On March 10, 2016, the Supreme Court of Canada granted AstraZeneca Canada Inc.’s (“AstraZeneca”) application for leave to appeal from the decision of the Federal Court of Appeal in: AstraZeneca Canada Inc et al v Apotex Inc et al, 2015 FCA 1581. The Federal Court of Appeal had dismissed AstraZeneca’s appeal from the Federal Court’s decision invalidating AstraZeneca’s patent (CA 2,139,635) on the basis of a promise made in the patent and not met by AstraZeneca’s product.

The ‘635 patent claimed a proton pump inhibitor used to reduce gastric acid and reflux esophagitis, and treat related conditions.

Apotex Inc. (“Apotex”) had applied to the Minister of Health for a Notice of Compliance which would allow it to sell a generic version of the drug. AstraZeneca responded by bringing a prohibition application under the Patented Medicines (Notice of Compliance) Regulations (SOR/93-133) to prevent Apotex from selling the drug during the term of the ‘653 patent.

The prohibition application was dismissed. Apotex received the Notice of Compliance and started selling the drug. AstraZeneca then sued Apotex for infringement of the ‘653 patent. Apotex sought to invalidate the ‘653 patent for, among other grounds, inutility.

The Federal Court construed the ‘653 patent as containing a promise which the Federal Court held the drug failed to meet. The Federal Court invalidated the patent.2  AstraZeneca appealed.

AstraZeneca argued that the Federal Court erred in law by misconstruing the promise of the relevant claims, erred by failing to consider utility, and any promise of utility, on a claim by claim basis, erred by construing utility in a manner inconsistent with the inventive concept, and erred by failing to apply a purposive construction to the promise of utility. The Federal Court of Appeal rejected each of these submissions.

In a judgment delivered on July 6, 2015, the Federal Court of Appeal held that while it is “well settled law that inutility must be assessed on a claim by claim basis”, “[it] is also now settled law that some promises can … impose utility requirements across each of a patent’s claims”. The Court further held that AstraZenica failed to provide authority supporting the proposition that “a promise of utility must be construed to be virtually coterminous with the inventive concept of the relevant claim[s].” Lastly, the Court held that AstraZeneca failed to demonstrate any legal error in the Federal Court’s construction of the promise of the claims at issue, and also failed to demonstrate any palpable and overriding error in the Federal Court’s appreciation of the evidence.

In response to the Federal Court of Appeal’s decision, AstraZeneca sought leave to appeal to the Supreme Court of Canada. Leave was granted on March 10, 2016.

The forthcoming decision by the Supreme Court of Canada should clarify the so called “promise doctrine” that has become a prominent issue in Canadian patent cases in which high-value pharmaceutical patents have been invalidated.