SanofiI-Synthelabo Canada Inc.. and SanofiI-Synthelabo v. Apotex Inc. and The Minister of Health


Federal Court per Shore J.


2005 FC 390


March 21, 2005



[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 Canada:

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 Canada. At paragraph 113, Layden-Stevenson J. concluded that the solution of the '377 Patent would, absent the "worth a try" approach, not be arrived at directly and without difficulty. There was evidence to support that conclusion. Genpharm has not demonstrated any palpable and overriding error in Layden-Stevenson J.'s conclusion on this point. (Emphasis added.)

[79]            Therefore, this position concerning obviousness was adopted rather than any other.