Legal Opinion
Apotex, Inc. v. Thompson
Court of Appeals for the Federal Circuit
Decided October 27, 2003No. 02-1295PublishedCited by 35 opinions
1Opinion of the Court
Opinion of the Court by Circuit Judge BRYSON. Concurrence by Circuit Judge PLAGER. Dissent by Circuit Judge PAULINE NEWMAN.
BRYSON, Circuit Judge.
A company that seeks to market a pharmaceutical drug in the United States must first obtain approval from the Food and Drug Administration (“FDA”). Ordinarily, a pharmaceutical company initiates that process by filing a New Drug Application (“NDA”), demonstrating through the presentation of test data that the drug in ques*1338tion is safe and effective. 21 U.S.C. § 355(b)(1)(A).
Before 1984, a pharmaceutical company that wished to make a generic version of…
2Cases cited18 opinions
- Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1984
- Friends of the Earth, Inc. v. Laidlaw Environmental Services (TOC), Inc.Supreme Court of the United States · 2000
- Franchise Tax Bd. of Cal. v. Construction Laborers Vacation Trust for Southern Cal.Supreme Court of the United States · 1983
- Van Dusen v. BarrackSupreme Court of the United States · 1964
- United States v. Mead Corp.Supreme Court of the United States · 2001
13 more not listed; retrieve them via the Exa API.
3Cited by35 opinions
- In Re Lipitor Antitrust LitigationCourt of Appeals for the Third Circuit · 2017
- Teva Pharmaceuticals, USA, Inc. v. LeavittCourt of Appeals for the D.C. Circuit · 2008
- Eli Lilly & Co. v. Teva Pharmaceuticals USA, Inc.Court of Appeals for the Federal Circuit · 2009
- Samsung Electronics Co., Ltd. v. Rambus, Inc.District Court, E.D. Virginia · 2005
- Trek Leasing, Inc. v. United StatesUnited States Court of Federal Claims · 2004
30 more not listed; retrieve them via the Exa API.