The Supreme Court of Canada has today granted AstraZeneca leave to appeal a Federal Court of Appeal decision, affirming a trial decision invalidating its patent relating to its successful esomeprazole drug (NEXIUM) for lack of utility.
The patent utility requirement in Canada has been the subject of controversy and debate. The appeal will present the Supreme Court with an opportunity to consider whether a promised utility doctrine properly exists, and the correct applicable standard for patent utility in Canada.
In AstraZeneca Canada Inc v Apotex Inc, 2014 FC 638, the trial judge found AstraZeneca’s Canadian Patent No. 2,139,653 claims novel and unobvious, and if valid would have been infringed by Apotex’s sale of its generic esomeprazole drug. The trial judge, however, found a “promise” of improved therapeutic profile, unmet at the filing date, to be “fatal” and held the patent invalid. The Federal Court of Appeal affirmed in 2015 FCA 158.