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IPSEN BIOPHARMACEUTICALS, INC. v. BECERRA

No. 23-5142.

108 F.4th 836 (2024)

IPSEN BIOPHARMACEUTICALS, INC., Appellant v. Xavier BECERRA, in his official capacity as Secretary of Health and Human Services, et al., Appellees.

United States Court of Appeals, District of Columbia Circuit.

Decided July 9, 2024.

Reissued July 25, 2024.

Attorney(s) appearing for the Case

Catherine E. Stetson argued the cause for appellant. With her on the briefs were Susan M. Cook, Marlan Golden, and Dana A. Raphael.

Urja Mittal, Attorney, U.S. Department of Justice, argued the cause for federal appellees. With her on the brief were Brian M. Boynton, Principal Deputy Assistant Attorney General, Daniel Tenny, Attorney, and Samuel R. Bagenstos, General Counsel, U.S. Department of Health & Human Services. Anna O. Mohan, Senior Counsel, U.S. Department of Justice, entered an appearance.

Brian T. Burgess argued the cause for appellee InvaGen Pharmaceuticals, Inc. With him on the brief was Gerard J. Cedrone.

Before: Wilkins, Katsas and Rao, Circuit Judges.

In 2007, the Food and Drug Administration ("FDA") approved Ipsen Biopharmaceuticals, Inc.'s application to sell Somatuline Depot as a drug product under the Federal Food, Drug, and Cosmetic Act ("FDCA"). This approval gave Somatuline Depot a period of market exclusivity, and the FDA did not authorize any competing generic...

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