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EAGLE PHARMACEUTICALS, INC. v. AZAR

No. 18-5207. Consolidated with 18-5254, 18-5255, 18-5292.

952 F.3d 323 (2020)

EAGLE PHARMACEUTICALS, INC., Appellee, v. Alex Michael AZAR, II, In His Official Capacity as Secretary of Health and Human Services, et al., Appellees, Apotex, Inc., Appellant, Fresenius Kabi USA, LLC, Appellee.

United States Court of Appeals, District of Columbia Circuit.

Decided March 13, 2020.

Attorney(s) appearing for the Case

Melissa N. Patterson , Attorney, U.S. Department of Justice, argued the cause for federal appellants. With her on the briefs was Scott R. McIntosh .

Steven E. Feldman , Sherry L. Rollo , Chicago, IL, John K. Hsu , and Jeffrey D. Skinner , Washington, DC, were on the briefs for intervenors-appellants Apotex, Inc, et al.

Gregory G. Garre , Washington, DC, argued the cause for plaintiff-appellee. With him on the brief were Phillip J. Perry , Andrew D. Prins , and Benjamin W. Snyder ,

Dissenting Opinion filed by Senior Circuit Judge Williams.

In 2014, the United States Food and Drug Administration (FDA) designated a drug developed by Eagle Pharmaceuticals, Inc. (Eagle) as an "orphan drug" under the Orphan Drug Act (ODA), 21 U.S.C. §§ 360aa-360ee. In 2015, the FDA approved Eagle's drug for marketing...

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