Drug: modafinil

In this action, brought pursuant to section 8 of the NOC Regulations, the Defendant Shire, was partially successful in its motion to amend its Statement of Defence.

Shire sought to amend its Statement of Defence to allege that the owner of the patent had commenced an infringement action against Apotex in a different court file and to allege that if the other action resulted in a finding of patent infringement and validity, Apotex should not be entitled to recover any damages for loss of sales in this action. The Court held that Shire was trying to allege a defence on the basis of a future uncertain event which is not susceptible to being determined or even influenced in the context of the present action. Thus, it was a speculative and hypothetical pleading and should not be permitted.  

Shire also sought to amend its Statement of Defence on the basis of another Notice of Allegation (NOA) sent by Apotex to Shire relating to a different use patent for modafinil. Shire alleged that in that NOA, Apotex undertook that it would not infringe the patent at issue. However, Shire alleged that when Apotex came to market, its product monograph stated that its Apo-modafinil product was indicated for the patented use and it has in fact been sold for that use in breach of that undertaking. Thus, Shire alleged that said breach of undertaking gives rise to grave consequences. The Court held that the interpretation of the NOC Regulations relied upon by Shire is a difficult one which cannot be determined on a motion to strike. Finally, the Court held that Shire had pled factual allegations that were capable of supporting a reasonably arguable defence. Thus, these amendments were allowed.