Legal Opinion
Takeda Pharmaceuticals, U.S.A., Inc. v. Burwell
District Court, District of Columbia
Decided January 13, 2015No. Civil Action No. 14-cv-1668 (KBJ), Civil Action No. 14-cv-1850 (KBJ)PublishedCited by 11 opinions
1Opinion of the Court
UNDER SEAL
MEMORANDUM OPINION
KETANJI BROWN JACKSON, United States District Judge
Table Of Contents
I.BACKGROUND ... 69
A. Colchicine: A Drug For The Treatment Of Gout ... 69
B. FDA’s Drug Approval Framework: The Hatch-Waxman Amendments ... 71
1. NDAs, ANDAs, and 505(b)(2) NDAs ...71
2. The Patent Certification Requirement ...72
3. The Labeling Requirements ... 73
C. FDA’s Approval Of Colcrys (A Col-chicine Tablet) ... 74
1. Mutual Relies On ColBenemid, Published Literature, And Its Own Clinical Studies To Support The Colcrys Application For Acute Flares Of Gout ... 74
2. Mutual Relies on ColBenemid and…
2Cases cited41 opinions
- 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
- Citizens to Preserve Overton Park, Inc. v. VolpeSupreme Court of the United States · 1971
- Califano v. SandersSupreme Court of the United States · 1977
- Food & Drug Administration v. Brown & Williamson Tobacco Corp.Supreme Court of the United States · 2000
36 more not listed; retrieve them via the Exa API.
3Cited by11 opinions
- 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
- Ranbaxy Laboratories, Ltd. v. BurwellDistrict Court, District of Columbia · 2015
- Littlefield v. United States Department of the InteriorDistrict Court, D. Massachusetts · 2016
- Takeda Pharmaceuticals U.S.A., Inc. v. BurwellCourt of Appeals for the D.C. Circuit · 2016
6 more not listed; retrieve them via the Exa API.