Latest News




Implications of the AstraZeneca V Apotex decision rejecting “Promising Utility” doctrine in Patent Jurisprudence

Over the past years, the “Promise Doctrine” as applied in Canada has attracted attention worldwide, mainly due to the criticism it has received accusing it of hardening the task of inventors to obtain patent registrations for their inventions in Canada.

The promise doctrine is applied as an essential precondition requirement required to be fulfilled along with other standard requirements for patentability in order to obtain a patent registration in Canada.

As we know, ‘utility’ is one of the main criteria for patentability, worldwide. In other words, an invention needs to have ‘utility’ (have a useful application) in order to be granted a patent registration. The ‘Promise Doctrine’ (a principle that has been developed and relied on in Canadian Federal courts over the past decade or so) goes a step further in laying down that “if a patentee’s patent application promises a specific utility, only if that promise is fulfilled, the invention will be deemed to have the requisite utility” (AstraZeneca v Apotex, para 28 of SCC judgment). Thus, it says that in order to constitute a useful invention, the invention should fulfil the utility promised in the form of the statements in the patent specification, failure of which would lead to the patent being declared invalid.

Earlier, in various cases such as Eli Lily V Novopharm (2010), patents have been declared invalid in Canada because the Promise Doctrine could not be satisfied. It was observed that the use of terms such as “will” or “can” in the patent specification resulted in the patent application being declared invalid (or rejected) on the ground that the promise of the invention in terms of its utility as declared in the specification was not fulfilled. Since it has been advisable to draft patent specifications in this jurisdiction with the use of terms such as “may” instead of “will” or “can”.

The Development –

Recently, however, in the judgment on AstraZeneca V Apotex, the SCC rejected the “Promise Doctrine” thus opening gates for patent filings in Canada through only following the standard requirements of patentability accepted worldwide which are novelty, non-obviousness and utility.

In the above-mentioned case, AstraZeneca brought an action against Apotex for patent infringement and Apotex counterclaimed to have the 2,139,653 patent impeached based on the “promise of the patent” doctrine. Thus the court had to decide whether AstraZeneca’s patent 2,139,653, claiming (optically pure salts of esomeprazole, a proton pump inhibitor used in the reduction of gastric acid) is invalid or not for the want of utility and non-fulfilment of the promise doctrine.

In the SCC judgment released on 30th June 2017, Justice Rowe J. rejected the “Promising Utility” doctrine observing in the para 24 that the Promise Doctrine is not a correct method of determining whether the utility requirement under Section 2 of the Canadian Patent act is met or not. Further, the judgment proposes in Paras 54 and 55 than 1. Courts must identify the subject-matter of the invention (as claimed) in the patent and 2. Courts must ask whether that subject-matter is useful – is it capable of a practical purpose or an actual result – and that a single use related to the subject-matter is sufficient and the utility must be established by either demonstration or sound prediction, as on the filing date. In conclusion, the SCC held that AstraZeneca’s Patent was, in fact, valid, as the utility of the drug as a (proton pump inhibitor used to reduce production of gastric acid) was predictable.

This decision is bound to result in an increase in the number of patent filings in Canada as the decision dilutes the ‘utility’ requirement and strikes a balance with the internationally accepted standards of patentability. Although the ‘Promising Utility’ doctrine has been rejected through this judgment by the Supreme Court of Canada, but to secure a patent safely in Canada and to enjoy the monopoly rights until the expiry, using the right words in the patent specification maintains the application with high level of security from any Post grant invalidation check.

Reference: – 1. Supreme court of Canada Judgment of “AstraZeneca V Apotex” dated 30th June 2017.

Abbreviations; SCC- Supreme Court of Canada

Keywords; Promise Doctrine, utility, AstraZeneca, Apotex, Supreme Court of Canada

United IPR

No Comments

Sorry, the comment form is closed at this time.