Apotex v. Shire

Drug: modafinil

Shire brought a motion seeking leave to amend its Statement of Defence to add a new defence of infringement as well as a defence of failure to mitigate. The Court noted that a schedule had been set for the next steps in the proceeding and dates had been fixed for a four-week trial to begin in April 2012.

This action relates to a claim by Apotex pursuant to Section 8 of the Patented Medicines (Notice of Compliance) Regulations. The Court noted that Shire has amended its Statement of Defence several times. In particular, Shire previously had brought a motion seeking to amend its Statement of Defence to include a defence based on the outcome of a patent infringement trial brought by Cephalon, the patentee of the patent in issue in the within case. The Court denied that motion.

The Court noted that allowing the appeal would lead to the adjournment of the trial and no explanation had been provided as to why this defence was not proposed earlier in the litigation. The Court found that it would not be in the interests of justice to allow Shire to amend its Statement of Defence to plead infringement as a Defence and Counterclaim. However, Shire’s motion seeking to include a defence of failure to mitigate, arising from information obtained on discovery, was allowed.