Legal Opinion
Apotex, Inc. v. Food & Drug Administration
Court of Appeals for the D.C. Circuit
Decided June 6, 2006No. 06-5105PublishedCited by 54 opinions
1Opinion of the Court
Opinion for the Court filed PER CURIAM.
On Motion for Summary Affirmance
2Per curiam
This case is the latest flare-up in a long-running dispute between the Food and Drug Administration (FDA) and several generic drug manufacturers as to what qualifies under the Hatch-Waxman Act as “a decision of a court ... holding [a challenged] patent ... to be invalid or not infringed.” 21 U.S.C. § 355(j)(5)(B)(iv) (2000) (amended 2003). The stakes are high: any such decision triggers the start of a 180-day exclusivity period during which one generic manufacturer — the first to file an abbreviated new drug application…
3Cases cited7 opinions
- A.C. Aukerman Company v. R.L. Chaides Construction Co.Court of Appeals for the Federal Circuit · 1992
- Mova Pharmaceutical Corp. v. ShalalaCourt of Appeals for the D.C. Circuit · 1998
- Super Sack Manufacturing Corporation v. Chase Packaging CorporationCourt of Appeals for the Federal Circuit · 1995
- City of Las Vegas v. LujanCourt of Appeals for the D.C. Circuit · 1989
- Arizona Public Service Co. v. Environmental Protection AgencyCourt of Appeals for the D.C. Circuit · 2000
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4Cited by54 opinions
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