Harry B. Radomski

The Court of Appeal for Ontario dismissed Apotex Inc.'s appeal regarding its claim for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations.

Apotex sought damages for delayed market entry of its generic drug due to Eli Lilly's prohibition application.

The trial judge found that Apotex was not entitled to damages, as the prohibition application was dismissed as moot, not on the merits, and that Apotex would not have entered the market earlier in a hypothetical world without the prohibition application due to risk aversion and potential patent infringement liability.

The Court of Appeal upheld these findings, concluding that Apotex failed to demonstrate any actual entitlement to damages.

This is a costs endorsement following the dismissal of an appeal.

The respondents, who won the appeal, claimed over $157,000 in costs.

The appellants, who lost the appeal, proposed $25,000.

The court found the respondents' costs submissions inadequate, lacking sufficient explanation for the hours claimed and indicating potential over-preparation.

The court ultimately awarded $25,000 in costs, finding the appellants' offer to settle on costs to be the best evidence of a reasonable, fair, and proportionate amount in the circumstances.

The court issued trial management directions and an endorsement, adjourning a bifurcated liability trial scheduled to commence on May 21, 2019.

The adjournment was necessitated by the parties' lack of trial readiness, specifically concerning the plaintiff's uncertainty regarding witness identities (over 20 potential witnesses, some unnamed) and the failure to finalize an agreed statement of facts.

Additionally, the plaintiff's last-minute motion to add another foreign defendant, Eli Lilly S.A., introduced unresolved jurisdictional issues that would further complicate and extend the trial.

The court emphasized the importance of efficient trial management and the fair allocation of judicial resources, concluding that proceeding with the trial under these circumstances would risk exceeding the allotted time and prejudice other litigants.

The defendants moved to amend a Protective and Confidentiality Order to add a second law firm, Norton Rose Fulbright LLP, as "outside counsel" alongside their existing counsel.

The plaintiff opposed, citing a potential conflict of interest as Norton Rose Fulbright also represents another drug manufacturer with similar claims against the plaintiff in a separate action.

The court found that the defendants failed to provide a sufficient explanation for seeking to add Norton Rose Fulbright as co-counsel under paragraph 10(b) of the order, rather than simply seeking leave under paragraph 10(g) to allow them to view confidential information.

The court identified a foreseeable risk of conflict of interest due to Norton Rose Fulbright's dual representation and the lack of evidence regarding screening mechanisms or waivers.

The motion was dismissed.

The Court allowed AstraZeneca’s appeal and held the patent ‘promise doctrine’ is not the correct approach to utility under s. 2 of the Patent Act.

It found the doctrine improperly imports disclosure obligations into the utility requirement and wrongly invalidates patents when one of multiple promised uses is unproven.

The correct test asks whether the claimed subject-matter has at least one practical use related to that subject-matter, demonstrated or soundly predicted at filing.

Applying that test, the ‘653 patent had sufficient utility and was not invalid.

In this patent damages appeal under s. 8 of the Patented Medicines (Notice of Compliance) Regulations, the Court upheld the Federal Court of Appeal decision and dismissed the patentees' appeal.

The Court agreed with the majority's reasoning on liability period, market-entry assumptions, and compensation for lost sales tied to unapproved indications.