In 2008, the Supreme Court of Canada (SCC) released its decision in Apotex v. Sanofi, setting out a series of steps to consider when assessing obviousness in a patent validity challenge.1 The test was enumerated as follows:
(1) (a) Identify the notional "person skilled in the art";
(b) Identify the relevant common general knowledge of that person;
(2) Identify the inventive concept of the claim in question or if that cannot readily be done, construe it;
(3) Identify what, if any, differences exist between the matter cited as forming part of the "state of the art" and the inventive concept of the claim or the claim as construed;
(4) Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?2
At the fourth step, the SCC held that the issue of whether something is "obvious to try" may arise. The SCC set out three further factors for consideration at this stage of the inquiry:
- 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?
- 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?
- Is there a motive provided in the prior art to find the solution the patent addresses?3
Importantly, the SCC considered the United States and United Kingdom jurisprudence on obviousness at that time, and adopted this test, rather than the tests that may be easier to meet. Furthermore, the Court held that "the "obvious to try" test will work only where it is very plain or, to use the words of Jacob L.J., more or less self-evident that what is being tested ought to work."4 The mere possibility that something may turn up was held not to be enough to render an invention obvious.5
Despite this clear language, the Federal Court, in a series of decisions, appeared to accept arguments from generic companies that the "obvious to try" test was met if there was a "fair expectation of success" in any solution tried in response to a problem. This lower standard was cited to a Federal Court of Appeal (FCA) case interpreting Apotex.6 However, a thorough reading of that case shows that the FCA did not lower the standard for obviousness at all. In fact, the FCA was referring only to the motivation factor of the "obvious to try" analysis.
Due to the inability of many patentees to appeal judgments against them in NOC proceedings in Canada, this lower obviousness standard was becoming pervasive. As a result, the standard for patents to be invalidated due to obviousness allegations was being lowered.
However, recently, the FCA was able to hear a patentee's appeal on this issue. Despite ruling against the patentee overall, the FCA took the time to restate that the SCC's statement did, indeed, govern the obviousness analysis:
First, Eli Lilly asserts that the Judge erred in law in his obviousness analysis by applying an incorrect test for obviousness when he wrote, at paragraph 150 of his reasons, that the "test, rather, is whether the skilled person had good reason to pursue predictable solutions or solutions that provide a 'fair expectation of success'". We agree that the correct test, and the test that ought to be applied by the Federal Court, is that articulated by the Supreme Court of Canada in Apotex Inc. ...: "For a finding that an invention was 'obvious to try', there must be evidence to convince a judge on a balance of probabilities that it was more or less self-evident to try to obtain the invention. Mere possibility that something might turn up is not enough."7 [emphasis added; citations omitted]
This confirmation that the standard for invalidity due to obviousness has not been lowered should be welcome to patentees.
Footnotes
1 Apotex Inc. v. Sanofi-Synthlabo Canada Inc., [2008] 3 S.C.R. 265 [hereinafter Apotex].
2 Apotex, at para. 67.
3 Apotex, at para. 69.
4 Apotex, at para. 65.
5 Apotex, at para. 66.
6 Apotex Inc. v. Pfizer Canada Inc., 2009 FCA 8 at para. 44
7 Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC, 2015 FCA 286 at para. 4.
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