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Apotex’s Infringement of AstraZeneca’s Omeprazole Formulation Patent Upheld

Authored byLynn Ing

The Federal Court of Appeal, in a unanimous decision released on January 12, 2017 (2017 FCA 9), has affirmed the validity of AstraZeneca’s Patent No. 1,292,693. The patent covered AstraZeneca’s successful product, LOSEC, for inhibiting gastric acid secretion and treating gastrointestinal diseases such as stomach ulcer.

Apotex appealed from a Federal Court decision that found the patent valid and infringed by Apotex (2015 FC 322, amended 2015 FC 671; see our previous article here). The main issue on appeal was construction.  The 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 Court of Appeal’s findings in a PMNOC case on the same patent.  On its own analysis of the patent, the Court of Appeal was satisfied 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 Court of Appeal dismissed Apotex’s overlapping arguments of sufficiency, overbreadth 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 possible limitation periods applicable to one of the two consolidated proceedings which were under appeal.  The trial judge had declared the plaintiff AstraZeneca AB was statute barred from obtaining relief for infringing activity more than six years before it commenced its action.  The 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 erred in precluding the possibility that a provincial limitation period might apply to specific acts of infringement.

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

AstraZeneca was represented by Smart & Biggar’s Gunars Gaikis, Nancy Pei, and Lynn Ing.

For further information, please contact a member of our firm’s Pharmaceutical group.

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