Legal Opinion
Depomed, Inc. v. United States Department of Health & Human Services
District Court, District of Columbia
Decided September 5, 2014No. Civil Action No. 2012-1592PublishedCited by 11 opinions
1Opinion of the Court
MEMORANDUM OPINION
KETANJI BROWN JACKSON, United States District Judge
Plaintiff Depomed, Inc. (“Depomed”) is a pharmaceutical company that, as rele vant here, has developed a drug to treat a rare condition known as post-herpetic neuralgia (“PHN”). 1 Depomed contends that its drug, which is called Gralise, was automatically entitled to a seven-year period of marketing exclusivity under the Orphan Drug Act (the “Act”), 21 U.S.C. §§ 360aa-360ee, once the drug satisfied two statutory requirements: (1) designation by the Food and Drug Administration (“FDA”) as a so-called “orphan drug” for use in…
2Cases cited25 opinions
- Anderson v. Liberty Lobby, Inc.Supreme Court of the United States · 1986
- Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1984
- Motor Vehicle Mfrs. Assn. of United States, Inc. v. State Farm Mut. Automobile Ins. Co.Supreme Court of the United States · 1983
- United States v. Ron Pair Enterprises, Inc.Supreme Court of the United States · 1989
- Pennsylvania Department of Corrections v. YeskeySupreme Court of the United States · 1998
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3Cited by11 opinions
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- H. Lee Moffitt Cancer Ctr. & Research Inst. Hosp., Inc. v. AzarCourt of Appeals for the D.C. Circuit · 2018
- Veloxis Pharmaceuticals, Inc. v. United States Food and Drug AdministrationDistrict Court, District of Columbia · 2015
- Otsuka Pharm. Co. v. BurwellCourt of Appeals for the D.C. Circuit · 2016
- Braeburn Inc. v. U.S. Food & Drug Admin.Court of Appeals for the D.C. Circuit · 2019
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