• Disclosure Part of Test for Anticipation Determined on Balance of Probabilities
  • July 24, 2013
  • Law Firm: Borden Ladner Gervais LLP - Toronto Office
  • Hoffmann-La Roche Limited v. Apotex Inc., 2013 FC 718

    In an application brought pursuant to the Patented Medicines (Notice of Compliance) Regulations, the Court found the allegations of invalidity and non-infringement justified. In particular, Apotex alleged that the impugned patent was invalid on the basis of anticipation, obviousness and overbreadth. Apotex also alleged non- infringement in the alternative on the basis that the invention relates to crystallinity and the Apotex product is amorphous (non-crystalline).

    The Court considered the test for anticipation, and particularly the disclosure part of the test and whether an exact description of the invention is necessary in the prior art. The Court concluded that “many cases have cited Justice Hughes’ principles and have also referred to the first branch of the anticipation test as requiring that it ‘necessarily infringe’ or ‘inevitably result’ in infringement, yet have applied the test on a balance of probabilities to determine whether the claim has been disclosed in the prior art.” The Court then concluded “I find that  the invention of the ‘721 was disclosed in EP 329 and enabled. The POSITA would understand the invention and make it without extensive efforts and with no additional inventive step, and in so doing, would on a balance of probabilities infringe the patent.”

    The Court found the invention to be obvious but the allegations of overbreadth were not justified. In respect of the allegation of non-infringement made in the alternative, the Court found that the allegation is justified. Apotex did not provide samples to Roche. Roche’s expert conducted experiments to model the Apotex process that was provided by Apotex. The Court concluded that it was not persuaded by Roche’s evidence, and Apotex provided evidence that its product was not crystalline and highlighted “frailties in the experiments conducted” by Roche. Costs were awarded to Apotex.