Nando De Luca

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 brought a proposed class action against numerous pharmaceutical manufacturers and distributors regarding the marketing and sale of opioids in Canada.

The defendants moved to strike the statement of claim for failing to disclose a reasonable cause of action, and one defendant, Pro Doc Limitée, moved to dismiss the action against it for lack of jurisdiction.

The court granted Pro Doc's jurisdiction motion, finding no real and substantial connection to Ontario.

The court struck the claims against the distributor defendants without leave to amend, finding no viable cause of action.

The court found that while there were viable causes of action against the manufacturer defendants for breach of the Competition Act, negligent misrepresentation, fraudulent misrepresentation, and failure to warn, the plaintiff's pleading was defective.

The court struck the claims against the manufacturer defendants with leave to amend to join representative plaintiffs for each defendant group and to comply with the rules of pleading.

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 defendants in a proposed opioid class action moved to dismiss the proceeding for delay under s. 29.1 of the Class Proceedings Act, 1992.

In response, the plaintiff brought a cross-motion for a nunc pro tunc timetable order and commenced parallel proceedings in Manitoba.

The parties reached a settlement wherein the competing motions were dismissed without costs, the Manitoba proceedings would be discontinued, and the Ontario action would be deemed commenced on October 2, 2020, making it subject to the amended certification test under the Smarter and Stronger Justice Act, 2020.

The court approved the settlement and issued the consent orders.

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.

In a case management endorsement, the court stayed most of the plaintiff's claims for delayed generic drug market entry pending the appeal of a related decision, except for a claim under section 8 of the Patented Medicines (Notice of Compliance) Regulations.

The court also lifted a prior consent bifurcation order, directing that the trial of the section 8 claim proceed on both liability and damages to prevent technical delays and ensure the efficient resolution of the ten-year-old case.

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 sought to adjourn a scheduled 20-day trial to bring a summary judgment motion, or alternatively, to await a decision in a similar case.

The plaintiff opposed, arguing procedural requirements for such an adjournment.

Following a relevant summary judgment decision by another judge in a related action, the court vacated the trial date and ordered a schedule for the defendants' summary judgment motion.

The court found that a summary judgment could resolve the case more quickly and cheaply, emphasizing judicial economy and the principle of stare decisis, and that prior decisions refusing summary judgment in similar cases did not preclude reconsideration given new circumstances.

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 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.

The defendants sought to schedule a further motion for summary judgment on the Monopolies Act issue, having previously failed on a Rule 21 motion concerning the same claim.

The court denied the request, emphasizing that partial summary judgment is rarely appropriate in complex litigation, especially when recent amendments to pleadings have re-opened other significant issues, such as patent validity.

The judge concluded that the case should proceed to a single trial on all issues to avoid fragmented litigation and multiple appeals, which would prolong the proceedings and consume vast judicial resources.

The appellants (Sanofi-Aventis and Schering Corporation) appealed a motion judge's decision dismissing their motion to amend their statement of defence.

The appellants sought to plead that a 2009 Federal Court decision invalidating their patent for the drug Ramipril was based on wrong legal principles, specifically the "promise doctrine," which was subsequently struck down by the Supreme Court of Canada in 2017.

The motion judge had dismissed the motion on the basis of issue estoppel, finding no change in law justified departing from the doctrine.

The Court of Appeal allowed the appeal, holding that the Supreme Court's decision striking down the promise doctrine constituted a change in law that warranted exercising discretion not to apply issue estoppel, particularly given the centrality of the patent validity issue to the respondent's claim for damages.

The defendants brought a motion for leave to amend their Statements of Defence to plead that a patent previously declared invalid by the Federal Court was actually valid, relying on a recent Supreme Court of Canada decision that overturned the 'promise doctrine' used to invalidate it.

The Superior Court of Justice dismissed the motion, holding that the proposed amendments constituted an impermissible collateral attack and were barred by issue estoppel.

The court found no 'special circumstances' to justify re-litigating the patent's validity, noting that under section 62 of the Patent Act, the Federal Court's declaration rendered the patent void ab initio.

This endorsement addresses a refusals motion where the defendants, Eli Lilly, sought to question the plaintiff, Apotex, regarding communications with the government during Apotex's abbreviated new drug submission (ANDS) process.

Apotex argued that its drug approval process was immune from challenge by Lilly.

The court distinguished between an impermissible collateral attack on Health Canada's regulatory approval and a permissible inquiry into factors that might affect the "start date" for damages under s. 8(1)(a)(ii) of the Patented Medicines (Notice of Compliance) Regulations.

The court found Lilly's request to be probative of a properly pleaded issue concerning the quantum of damages, rather than the validity of the approval itself.

Consequently, the motion was granted, and the question was ordered to be answered.

The defendants abandoned their motion to strike the plaintiffs' claim on the day of the hearing.

The plaintiffs sought substantial indemnity or partial indemnity costs for preparing for this motion.

The court considered various factors under the Rules of Civil Procedure, including the complexity of the issues, the importance of the issues, and the parties' conduct.

The court found the hourly rates reasonable but the time docketed excessive given the nature of the motion and the plaintiffs' prior experience with similar motions.

The court awarded partial indemnity costs, finding that the defendants' conduct did not warrant substantial indemnity.