Post-AstraZeneca: Has the Promise Doctrine Vanished from Patent Litigation? Likely, Yes.

The Supreme Court of Canada abolished the Promise Doctrine over a year ago[1] and, as discussed in our blog, it marked an important course correction for Canadian courts in the assessment of utility of a patent under section 2 of the Patent Act. In the past ten years, several patents — notably in the biopharmaceutical industry — were invalidated solely based on the promise of the patent doctrine and long before these pharmaceutical patents were due to expire. Although the Supreme Court of Canada’s AstraZeneca decision last year did not have an instant impact on the promise doctrine, we predict the doctrine will soon vanish from patent litigation. Here’s why.

Canadian Case Law Developments

In the post-AstraZeneca world,[2] Canadian courts have been wary of breathing life into the promise doctrine, signaling the courts’ commitment to preventing the doctrine from “resurfac[ing] under another principle without clear language to do so” (see Hospira at para 258). In several cases, the courts have upheld patents even where not all the promised utilities of a claim had been demonstrated or soundly predicted (see Bristol-Meyers at para 37). In applying the “mere scintilla of utility” standard (see Regents of the University of California at para 198), the courts have found that the utility requirement has been satisfied — provided that the patent shows “a clear practical purpose” (see Shapiro at para 158).

Both federal and provincial courts have rejected arguments that attempt to use the abolished doctrine under the guise of insufficiency or overbreadth. In a recent decision of the Superior Court of Ontario, Justice Quigley refused Apotex’s amendments of its defence as being legally untenable, as the fresh invalidity arguments were a “repackaging of ‘Promise Doctrine’ based pleadings to satisfy the invalidity grounds set out in ss. 28 and 53 [of the Patent Act]”.[3] Before Justice Quigley, Apotex argued that “even if the Promise Doctrine is no longer good law for s. 2 validity purposes, it could nevertheless still invalidate a patent based on s. 28 or 53 if the facts pleaded would support findings of invalidity under…overbreadth or misrepresentation or fraud”. The Court disagreed, holding that the Supreme Court of Canada did not intend the doctrine’s rationale to permeate other patent requirements. In doing so, the Ontario Court considered extensive support for its position in a number of cases in which the Federal Court made clear that the promise doctrine rationale cannot be used to yield findings of insufficiency or overbreadth (i.e., Pfizer Canada Inc v. Teva Canada Limited and Apotex Inc v. AstraZeneca Canada Inc).

The Bottom Line

In the last decade, the promise doctrine was the sole ground for invalidating patents in over a dozen of cases.[4] Today, Canadian courts are taking a much more circumspect approach before invalidating patents for lack of utility. The effects of AstraZeneca in subsequent decisions suggest that the promise doctrine is vanishing from its prominence in Canadian patent litigation.

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[1] AstraZeneca Canada Inc. v. Apotex Inc., [2017] 1 SCR 943, 2017 SCC 36  (“AstraZeneca”).

[2] Bristol-Meyers Squibb v. Apotex, 2017 FCA 190; Pfizer Canada Inc v. Apotex Inc, 2017 FC 774; Pfizer Canada Inc v. Teva Canada Limited, 2017 FC 777; Regents of the University of California v. I-MED Pharma Inc, 2018 FC 164; Sernova Corp v. Shapiro, 2018 ONSC 841;, LLC v. Wulftec International Inc, 2018 FC 41; Apotex Inc v. AstraZeneca Canada Inc, 2018 FC 181; Hospira Healthcare Corp v. Kennedy Trust for Rheumatology Research, 2018 FC 259.

[3]Apotex Inc. v. Abbott Laboratories, Limited, 2018 ONSC 5199 at para 27; see also Pfizer Canada Inc, at para 360.

[4] Pfizer Canada Inc. v. Canada (Minister of Health), 2011 FCA 236, at paras 26-29, 54; Bristol-Myers Squibb Co. v. Apotex Inc., 2007 FCA 379, at paras 27 and 32; Sanofi-Aventis Canada Inc. v. Apotex Inc., 2009 FC 676 paras 123-124 [obviousness discussed only in obiter at para 319], aff’d 2011 FCA 300; Eurocopter c. Bell Helicopter Textron Canada Ltée, 2012 FC 113, at paras 362 and 386; Alcon Canada Inc. v. Cobalt Pharmaceuticals Co., 2014 FC 149, at paras 54-66, 241; Eli Lilly Canada Inc. v. Hospira Healthcare Corp., 2016 FC 47, paras 24-30, 112, 117.



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