Pharma In Brief - FCA Considers Impact Of Successful Infringement Judgement On Prior Order For S. 8 Damages

Case: AstraZeneca Canada inc. v. Apotex Inc., 2016 FCA 194 (Court File No. A-311-15, A-187-12), aff'g 2015 FC 799 Drug: LOSEC® (omeprazole) Nature of case: Appeal from motion to vary decision under section 8 of the Patented Medicines (Notice of Compliance) Regulations (Regulations) Successful party: Apotex Date of decision: July 7, 2016

Summary

This decision is an appeal from a judgement of the Federal Court declining to vary its decision awarding damages to Apotex under section 8 of the Regulations. AstraZeneca brought the motion to vary the section 8 decision following its success in an infringement action relating to the same product. The Federal Court of Appeal dismissed AstraZeneca's appeal.

Background

On May 11, 2012, Justice Hughes held that Apotex was entitled to compensation under section 8 of the Regulations as a result of a prohibition proceeding relating to omeprazole and Canadian Patent No. 2,133,762, which was dismissed on March 2, 2004 (see our summary of the decision here). Damages will be quantified in a subsequent reference. In the section 8 proceeding, AstraZeneca argued that Apotex was not entitled to damages because any sales of Apotex's omeprazole product made during the relevant period would infringe another AstraZeneca patent, Canadian Patent No. 1,292,693 (693 Patent). The 693 Patent was the subject of a pending infringement action between the same parties. AstraZeneca also argued that such infringement was a relevant consideration to reduce or eliminate the damages owed to Apotex in the section 8 proceeding. Justice Hughes rejected both arguments. He held it was for the Court hearing the pending infringement action to craft an appropriate remedy in light of any compensation awarded in the section 8 proceeding, if the Court concluded that the patent is valid and infringed. Refusing to compensate the generic in the section 8 proceeding based on an infringement action would not be appropriate. Justice Hughes' decision was affirmed by the Federal Court of Appeal on March 11, 2013. On March 16, 2015, Justice Barnes of the Federal Court held that the 693 Patent was valid and infringed by Apotex (see our summary of the decision here). Following his decision, AstraZeneca moved to vary Justice Hughes' judgement in the section 8 proceeding to allow the reference judge to have regard to Justice Barnes' decision both in determining Apotex's entitlement to damages and under section 8(5) of the Regulations. AstraZeneca argued...