Jerry Paul Krzysztof Topolski

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.

The plaintiff, a generic drug manufacturer, brought an action for damages against the defendants under s. 8 of the Patented Medicines (Notice of Compliance) Regulations for delayed market entry of its generic drug.

The plaintiff argued it was entitled to damages because the defendants' prohibition proceeding was dismissed for mootness after the underlying patent was invalidated in a separate proceeding.

The court dismissed the claim, finding that the plaintiff's allegations in the prohibition proceeding had failed on the merits, and s. 8 does not provide redress where the innovator prevailed on the merits but the patent was later invalidated by a third party.

The court also found that, even if liability existed, the plaintiff would not have entered the market any sooner in the hypothetical world due to its risk-averse nature.

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 appellants, generic drug manufacturers, sought damages exceeding one billion dollars against the respondents, innovator drug companies, after the respondents' patent for the drug Olanzapine was declared invalid.

The appellants claimed damages under the Statute of Monopolies, the Trademarks Act, and the common law tort of civil conspiracy for the period they were kept out of the market.

The Court of Appeal upheld the motion judge's dismissal of the action, finding that the Patent Act and the PM(NOC) Regulations provided a complete code for remedies, and the respondents were not liable for damages caused by the lawful operation of the statutory regime.

The court also upheld the motion judge's $700,000 partial indemnity costs award against the appellants.

Following the dismissal of the plaintiff's action on a motion for summary judgment, the defendants sought costs on a substantial indemnity basis.

The court found that the plaintiff's unfounded allegations of intentional misconduct, fraud, and conspiracy warranted an elevated scale of costs.

The court distinguished a previous decision involving the same plaintiff and awarded the defendants substantial indemnity costs fixed at $900,000.

The defendants brought a motion for summary judgment to dismiss the plaintiff's action for treble damages and double costs under the Statute of Monopolies and common law torts, following the invalidation of the defendants' patent for Viagra.

Relying on a recent coordinate decision, the court found that the Patent Act and the Patented Medicines (Notice of Compliance) Regulations operate as a complete code, precluding the plaintiff's claims.

The court also dismissed the plaintiff's additional claims for unjust enrichment and nuisance on their merits.

The motion for summary judgment was granted, and both the claim and counterclaim were dismissed.

Following the dismissal of the plaintiffs' action on a summary judgment motion, the successful defendants sought costs on an elevated or substantial indemnity basis of over $850,000, or alternatively partial indemnity costs of over $730,000.

The plaintiffs argued for an award of $150,000.

The court declined to award elevated costs, finding the plaintiffs' conduct did not rise to the level of being reprehensible or outrageous, despite making unfounded allegations of fraud and conspiracy.

Recognizing the high stakes and complexity of the litigation between two well-resourced pharmaceutical companies, the court awarded the defendants partial indemnity costs fixed at $700,000 inclusive of disbursements and taxes.

The defendants (Lilly) brought a motion for summary judgment to dismiss the plaintiffs' (Apotex) action for damages arising from Lilly's use of the PM(NOC) Regulations to delay Apotex's generic drug from entering the market.

Apotex claimed damages under the Statutes of Monopolies, the Trademarks Act, and common law conspiracy after Lilly's patent was later declared invalid.

The court found that while the action was not barred by the Limitations Act, 2002, the claims failed because the Patent Act and PM(NOC) Regulations constitute a complete code.

Lilly's actions in listing its presumptively valid patent and pursuing prohibition proceedings were authorized by law.

The motion for summary judgment was granted and the action was dismissed.

The defendants brought a motion for summary judgment.

Prior to the hearing, the plaintiffs objected to proceeding with the motion virtually via Zoom and requested an adjournment until an in-person hearing could be held.

The court denied the adjournment request, finding no prejudice to the parties in proceeding virtually.

The court noted that the Zoom platform is effective, the documentary record is easily accessible electronically, and an adjournment would cause unnecessary delay.

The motion was ordered to proceed virtually as scheduled.

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 court issued trial management directions for an upcoming ten-day bifurcated trial on liability concerning a patent invalidity and public nuisance claim.

Directions were given regarding the exchange of witness affidavits for evidence in chief, read-ins from discovery transcripts, opening statements, and scheduling.

The court also directed that outstanding issues regarding document production and particulars of special damages be resolved summarily at an upcoming case conference.

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 defendants sought directions for motions to strike portions of the plaintiff's Reply, which argued that the original patent invalidity decision could be supported on grounds other than the "promise doctrine" overturned by the Supreme Court.

The court, acting as case management judge, emphasized the need to move the complex, long-standing litigation towards trial and avoid further "silver bullet" motions on narrow legal points.

The judge ruled against scheduling Rule 21 or Rule 20 type motions, stating that the trial judge should determine the factors for exercising equitable discretion regarding the "special circumstances" doctrine.

However, motions within a Master's jurisdiction were directed to Master Sugunasiri.

Apotex brought a motion to amend its pleadings in an ongoing patent dispute over the drug Lansoprazole.

Following the Supreme Court's rejection of the 'Promise Doctrine' in AstraZeneca, Apotex sought to recast its previous Promise Doctrine allegations as claims of insufficiency, overbreadth, and fraud under sections 27 and 53 of the Patent Act.

The court dismissed the motion, finding that the proposed amendments were legally untenable and merely repackaged the defunct Promise Doctrine.

Furthermore, the court held that the fraud allegations lacked the strict particularity required by the Rules of Civil Procedure and awarded elevated costs to the respondents.

The moving parties (innovator drug manufacturers) brought a motion for summary judgment to dismiss the responding party's (generic drug manufacturer) claim for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations.

The moving parties argued that the generic drug could not have been lawfully approved by Health Canada in April 2007 due to non-compliance with bioequivalence study guidelines, rendering the section 8 claim invalid.

The court dismissed the motion, finding that Health Canada's guidelines did not have the force of law and that the evidence established the generic drug would have received a Notice of Compliance in April 2007 but for the moving parties' prohibition proceedings.

The court also distinguished prior case law and held that the moving parties lacked standing to challenge the Minister's drug approval decisions in a section 8 damages action.

The appellant appealed the dismissal of her application for an oppression remedy under s. 248 of the Business Corporations Act.

The dispute centered on a numbered company incorporated by the appellant's late husband to hold a Florida condominium, with shares held by the appellant and the husband's children.

The motion judge found that the husband had loaned money to the corporation and had not forgiven the loan prior to or upon his death.

The Divisional Court upheld the motion judge's findings that the loan remained an obligation of the corporation and that the failure of the estate to forgive the loan did not constitute oppressive conduct by the corporation or its directors.

The appeal was dismissed.