Should an action under section 6(1) of the Patented Medicines (Notice of Compliance) Regulations be rendered moot if the asserted patent will expire before the trial date and the 24-month mandatory stay?
This was the issue before Justice O’Reilly, whom had to determine whether AstraZeneca’s was entitled to a declaration that its infringement action was not moot because its patent, Canadian Patent No 2,402,894, will expire on March 5, 2021, approximately seven months before the scheduled trial in October 2021. In deciding this motion, Justice O’Reilly had to consider whether there “remains a live issue even after the expiry of the ‘894 patent.”
Justice O’Reilly found the infringement action remains a live issue and would not be moot for two reasons. First, AstraZeneca is entitled to any remedies under the Patent Act including damages from any infringing activities by the defendant, such as commercial manufacturing, before the expiration of the 894 patent.
Second, Justice O’Reilly acknowledged that this issue could be addressed in a section 8 action, if the defendant sought damages, but it was more efficient and consistent with the regulations to address the issue now. As he noted, the current scheme “envisages the determination of substantive patent issues within a single proceeding.” Furthermore, he stated that section 8 actions:
… have typically been confined to damages calculations, leaving substantive patent matters to s 6 proceedings. For example, attempts to re-litigate infringement within a s 8 action have been discouraged: Apotex Inc v Pfizer Canada Inc, 2013 FC 493 at para 26.
In the alternative, Justice O’Reilly would have heard the action because the preparations by the parties made it more “efficient and economical.”
A copy of the decision can be found here.