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Civil and Administrative
Litigation Opinions
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Patents - Inutility

. Sandoz Canada Inc. v. Janssen Inc.

In Sandoz Canada Inc. v. Janssen Inc. (Fed CA, 2023) the Federal Court of Appeal considered (and dismissed) an appeal from a dismissed action for 'patent invalidity', here on the ground of lack of utility:
[7] On lack of utility, the Federal Court acknowledged the requirement that, at the time of filing the application for a patent, utility must have been demonstrated or the requirements for a sound prediction of utility must be met. It found that, though utility had not been demonstrated, the requirements for soundly predicting utility were met, and hence the lack of utility argument failed. The relevant requirements for sound prediction were identified in Apotex Inc. v. Wellcome Foundation Limited, 2002 SCC 77, [2002] 4 S.C.R. 153 at para. 70 (Wellcome), and correctly cited as follows by the Federal Court, which stated that there must be:
A. A factual basis for the prediction;

B. An articulable and sound line of reasoning from which the desired result can be inferred from the factual basis; and

C. Proper disclosure.
[8] Of particular importance to Sandoz’ appeal, the Federal Court did not mention the decision of this Court in Eli Lilly Canada Inc. v. Novopharm Limited, 2010 FCA 197, 405 N.R. 1 (Eli Lilly), and the following passage therein:
[84] [Wellcome] does not define the threshold required for sound prediction. However, Binnie J. states that more than mere speculation is required (para. 69). He also provides the following indicia:
. the requirement is that the claims be fairly based on the patent disclosure (para. 59);

. it must be prima facie reasonable that the patentee should have a claim (para. 60);

. it cannot mean a certainty (para. 62);

. the desired result must be able to be inferred from the factual basis (para. 70).
[85] In my view, these indicia signify that a sound prediction requires a prima facie reasonable inference of utility…

[14] At this point, it is advisable to look again at the statement in Eli Lilly (on which Sandoz relies), and at Wellcome, which inspired the statement. Clearly, Eli Lilly was not purporting to change the legal test set out in Wellcome. Rather, it was attempting to glean, from the reasons in Wellcome, the appropriate threshold for finding that a prediction is sound. This Court in Eli Lilly expressed the “prima facie reasonable inference of utility” requirement based on cited passages from paragraphs 59, 60, 62, 69 and 70 of Wellcome.

[15] Sandoz also cites several additional passages from Wellcome that indicate what is not sufficient for a prediction to be sound:
1. No more than a mere belief that something might be useful (para. 25);

2. Little more than an announcement of a research project (para. 64); and

3. Only a promise that a hypothesis might later prove useful (para. 84).
[16] In my view, there is nothing in Eli Lilly that represents any kind of departure from what one would glean from a complete reading of Wellcome. While it is not necessary that the prediction be certain (see Wellcome at paragraph 62), or to a regulatory standard (see Wellcome at paragraph 63), the public is entitled to a teaching that is solid (see Wellcome at paragraph 69) and accurate and meaningful (see Wellcome at paragraph 83), and based not on speculation but exact science (see Wellcome at paragraph 84).
. Western Oilfield Equipment Rentals Ltd. v. M-I LLC

In Western Oilfield Equipment Rentals Ltd. v. M-I LLC (Fed CA, 2021) the Federal Court of Appeal considered the patent issue of inutility in challenging a grant:
[124] ... The threshold for utility in a patent context is not commercial usefulness. A scintilla of utility will do: AstraZeneca Canada Inc. v. Apotex Inc., 2017 SCC 36, [2017] 1 SCR 943 at para. 55. ...


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Last modified: 10-11-23
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