Nando De Luca

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.

Following the dismissal of the defendants' motion for leave to appeal, the plaintiff sought costs of $40,000 on a substantial indemnity basis, relying on an offer to settle.

The court rejected the request for substantial indemnity costs, finding the offer was not a true compromise and did not trigger Rule 49.10.

Considering the complexity and significance of the litigation, the court fixed costs at $10,000 inclusive of disbursements and HST.

The defendants sought leave to appeal an order dismissing their motion to strike the plaintiff's claims for damages arising from delayed market entry of a generic drug.

The defendants argued the Patent Act provided a complete code, precluding common law claims.

The Divisional Court dismissed the motion for leave to appeal, finding no conflicting Ontario decisions and no good reason to doubt the correctness of the motion judge's order, emphasizing that pleadings motions should rarely warrant appellate review.

The defendants, Pfizer, brought a motion under Rule 21.01(1)(b) to strike various claims in the plaintiff Apotex Inc.'s Amended Statement of Claim.

Apotex sought relief for being kept out of the market by Pfizer's invalid patent for Viagra, asserting statutory claims under the Patented Medicines (Notice of Compliance) Regulations, Statutes of Monopolies, and Trade-marks Act, and common law claims for unjust enrichment, nuisance, Ashby v. White, and conspiracy.

The court struck the claims under s. 8 of the PMNOC Regulations and the independent cause of action based on Ashby v. White, finding that the statutory conditions for PMNOC damages were not met and Ashby v. White is a principle, not a cause of action.

However, the court dismissed Pfizer's motion to strike the claims under the Trade-marks Act, unjust enrichment, nuisance, and conspiracy, rejecting the 'complete code theory' as insufficiently settled for a preliminary stage motion and finding the pleadings for these claims to disclose a reasonable cause of action.

The defendants moved to strike various claims by the plaintiff, Apotex Inc., including claims under the Trade-marks Act and the Monopolies Acts, as well as claims for unjust enrichment and a "basket clause" for other relief.

The motion was brought under Rules 21.01(1)(b) and 25.11(b) and (c) of the Rules of Civil Procedure, arguing no reasonable cause of action, frivolousness, vexatiousness, or abuse of process, and also raising arguments of "complete code" and res judicata.

The court dismissed the defendants' motions, except for the unjust enrichment and "basket clause" claims which Apotex did not oppose, finding that the legal issues were insufficiently settled to be decided at the pleadings stage.

The court emphasized the need to avoid piecemeal appeals and directed a case conference to expedite the matter to trial.

The defendants brought a motion to strike the plaintiff's claims based on the 1624 Statute of Monopolies and the 1897 Ontario Monopolies Act.

The plaintiff, a generic pharmaceutical manufacturer, alleged that the defendants unlawfully delayed its entry into the market by obtaining and asserting an invalid patent.

The defendants argued that the Patent Act and NOC Regulations constituted a complete code and that the Monopolies Acts did not apply.

The court dismissed the motion, finding that it was not plain and obvious that the claims could not succeed, as the law regarding the complete code argument was unsettled and the Monopolies Acts could arguably apply to invalid patents.

Apotex's generic version of a patented drug was kept out of the market for two years by Eli Lilly using the Patented Medicines (Notice of Compliance) Regulations.

After the patent was invalidated, Apotex sued for unjust enrichment, seeking disgorgement of Eli Lilly's monopolistic profits.

The Court of Appeal upheld the Divisional Court's decision to strike the claim, finding that Apotex suffered no corresponding deprivation of the monopolistic profits because it would never have earned them.

The defendants brought a Rule 21 motion to strike a claim arising from litigation related to the Patented Medicines (Notice of Compliance) Regulations.

The court adjourned the motion pending the outcome of a related appeal before the Court of Appeal involving the same underlying facts and legal issues.

The judge held that the appellate decision would likely have a significant impact on the issues in the motion, particularly regarding the availability of ancillary remedies in PM(NOC) Regulations litigation.

The adjournment was justified on grounds of judicial economy, efficiency, and the avoidance of potentially duplicative proceedings.

The court concluded that the short delay would not cause real prejudice and any financial impact could be compensated by interest.

The appellants appealed a decision dismissing their motion to strike a portion of the respondent's amended claim seeking disgorgement of profits based on unjust enrichment.

The respondent, a generic drug manufacturer, argued it had an independent cause of action outside the Patented Medicines (Notice of Compliance) Regulations due to the invalidity of the appellants' patent and alleged false representations.

The Divisional Court allowed the appeal, holding that the Patent Regulations constitute a complete code and leave no room for stand-alone equitable remedies like unjust enrichment in these circumstances.

The claim was struck for disclosing no reasonable cause of action.

The defendants moved to strike parts of the plaintiff's statement of claim, which sought damages for the delay in marketing its generic drug caused by the defendants' actions under the Patented Medicines (Notice of Compliance) Regulations.

The plaintiff claimed damages under s. 8 of the Regulations, unjust enrichment, and the Trade-marks Act after the defendants' patent was declared invalid.

The court dismissed the motion to strike these claims, finding they had a reasonable prospect of success and raised unsettled legal questions, but struck a bald claim for remedies 'otherwise available at law'.

Apotex Inc. sought judicial review of decisions by the Executive Officer of the Ontario Public Drug Programs refusing to increase the reimbursable pricing of three generic antibiotic drugs.

The applicant argued that the historic pricing exemption should apply to allow price increases and challenged the Executive Officer's reliance on the single source pricing exemption to negotiate a price increase with a competitor.

The Divisional Court dismissed the application, finding that the Executive Officer's interpretation of the legislation and regulations was reasonable and that her actions to ensure a continued supply of the drugs were lawful and in the public interest.

Seven generic drug manufacturers sought judicial review of a decision by the Executive Officer of the Ontario Public Drug Programs to designate Apotex's product, Apo-Lisinopril, as a benefit under the Ontario Drug Benefit Formulary.

The applicants argued that Apotex could not meet the supply pre-condition at the time of its application due to a patent injunction.

The Divisional Court dismissed the application, finding that the Executive Officer correctly interpreted the regulations to require a prospective assessment of the manufacturer's capability to supply the product to meet anticipated demand, rather than requiring sufficient inventory on hand at the moment of application.

The applicants sought leave to bring an application for judicial review before a single judge of the Superior Court pursuant to s. 6(2) of the Judicial Review Procedure Act, arguing urgency.

The matter concerned the proposed designation of Apotex Inc.'s version of Lisinopril as a benefit under the Ontario Drug Benefit Act.

The respondent Minister opposed the application, arguing the urgency was self-created and economic loss was insufficient.

The court granted leave, finding the potential economic loss significant and the applicants' prior inaction not fatal.

Apotex Inc. sought judicial review of regulations enacted by the Ontario government that reduced the reimbursement price of generic prescription drugs to 50% of brand-name drugs.

Apotex argued the government failed to meet its statutory obligations for public consultation and consideration under Bill 102, and breached procedural fairness based on legitimate expectations.

The Canadian Generic Pharmaceutical Association intervened.

The Divisional Court dismissed the application, finding that the government met the notice and consultation requirements, the Lieutenant Governor in Council did not exceed its jurisdiction in altering the proposed regulations, and the doctrine of legitimate expectations does not apply to purely legislative functions.

The appellants, a secured creditor and an interim receiver, appealed a decision granting priority to carriers over funds collected by a bankrupt freight broker.

The broker had failed to maintain a separate trust account for carriers' charges as required by provincial regulation, instead co-mingled the funds while tracking them in an accounting system.

The Court of Appeal held that provincial statutory deemed trusts do not exclude property from a bankrupt estate unless they satisfy general trust principles, which require strict segregation.

Consequently, the co-mingled funds collected before the receivership lost their trust character and were subject to the secured creditor's interest.

However, the interim receiver was obligated to hold funds collected after its appointment in trust for the carriers.

The Ontario Securities Commission approved a settlement agreement concerning the respondents' involvement in an 'overtrade' of Bioscrypt Inc. shares.

Paradigm Capital Inc., acting as an agent for a private placement, facilitated secondary market trades for a mutual fund manager who had been solicited for the private placement.

This resulted in shares being sold by persons with knowledge of an undisclosed material fact to persons without such knowledge.

The Commission found this conduct contrary to the public interest, reprimanded the respondents, imposed trading restrictions, and ordered settlement payments and costs.

The appellant leased truck trailers to a company that subsequently went bankrupt.

A priority dispute arose between the appellant and the bankrupt's secured creditor over the trailers.

The trailers were used in multiple jurisdictions but the debtor was located in Alberta.

The Court of Appeal held that although the lease was a 'true lease' not requiring registration under the Ontario PPSA, the choice of law provisions in s. 7(1) of the Ontario PPSA still applied.

Consequently, Alberta law governed the dispute.

Under the Alberta PPSA, the lease was deemed a security interest requiring registration, and because the appellant registered against the wrong entity, its interest was subordinate to the secured creditor's perfected security interest.

The appeal was dismissed.

The union brought a motion for leave to appeal an order that amended a receivership order to protect the receiver from successor employer status and denied the union leave to proceed against the receiver before the Ontario Labour Relations Board.

The Court of Appeal granted leave to appeal, finding that the legal issues regarding the relationship between bankruptcy courts and labour boards, and the status of a receiver as a successor employer, were significant to commercial practice and warranted consideration by the appellate court.