Data Requirements and Sound Prediction

Data Requirements and Sound Prediction
Suzanne Hof, November 29, 2012

This article provides a brief summary of the state of the law in Canada regarding utility, in particular, how Section 2 of the Canadian Patent Act is being used by the Canadian Patent Office during prosecution of biotechnology and pharmaceutical patents to refuse claims based on an alleged lack of a factual basis (i.e., data) to support a sound prediction of utility.

Section 2 of the Act requires that an invention be “new and useful”.  

Where utility has been demonstrated at the filing date of the patent application, evidence of utility need not be included in the patent disclosure.  This is consistent with the Supreme Court of Canada decision in Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504, which set out that the disclosure of a patent is not required to provide data demonstrating exactly how well the invention works, i.e., the utility of the invention, and that all that is required is that the specification provides enough information so that a person skilled in the art may work the invention as promised in the patent.  

Where utility has not been demonstrated, the utility may be based on sound prediction.  Whether a prediction of utility is sound is determined according to the following three criteria established by the Supreme Court of Canada in Apotex Inc. v. Wellcome Foundation Ltd., 2002 SCC 77:

1.    there must be a factual basis for the prediction;
2.    the inventor must have at the date of the patent application an articulable and "sound" line of reasoning from which the desired result can be inferred from the factual basis; and
3.    there must be proper disclosure

The doctrine of sound prediction is particularly significant, and is frequently invoked, for biotechnology and pharmaceutical inventions where, for example, in vitro or animal studies provide the basis for predicting the usefulness of a therapeutic in treating a disorder in a human subject, or in respect of a genus patent where a large number of compounds are claimed, but not all have been made and tested.  

For those seeking to protect such subject matter, the Federal Court of Appeal, in Eli Lilly Canada Inc. v. Apotex Inc., 2009 FCA 97 (aff’g 2008 FC 142), may have established an obligation in cases of sound prediction to disclose in the patent specification the underlying facts and the line of reasoning that support the prediction.  This is in direct contradiction of the principles set out in the Consolboard decision.  This decision has effectively created two different disclosure requirements according to whether the utility is demonstrated (no data required) or based on a sound prediction (data required).  

It is this case upon which the Patent Office has been relying to reject claims directed to subject matter that relies upon soundly predicted (as opposed to demonstrated) utility.  As a result, where utility is based on a sound prediction, a patent specification drafted in accordance with the data requirements for other jurisdictions (e.g., U.S. or Europe) may not be sufficient in the eyes of the Patent Office for patentability under the new data requirements established by the Courts.  

For those who have encountered these or similar objections during prosecution of their patent applications, we would be happy to discuss strategies for overcoming such road blocks.

For more information please contact Suzanne Hof.