AstraZeneca holds patent 2,139,653 (patent “653”), which claims the optically pure salts of esomeprazole, a proton pump inhibitor used in the reduction of gastric acid, in particular reflux esophagitis. Apotex applied to the federal Minister of Health for a Notice of Compliance, allowing it to sell its generic version of the drug. AstraZeneca instituted proceedings to prohibit the Minister from issuing a Notice to Apotex. The application was dismissed. AstraZeneca then brought an action against Apotex for patent infringement, and Apotex counter-claimed to have the ‘653 patent impeached. The Federal Court held that the ‘653 patent was invalid for lack of utility because, applying the promise of the patent doctrine (“Promise Doctrine”), it promised more than it could provide. The Federal Court of Appeal upheld this decision. AstraZeneca then appealed to the Supreme Court, arguing that its patent couldn’t be invalidated on the basis of the Promise Doctrine.
On June 30, 2017, the nine justices of the Supreme Court ruled that the purported “Promise Doctrine” was not part of Canadian patent law and defined a new approach to the utility test that significantly relaxed the rules applicable to proving the utility of inventions patented in Canada. This decision considerably changes the law on patents and will likely be welcomed by patent holders, particularly in the pharmaceutical industry and life sciences sector.
The Fédération internationale des conseils en propriété intellectuelle (FICPI), an intervener in this important dispute, was represented by Julie Desrosiers (Technology and Intellectual Property).