No Section 8 Liability For Valid And Infringed Patent In NEXIUM Proceeding

What happens when a patentee is unsuccessful in a prohibition application under the Patented Medicines (Notice of Compliance) (PMNOC) Regulations against a generic entrant, but subsequently prevails in an infringement action on the same patent? Can it be liable for section 8 damages under the Regulations? The answer appears to be no.

On February 15, 2018, the Federal Court issued a decision in Apotex Inc v AstraZeneca Canada Inc, 2018 FC 181, an action under section 8 of the PMNOC Regulations in which Apotex claimed damages for being delayed in marketing its esomeprazole magnesium product (a generic version of AstraZeneca's NEXIUM).

The Court held that AstraZeneca was not liable for any losses suffered by Apotex, as Apotex's claim would be fully offset by its liability for patent infringement in the but-for world.