Apotex v Sanofi: SCC Softens Canadian Obviousness Test
Yesterday, Jeremy Barretto canvassed the Supreme Court of Canada’s (“SCC”) most recent decision in Apotex Inc v Sanofi-Synthelabo Canada Inc,  3 SCR 265 [Apotex] concerning selection patents. Since Jeremy already surveyed the facts, procedural history, and analyses of the case, I will focus today on the issue of obviousness, noting some distinctions between the obviousness standard set out in the Apotex decision with the latest American decision on obviousness in KSR International Co v Teleflex Inc, 127 S Ct 1727 (2007) [KSR].
The Apotex Decision
As noted by Rothstein J. at para 52, the oft-quoted standard for obviousness in Canada was set out in Beloit Canada Ltd v Valmet-Dominion Inc,  3 FCR 497 [Beloit]:
The classical touchstone for obviousness is the technician skilled in the art but having no scintilla of inventiveness or imagination; a paragon of deduction and dexterity, wholly devoid of intuition; a triumph of the left hemisphere over the right. The question to be asked is whether this mythical creature (the man in the Clapham omnibus of patent law) would, in the light of the state of the art and of common general knowledge as at the claimed date of invention, have come directly and without difficulty to the solution taught by the patent. It is a very difficult test to satisfy (294).
Recognizing that such a test likely does not encompass a “worth a try” inquiry (where the claimed subject matter is a reasonable attempt at a solution of the problem by a hypothetical technician skilled in the art), and noting that both UK and US jurisdictions allow such an inquiry, Rothstein J. moved to reduce the rigidity of the Canadian test. At paras 60-62, he writes,
 There is a similarity between the current state of the law in the United Kingdom and the United States in respect of ‘obvious to try.’ It is now clear that both jurisdictions accept that an ‘obvious to try’ test can be relevant in an obviousness inquiry. The United States Supreme Court has now stated so explicitly in KSR. The convergence of the United Kingdom and the United States law on this issue suggests that the restrictiveness with which the Beloit test has been interpreted in Canada should be re-examined.
…  I do not think that Hugessen J.A. in Beloit intended that the rather colourful description of obviousness that he coined be applied in an acontextual manner applicable to all classes of claims. I note particularly that ‘obvious to try’ is not a mandatory test in the United Kingdom or in the United States. It is one factor of a number that should be considered, having regard to the context and the nature of the invention.
After reiterating a formal four-step analysis for obviousness, Rothstein J. then elaborates on when an “obvious to try” test might be appropriate. Moreover, he spells out a non-exhaustive list of considerations to be taken into account when conducting such an inquiry. At paras 68-70, he writes,
When Is the “Obvious to Try” Test Appropriate? In areas of endeavour where advances are often won by experimentation, an ‘obvious to try’ test might be appropriate. In such areas, there may be numerous interrelated variables with which to experiment. For example, some inventions in the pharmaceutical industry might warrant an ‘obvious to try’ test since there may be many chemically similar structures that can elicit different biological responses and offer the potential for significant therapeutic advances.
“Obvious to Try” Considerations If an ‘obvious to try’ test is warranted, the following factors should be taken into consideration at the fourth step of the obviousness inquiry. As with anticipation, this list is not exhaustive. The factors will apply in accordance with the evidence in each case.
(1) Is it more or less self-evident that what is being tried ought to work? Are there a finite number of identified predictable solutions known to persons skilled in the art?
(2) What is the extent, nature and amount of effort required to achieve the invention? Are routine trials carried out or is the experimentation prolonged and arduous, such that the trials would not be considered routine?
(3) Is there a motive provided in the prior art to find the solution the patent addresses?” Another important factor may arise from considering the actual course of conduct which culminated in the making of the invention. It is true that obviousness is largely concerned with how a skilled worker would have acted in the light of the prior art. But this is no reason to exclude evidence of the history of the invention, particularly where the knowledge of those involved in finding the invention is no lower than what would be expected of the skilled person.
KSR ushered US Patent practice into a new era with regards to obviousness. By rejecting a strict adherence to the Teaching-Suggestion-Motivation test and inviting a broader use of secondary considerations, the US Supreme Court made it more difficult for new patent applicants to obtain patents because rejections on obviousness grounds could be more easily sustained.
I will highlight several areas where Apotex does not seem to have softened the obviousness test as much as KSR.
No mention of other rationales besides “obvious to try”
While this decision approvingly incorporates ideas from KSR, such as at para. 63 where Rothstein J. approves of “an expansive and flexible approach that would include ‘any secondary considerations that [will] prove instructive,’” this decision seems confined to the inquiry of “obvious to try.” Unlike KSR, Apotex does not explore other rationales for obviousness, such as combining prior art elements according to known methods to yield predictable results, or substituting one known element for another to obtain predictable results.
Nevertheless, despite the absence of any explicit mention of these additional rationales, it may be the case that ‘obvious to try’ may be used as an overall umbrella for the unmentioned reasons. That is, as mentioned in KSR, patent examiners and potential infringers may argue that “the combination of elements was ‘obvious to try’” (cited by Rothstein J., para 58), or conceivably, that a substitution was “obvious to try.”
Despite this possibility, the absence of an explicit mention of these rationales means that patent examiners and potential infringers will have to do more work in showing that these reasons are appropriate “obvious to try” findings. As such, in this regard, the Canadian test is still more rigid than the American test.
Limitation on Applicability of Test
An additional limitation on the flexibility of the new ‘obvious to try’ test is the hurdle of determining when the test is appropriate. As noted above, Rothstein J. explains at para 68 that the test “might be appropriate” “in areas of endeavor where advances are often won by experimentation.” Given this, it could conceivably be argued that the test should not be employed in industries which are not characterized by experimentation, such as industries where advances are typically reliant on strategic planning and execution.
Solutions Must be Self-Evident to the Given Problem
Moreover, in the actual application of the test, Apotex also seemingly requires more to satisfy a finding of obviousness. Whereas in KSR, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed,” (1732) (emphasis mine) Apotex requires that it should be more or less self-evident that what is being tried ought to work (para 69).
The phrasing that it must be self-evident that the method being tried ought to “work” in solving that particular problem seems to indicate that the inquiry must be restricted to the particular problem the patent addresses. That is, there would seemingly only be a finding of “obvious to try” if it was self-evident that the solution would solve the intended problem, even if it is the case that the solution may have been self-evident given another problem.
This point is especially poignant given Rothstein J.’s admonition to take into account “the actual course of conduct which culminated in the making of the invention,” (para 70) even though the analysis should typically only involve the typical person skilled in the art and not the actual solution that lead to the patent.
The SCC has recognized in Apotex that Canada’s difficult-to-satisfy test in Beloit with regards to obviousness was out of sync with our common law counterparts. As such, Rothstein J.’s judgment brings the Canadian test closer to its American counterpart. In light of the above, however, it would seem that the Canadian test remains more rigid than the American test. Looking forward, it’ll be interesting to see how the Patent Office and lower courts apply this new “obvious to try” inquiry.
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