Appeal of an infringement action; 2009 FCA 222; perindopril; June 30, 2009

The Court of Appeal upheld the decision of the Trial Division finding that the patent was both valid and infringed. A summary of the trial decision can be found here.

The Court upheld the trial judge on construction and the nature of the invention; found that Apotex cannot succeed on its allegation that the ADIR scientists were not the first inventors; and also found no error in the trial judge’s decision with respect to the allegations of a lack of utility.

The Court found that many of Apotex’ arguments relating to obviousness were the same as those made before the trial judge. As obviousness is a largely factual inquiry, it was open on the evidence for the trial judge to make the conclusions that she did. Furthermore, although the case was decided before the Supreme Court decision in Sanofi, the factual determinations are equally relevant to Sanofi analysis. The Court of Appeal found that the trial decision was consistent with the Sanofi framework and there was no error in concluding that the obviousness challenge should fail.

With respect to the allegations of a lack of sound prediction, Apotex argued that there needed to be a sound prediction that the invention could be made. The Court of Appeal rejected this allegation saying that sufficiency is a separate allegation. According to the Supreme Court’s test in Wellcome, utility is the only relevant inquiry in regard to sound prediction and utility of the class of compounds can be soundly predicted by reference to the architecture of that class.

The Court of Appeal also dealt with Apotex’ challenge to the corrections made to one of the claims in the application, holding that the trial judge had made factual determinations. Thus, the Court of Appeal will not interfere in the absence of palpable or overriding error, which had not been shown.

Finally, the Court addressed Apotex’ Competition Act allegations. ADIR and two other parties had engaged in a conflict proceeding regarding this patent and others. This proceeding was appealed to the Federal Court, where the parties settled their differences and the patents issued pursuant to that settlement. Apotex had asserted that that settlement agreement was anti-competitive. The Court held that, in order for the allegation to succeed, there must be something more than a mere exercise of rights under the Patent Act. There was nothing “more” in this case. Furthermore, an undue impairment of competition cannot be inferred from the evidence of exercise of rights under the Patent Act alone. Apotex’ arguments in this case were based on speculation. Furthermore, there was no suggestion that the Federal Court could not have awarded the claims precisely as they were allocated in the settlement.

The full text of the decision can be found at:

http://decisions.fca-caf.gc.ca/en/2009/2009fca222/2009fca222.html