Kiernan Murphy

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.