Canada’s Utility Requirement For Patentability – Looking For Good News For The Innovative Pharmaceutical Industry

Background

To be patentable in Canada, an invention must not only be new and non-obvious, it must also have utility.1 As evidenced by Eli Lilly's recent filing of a Notice of Arbitration in a $500 million NAFTA2 dispute against Canada for the invalidation of two of its patents covering its key drug products, Strattera and Zyprexa, on the basis of lack of utility3, it is clear that the issue of utility is currently a controversial subject at the forefront of the Canadian patent law.

The utility requirement may be met by either demonstrating that the invention possesses the claimed utility or by relying on sound prediction. In either case, it has been established that the relevant date for determining utility is the Canadian filing date.4 Accordingly, post-filing evidence and/or knowledge is not presently of assistance for establishing utility.

Two sub-issues emerge upon review of the case law from the past 10 years related to utility of a claimed invention. These two sub-issues are (1) the doctrine of the promise of the patent and (2) the doctrine of sound prediction. One of the bases for Eli Lilly's claims in its NAFTA challenge against Canada, is that the courts have established a "heightened disclosure requirement" for utility and, in their reasons, Lilly refers to these two doctrines.

Often cited as the case for the basis of the doctrine of the promise of the patent is the Supreme Court of Canada (SCC) decision in Consolboard Inc v MacMillan Bloedel5, "Consolboard", in which it stated on page 525:

There is a helpful discussion in Halsbury's Laws of England, (3rd ed.), vol. 29, at p. 59, on the meaning of "not useful" in patent law. It means "that the invention will not work, either in the sense that it will not operate at all or, more broadly, that it will not do what the specification promises that it will do".

A more recent citation, Eli Lilly Canada Inc v Novopharm Limited6, "Olanzapine", is also frequently referred to when addressing the promise of a patent in a utility analysis. In that decision, the following passage at paragraph 76 is often quoted:

Where the specification does not promise a specific result, no particular level of utility is required; a "mere scintilla" of utility will suffice. However, where the specification sets out an explicit "promise", utility will be measured against that promise: Consolboard; Pfizer Canada Inc. v. Canada (Minister of Health), [2009] 1 F.C.R. 253, 2008 FCA 108 (Ranbaxy). The question is whether the invention does what the patent promises it will do.

The seminal case for citations related to the doctrine of sound prediction is Apotex Inc v Wellcome Foundation Ltd7, "AZT", in which the SCC confirmed that utility may be based upon a sound prediction so long as there is a factual basis for the prediction, the inventor has an articulable and sound line of reasoning from which the desired result can be...