In Canada, for subject matter to be patentable, it must be novel, inventive, and have utility. A patent will fail for lack of utility if it can be shown 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" (Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd., (1981) 56 CPR (2d) 145 (S.C.C.)). At the time a patent is applied for, the inventor must be in a position to establish utility, "on the basis of either demonstration or sound prediction" (Apotex Inc. v. Wellcome Foundation Ltd.,  4 S.C.R. 153, 2002 SCC 2007, 2002 SCC 77).
As is often the case for both biotechnology and pharmaceutical inventions where working examples demonstrating promised utility are not available at the time of filing, the doctrine of sound prediction, as established by the Supreme Court of Canada in Apotex Inc. v. Wellcome Foundation Ltd., must be relied on to support the utility of the invention.
To meet the test for "sound prediction," there must be:
(i) a factual basis for the prediction;
(ii) an articulable and "sound" line of reasoning from which the desired result can be inferred from the factual basis, and
(iii) proper disclosure.
With respect to the first requirement, the factual basis from which utility can be soundly predicted may be provided by way of examples but there is no requirement to do so. Nor is there any requirement to establish the factual basis with human clinical trial data. In fact, in Apotex Inc. v. Wellcome Foundation Ltd., the factual basis was provided by way of in vitro examples.
A recent Canadian Federal Court of Appeal decision in Eli Lilly Canada Inc. v. Apotex Inc., 2009 FCA 97, has examined the sound prediction doctrine and sets a troubling precedent with regard to inclusion of performed clinical trial data in pharmaceutical applications in order to satisfy the third prong of the test relating to disclosure.
On March 25, 2009, the Federal Court of Appeal dismissed Eli Lilly Canada's appeal of a lower court decision pursuant to the Patented Medicines (Notice of Compliance) Regulations ("PM(NOC) Regulations") in favor of Apotex for its raloxifene hydrochloride drug (generic version of EVISTA7). The PM(NOC) Regulations are Canada's version of a Hatch-Waxman-type regime linking the approval of generic drugs under the Canadian Food and Drugs Act and Regulations with the Canadian Patent Act.
The patent at issue, Canadian Patent No. 2,101,356 ('356 patent) is directed to the use of a group of compounds (including raloxifene) in the treatment or prevention of osteoporosis and for inhibiting bone loss in a human. The patent specification disclosed four examples of in vivo rat studies and a fifth example of an anticipated study on a group of post-menopausal women where certain results were expected. In its Notice of Allegation, Apotex alleged that the rat studies disclosed in the '356 patent did not provide a factual basis for a sound prediction; specifically, that it could not be soundly predicted that the results obtained from in vivo testing in rats would demonstrate utility in humans. According to Apotex, the inventors had not demonstrated that raloxifene HCl could be used as a treatment for the prevention of osteoporosis and/or bone loss in humans and that, while the disclosure mentioned that a clinical trial in healthy post-menopausal women was underway to confirm this, the results of the study were not reported in the '356 patent.
The first instance trial judge agreed with Apotex and held that the '356 patent lacked proper disclosure as required by the sound prediction test articulated in Apotex Inc. v. Wellcome Foundation Ltd. Of relevance was an abstract published by Eli Lilly before the Canadian filing date of the '356 Patent, but after its U.S. priority date which described a study (referred to as the Hong Kong study) conducted on a group of post-menopausal women demonstrating that raloxifene showed promising skeletal anti-resorptive properties. The Court ruled that, although there was a good basis for a prediction as of the priority date of the application based on the in vivo rat studies described in the application, and a sound line of reasoning as of the Canadian filing date based on the Hong Kong study, the third prong of the test had not been met as the Hong Kong study itself was not disclosed in the '356 patent. Eli Lilly argued that the Hong Kong study abstract was available to the public at the Canadian filing date and that, as such, sufficient disclosure to satisfy the third prong of the test had been made. However, this was rejected by the trial judge who, as mentioned above, ruled that the disclosure must be in the patent, not elsewhere.
On appeal, Eli Lilly argued, inter alia, that the trial judge had committed a legal and factual error as recent case law on the issue of sound prediction had established that there was no requirement that the underlying data supporting a sound prediction be disclosed in the patent. The Federal Court of Appeal disagreed with Eli Lilly and confirmed that a heightened obligation to disclose the underlying facts and the line of reasoning for inventions that comprise the prediction was required in sound prediction cases. According to the Court, "when a patent is based on a sound prediction, the disclosure must include the prediction. As the prediction was made sound by the Hong Kong study, this study had to be disclosed."
It is unclear from the decision why both the trial level and appeal Courts found (and Eli Lilly's counsel accepted) that the particular Honk Kong study was necessary to provide a sound line of reasoning, i.e., that in vivo data in rats alone was not sufficient to provide both the factual basis and the sound line of reasoning. Eli Lilly appears to have simply argued its case on the basis that the doctrine of sound prediction did not require that the study be actually disclosed in the application. Perhaps it should have gone still further and argued that the judge had erred in finding that it was the testing in humans that made the prediction sound. In the vast majority of cases, when a patent application is filed, no such human clinical trial data is available; therefore, it is typical for applicants to support their sound predictions with in vitro or animal in vivo data only.
Therefore, this case should not be taken as establishing a requirement to provide human clinical trial studies in support of a sound prediction. As mentioned above, in the Apotex Inc. v. Wellcome Foundation Ltd. case itself, the factual basis had been established by in vitro data only. However, if an applicant does have human clinical trial studies available prior to filing its Canadian patent application (as was the case for Eli Lilly in the case at hand), then it would be advisable for the applicant to include the results of the studies in the patent application.
For more information regarding the Doctrine of Sound Prediction please contact Ariadni Athanassiadis (firstname.lastname@example.org), Catherine Lemay (email@example.com) or Claire Palmer (firstname.lastname@example.org).