Case: AstraZeneca Canada Inc. v. Apotex
Inc. (SCC file no. 36654)
Drug: NEXIUM® (esomeprazole)
Nature of case: Leave to Appeal of a judgment
on invalidity of Canadian Patent No. 2,139,653
Successful party: AstraZeneca Canada Inc.
Date of decision: March 10, 2016
On March 10, 2016, the Supreme Court of Canada
(SCC) granted AstraZeneca Canada Inc.
(AstraZeneca) leave to appeal an order of the
Federal Court of Appeal (FCA) affirming the Trial
Judge's finding that the '653 Patent is invalid for lack of
The FCA Decision contains an extensive discussion on the
applicable standard for patent utility in Canada, including the
"promise" doctrine. This is an opportunity for the SCC to
provide guidance on an issue that has been the subject of much
debate over recent years.
The prior '653 patent proceedings
Apotex Inc. (Apotex) sought to impeach the
'653 Patent on the basis of lack of utility, anticipation and
obviousness. Justice Rennie held that the promised utility of the
'653 Patent (compounds provide improved pharmacokinetic and
metabolic properties with an improved therapeutic profile) was not
demonstrated nor soundly predicted at the Canadian filing date.
Apotex's allegations of obviousness and anticipation were
AstraZeneca appealed Justice Rennie's decision on the
following grounds: (a) he failed to consider the patent's
promised utility on a claim by claim basis; (b) he failed to
construe the utility of the claims in a manner consistent with the
inventive concept and; (c) he failed to apply a purposive
construction to the promise of utility. The Federal Court of Appeal
determined that the trial judge properly construed the
"promise" of the patent by considering the patent as a
whole through the eyes of the skilled reader, and properly
considered the difference between "goals" and
"promises". The appeal was dismissed.
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