Thursday, June 26, 2014

Promise of the Patent Met on the Facts

Allergan Inc v Cobalt Pharmaceuticals Company 2014 FC 566 O'Reilly J
Allergan Inc v Apotex Inc 2014 FC 567 O'Reilly J
            2,585,691 / bimatoprost / LUMIGAN RC / NOC

The background to this decision is provided in yesterday’s post.

O’Reilly J began his discussion of utility by stating that “On my reading of the patent, the stated utility of the claims in issue is that new Lumigan would have a comparable effect to old Lumigan, with less [bimatoprost] (and, therefore, fewer side effects)” [37]. In fact, the claims themselves make no mention of efficacy or side-effects. This conclusion as to stated utility is evidently derived from O’Reilly J’s reading of the description, not just the claims. It is also evident that the utility identified by O’Reilly J is higher than would otherwise be necessary to satisfy the utility requirement, since it was not disputed that LUMIGAN RC is effective in treating glaucoma and an invention is useful if it affords the public a useful choice: Consolboard [1981] 1 SCR 504, 525. Therefore, this is a case in which utility was measured against the promise of the patent, without any thorough assessment of whether such a promise was made, and despite the FCA’s recent admonition in Plavix 2013 FCA 186 (blog) that the promise must be explicit and not every patent necessarily has a promise. Moreover, on my own reading of the description, I did not see a clear statement of an explicit promise. This could potentially be a problematic departure from the Plavix guidance, except that on the facts, the promise was met [45]. Consequently, I do not really see this as an aggressive application of the promise doctrine; given that the highest arguable promise was satisfied, it may have been simpler to deal with the issue on the evidence, rather than conducting a complex investigation as to whether a promise was made, and exactly what it might have been.

Similarly, O’Reilly J held that because the exact formulation of the claim in question had not been tested, utility had to be based on sound prediction [37]. He then accepted that both the factual basis for the prediction and the sound line of reasoning had to be set out in the patent. However, he concluded that both these requirements were met [39], so this challenge failed as well.

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