All Circumstances Rule of Medimmune Gives ANDA Applicant Standing

Teva Pharmaceuticals v. Novaritis Pharmaceuticals Corp., [06-1181](March 30, 2007)[GAJARSA, Mayer, Friedman] The Federal Circuit reversed the trial court's determination that Teva failed to establish reasonable apprehension of suit, in view of the Supreme Court's decision in Medimmune.
BRIEF: Teva brought filed an ANDA with the FDA relating to tmake a generic version of Novaritis' Famvir drug. Novaritis sued Teva on one of the five patents covering Famvir, so Teva brought a declaratory judgment action on the remaining four patents. The district court dismissed the declaratory judgment action, but the Federal Circuit reversed. LOF: The determination of whether an actual controversy exists under the Declaratory Judgment Act in a patent case is a question of law" that is review de novo. The Federal Circuit said that the most determinative requirement for standing is injury-in-fact. The injury must be person, concrete and particularized, and actual or imminent. The Federal Circuit said that its two part test was overruled by Medimmune, and instead applied the Supreme Court's "all circumstances" test, and concluded under the all circumstances test, Teva did show an injury-in-fact.Article III standing requires a plaintiff to allege personal injury fairly traceable to the defendant's allegedly unlawful