IL, for Defendant-Appellee KrimJacobus Pharmaceutical Company, Inc.

Before LAGOA, ANDERSON, and MARCUS, Circuit Judges.


This appeal asks us to determine whether the statutory phrase "same disease or condition" contained in the Orphan Drug Act, see 21 U.S.C. § 360cc, is ambiguous. It is not. By finding this statutory phrase ambiguous and then deferring to the U.S. Food and Drug Administration's interpretation of it, the district court...

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