The Federal Court Does The Hokey Pokey With The Disclosure Requirement In The Sound Prediction Of Utility

The doctrine of "sound prediction" was ushered into Canadian law as a means to protect useful inventions. A review of the case law, however, reveals that it has evolved into the impetus for a sharp distinction between demonstrated and soundly predicted utility. As a result, uncertainty has arisen with respect to what the patentee must disclose to the public where utility is predicted.

The Supreme Court of Canada's (SCC) decision in Apotex v Wellcome Foundation1 (AZT ) marked the first step towards an elevated substantive requirement for the disclosure of a sound prediction of utility. In AZT, the SCC established a three-part test for sound prediction:

There must be a factual basis for the prediction; There must be a sound line of reasoning; and There must be proper disclosure. The jurisprudence in both the Federal Court (FC) and Federal Court of Appeal (FCA) demonstrates that the courts continue to struggle with the application of the third step relating to proper disclosure. On one extreme, courts have interpreted this element as requiring disclosure of the factual basis and sound line of reasoning for the predicted utility in the patent itself.2 The "heightened" disclosure has resulted in several pharmaceutical patents being held invalid for lack of utility.3 Other cases have found that this enhanced requirement for disclosure exists only in respect of patents claiming the new use of known compound.4

Importantly, there is no statutory basis requiring that predicted utility be...