The Court heard this patent infringement action relating to olanzapine in 2009 and found that the patent was invalid. The Court of Appeal held that the Court erred in finding that the conditions for a valid selection patent can be an independent allegation of invalidity. The Court of Appeal found that the patent at issue was not invalid for anticipation, double patenting or obviousness, and referred the issues of utility and sufficiency back to the Court. Upon reconsideration, the Federal Court held that there was no demonstration of utility and no sound prediction for the promise found by the Court. The patent contained the results of human clinical trials on patients suffering from schizophrenia, and information relating to olanzapine’s side effect profile.
The Court of Appeal dismissed the appeal, finding no error of law or principle or any palpable and overriding error of fact.