• Oder of Prohibition Issues - No Promise to Treatment in Humans or Reduced Side Effects was Found
  • May 7, 2014 | Authors: Adrian J. Howard; Beverley Moore; Chantal Saunders; Ryan Steeves
  • Law Firm: Borden Ladner Gervais LLP - Ottawa Office
  • Pfizer Canada Inc. v. Apotex Inc., 2014 FC 314
    Drug: celecoxib

    Pfizer’s Canadian Patent No. 2,177,576 for Celebrex® has withstood Apotex’s allegations and was found to be valid; therefore the Minister is prohibited from issuing a NOC to Apotex. Apotex had alleged that the inventors lacked demonstrated utility or a sound prediction of utility at the time of filing, and that the patent was not properly disclosed. Celebrex® is used for treating inflammation and associated pain.

    The same ‘576 patent had been considered twice previously, once where the patent was construed to claim both the anti-inflammatory properties and lesser side effects, and once where there was no promise of reduced side effects.

    The Court noted that the patent refers to the treatment of a “subject”, not humans. The patent described testing in rats, and thus demonstrated its utility in rats. Since that was all that was promised, that was all that needed to be delivered. Following the recent jurisprudence from the Court of Appeal, the judge found that this means there was no clear promise that Celebrex® would be useful in treating inflammation in humans.

    A similar decision was made in regard to whether the patent promised reduced side effects. Although the Court noted that the patent specification referred to side effects, a statement of mere advantage, or a target, without more, is not a promise.

    Lastly, the patent was not found to be insufficient. The Court held that the true invention was a class of compounds. The claims narrowed down from a genus of compounds to three individually claimed compounds, and the Court found that all three compounds had demonstrated utility. Although claim 4 was the lead compound at the time, there was no obligation for the patentee to disclose that hope, as the best mode requirement applies to machines. Also, the Court said that a person of skill in the art would find it surprising if all the compounds made it to market, as commercial viability depends on a number of factors which would be developed later in the process.

    Apotex has appealed the decision (A-194-14).