2017 was a busy year in Canadian patent law. The contentious Promise Doctrine was rejected by the Supreme Court of Canada in AstraZeneca v Apotex, the largest monetary judgment for patent infringement in Canadian history was awarded in The Dow Chemical Company v Nova Chemical, the Patented Medicines (Notice of Compliance) Regulations and the Patent Rules were significantly amended, and Bill C-30 introduced an ability to seek patent term restoration through a "Certificate of Supplementary Protection" in certain circumstances.
This article summarizes these and other noteworthy decisions and developments in Canadian patent law from 2017.
NOTABLE CASES AND DECISIONS
Promise Doctrine Abolished - AstraZeneca v Apotex
The Supreme Court of Canada ("SCC") involved itself in matters of substantive patent law for the first time since 2012 in AstraZeneca v Apotex ("AstraZeneca"1). The SCC found that the so-called Promise Doctrine is incongruent with the Patent Act's utility requirement, and thus that it provided an incorrect basis on which to determine whether an invention met the required threshold of being "useful".
The Promise Doctrine was found to be excessively onerous for two reasons. First, it required that the standard of utility be measured as against "promise(s)" expressed in the patent in a manner that conflated the s. 2 utility requirement with the s. 27 disclosure requirement. The SCC confirmed the holding from Consolboard v MacMillan Bloedel2 that utility and disclosure are separate requirements, and that any "use" disclosed by virtue of s. 27(3) need not be demonstrated or soundly predicted in order to meet the s. 2 "utility" requirement.
Second, Rowe J., writing for a unanimous panel, found that the Promise Doctrine went beyond the scope of the Patent Act as, in situations where a patent contained multiple "promises", it required that each promise be fulfilled in order for a patent to be valid. Rowe J. found that "a single use makes a subject-matter "useful" under s. 2 of the Patent Act.
The SCC set out a new test for utility after its discussion and rejection of the Promise Doctrine. The two-part test set out by the SCC requires courts to:
Identify the subject-matter of the claimed invention; and Ask whether that subject-matter is useful, in that it is capable of even a scintilla of any practical purpose that is related to the nature of the subject-matter identified in question 1. Thus, following AstraZeneca, patents whose claimed subject-matter were demonstrated or soundly predicted as of the filing date to have any scintilla of utility connected to the subject-matter of the claimed invention will meet the s. 2 utility requirement. The SCC found the patent at issue in AstraZeneca to be useful, overturning the trial judge's finding on point (which was based on the Promise Doctrine).
Failed Attempts to Revive the Promise Doctrine - Dasatinib FCA and Desvenlafaxine
The Federal Court ("FC") and Federal Court of Appeal ("FCA") were presented with arguments in separate proceedings as to the proper application of AstraZeneca following its release. In each instance, the lower courts read AstraZeneca contextually and rejected arguments that sought to revive the Promise Doctrine.
Bristol-Myers Squibb v Apotex ("Dasatinib FCA")3 was an appeal brought by Bristol-Myers after an allegation of inutility brought by Apotex succeeded before the FC in a decision pre-dating AstraZeneca.4 The claim at issue, claim 27, was to the compound known as dasatinib, which is used in the treatment of a type of leukemia. The FC found that the patent at issue made promises that dasatinib would treat a range of ailments despite the bare nature of the claim, and that these promises were not all demonstrated or soundly predicted as of the filing date.
AstraZeneca was released before the FCA issued its decision. Bristol-Myers argued that the pre-filing date demonstration that dasatinib inhibited certain enzymes in in vitro tests satisfied the scintilla threshold set out in AstraZeneca. Apotex countered by arguing that the subject-matter of claim 27 was to the potential therapeutic uses of dasatinib, and that in vitro kinase inhibition "cannot constitute a use at law" as it was only a "laboratory curiosity" and not capable of a practical purpose. The FCA disagreed, holding that the in vitro kinase inhibition was a useful discovery that met the "minimal utility requirements" put in place in AstraZeneca. Bristol-Myers succeeded on its appeal.
Pfizer v Apotex5 (Pristiq Apotex) and Pfizer v Teva6 (Pristiq Teva) were applications for orders of prohibition that were heard before but decided after AstraZeneca's release. The FC invited the parties to make submissions as to the impact of AstraZeneca following the hearing in the Pristiq matters.
The claims at issue were found to meet the s. 2 utility requirement following an application of AstraZeneca in both cases. Notably, Apotex in its supplemental submissions also argued that the patent at issue was invalid because it contained "overpromises", which Apotex argued were identified as a "mischief" in AstraZeneca that would lead to the...
