The Supreme Court of Canada has released its eagerly-awaited ruling in AstraZeneca Canada v Apotex, striking down the so-called “promise doctrine” and clarifying the requirement for patent utility.
The doctrine required patent owners to establish arguable statements of utility in the patent disclosure or risk losing their patents.
“The Promise Doctrine is not the correct method of determining whether the utility requirement under s. 2 of the Patent Act is met,” said the court in the ruling, released on June 30.
The court said the doctrine is “unsound” and “not good law”, adding: “It is an interpretation of the utility requirement that is incongruent with both the words and the scheme of the Patent Act.”
The doctrine is “excessively onerous” the court said because it determines the standard of utility that is required of a patent by reference to the promises expressed in the patent and, where there are multiple expressed promises of utility, it requires that all be fulfilled for a patent to be valid.
The court laid out a two-step test to determine whether a patent discloses an invention with sufficient utility: “First, 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)?”
The case involved AstraZeneca’s patent covering the compound esomeprazole in Nexium, a proton pump inhibitor drug that reduces gastric acid. The patent was found novel and unobvious at trial but invalid for lack of utility.
The Supreme Court found AstraZeneca’s patent was valid. The trial judge had found the claimed subject-matter of optically pure salts of the enantiomer of omeprazole to be useful as a proton pump inhibitor to reduce production of gastric acid. This was sufficient for the Supreme Court to find utility to make the subject-matter useful.
AstraZeneca was represented by Smart & Biggar attorneys Gunars Gaikis, Yoon Kang and Kynn Ing.
Apotex was represented by Goodmans attorneys Harry Radomski, Andrew Brodkin, Richard Naiberg and Sandon Shogilev.
Smart & Biggar’s Ing commented in an article on the decision: “The unanimous decision represents an important victory for innovators seeking protection in Canada, and is especially welcome in the highly litigated area of pharmaceutical patents.”
The decision was welcomed by Pharmaceutical Research and Manufacturers of America (PhRMA).
“The ‘promise’ doctrine that enabled Canada to invalidate Astra Zeneca’s patents had undermined Canada’s stated goal of building an innovation economy,” said Robert Zirkelbach, executive vice-president at PhRMA, in a statement. “With this decision Canada will rejoin the rest of the world in terms of how it defines patent utility.”
Zirkelbach said Canada has used this discriminatory policy in 29 court decisions that invalidated 26 patents on 22 medicines over the past decade, targeting only pharmaceutical companies.
Business organisation the US Chamber of Commerce through its Global Intellectual Property Center also welcomed the decision. Patrick Kilbride, vice-president of international intellectual property policy, commented: “The Doctrine’s extremely restrictive approach has created harmful instability and uncertainty for medical innovators by making it difficult to obtain or defend a life science patent in Canada. Today, the Supreme Court has begun to restore much-needed clarity and confidence that biopharmaceutical innovators will be afforded equal protections under the law.”
But not all welcomed the decision. For example, James McGill professor Richard Gold commented on Twitter: “The winners of the #SCC AstraZeneca case are: i) the 87% of patent holders outside of Canada; and ii) patent lawyers.”
