ANDA case dismissed over generic company's objection
Merck & Co., Inc. v. Apotex, Inc., No. 06-230-GMS, May 21, 2007.
Sleet, J. The Court dismissed the action where actual controversy was resolved by plaintiff’s execution of covenant not to sue.
The disputed technology relates to a generic version of Fosomax. Defendant counterclaimed for declaratory judgment of invalidity and noninfringement. After receiving more detailed information from the defendant regarding its generic version, plaintiff granted defendant a comprehensive covenant not to sue. Subsequently, plaintiff moved to dismiss the action as a result of the covenant claiming that the action was moot and the court lacked subject matter jurisdiction over the purported controversy. Defendants opposed the motion claiming that dismissal without a ruling on their counterclaim would operate to deny it the right to compete with plaintiff for want of a “triggering event” thereby delaying defendant’s entry into the market. The Court dismissed the case finding that an actual controversy must be present at all stages of the litigation and not merely at the time of the filing of the complaint. The Court reasoned that having received the covenant not to sue which removed any concern that defendant could be held liable for infringement of the patents in suit, further court action on defendant’s counterclaim would amount to an impermissible advisory decision. In so ruling, the Court addressed defendant’s argument that plaintiff’s actions of filing suit, covenanting not to sue, and moving to dismiss for lack of subject matter jurisdiction constituted an unlawfully anticompetitive and monopolistic scheme to delay entry of generic filers into the market. Acknowledging the potential for abuse inherent in the Hatch-Waxman Act, the Court went on to adopt the Federal Circuit’s analysis in Teva v. Pfizer, finding defendant’s claim of injury to be nothing more than a business disadvantage. Finding no Article III controversy, the Court dismissed the action.
A copy of the full opinion is available here.

