AstraZeneca Canada Inc., et al. v. Apotex Inc., et al.

(Federal) (Civil) (By Leave)

(Sealing order)




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Intellectual property – Patents – Medicines – Utility – Validity of patent for drug used in treatment of gastric acid conditions challenged in infringement and impeachment action – Whether “promise” in patent of improved pharmacokinetic and metabolic properties for improved therapeutic profile demonstrated or soundly predicted at time patent filed – What is the correct applicable standard for patent utility in Canada? – Whether a promised utility doctrine properly exists.

The applicants, (collectively, “AstraZeneca”) owned the Canadian ‘653 patent for the compound, esomeprazole, a proton pump inhibitor used in the reduction of gastric acid, reflux esophagitis and related conditions. It was sold under the name Nexium, and was a very successful drug for AstraZeneca. The respondents (collectively, “Apotex”) applied to the Minister of Health to obtain a Notice of Compliance which would allow it to sell its generic version of the drug. In response, AstraZeneca brought a prohibition application under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 to prevent Apotex from entering the market until after the expiry of the ‘653 patent. In 2010, that application was dismissed and Apotex received its Notice of Compliance and commenced sales of its generic esomeprazole. AstraZeneca brought an action against Apotex for patent infringement. Apotex counter-claimed to impeach the ‘653 patent on several grounds.

Lower Court Rulings

July 2, 2014
Federal Court

T-1668-10, 2014 FC 638
Respondents’ counter-claim for declaration that ‘653 patent invalid granted on basis of inutility
July 6, 2015
Federal Court of Appeal

A-420-14, 2015 FCA 158
Applicants’ appeal dismissed