Appeal of 55.2 proceeding; 2009 FCA 97; raloxifene; March 25, 2009

In the underlying decision on the merits, the Federal Court dismissed the application on the basis that the allegation as to a lack of sound prediction because the patent lacks adequate disclosure was justified. The Court of Appeal upheld that decision.

The Court reiterated the test articulated by the Supreme Court in AZT, namely that when an invention had not yet been reduced to practice, the disclosure must give both the underlying facts and the sound line of reasoning to justify the prediction. The Court of Appeal then stated that "[i]n sound prediction cases there is a heightened obligation to disclose the underlying facts and the line of reasoning for inventions that comprise the prediction." In this case, the Court found that neither of those elements were present in the disclosure.

The Court of Appeal found that whether a prediction is sound is a factual question which cannot be overturned without a palpable and overriding error. The Court of Appeal held that on the relevant evidence, it was open to the Federal Court judge to conclude that patent at issue disclosed no more than the prior art.

The full text of the decision can be found at: http://decisions.fca-caf.gc.ca/en/2009/2009fca97/2009fca97.html