Legal Opinion
Teva Pharmaceuticals USA, Inc. v. Food & Drug Administration
Court of Appeals for the D.C. Circuit
Decided March 16, 2006No. 05-5401, 05-5460PublishedCited by 30 opinions
1Opinion of the Court
Opinion for the Court filed by Circuit Judge RANDOLPH.
RANDOLPH, Circuit Judge:
The Federal Food, Drug, and Cosmetic Act grants a 180-day exclusive marketing period to the first generic drug manufacturer to file an Abbreviated New Drug Application (“application”) that contains a challenge to the patents protecting a brand name drug. This exclusivity period begins to run either upon “notice [to the FDA] of the first commercial marketing of the drug” or on “the date of a decision of a court ... holding the patent [to the branded drug] to be invalid or not infringed, whichever is earlier.” 21…
2Cases cited16 opinions
- Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1984
- Securities & Exchange Commission v. Chenery Corp.Supreme Court of the United States · 1943
- National Cable & Telecommunications Assn. v. Brand X Internet ServicesSupreme Court of the United States · 2005
- PDK Laboratories Inc. v. United States Drug Enforcement AdministrationCourt of Appeals for the D.C. Circuit · 2004
- Mova Pharmaceutical Corp. v. ShalalaCourt of Appeals for the D.C. Circuit · 1998
11 more not listed; retrieve them via the Exa API.
3Cited by30 opinions
- Peter Pan Bus Lines, Inc. v. Federal Motor Carrier Safety AdministrationCourt of Appeals for the D.C. Circuit · 2006
- Apotex, Inc. v. Food & Drug AdministrationCourt of Appeals for the D.C. Circuit · 2006
- Nat'l Ass'n v. TrumpCourt of Appeals for the D.C. Circuit · 2018
- Alliance Hippocratic Medicine v. FDACourt of Appeals for the Fifth Circuit · 2023
- Am. Hosp. Ass'n v. AzarCourt of Appeals for the D.C. Circuit · 2018
25 more not listed; retrieve them via the Exa API.