In an action brought by Apotex for damages pursuant to Section 8 of the PMNOC Regulations against Shire after an unsuccessful PMNOC proceeding brought by Shire, Shire moved to amend the statement of defence. The first of the two new pleadings sought to be introduced by Shire was denied by the Prothonotary. The pleading in question related to a defence that in the event Apotex is held to have infringed the ‘967 patent in the patent infringement proceeding commenced by the patentee of the ‘967 patent, then Apotex should be precluded from recovering damages in the present proceeding for loss of sales ultimately found to be infringing in another action. In dismissing the amendment, the Prothonotary held that the outcome in the parallel proceeding was an uncertain event; the extent of which could not be determined in the present case. Moreover, any success or failure in the parallel proceedings was contingent upon the actions of a third party and therefore the proposed pleading was no more than speculative and hypothetical. The Prothonotary also referred to (and was clearly influenced by) the potential delay that would be caused should she allow this particular amendment to the pleadings.

The second ground sought to be introduced by Shire related to an undertaking alleged to have been given by Apotex in 2005 in respect of a patent related to the ‘967 patent. That patent (the ‘824 patent) was directed to a particular use of modafinil and Shire alleged that Apotex had undertaken not to make, use or sell its tablets for that patented use. Shire submitted that Apotex’s Monograph declares that its Apo-modafinil product is indicated for the use covered by the ‘824 patent and, furthermore, states that Apotex had already sold its product for that use in Canada and therefore was in breach of the undertaking. In response, Apotex argued that any such misrepresentation or breach of undertaking (if established) occurred in respect of another patent (i.e. the ‘824 patent) and not the patent at issue in these proceedings (i.e. the ‘967 patent) and therefore cannot be a proper defence to the present proceedings. The Prothonotary allowed the amendment. She said that this is a difficult decision on a point of law and it should not be determined upon a motion. She said that Apotex’s alleged breach of an undertaking in relation to another patent, if established, may influence the starting point for determining the period in which damages should be paid in the present proceeding. Therefore it was a proper defence, or at least an arguable defence, in the present proceedings.

The full text of the decision can be found at: