Monday, March 15, 2021

Obvious-to-Try Clarified

Apotex Inc v Janssen Inc 2021 FCA 45 Locke JA: Webb, Boivin JJA affg Janssen Inc v Apotex Inc 2019 FC 1355 Phelan J

            2,661,422 / abiraterone acetate & prednisone / ZYTIGA / old NOC

The invention at issue in this case relates to the use of the combination of abiraterone acetate (AA) & prednisone for the treatment of prostate cancer. Wednesday’s post provides an outline of the facts and a discussion of patentable subject-matter. This post discusses the obviousness analysis, where the main point of interest is a clarification of the obvious-to-try analysis set out in Sanofi 2008 SCC 61.

Apotex argued that Phelan J had not applied the obvious-to-try analysis correctly because he had focused unduly on the question of whether it is “more or less self-evident that what is being tried ought to work” and had erroneously considered that question to be a requirement rather than merely a factor to be considered [30]. Locke JA agreed that that question is merely a factor, not a requirement, and noted that there were passages which gave the impression that Phelan J had indeed considered this to be the overarching requirement [33]. However, on a reading of the decision as a whole, Locke JA concluded that Phelan J had properly considered all of the relevant factors [34] and he therefore affirmed Phelan J’s holding that the invention was not obvious.

Locke JA noted that some confusion was understandable, as the SCC had given “mixed signals” on the issue [36]. He pointed out that the SCC in Sanofi at [65] stated that “I am of the opinion that the ‘obvious to try’ test will work only where it is […] more or less self-evident that what is being tested ought to work.” This makes it seem that being self-evident that what is being tested ought to work is a requirement, such that if the answer is no, the invention is not obvious [36]. But the SCC at [69]–[70] clearly listed the same consideration as being simply one factor among several, which is not in itself determinative. In this decision, Locke JA reaffirmed his view, previously expressed in Hospira 2020 FCA 30 [88]–[90], that read as a whole, the SCC in Sanofi intended that whether it is self-evident that what is being tried ought to work should be considered as a factor, and not a requirement [36].

I agree with Locke JA’s analysis, which strikes me as being consistent both with the purpose of the obvious-to-try analysis and with a contextual analysis of the text. In a passage in Hospira, quoted at [31], Locke JA had pointed out that the SCC in Sanofi [66] had stated that whether it is “more or less self-evident to try to obtain the invention”—as distinct from whether it is self-evident that it will work—is a requirement. If the particular solution arrived at by the inventor was not obvious to try, then it cannot have been obvious, as the inventive step lay in the very decision to try pursuing a line of research that would not have occurred to a skilled person.

If the inventor’s solution was obvious to try, things get more complicated. One might suppose that even if the solution was obvious to try, if it was not self-evident that it ought to work, the invention would therefore be non-obvious, as there is a non-obvious step along the path from the problem to the solution. That logic supports the view that being self-evident that it ought to work is a requirement. But that logic is wrong, as is illustrated by Johns-Manville’s Patent [1967] RPC 479 (CA). The claimed invention was the use of a particular compound, polyacrylamide, as a flocculating agent for filtration of cement. Flocculating agents were well known as being useful in filtration processes generally and the possibility of using such an agent to improve filtration of cement had long been appreciated, but all those previously tried had decreased the quality of the final cement product. Polyacrylamide had been recently developed by a third party as a general flocculating agent and its use in cement filtration had been suggested. Because it was particularly effective and could be used at low concentrations, there was reason to think that it would prove useful for cement where other agents had not. However, the nature of cement making is such that nothing is certain until it is tried. It was therefore self-evident to try polyacrylamide as a flocculating agent in cement, but it was not more or less self-evident that it would work. The patentee tried polyacrylamide and found that it did indeed work without difficulty.* The Court of Appeal held the invention to be obvious: there was no invention in the decision to try, and there was no invention in getting it to work. This illustrates why being “more or less self-evident that what is being tested ought to work,” should not be a requirement; and given that Johns-Manville’s was cited with approval in Sanofi [59], [61], this reinforces Locke JA’s point that read as a whole, the SCC did not intend it to be a requirement. The flaw in the logic set out at the beginning of the paragraph lies in supposing that there must be an inventive step in carrying out an experiment, simply because the outcome cannot be predicted in advance. Johns-Mansville illustrates why that assumption is not correct.

While not a requirement, whether it is self-evident that the solution ought to work is nonetheless a factor; if the invention was obvious to try, and it was self-evident that it would work, then it is almost certainly obvious. But the converse is not true; if the invention was obvious to try, and not self-evident that it would work, the other factors come into play. If it is tried and works readily with routine methods, as in Johns-Manville, or in a routine salt-screen, then it will be obvious, even if the outcome was not predictable in advance; if it is tried and eventually works, but only after long and arduous trials, or after unforeseen hurdles are overcome, then it may not be obvious. (And because being obvious to try is a requirement, if it was not obvious to try in the first place, it will not be obvious, even if it was self-evident that it would work once the idea was conceived of.)

I must say that I have always found the discussion of the obvious-to-try analysis in Sanofi to be oddly elusive; it makes sense at first, but then the more you try to pin it down to a structured test, the less sense it makes. Locke JA’s decision is very helpful in pinning down one source of the of the confusion, and properly laying it to rest.

*In fact, polyacrylamide had not worked when the patentee had initially tried it, but it was held that it would have worked had a person skilled in the art tried it, and it was the patentee’s incompetence that had led to the initial failure. The patentee was obliged to accept this position, as the patent did not disclose the particular procedure the patentee had successfully implemented and if the procedure was not obvious then the patent would have been void for insufficiency.

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