Apotex sent a NOA regarding the validity of a patent list on the Patent Register for an orally disintegrating tablet form of a drug. It had previously sent an NOA regarding the validity of the same patent with respect to a standard tablet form of the drug. In that prior proceeding, Apotex' NOA had been found not justified. Subsequently, another generic company sent an NOA regarding validity of the same patent. This second generic company's NOA was found to be justified. Thus, the second generic company, and all subsequent senders of NOAs entered the olanzapine market, but Apotex was prohibited due to its first NOA.
In response to Apotex' latest NOA, Lilly started a proceeding seeking a declaration that the NOA is an abuse of process and otherwise null and void. Apotex brought a motion to dismiss the proceeding as an abuse of process. The Court held that Lilly's application should be dealt with prior to Apotex' motion.
The Court then held that the requirements for issue estoppel had been met. The previous Court proceeding between Apotex and Lilly involving this patent had become final and addressed the same issue as the current proceeding. The fact that the formulation sought to be marketed by the generic in the context of this proceeding is different, does not change that the cause of action is the same.
Furthermore, Apotex had already commenced an impeachment action. Thus, there is no reason to exercise discretion not to apply the doctrine of issue estoppel. As a result, Lilly is entitled to a declaration that Apotex is precluded for pursuing its current NOA which is null, void and of no effect. Thus, the current prohibition application is terminated.
The full text of the decision can be found at: http://decisions.fct-cf.gc.ca/en/2009/2009fc1053/2009fc1053.html