Cour d’appel fédérale réitère les principes de la prédiction valable

Un bon rappel dans la semaine précédant les examens d’agents:

Eli Lilly Canada Inc. v. Apotex Inc., 2009 FCA 97, (March 25, 2009)

[14]                 The decision of the Supreme Court in AZT is particularly significant to the disposition of this appeal. According to AZT, the requirements of sound prediction are three-fold: there must be a factual basis for the prediction; the inventor must have at the date of the patent application an articulable and sound line of reasoning from which the derived result can be inferred from the factual basis; and third, there must be proper disclosure (AZT, supra, at paragraph 70). As was said in that case (para. 70): “the sound prediction is to some extent the quid pro quo the applicant offers in exchange for the patent monopoly”. In sound prediction cases there is a heightened obligation to disclose the underlying facts and the line of reasoning for inventions that comprise the prediction.


[15]                 In my respectful view, the Federal Court Judge proceeded on proper principle when he held, relying on AZT, that 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.


[16]                 Absent a legal error, a decision as to whether or not a prediction is sound gives rise to a question of fact which cannot be overturned in the absence of a palpable and overriding error.


[17]                 In this respect, the appellant properly accepted that the Hong Kong study was required in order to make the prediction underlying the ‘356 Patent sound. After taking all of the relevant evidence into consideration, it was open to the Federal Court Judge to find that as of the priority date the prior art Jordan article and the disclosure of the ‘356 Patent were at the same point given that both studies demonstrated positive effects in respect of bone loss in rats and both concluded that human studies were warranted. In particular, the ‘356 Patent did not disclose any more than the Jordan article did, and as such, the person skilled in the art was given, by way of disclosure, no more than such a person already had available in the prior art.


[18]                 The appellant argues that in requiring the complete disclosure of the factual basis underlying the sound prediction (i.e. requiring data to substantiate the invention), the Federal Court Judge has changed the disclosure requirements as set out in subsection 27(3) of the Patent Act, R.S.C. 1985, c. P-4. I respectfully disagree. In AZT, the Supreme Court, with obvious reference to subsection 34(1) of the Patent Act (the predecessor to subsection 27(3)), held that where the claimed invention had not yet actually been reduced to practice, the patent must provide a disclosure such that a person skilled in the art, given that disclosure, could have as the inventors did, soundly predicted that the invention would work once reduced to practice. Significantly, in AZT, the Court went on to state that the disclosure requirements had been met given that both the underlying facts (the test data) and the sound line of reasoning (the chain terminator effect) were in fact disclosed (AZT, para. 70).


[19]                 The appellant further argues that requiring the complete disclosure of the factual basis underlying the sound prediction is inconsistent with the Patent Cooperation Treaty, 1970, 28 U.F.T. 7647 (Treaty). However, this Treaty specifically contemplates the supremacy of national law in setting the rules for substantive conditions of patentability (see article 27(5) of the Treaty). We are concerned here with substantive conditions of patentability.


[20]                 Finally, the appellant contends that the respondent did not allege that there had been a failure to properly disclose the facts underlying the sound prediction within the ‘356 Patent specification and that the Federal Court Judge breached the duty of procedural fairness in disposing of the application on that basis. However, a review of the Notice of Allegation (NOA) shows that the respondent did in fact allege that the ‘356 Patent was invalid on the basis of lack of sound prediction. More specifically, the respondent alleged that the inventors’ rat studies did not provide a factual basis for a sound prediction i.e. it could not be soundly predicted that the results obtained from in vivo testing in rats would demonstrate utility in humans. Further, the respondent alleged that by the Canadian filing date, the inventors had not demonstrated that raloxifene hydrochloride could be used as a treatment for the prevention of osteoporosis and/or bone loss in humans. In its NOA, the respondent notes that while the disclosure of the ‘356 Patent indicates that a clinical trial in healthy post-menopausal women was underway to compare the effects of conjugated estrogen and raloxifene, the results of the study were not reported in the patent. When regard is had to the NOA, the lack of sound prediction, specifically the lack of disclosure of any human data in the ‘356 Patent as a ground of invalidity, was clearly in issue.


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