Richard Dearden

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.

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.

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.