Christopher C. Van Barr

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.

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.