• Federal Court Finds Patent Obvious and Not Soundly Predicted
  • July 21, 2010 | Author: Jason C. Markwell
  • Law Firm: Ogilvy Renault LLP - Toronto Office
  • CASE:
    AstraZeneca Canada  Inc.et al. v. Apotex Inc.  et al.

    NEXIUM® (esomeprazole)

    PM(NOC) Regulations - section 6 proceeding

    Apotex Inc.

    June 30, 2010


    On June 30, 2010, the Federal Court dismissed AstraZeneca's application for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex in respect of its generic version of esomeprazole (NEXIUM) until after the expiry of Canadian Patent No. 2,139,653 ("653 Patent").  Justice Hughes found two of Apotex's allegations of invalidity of the 653 Patent justified.   

    The 653 Patent presents an "improved process for preparing a highly optically pure.enantiomer of omeprazole and its salts, which is stable as against racemisation [recombination]".  The Court construed the claim in issue to read "A salt (e.g. magnesium) of esomeprazole having an optical purity of 99.8% or greater."

    Justice Hughes held that the promised utility of the patent was to provide an "improved therapeutic profile", as disclosed by the inventors in the description of the 653 Patent.  In considering whether the requirements of sound prediction had been established as of the Canadian filing date, Hughes J. found that the inventors did not have either a factual basis for the prediction or an articulable and sound line of reasoning for the prediction and that there was no proper disclosure.  Accordingly, Apotex's allegation of no sound prediction was justified.

    Justice Hughes then considered Apotex's allegations of anticipation and obviousness.  In respect of anticipation, Hughes J stated that "a disclosure in and of itself may be sufficient to constitute anticipation".  This appears to contradict recent jurisprudence from the Supreme Court of Canada which requires both disclosure and enablement for a finding of anticipation.  In any event, Hughes J. held that the 653 Patent was not enabled by a prior teaching and therefore the allegation of anticipation was not justified.

    In respect of obviousness, Justice Hughes determined that "[t]here was the means and motivation to make an enantiomer of high purity such as 99.8%.  This satisfies the requirements of obviousness."  Justice Hughes did not comment on whether the claimed invention was "more or less self-evident" or whether the "improved therapeutic profile" being a conseqeuence of such purity was also obvious.   Based on this 'means and motivation' test, Justice Hughes found Apotex's allegation of obviousness justified.

    The decision has not yet been published on the Federal Court website but will have the following neutral citation:  2010 FC 714.