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“AstraZeneca Canada Inc. v Apotex Inc.: The Supreme Court Overturns the Promise Doctrine
BY SCOTT LIN · DECEMBER 7, 2017
Patents exist to reward inventors and to facilitate the fulsome disclosure of inventions to the public’s benefit. However, prospective patents must meet statutory requirements in order to be approved. As per the Patent Act, RSC, 1985, c P-4 [Patent Act], prospective inventions must demonstrate that they are “useful” in order to enjoy protection under the Act.
Unquestionably, a patent should not be valid if it lacks utility. But what qualifies as useful? What is the legal standard for such utility? How should the court reconcile frivolously filed patents with the need for innovation? Such questions are at the heart of the Supreme Court of Canada (“SCC”) case AstraZeneca Canada Inc. v Apotex Inc., 2017 SCC 36 [Apotex, SCC], a case closely monitored by major pharmaceutical and technology companies alike.
AstraZeneca is a global pharmaceutical company that sold a gastric drug under the name Nexium. In connection with this drug, AstraZeneca owned Canadian Patent No. 2,139,653 (the “Patent 653”), which it allowed it to lay claim to optically pure salts of esomeprazole, an active ingredient of the drug.
Apotex is a Canadian pharmaceutical company that sought to release its own generic version of esomeprazole. In response, AstraZeneca brought an action for patent infringement of Patent 653 against Apotex. Apotex counterclaimed and sought a declaration that Patent 653 was invalid due to lack of usefulness and utility.
The Promise Doctrine
Under the Patent Act, an invention is described as:
“any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter” (Patent Act, section 2) (emphasis my own)
At the Federal Court, Justice Rennie ruled in favour of Apotex. The Court found that, while Patent 653 was indeed a new and novel invention, AstraZeneca did not meet the utility requirement of the invention as laid out in section 2 of the Patent Act (Federal Court, 2014 FC 638 (Apotex, FC at para 367). In assessing utility, the Federal Court relied upon the common law “promise of the patent” doctrine (the “Promise Doctrine”).
According to the Promise Doctrine, if the application documents of a Canadian patent sets out an explicit promise of utility, then utility will be measured against that promise.
More specifically, Justice Rennie provides:
“In the words of the Supreme Court, inutility means “that the invention will not work, either in the sense that it will not operate at all or, more broadly, that it will not do what the specification promises that it will do”: Consolboard Inc v MacMillan Bloedel (Saskatchewan) Ltd, 1981 CanLII 15 (SCC),  1 SCR 504 at 525. Thus, if a patent makes a promise, it will have utility only if that promise is fulfilled.” (Apotex, FC at para 86) (emphasis my own)
In this case, the Federal Court found that AstraZeneca’s Patent 653 contained two promises, but that only one of those promises had been met. More specifically, the initial patent application promised improved therapeutic properties at the time of filing—a promise that was not subsequently fulfilled. As a result, Patent 653 was found to be invalid for lack of utility, opening the way for Apotex to release its generic drug. The Federal Court of Appeal adopted the Federal Court’s analysis, dismissing AstraZeneca’s appeal (Federal Court of Appeal, 2015 FCA 158). AstraZeneca was granted leave to appeal to the SCC.
Please go to thecourt.ca to read the entire article.