Canadian patents have utility requirements. A claimed invention
must have some level of utility. A 'mere scintilla' of
utility is all that the Patent Act requires.
However, where a patent contains an explicit promise of a specific
result, the case-law has developed a requirement that this
so-called 'promised utility' be demonstrated or soundly
predicted as of the Canadian filing date of the patent
There has been much controversy over this 'promise
doctrine' as well as the 'heightened disclosure
requirement' that has been applied in the case of a sound
prediction. The controversy includes a NAFTA challenge by Eli Lilly scheduled to be
heard later this year.
Today, the Supreme Court of Canada granted leave
from the Federal Court of Appeal's relatively short ruling in
AstraZeneca v Apotex. In this case,
Astra's '653 patent was invalidated for lack of utility.
The patent pertains to the compound esomeprazole sold in Canada as
The utility issue turned on the interpretation of the patent and
specifically, whether the following statement in the patent
disclosure amounts to a 'promised utility':
It is desirable to obtain compounds with improved
pharmacokinetic and metabolic properties which will give
an improved therapeutic profile such as a lower degree of
interindividual variation. The present invention
provides such compounds, which are novel salts of single
enantiomers of omeprazole [emphasis added]
The dispute between the parties centered around whether the
above-emphasized statement amounts to merely a goal, or a promise
against which utility will be measured. At trial, the Court characterized this as a
promise of the patent, finding that the evidence fell short of
demonstrating or soundly predicting this promised utility.
In addition, the Court went on to consider the 'disclosure
requirement' in so far as it is relates to sound prediction.
The Court stated that the law in this area is
"unsettled", but found that the heightened disclosure
requirement vis-à-vis sound prediction only applies in the
case of a "new use" patent, if it exists at all.
Accordingly, the Court concluded that the failure by Astra to
disclose in its patent the studies it relied on at trial for
demonstrated and soundly predicted utility was irrelevant in
On appeal, a unanimous panel of the Federal Court
of Appeal upheld the trial judge's inutility ruling. Astra
argued that the trial judge had erred in law by misconstruing the
promise of the relevant claims. In other
words, Astra argued that utility, and indeed the promise, ought to
have been considered on a claim-by-claim basis, consistent with the
inventive concept of the claims (a matter relevant to obviousness)
based on a purposive construction. The Court of Appeal
First, the Court of Appeal agreed that utility is to be assessed
on a claim-by-claim basis. Further, that some promises can impose
utility requirements across all claims, while other promises may
touch only a subset. This is, in every case, "a question of
proper construction of the relevant claims." However, there
was no reversible error. According to the Court of Appeal, Astra
had not asked the trial judge to construe the promise on a
Second, with respect to consistency with the inventive concept,
Astra argued that because the inventive concept of the claims did
not include an improved therapeutic profile, neither could their
promise. The Court of Appeal rejected this argument on the basis
that there was no support for it in the case law.
Finally, the Court of Appeal concluded that the promise was
determined by way of purposive construction rather than a
Notably, the Court of Appeal did not address the issue of what,
if any, disclosure requirement would apply in the case of a soundly
Undoubtedly, this case will be closely watched. The Supreme
Court not long ago granted leave in another case raising issues about the
appropriate legal standard for utility, whether the 'promise
doctrine' is valid and how it should apply, as well as what, if
any, disclosure requirements exist in the case of utility based on
a sound prediction. That case was, however, never heard as Apotex
withdrew its appeal on the eve of hearing by the Supreme Court.
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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