Like the U.S., Canada has a three-prong patentability standard that requires inventions to be novel, inventive, and useful. According to the law in Canada and the U.S., the utility standard has to be satisfied through demonstration, either an example in the patent application or in archived data.
However, a recent court decision could change how Canada enforces the utility standard by adding a “sound prediction” test of utility, in which inventors explain why they believe their inventions will work as designed. Kitt Sinden, a professional with the patent-agent partnership Sim & McBurney, explained to GEN how this could impact life science applications. “Say you claim you treat X, Y, and Z diseases, but you only actually have examples of treating disease X; you don’t have anything to show that you’ve demonstrated that it’s useful for Y and Z. If you explain in your application why you believe that it will work for Y and Z based on a sound line of reasoning in your application, you would satisfy utility under ‘sound prediction.’”
On December 6, Canada Federal Court Judge Richard Boivin—the equivalent of a U.S. District Court judge—held that Apotex infringed Sanofi’s ’777 patent, which claims clopidogrel bisulfate (Sanofi’s Plavix), but that the patent was invalid. The patent discloses and claims the enantiomer clopidogrel and its bisulfate salt as well as processes for its manufacture. In the U.S., however, District Judge Sidney Stein in Manhattan found Sanofi’s patent valid and enforceable.
The Canadian court rejected Apotex’ assertions that the ‘777 patent was invalid for overbreadth, insufficiency, lack of novelty, and double-patenting. However, the Federal Court found the patent invalid on the basis of lack of utility, both demonstrated and soundly predicted, as well as obviousness.
Sanofi argued that utility was demonstrated as of the Canadian filing date, at which time a Phase I study was under way. The Federal Court said that the early results known by Sanofi were inconclusive on the issue of the promised utility.
With regard to sound prediction, the Federal Court found that Sanofi had prior experience studying compounds with similar structures to clopidogrel bisulfate. As a result of this track record, the firm established that it had a factual basis and sound line of reasoning for predicting that clopidogrel bisulfate could be used in humans. However, the Court found that the patent did not disclose this “track record,” which the Court held was needed to assist the skilled person to predict the promised use. As a result, the patent failed the disclosure branch of the sound prediction test.
Sinden expressed concern that this recent court decision could be the tipping point, and Canada may write “sound prediction” into law as a criterion for patent examiners to use in assessing utility. “Hopefuly, the courts are going to take a step back and revisit this. It’s not good for patentees,” said Sinden, as applicants may find reviews taking longer as patent examiners would have to ascertain “sound prediction.”
According to Sinden, the “sound prediction” test poses another problem for patentees: Once they discover a compound, gene sequence, or protein and have useful data, inventors are inclined to file as quickly as they can, a consequence of the first-inventor-to-file system the U.S. will adopt in America Invents.
“If you’re going to say it’s useful in humans, it’s almost like the courts are saying, you have to wait till you have data in humans to satisfy that disclosure. From a patentee’s perspective, it’s ludicrous,” Sinden said. “By the time you get into clinical trials and you actually get the data back, it can be several years from when you first discover the compound and realize that it would have potential for use, and you might be missing the boat.”
The challenges faced by Canada, Europe, and the U.S. differ from those of Australia—where lawmakers are debating the first significant rewriting of the nation’s patent law since 1990—and Japan. How the Australian and Japanese systems compare with that of the U.S. will be covered in a follow-up article.