Squeezing Through the Utility / Obviousness Gap

Pharmascience Inc v Teva Canada Innovation 2022 FCA 2 Locke JA: Stratas, Monaghan JJA affg 2020 FC 1158 Kane J

2,702,437 / 2,760,802 / glatiramer acetate / Copaxone / Glatect / NOC / FC Anticipation

In this decision, Locke JA, writing for the FCA, affirmed Kane J’s holding that the 802 patent was valid and that it would be infringed by Pharmascience’s generic product. The 802 patent at issue in this case relates to the use of glatiramer acetate for the treatment of multiple sclerosis, and in particular a dosing regime of 40mg three times a week [11]. Pharmascience argued that the 802 patent was invalid either for lack of sound prediction of utility or obviousness. (Kane J’s holding that the 447 patent was novel, but invalid for obviousness, was not appealed.)

Locke JA’s decision of sound prediction began by mentioning the putative enhanced disclosure requirement for utility based on sound prediction, which would require the factual basis for the sound prediction to be disclosed in the patent itself.* However, it was not necessary for Locke JA to engage with this issue because he found that Kane J had not in any event relied on a factual basis that was not disclosed; her holding that a sound prediction of utility was established was based on the common general knowledge and the logic disclosed in the specification [21]–[22].

This gave rise to a squeeze: “Pharmascience argues that, if the common general knowledge was sufficient to support a sound prediction of utility of the invention of the 802 Patent, then the same common general knowledge would make the invention obvious to try, and therefore invalid for obviousness” [6]. Locke JA rejected the squeeze on the basis that there is a gap between the two requirements:

[38] There is no necessary inconsistency between the finding, on the one hand, that an idea is sufficiently described in the patent disclosure and the common general knowledge to support a sound prediction that it will be useful. . . and, on the other, that the idea is not sufficiently known in the prior art (including but not limited to the common general knowledge) to lead the PSA directly and without difficulty to the solution taught in the patent.

In effect, an expert might say “I would never have thought of trying that, but now that you mention it, yes, I would say that it would probably work.” This makes sense to me, particularly in a case where the inventive concept lies in the insight that a particular approach is worth trying.

*Locke JA prefaced his comments by noting that “the parties do not disagree on the question of whether there is indeed a heightened disclosure requirement applicable to inventions based on sound prediction. Accordingly, it is not necessary to comment on that question here” [16]. I take this to be saying that he is not commenting on whether the law actually requires a heightened disclosure requirement. But in the next paragraph he went on to say that “In my view, the Trial Judge did not misunderstand the disclosure requirement under the sound prediction doctrine” [17]; this evidently says she was correct, not just that it was not necessary to address whether she was correct, given that the parties were in agreement. Locke JA contined by saying “at paragraph 874, she discussed the disclosure requirement specific to the context of the doctrine of sound prediction,” quoting from Eurocopter 2013 FCA 219 [153], which is ambiguous, at least as I read it. I find all this a bit opaque, but it at least seems clear that this decision does not change anything one way or the other in respect of the putative heightened disclosure requirement.