Delivery to a New Non-Promise Land – Canada finally does away with promises
Executive Summary: The Supreme Court of Canada ruled on June 30, 2017 that promises made in a patent are not the standard against which the utility of a patent is measured. This is a significant departure from previous lower court decisions in which utility was measured against promises made in the patent specification. The Court said that “[w]hat matters is that an invention ‘be useful, in the sense that it carries out some useful known objective’” (emphasis added).[1] The decision provides welcome relief to those seeking patent protection in Canada for pharmaceutical and other inventions – no longer can Canadian patents be struck down for a technical failure to meet the “promise” of an invention.
In a much awaited decision, the Supreme Court of Canada has taken a significant departure from previous case law requiring that a patent specification meet the “Promise of the Patent”. In previous decisions, the Promise of the Patent, often arrived at from advantages stated in the specification, was the yardstick against which a patent’s utility was measured. On June 30, 2017, the Supreme Court laid to rest this onerous requirement, stating quite resolutely that “the application of the Promise Doctrine is not the correct approach to determine whether a patent has sufficient utility”.[2]
The death of the so-called “Promise Doctrine” is a welcome relief for pharmaceutical patent holders. Since 2005, the number of patents invalidated at the lower courts for failure to meet the “promise” of the patent under section 2 of the Patent Act increased significantly from previous years, much to the chagrin of innovators looking to protect their investments in Canada. In fact, the application of the uniquely Canadian Promise Doctrine had become so problematic that the Government of Canada was challenged for contravening NAFTA due to the heightened disclosure standard resulting from this judge-made doctrine. According to innovative organizations that relied on a strong patent regime to protect the outcome of their R&D efforts, the Promise Doctrine was unfairly leading to the invalidation of pharmaceutical patents at an alarming rate. The concerns of the pharmaceutical innovators were legitimate as they relied heavily on patents to protect R&D investments of often close to a billion dollars to bring a drug from the lab to the clinic. In April of this year, a NAFTA tribunal, however, sided with the Canadian government and held that the Promise Doctrine was not a fundamental or dramatic change under Canadian law. In their view, Canada was free to impose its own laws on utility requirements as it saw fit.
This makes the Supreme Court’s decision such a surprising, albeit positive, turn of events with regard to the state of the law on utility and, notably, brings Canada into line with the utility requirements of other developed countries. In essence, in order for a patent to possess utility, its specification need only demonstrate or soundly predict that the invention has some known use.
The heightened disclosure standard that resulted from the promise doctrine becomes apparent when digging deeper into the particular facts surrounding the case on appeal. The patent at issue before the Supreme Court was for a drug (esomeprazole) that reduced gastric acid in the stomach and consequently alleviated heart burn. Indeed, the drug had already been shown to be effective in human patients as it passed a stringent regulatory approval process and is currently being sold by AstraZeneca to treat patients that suffer from acid reflux. At trial it was determined that the promise of utility in the patent ultimately depended upon two statements made in the patent’s description. First, the patent said that the drug was a proton pump inhibitor (PPI inhibitor), meaning that it exerted its antacid effects by blocking the function of a cellular “pump” that moves protons (hydrogen atoms) across a cell membrane. Second, and at issue on appeal, were statements made in the description that the drug would work effectively for a wide range of persons – in other words, display less variation in therapeutic effect among different patients. The first promise was not in dispute as the drug clearly exerted its effects by inhibiting the proton pump. However, the trial judge held that the second promise regarding uniform therapeutic effect among patients was not met at the filing date, and this was affirmed by the Federal Court of Appeal. Consequently, the entire patent was held to be invalid by the lower courts, despite the fact that the drug covered by the patent was an actual product on the market with a proven therapeutic utility.
The Supreme Court overturned these former decisions on appeal, stating that the promise doctrine “is unsound” and that “[i]t is an interpretation of the utility requirement that is incongruent with both the words and the scheme of the Patent Act”.[3] The Court further stated that “[t]he effect of the Promise Doctrine to deprive such an invention of patent protection if even one “promised” use is not soundly predicted or demonstrated is punitive and has no basis in the Act”.[4] The patent was predicted to be useful simply as a PPI and this was “sufficient to satisfy the requirements of s. 2”.[5] Thus, the appeal was allowed and the patent was not invalidated for lack of utility.
So what is the new standard for meeting utility in Canada? The decision stated that “[f]irst, courts must identify the subject-matter of the invention as claimed in the patent. Second, courts must ask whether that subject-matter is useful – is it capable of a practical purpose (i.e. an actual result)?” (emphasis added).[6] The Court further stated that an overly broad claim can be declared invalid, but that “remaining valid claims can be given effect”.[7] On the other hand, the Court re-affirmed the doctrine of sound prediction, which is a test to determine if the disclosure of a patent is adequate through either demonstration or sound prediction of utility,[8] and that an invention cannot be merely a “laboratory curiosity whose only possible claim to utility is as a starting material for further research”.[9] The lower courts will likely refine this decision in coming years, but it appears that sufficiency of disclosure will be assessed under subsections 27(3)(a) and 27(3)(b) of the Patent Act, which generally state that a patent specification must “correctly and fully describe the invention and its operation or use as contemplated by the inventor” and “set out clearly [the invention] in such full, clear, concise and exact terms as to enable any person skilled in the art or science to which it pertains, or with which it is most closely connected, to make, construct, compound or use it”.[10] Regardless, the decision makes clear that the Promise Doctrine will no longer be an obstacle to those seeking fair reward for the hard earned products of their innovation.
Please note that the above is not to be taken as legal advice. As you will appreciate, our advice depends on the particular facts of a case. If you have any questions regarding a patent application, please contact one of our patent agents. Through our many decades of experience, we will be happy to help navigate you through the often complex process of securing patent protection in Canada.
Footnotes
[1] AstraZeneca Canada Inc. v. Apotex Inc., 2017 SCC 36 at para 56
[2] Ibid at para 2.
[3] Ibid at para 36.
[4] Ibid at para 51.
[5] Ibid at para 63.
[6] Ibid at para 54.
[7] Ibid at para 46.
[8] Ibid at para 56, the Court stated that “[t]he utility requirement serves a clear purpose. To avoid granting patents prematurely, and thereby limiting potentially useful research and development by others, the case law has imposed a requirement that an invention’s usefulness be demonstrated or soundly predicted at the time of application, rather than at some later point.”
[9] Ibid, citing Re Application of Abitibi (1982), 62 C.P.R. (2d) 81.
[10] Ibid at para 51.