Teva Phanns. USA, Inc. v FDA, 182 F.3d 1003 (DC Cir. 1999) (‘Teva I’) and Teva Pharms. USA, Inc. v FDA, 2000 WL 1838303 (DC Cir. 15th November, 2000) (‘Teva II’).
2.
Teva's ANDA was filed before the enactment of the Medicare Modernization Act (MMA), therefore all references in this case report to 21 USC §355 refer to the pre-MMA statute.
3.
Teva I concerned Teva's appeal of the FDA's determination that the dismissal of Teva's declaratory judgment action against Syntex (regarding Syntex's ticlopidine formulation patent) was not a ‘court decision’. The DC Circuit held that the statutory terms ‘decision’ and ‘holding’ were ambiguous, but did not rule on whether the FDA's interpretation of such terms was correct. See Teva I, 182 F.3d at 1007–08. The DC Circuit instead remanded because the FDA had failed to explain its reasoning and also failed to explain why it had taken seemingly inconsistent positions in other contexts. See Teva I, 182 F.3d at 1009. According to Teva III, Teva I merely criticised FDA's failure to adequately support its determination that the dismissal of Teva's declaratory judgment action against Syntex was not a ‘court decision’. See Teva III, 441 F.3d at 4.
4.
Teva II was another appeal regarding FDA's continued determination that the dismissal of Teva's declaratory judgment action against Syntex was not a ‘court decision’. In Teva II, the DC Circuit again criticised the FDA's underlying reasoning for its statutory interpretation: ‘FDA did not meaningfully address question on remand’. See Teva II, 2000 WL 1838303 at *1–2. As the Teva v FDA District Court had explained, ‘he lesson of Teva II, then, is that when a dismissal includes a predicate finding of fact by the trial judge, which is based on documents other than the pleadings that have functionally become part of the dismissal order, and FDA has committed itself to a case-by-case analysis of such dismissals, FDA's determination as to whether the dismissal is a ‘decision of a court’ under the language of Hatch-Waxman will not stand unless the agency has considered all of the materials that constitute the dismissal order.’ Teva v FDA, 398 F. Supp. 2d at 187.
5.
Chevron USA, Inc. v Natural Resources Defense Council, 467 US 837 (1984).
6.
25th April, 2006 Press Release: ‘Teva Receives First FDA Approval for Generic Pravachol’ Appellate Court Denies Apotex Request for Injunctive Relief (http://www.tevapharm.com/pr/2006/pr_601.asp).
