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 disclosed within the patent and many question whether a utility disclosure requirement exists at all. While a valid patent requires public disclosure of its invention, the enhanced disclosure requirement to establish a sound prediction utility undermines the purpose of the patent system and violates Canada's treaty obligations. In particular, the disclosure requirement for sound prediction goes beyond the substantive requirements of both Article 29.1 of TRIPS and Article 27 of the Patent Cooperation Treaty (PCT), which provisions determine what is necessary to be disclosed in a Canadian Patent.5

Recent Developments

The unsettled law concerning the disclosure requirement continues to plague the FC and FCA in sound prediction cases.

Recently, it appears that the lower court has attempted to reconcile the disclosure requirement for predicted utility with previous case law and the fact that utility and disclosure are treated separately under the Patent Act.

In...