Supreme Court Revokes the Promise Doctrine of Canadian Patents

July 4th, 2017

Good News for Canadian Patentees

On June 30, 2017, the Supreme Court of Canada issued a landmark decision breaking the so-called “Promise Doctrine”. The decision is good news for those seeking to obtain and uphold patents in Canada, particularly for the life sciences and pharmaceuticals. This decision positively affects the value of Canadian patents as business assets since it decreases the uncertainty the Promise Doctrine was casting over validity of Canadian patents. The ruling promises to reduce the refusal and invalidation of otherwise meritorious patents for want of “usefulness”; increase predictability of the patent system; and bring Canadian patent law back in line with international norms.

The Patent Act states that “invention means any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement [thereof]” (Section 2; emphasis added). Thus only subject-matter that is useful can meet the requirements for patentability. The Supreme Court of Canada interpreted this requirement as a “necessary pre-condition to patentability” and held that only a single use is required. There is no requirement to disclose the utility of the invention in the patent, as long as the patented invention has a practical use (Supreme Court of Canada, Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd. 1981 and Apotex Inc. v. Wellcome Foundation Ltd. 2002).

In contrast, the “Promise Doctrine” as applied by the Federal Courts over the last 10 to 15 years holds that if a patent or patent application promises one or more specific uses for an invention, then each and every one of the promised uses must be proven as of the filing date of the patent application. Proof requires either demonstration or sound prediction (based on factual evidence) of the utility. If any one of the uses promised in the patent or patent application is not proven as of the filing date, then the entire patent is invalid for failing to meet the utility requirement.

The Promise Doctrine was the basis for invalidation of AstraZeneca’s 2,139,653 patent (the ‘653 patent) for want of utility by the Federal Court and the Federal Court of Appeal. The ‘653 patent claims the optically pure salts of the (-) enantiomer of omeprazole, esomeprazole, which is a proton pump inhibitor used in the reduction of gastric acid, reflux esophagitis and related maladies, and commercialized under the name NEXIUM. The Federal Court judge found that although the ‘653 patent was novel and non-obvious, it was invalid because it lacked utility under the Promise Doctrine. Specifically, of two promises made in the patent: 1) use of NEXIUM as a proton pump inhibitor, and 2) improved pharmacokinetic properties and metabolic properties which would give an improved therapeutic profile, only the first promise was proven as of the filing date. The patent was invalidated for lacking utility under the Promise Doctrine for failing to prove the second promise (improved therapeutic profile) as of the filing date, despite the obvious usefulness of NEXIUM for treating patients. AstraZeneca appealed, first to the Federal Court of Appeal and then to the Supreme Court.

In a unanimous decision, the Supreme Court of Canada upheld the appeal and ruled the Promise Doctrine unsound. The Court states explicitly that the Promise Doctrine is not the correct method of determining whether the utility requirement under s. 2 of the Patent Act is met: “It is an interpretation of the utility requirement that is incongruent with both the words and the scheme of the Patent Act.” The Court states further that the Promise Doctrine is “excessively onerous”, “punitive”, “has no basis in the [Patent] Act”, and “is not good law”.

This repudiation of the Promise Doctrine is good news for those seeking to obtain and uphold patents in Canada. A patentee can now comply fully with other requirements of the Patent Act, such as the requirement to fully describe the invention and its operation or use, without worry of inadvertently violating the utility requirement. A patentee need no longer fear being punished for describing potential uses and advantages of the technology fully and completely, even if all such potential uses and advantages have not yet been conclusively demonstrated.

This freedom to disclose potential uses and advantages of the invention is to the advantage of the public, who benefit from the most complete and detailed description of the invention. Disclosure serves the public policy basis that underpins patent law, whereby inventors are asked to fully disclose the invention in exchange for a limited monopoly.

Invalidation of several pharmaceutical patents upheld elsewhere (such as patents for Eli Lilly’s STRATTERA and ZYPREXA) under the Promise Doctrine had made Canada an unpredictable jurisdiction for innovators. The decision should restore a measure of predictability to Canadian patent law. By bringing Canada back in line with international norms for utility as well as with certain intellectual property obligations under the NAFTA and TRIPS agreements, it will hopefully send a message that Canada is not unfriendly to innovation.

A link to the decision can be found here.

Please contact one of our life sciences and health technology patent experts for more information.

Emma Saffman

Andreanne Auger

Tuba Yamaç