Sound Prediction: Self-evident Elements Need Not Be Explicitly Disclosed

On June 3, 2015, the Federal Court of Appeal held that elements that would be self-evident to the skilled person need not be explicitly disclosed in the patent for the purpose of predicting utility. In the decision under appeal, 2014 FC 567, Justice O’Reilly had found that Apotex’s allegations were not justified and accordingly granted the prohibition application. The evidence before Justice O’Reilly established that while the sound line of reasoning was not explicitly stated in the patent it was implicit in the disclosed data and would be apparent to the skilled reader.

On Appeal, Apotex argued that the utility of the invention was not soundly predicted because the line of reasoning from which the desired result can be inferred was not explicitly disclosed in the patent. Referring its earlier decision in Eurocopter, the Court of Appeal rejected Apotex’s argument, holding:

[9] The Federal Court identified the factual basis for the prediction (the minimum inhibitory concentration values of several compounds tested against a number of bacteria species together with comparative data) and the line of reasoning that would, to the skilled reader, flow from that data. As this Court observed in Eurocopter v. Bell Helicopter Textron Canada Ltée, 2013 FCA 219, 449 N.R. 111, at paragraphs 152 and 153, the factual basis, line of reasoning and level of disclosure required by the doctrine of sound prediction are to be assessed as a function of both the knowledge that the skilled person would have to base that prediction on and what the skilled person would understand as a logical line of reasoning leading to the utility of the invention. Those elements of the doctrine of sound prediction that would be self-evident to the skilled person need not be explicitly disclosed in the patent.

In dispensing with Apotex’s other arguments, the FCA noted that Apotex largely sought to re-argue the issues it had raised in the Federal Court but that there was no basis to overturn Justice O’Reilly’s the findings regarding obviousness or anticipation.

A copy of the Court of Appeal’s Reasons and Judgment can be found here.