On July 24, 2013 the Federal Court of Appeal released its
decision reversing the trial court's ruling that Sanofi's
patent covering Plavix is invalid. For the full written
decision see: Apotex Inc. v. Sanofi-Aventis, 2013 FCA
In its decision, the Court of Appeal provides clarification on
invalidity in light of the so-called promise of the patent.
Not all patents contain a promise. For there to be a promise,
it must be both explicit and specific. The Court of Appeal
also reiterates the requirement that for an invention to be
obvious, it must be self-evident that what is obvious to try will
Law of Utility and the Promise of the Patent
A patentee need not describe the utility of her invention in the
patent itself. Where a lack of utility is alleged, a patentee
must show that at the time that the patent was applied for, the
utility of the invention could either be demonstrated or soundly
predicted. This is where the notion of the promise of the
patent is relevant.
According to the Court of Appeal, "[t]he promise of the
patent is the standard against which the utility of the invention
described in the patent is measured." The Court of
Appeal notes that an inventor need not describe the utility of her
invention in the patent; however, if she does, then she will be
held to the promise made. Where there is no explicit promise
of a specific result, the test for utility is a "mere
scintilla". However, where an explicit promise of a
specific result is made, utility will be assessed "by
reference to the terms of the explicit promise."
What does that mean?
First the Court of Appeal clarifies that not every patent
contains an explicit promise of a specific result. A court
must therefore construe the patent to determine if it would be
understood by a skilled person to contain an explicit promise that
the invention will achieve a specific result. If not, then
there is no promise and only a mere scintilla of utility is
Part of the debate in this appeal revolved around whether the
'777 Patent contained an explicit promise regarding a specific
result in humans. The trial judge had found that it did based
on expert testimony from one expert who came to that conclusion on
the basis of inferences drawn from expressions used in the
patent. However, the Court of Appeal views those inferences
as being equivocal. The Court of Appeal also notes that the
trial judge drew on additional inferences that he found from his
reading of the patent and states that construing the patent in such
a way is an "unreliable guide to the skilled persons reading
of such a document."
Importantly, the Court of Appeal indicates a distinction in the
jurisprudence between "the potential use of an invention and
an explicit promise to achieve a specific result". That
should guide the interpretive exercise in future cases.
The key takeaway here seems to be that with regard to the
promise of the patent, the promise must be explicit and it must be
of a specific result. Efforts to impute a promise to the
patent through inferences and implicit suggestion will be rarely,
if ever, permissible in law.
Canadian Law of Obviousness Remains
On the issue of obviousness the Court of Appeal reiterates that
the Canadian test for obviousness is not met where the inventive
concept of a patent and the common general knowledge cannot be
bridged by routine experimentation because results of such
experimentation are unknown.
More to come
These parties have been involved in litigation over Plavix for
quite some time.
Although Sanofi was successful against Apotex in its PM(NOC)
case, Apotex commenced an action in the Federal Court seeking a
declaration that Sanofi's Plavix patent (the '777 Patent)
is invalid. Sanofi countered for damages owing due to
Following a 26 day trial, the Federal Court found the '777
Patent invalid: Apotex Inc. v. Sanofi-Aventis, 2011 FC
1486. That ruling was made on the basis that the promise
of the patent was neither demonstrated nor soundly predicted:
In addition, and somewhat surprisingly, the trial judge also found
that the invention in the '777 Patent was obvious despite the
Supreme Court finding the opposite in 2008.
The Federal Court of Appeal reversed the trial judge on both
accounts. Apotex is now an adjudged infringer and will be
subject to a damages case.
We should know in about six months whether the Supreme Court of
Canada will once again consider a Plavix appeal. In the
meantime, Sanofi may pursue its damages claim against Apotex.
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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