Christopher C. Van Barr

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.

This is a costs endorsement following an appeal in a pharmaceutical patent dispute.

The Court of Appeal determined that costs in the cause was not appropriate and awarded costs to the respondent on a partial indemnity basis: $15,000 from Takeda and $25,000 from Abbott, inclusive of disbursements and HST.

This appeal concerns damages claimed by Apotex for lost sales of its generic drug Apo-lansoprazole due to proceedings initiated by Abbott and Takeda under section 6 of the Patented Medicines (Notice of Compliance) Regulations.

The motion judge dismissed the defendants' motion for summary judgment, finding that Apotex would have received regulatory approval on April 17, 2007, but for the section 6 proceedings.

The appellants argued that Apotex's submission was deficient because it lacked a high-fat meal bioequivalence study.

The Court of Appeal upheld the motion judge's decision, finding no legal requirement for such a study and ample evidence supporting approval on the original submission.

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 a partial summary judgment dismissing its unjust enrichment claim for disgorgement of the respondents' profits.

The appellant argued that if a settlement agreement between the parties was found unenforceable under section 8 of the Patented Medicines (Notice of Compliance) Regulations, it should be entitled to disgorgement.

The Court of Appeal dismissed the appeal, finding that the appellant's deprivation could not exceed damages calculated under section 8, which do not include disgorgement.

Furthermore, the regulatory scheme provided a valid juristic reason for the respondents' profits, precluding the unjust enrichment claim.

Innovator pharmaceutical companies brought a motion for partial summary judgment seeking dismissal of a generic manufacturer’s claim for disgorgement of revenues or profits based on unjust enrichment.

The claim arose from alleged wrongful invocation of the Patented Medicines (Notice of Compliance) Regulations, which had delayed the generic manufacturer’s market entry for a drug containing lansoprazole.

The court held that s. 8 of the NOC Regulations constitutes a complete statutory code governing compensation for delayed market entry and excludes equitable remedies such as disgorgement of innovators’ profits.

The Federal Court of Appeal’s decision in Apotex v. Eli Lilly Canada Inc. was followed as highly persuasive authority confirming that Parliament deliberately excluded profit disgorgement through the 2006 amendments to the Regulations.

In any event, the statutory framework and the parties’ settlement agreement each constituted juristic reasons defeating the unjust enrichment claim.

On a motion by Takeda defendants to add Takeda Pharmaceuticals North America, Inc. and Takeda Pharmaceuticals LLC as plaintiffs-by-counterclaim in a patent dispute, the court held the proposed pleading disclosed a tenable cause of action and met the Ontario rules for joinder and amendment.

The court found the proposed entities’ pleaded licensee status and supply-chain damages allegations were sufficient at this stage, with particulars and evidentiary disputes to be addressed through discovery.

Applying joinder and amendment principles, the court concluded that adding the parties would avoid multiplicity of proceedings, promote convenient administration of justice, and not cause non-compensable prejudice to Apotex.

The motion was granted, and Takeda was awarded partial-indemnity costs payable within forty days, with quantum to be resolved if not agreed.

The appellant created a calendar and sold advertising space to pharmaceutical companies.

The respondent, a trade association, directed its members not to advertise in the calendar, claiming it violated their Code of Marketing Practices.

This direction destroyed the appellant's business.

The appellant sued for intentional interference with economic relations.

The trial judge found the respondent's initial letter was tortious but cured by a subsequent legitimate ruling.

The Court of Appeal allowed the appeal, finding the respondent had no authority under its Code to prohibit members from advertising in third-party products.

The Court held the unauthorized ruling constituted unlawful means, satisfying the elements of the tort of intentional interference with economic relations, and directed a reference on damages.