Bayer challenged the Minister's decision to issue a NOC to Sandoz in respect of vials of ciprofloxacin. The Court of Appeal upheld the decision of the Federal Court to dismiss the application with costs.
At the time Sandoz's NOC was issued, Bayer had withdrawn its similar product from the Canadian market. Thus, Sandoz's NOC was on the basis of establishing pharmaceutical equivalents of its product to an innovator product in an equivalent jurisdiction. However, Sandoz's ANDS continued to include reference to Bayer's product in Canada.
The Federal Court found that Sandoz did not compare its product to Bayer's for the purpose of showing bioequivalence. The comparison was only for the establishment of a safe limit of a certain impurity.
Thus, the Judge made no palpable and overriding error, and his decision was upheld.
The full text of the decision can be found at: http://decisions.fca-caf.gc.ca/en/2008/2008fca25/2008fca25.html