Tuesday, May 13, 2014

Restrained Construction of the Promise post-Plavix

Pfizer Canada Inc v Apotex Inc / celecoxib (NOC) 2014 FC 314 Harrington J
            2,177,576 / celecoxib / CELEBREX

Apotex / celecoxib raised two main issues, one relating to the promise of the patent, and the other to the disclosure of the invention. On the first issue, Harrington J followed the guidance of the FCA in Plavix 2013 FCA 186 (blog) (leave to appeal to SCC granted 30 Jan 2014) and construed the promise modestly, with the result that Apotex’ allegation of invalidity failed on this issue. I will discuss the second issue in tomorrow’s post.

The ‘576 patent has a number of cascading compound claims, including four claims to individual compounds, of which Claim 4 is to celecoxib, as well as claims for use in treating inflamation, and claim 16, for use in preventing colorectal cancer [26]. The two promise issues were whether the patent promised the compounds would be useful as anti-inflammatory agents in humans [27], and whether it promised reduced side-effects as compared with other NSAIDs.

In concluding that there was no promise of utility in humans, Harrington J did not engage in the fine parsing of the specification which was normal in pre-Plavix cases. He noted that competing arguments [27], and held that “that there was no clear promise that Celebrex® would be useful in treating inflammation in humans. That may have been a wish, an aspiration, a goal, a target or an advantage, but basing myself on the two decisions of the Federal Court of Appeal to which I have just referred, there was no actual promise” [28]. With respect to reduced side effects, Harrington J noted one sentence stating “The compounds are useful as antiinflammatory agents, such as for the treatment of arthritis, with the additional benefit of having significantly less harmful side effects” [30], and a contrasting statement that “Such preferred selectivity may indicate an ability to reduce the incidence of common NSAID-induced side effects” (his emphasis) [31]. He adverted both to the word “may” and to expert evidence in concluding that the reference to reduced side-effects “connotes a possibility, and does not constitute a promise” [35], but he also referenced the general principle expressed by Zinn J in Fournier / fenofibrate (NOC) 2012 FC 741 [126] (blog) “that a utility not expressed in the claim portion of the specification ‘[…] should be presumed to be a mere statement of advantage unless the inventor clearly and unequivocally states that it is part of the promised utility’” [36], and he noted that “a mere statement of advantage, or a target, without more, is not a promise” [40].

Thus on both points, Harrington J adopted a restrained approach to construing the promise, under which a promise must be clear and explicit. This is consistent with the recent case-law cited by Harrington J, in particular the Plavix FCA decision. It is also consistent with Harrington J’s own prior approach to the promise of decision in Mylan / celecoxib 2014 FC 38 (blog); that case involved the same patent, and while the result was the same, the more important point is the consistency in the restrained approach to construction of the promise.

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