Case: AstraZeneca Canada Inc. v. Apotex
Inc. 2015 FCA 158
Drug: NEXIUM® (esomeprazole)
Nature of case: Appeal of a judgment on
invalidity of Canadian Patent No. 2,139,653 ('653
Successful party: Apotex Inc. (on trial and
Date of decision: July 6, 2015
AstraZeneca Canada Inc. (AstraZeneca) appealed
from the decision of Justice Rennie of the Federal Court (reported
as AstraZeneca Canada Inc. v. Apotex Inc., 2014 FC 638)
holding that AstraZeneca's '653 Patent was invalid for lack
of demonstrated or soundly predicted utility. The Federal
Court of Appeal dismissed AstraZeneca's appeal on the basis
that the trial judge properly construed the "promise" of
By way of background, the trial decision dealt with an
impeachment action brought by Apotex Inc.
(Apotex), which alleged invalidity of the '653
Patent for lack of utility, anticipation and obviousness. Justice
Rennie concluded that the "promise" of the patent
(compounds provide improved pharmacokinetic and metabolic
properties with an improved therapeutic profile, such as a lower
degree of interindividual variation) was not demonstrated or
soundly predicated at the time of filing. Apotex's
allegations of obviousness and anticipation were dismissed.
Federal Court of Appeal Decision
On this appeal, AstraZeneca contended that the Federal Court
erred in law by: (a) failing to consider the patent's promised
utility on a claim by claim basis; (b) failing to construe the
utility of the claims in a manner consistent with the inventive
concept and; (c) failing to apply a purposive construction to the
promise of utility.
The Court of Appeal accepted that the law is "well
settled" that utility must be assessed on a claim by claim
basis, and further agreed with AstraZeneca that while some
"promises" may be "overarching" across claims,
"promises" may also be limited to a subset of the claims.
While the Court agreed that the trial judge did not
explicitly consider any single claim or subset of claims when
determining the "promise" of the patent, this was not an
error since AstraZeneca did not ask the Court to do so. The
trial judge could rightfully rely upon the "lis"
as presented by the parties.
With respect to AstraZeneca's submission on the
"inconsistency" between the trial judge's
construction of utility with the asserted claims' inventive
concept, the Federal Court of Appeal found that the argument that a
promise of utility must be construed to be "virtually
coterminous" with the inventive concept of the relevant claim
has no support in Federal Court jurisprudence.
Finally, 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". Having failed to
demonstrate any legal or palpable and overriding error, the appeal
Link to decisions:
The Federal Court of Appeal decision may be found here.
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