The last day of June 2017 saw the Supreme Court of Canada (SCC) quash the controversial Promise Doctrine. The issue at hand in AstraZeneca Canada Inc v Apotex Inc was whether the Promise Doctrine should be held as the correct standard of utility under the Patent Act. The SCC’s ruling finds the Promise Doctrine unsound due to its inconsistency with the language and form of the Patent Act as well as the high burden it places on patent applicants.
Per the Federal Court’s decision in Eli Lily Canada Inc v NovoPharm Ltd, the Promise Doctrine holds that if a patent application promised a particular utility, it was necessary to prove that function in order to acquire the patent. Furthermore, in the absence of any promised utility, proving even a miniscule amount of utility is enough to be found patentable. Since patents are deemed invalid if there is an insufficiency of utility under s. 2 of the patent act’s definition of ‘invention’ and per paragraph 46 of Apotex Inc v Welcome Foundation Ltd, the effect of the Promise Doctrine was to substantially raise the bar for applicants that alleged benefits to their inventions by denying patent protections for those who failed to meet the stated promises.
In court, the series of decisions and appeals in the AstraZeneca Canada Inc v Apotex Inc suit focused on whether the Promise Doctrine should be used to find AstraZeneca’s ‘653 patent – pertaining to optically pure salts of the (-) enantiomer of omeprazole, esomeprazole – invalid because the patent promised more utility than it could deliver.
At the Federal Court, Justice Rennie found two alleged utilities: using esomeprazole as a proton-pump inhibitor (effectively reducing stomach acidity) and having superior pharmokinetic and metabolic characteristics so that its therapeutic profile in clients would be more stable. By applying the Promise Doctrine, the ‘653 patent was found invalid for not meeting the utility requirement of s. 2 of the Patent Act for the alleged superior therapeutic profile, despite the utility of esomeprazole being proven as a proton pump inhibitor. At the Federal Court of Appeal, the judgment of the lower court and the applicability of the Promise Doctrine were affirmed.
However, the decision from the SCC demonstrated that the Promise Doctrine and the analyses of the lower courts run contrary to the form of the Patent Act by conflating the requirements set out in s. 2 and s. 27.3. S. 2 demands there be some useful aspect of a creation for it to be regarded as an invention at law. If some usefulness is present, the invention must be disclosed as specified in s. 27.3 of the Act in its patent application. In Consolboard Inc v MacMillan Bloedel (Sask) Ltd, Dickson J clarified that the usefulness standard set out in s. 2 of the Patent Act acts as a “condition precedent to an invention” whereas s. 27.3 merely sets out disclosure requirements that are to be interpreted independently of s. 2. So, the Promise Doctrine goes against the independent interpretation of these two sections of the Act by demanding that the utility requirement set out in s. 2 be fulfilled or predicted at the time of filing, or otherwise find the invention pre-condition for patentability vitiated.
The SCC noted that the Promise Doctrine is also at odds with the Act where multiple utility promises are made. Under the Doctrine, all utility promises would have to be satisfied for the usefulness threshold in s. 2 to be met. However, the opinion of the SCC is that any single use “that is demonstrated or soundly predicted by the filing date” would be adequate to satisfy the demands of s. 2. Requiring all utility promises to be met, would be “unfair” and can lead to “otherwise useful invention[s] to be deprived of patent protection” simply because some promises were not demonstrated or predicted.
Given the highly experimental and sometimes tangential nature of innovation, a lack of protection for inventions that have managed to achieve some, but not all, of the promised utilities highlights the inhibiting effect the Promise Doctrine appears to have on research and development. Citing the work of celebrated Osgoode Hall Law School scholar, and IP Osgoode member, Professor David Vaver, the SCC found that “inventions are like a many-faceted prism: multiple claims… covering all facets are allowed in the same patent if a single general inventive concept links them.”
Considering a multiplicity of promises is especially important in pharmaceutical development and organic syntheses where broad, overarching concepts like an improved therapeutic profile may be anticipated, but not proven in full. The possibility of off-target therapeutic effects or side-effects can make an exacting prediction of utility difficult and, under the Promise Doctrine, may bar legal protection. After all, as the SCC established in Teva Canada Ltd. v Pfizer Canada Inc., “the patent regime has a dual purpose – to incentivise [creation] and to encourage inventors to publicly disclose [their knowledge] for society’s benefit.” If the bar for acquiring a patent is set too high, some inventors may get cold feet.
Dominic Cerilli is the IPilogue content editor and social media coordinator as well as a JD candidate at Osgoode Hall Law School.