Monday, April 20, 2009

FCA: basis for a sound prediction must be in application

Also of interest – an FCA decision which supports the necessity of providing the facts to support a sound prediction in the patent application (the opposing position being that it is sufficient to have the facts at the time of the application, but that it is not necessary to put them in the application).

[10] Based on the foregoing, it is clear that the invention was based on a prediction. Although the rat studies were positive, only a prediction could allow for the proposition that raloxifene had the same effect on women, let alone estrogen deficient post-menopausal women who suffered from bone loss. In other words, the claimed utility required for patentability was not demonstrated but predicted based on the information provided in the ‘356 Patent.

[11] The appellant further argues that the Federal Court Judge erred in holding that the ‘356 Patent lacks adequate disclosure. In this respect, the appellant essentially alleges that there is no requirement that the underlying data supporting a sound prediction be disclosed in the patent. It contends that the Federal Court Judge misconstrued recent judicial pronouncements on the issue of sound prediction.

[12] In making this argument, the appellant at the hearing accepted for purposes of the appeal the conclusion reached by the Federal Court Judge at paragraphs 155 and 156 of his reasons that the Hong Kong study was required in order to turn the prediction on which the ‘356 Patent was predicated into a sound one. According to the Federal Court Judge, the Hong Kong abstract of the study conducted by the appellant on 251 post-menopausal women which concluded that “raloxifene show[ed] promise as a skeletal anti-resorptive” would have been a sufficient factual basis upon which a sound prediction of utility for raloxifene could have been made as of the filing date. However, this study was not disclosed in the ‘356 Patent with the result that the underlying factual basis for the prediction and the sound line of reasoning that grounded the inventors’ prediction were not disclosed.

[13] The importance of the disclosure obligation in applying for a patent has been emphasized by the Supreme Court of Canada on a number of occasions in recent years (Pioneer Hi Bred Ltd. v. Canada (Commissioner of Patents), [1989] 1 S.C.R. 1623 at paragraph 23; Cadbury Schweppes Inc. v. FBI Foods Ltd., [1999] 1 S.C.R. 142 at paragraph 46; Free World Trust v. Électro Santé Inc. 2000 SCC 66, [2000] 2 S.C.R. 1024 at paragraph 13; Apotex Inc. v. Wellcome Foundation Ltd., 2002 SCC 77, [2002] 4 S.C.R. 153 at paragraph 37 (commonly referred to as AZT and hereinafter referred to as such)).

[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.
Eli Lilly Canada v. Apotex (another one! - case names get repetitive in this area) 2009 FCA 97

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