Apotex Inc v. Shire LLC, 2016 FC 1099 Drug: lisdexamfetamine dimesylate

Apotex served an NOA alleging non-infringement and invalidity. Shire filed an application for a prohibition order. Apotex then started an action to impeach the patent at issue, and for a declaration of non-infringement. Shire asks the Court to partially consolidate the proceedings. Apotex opposes the motion, and instead proposes that Shire discontinue the prohibition application, and allow the action to continue to its conclusion. Apotex also proposes that if its product becomes approvable, it would remain out of the market until a decision is rendered, on the basis of an undertaking from Shire for damages. Apotex concedes that the Court has no jurisdiction to impose its proposal without consent. On the motion, Apotex argued that both proceedings should proceed in parallel to separate hearings. At the hearing, Shire proposed that the proceedings proceed as in Gleevec (2013 FC 142).

The Court considered the merits of Shire's proposal as well as Apotex' arguments of prejudice. The Court held that if the two proceedings had a common evidentiary record, the Court could apply the correct burden of proof to both the application and the action, thus, Apotex would suffer no prejudice in this regard. The Court recognized that strategies and tactics may be different as between actions and applications, but held that Apotex did not explain how the loss of any of these elements would be prejudicial. The Court held that all of Apotex' substantive rights would be protected if Shire's proposal were to be adopted. Furthermore, there would be very significant savings of time and expense for the parties as well as a judicious use of the Court's resources. The Court noted that Apotex has full control over the timing of the two proceedings and held that Apotex cannot impose its own schedule on Shire and the Court while at the same time resisting reasonable and just means to make the most efficient use of scarce judicial resources.

Thus, the Court heard that the two proceedings be heard at the same time and by the same judge. Furthermore, the Court held that the issue of whether the allegations in the NOA are justified shall be decided on the basis of evidence led at the trial of the action. Furthermore, evidence regarding the assertion that the NOA is not a valid NOA shall be adduced at the trial of the action.