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PATENTS - Criteria for patent protection - Utility - Doctrine of sound prediction - Invalidity of patent

Friday, June 30, 2017 @ 1:38 PM  

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Appeal by AstraZeneca Canada Inc., AstraZeneca Aktiebolag and AstraZeneca UK Limited (collectively, “AstraZeneca”) from a judgment of the Federal Court of Appeal which declared its 2,139,653 patent (“Patent”) invalid for want of utility. AstraZeneca’s Patent claimed the optically pure salts of the enantiomer of omeprazole, esomeprazole. Esomeprazole was a proton pump inhibitor used in the reduction of gastric acid, reflux esophagitis and related maladies. Commercialized under the name NEXIUM, it had been a very successful drug for AstraZeneca. Apotex sought to sell a generic version of esomeprazole and applied to the Minister of Health for a Notice of Compliance. In response, AstraZeneca brought an application for prohibition under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister from issuing a Notice of Compliance to Apotex. AtraZeneca’s application for prohibition was dismissed. Apotex subsequently began to sell its generic version of the drug. AstraZeneca then brought an action against Apotex for patent infringement, and Apotex counter-claimed to have the Patent declared invalid. The Federal Court found that the Patent was invalid because it lacked utility. The Federal Court accepted that the Patent was useful for certain purposes, but declared the patent invalid because, applying the “Promise of the Patent” Doctrine (“Promise Doctrine”), it “promised more than it could provide”. On appeal, AstraZeneca argued the Federal Court erred by relying on the Promise Doctrine to invalidate the Patent. The Federal Court of Appeal dismissed the appeal.

HELD: Appeal allowed. The Promise Doctrine, as developed by the Federal Courts’ jurisprudence, held that if a patentee’s patent application promised a specific utility, the invention could have the requisite utility only if that promise was fulfilled. It directed courts to read both the claims and the disclosure to identify potential promises, rather than the claims alone, even in an absence of ambiguity in the claims. The doctrine also provided that if any one of the promises was not fulfilled, then the utility requirement in s. 2 of the Patent Act (“Act”) was not met and the patent, in its entirety, was invalid. This doctrine was unsound. It was an interpretation of the utility requirement that was incongruent with both the words and the scheme of the Act and was excessively onerous. The Promise Doctrine effectively imported s. 27(3) of the Act into s. 2 inappropriately, by requiring that to satisfy the utility requirement in s. 2, any disclosed use (by virtue of s. 27(3)) be demonstrated or soundly predicted at the time of filing. The Promise Doctrine also ran counter to the words of the Act by requiring that where multiple promised uses were expressed, they all were required to be satisfied for the patent to meet the utility requirement in s. 2. It risked, as was the case here, for an otherwise useful invention to be deprived of patent protection because not every promised use was sufficiently demonstrated or soundly predicted by the filing date. The application of the utility requirement in s. 2 was to be interpreted in line with its purpose — to prevent the patenting of fanciful, speculative or inoperable inventions. To determine whether a patent disclosed an invention with sufficient utility under s. 2, courts were required to identify the subject-matter of the invention as claimed in the patent and determine whether that subject-matter was useful, or capable of a practical purpose. A scintilla of utility would be sufficient. In the case at bar, the Federal Court accepted that it was soundly predicted by the relevant date that the optically pure salts of the enantiomer of omeprazole would be useful as a proton pump inhibitor to reduce production of gastric acid. Use as a proton pump inhibitor was appropriately related to the subject-matter of the Patent and made it useful within the meaning of s. 2. AstraZeneca’s patent was therefore not invalid for want of utility.

AstraZeneca Canada Inc. v. Apotex Inc., [2017] S.C.J. No. 36, Supreme Court of Canada, B. McLachlin C.J. and R.S. Abella, M.J., Moldaver, A. Wagner, C. Gascon, S. Côté, R. Brown and M.Rowe JJ., June 30, 2017. Digest No. TLD-June262017013SCC