In a unanimous decision released on January 12 2017 (2017 FCA 9), the Federal Court of Appeal affirmed the validity of AstraZeneca's Patent 1,292,693. The patent covered AstraZeneca's successful product Losec, for inhibiting gastric acid secretion and treating gastrointestinal diseases such as stomach ulcers.

Apotex appealed the Federal Court's decision that found the patent valid and infringed by Apotex (2015 FC 322, amended 2015 FC 671). (For further details please see "AstraZeneca's LOSEC patent held valid and infringed by Apotex".) The main issue on appeal was construction. The Federal Court of Appeal rejected Apotex's arguments that, despite articulating correct principles, the trial judge adopted a fettered, results-oriented approach and improperly relied on the Federal Court of Appeal's findings in a Patented Medicines (Notice of Compliance) (PMNOC) case on the same patent. On its own analysis of the patent, the Federal Court of Appeal was satisfied that the invention was a pharmaceutical preparation having a specific structure in order to provide good long-term stability and gastric acid resistance.

On validity, the Federal Court of Appeal dismissed Apotex's overlapping arguments of sufficiency, over-breadth and ambiguity (considered together), and utility. Apotex did not challenge the findings of novelty, non-obviousness and infringement (if the patent was valid) at trial.

The appeal was allowed in part to reflect the possible limitation periods applicable to one of the two consolidated proceedings which were under appeal. The trial judge had declared that AstraZeneca was statute barred from obtaining relief for infringement more than six years before it commenced its action. The Federal Court of Appeal found that if the trial judge's conclusion was based on his interpretation of Section 39 of the Federal Courts Act, the trial judge had erred in precluding the possibility that a provincial limitation period might apply to specific acts of infringement.

The Federal Court of Appeal dismissed AstraZeneca's cross-appeal for punitive damages arising from Apotex's conduct in earlier PMNOC proceedings.

For further information on this topic please contact Lynn Ing at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar/Fetherstonhaugh website can be accessed at