SanofiI-Synthelabo
Canada Inc.. and SanofiI-Synthelabo v. Apotex Inc.
and The Minister of Health
Federal
Court per Shore J.
Obviousness
[78]
A patent is
only obvious if the solution to the problem is very plain. Suggestions or
signposts in the prior art are not sufficient to render a patent invalid for
obviousness. The person skilled in the art must be able to say that he or she
would know that the invention would work and would have the benefits associated
with the invention in light of the publicly available information. The person
skilled in the art must know that the solution or the benefits would be present
without testing (excluding, of course, simple verification of already
known information). The test for obviousness is not whether it was "worth
a try". These principles were enunciated in Farbwerke
Hoechst, in Bayer Aktiengesellschaft v. Apotex Inc.[41] (decision upheld by the Ontario Court of Appeal[42])and in AB
Hassle v. Genpharm Inc.[43]. In Farbwerke Hoechst[44], the Supreme
Court of Canada wrote:
On this point the Federal Court of Appeal reached a different
conclusion, Jackett C.J. saying (at p. 471):
The learned Trial Judge appears to have proceeded upon the assumption
that the requirement of "inventive ingenuity", is satisfied unless
the "state of the art" at the time of the alleged invention was such
that it would have been obvious to any skilled chemist "that he would successfully
produce isohalothane (assuming the monomer used here
and hydrogen bromide) in the 'liquid phase'." (The italics are mine.) I do
not think that the learned Trial Judge's assumption is correct as a universal
rule. I would not hazard a definition of what is involved in the requirement of
"inventive ingenuity" but, as it seems to me, the requirement of
"inventive ingenuity", is not met in the circumstances of the claim
in question where the "state of the art" points to a process and all
that the alleged inventor has done is ascertain whether or not the process will
work successfully.
In my view this statement of the requirement of inventive
ingenuity puts it much too high. Very few inventions are unexpected
discoveries. Practically all research work is done by looking in directions
where the "state of the art" points. On that basis and with
hindsight, it could be said in most cases that there was no inventive ingenuity
in the new development because everyone would then see how the previous
accomplishments pointed the way. The discovery of penicillin was, of
course, a major development, a great invention. After that, a number of workers
went looking for other antibiotics methodically testing whole families of
various microorganisms other than penicillium
notatum. This research work was rewarded by the
discovery of a number of antibiotics such as chloromycetin
obtained from streptomyces venezuelae
as mentioned in Laboratoire Pentagone v. Parke, Davis &
Co., [1968] R.C.S. 307, tetracycline as
mentioned in American Cyanamid Co. v. Berk Pharmaceuticals Ltd., [1976]
R.P.C. 231 where Whitford J. said (at p. 257):
"A patient searcher is as much entitled to the benefits of a monopoly as
someone who hits upon an invention by some lucky chance or an
inspiration". I cannot imagine patents obtained for antibiotics and for
various processes for their production being successfully challenged on the
basis that the discovery of penicillin pointed the way and there was no
inventive ingenuity in the search for other antibiotics and in the testing and the
development of processes. In my view, the true doctrine was clearly stated
by the Privy Council in Pope Appliance Corporation v. Spanish River Pulp and
Paper Mills, [1929] A.C. 269, where Viscount Dunedin said (at pp. 280-1):
... After all, what is invention? It is finding out something
which has not been found out by other people. This Pope in the present
patent did. He found out that the paper would so stick, and the practical
problem was solved. The learned judges below say that all this might have been
done by any one who experimented with "doctors" and air blasts
already known. That is that some one else might have hit upon the invention.
There are many instances in various branches of science of independent
investigators making the same discovery. That does not prevent the one who
first applies and gets a patent from having a good patent,....
(Emphasis added.)
In Bayer Aktiengesellschaft [45],the Ontario Court (General Division) stated:
...although
it may have been logical to an actual skilled person at the time, based on the
state of the art, to conduct certain testing, that is not open to the mythical
skilled technician. The mythical researcher cannot have an inquiring or
thinking mind which ultimately would lead him or her to the answer but rather
he or she is expected to instantly and spontaneously exclaim, without more,
"I already know the answer and it is obvious". Nor is it
appropriate to say that there were significant telltales which
pointed the way for the mythical expert or that there were sufficient clues
which made the invention "worth a try". (Emphasis added.)
Still in Bayer Aktiengesellschaft [46], the Ontario
Court (General Division) stated:
There appears, however, to be a significant difference in the abilities
of the English hypothetical skilled technician and the Canadian one. Indeed,
making inquiries or testing,
seems to be something outside the ken of the notional Canadian skilled
technician. In Cabot Corp. v. 318602 Ontario Ltd. (1988), 20 C.P.R.
(3d) 132 at p. 146, 19 C.I.P.R. 204, 9 A.C.W.S. (3d) 317 (F.C.T.D.), Rouleau J. quoted H.G. Fox in Canadian Law and Practice
Relating to Letters Patent for Inventions at pp. 70-1, as stating in part:
"In order that a thing shall be 'obvious', it must be something
that would directly occur to someone who was searching for something novel, a
new manufacture, or whatever it might be, without the necessity of his
having to do any
experimenting or serious thought, or research, whether the
research be in the laboratory or amongst literature."
(Emphasis added.)
In AB Hassle v. Genpharm[47], the Federal
Court of Appeal confirmed that the English "worth a try" approach was
not applicable in
With respect to
the '377 Patent, the argument is again one of obviousness. Genpharm
says that the '377 Patent addresses the stability of omeprazole
by the use of mechanically added salt to the omeprazole.
Genpharm says this means of achieving stability was
obvious from prior art. It says there were four routes for arriving at this
result and a formulator would arrive at the '377 result in the ordinary course
of his work.
The context in
which Genpharm makes its argument was described by Layden-Stevenson J. at paragraph 111 of her reasons:
It must be
recalled that the uncontradicted evidence is that it
is not known from the prior art that instability existed in enteric coated
solid dosage forms, let alone that pH was a causative factor of instability.
Nor was the use of an alkaline compound to stabilize omeprazole
in the solid state previously disclosed. It is within this context that Genpharm makes its argument.
She found
that Genpharm's position regarding obviousness
respecting the '377 Patent resembled the English "worth a try" test.
Before this Court, Genpharm agreed that the English
"worth a try" test is not applicable in
[79]
Therefore,
this position concerning obviousness was adopted rather than any other.