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
The '635 patent claimed a proton pump inhibitor used to
reduce gastric acid and reflux esophagitis, and treat related
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,
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
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.
1. 2015 FCA 158.
2. 2014 FC 638.
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A recent Saskatchewan Court of Queen's Bench decision allowed a court-appointed receiver to sell and transfer intellectual property rights free and clear of encumbrances, finding that a license to use improvements of an invention was a contractual interest and not a property interest.
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