Patent infringement proceeding; 2009 FC 676; ramipril; June 29, 2009

The Court found the patent infringed, but invalid and thus dismissed two actions for infringement.

The Court considered the issue of sound prediction, holding that under the test in Wellcome, when looking at whether a sound prediction has been made, the knowledge, activities and endeavours of the inventors must be considered. In this case, the Court found there was a factual basis for a sound prediction as the inventors’ own work showed that some of the compounds that fell within the claims, were inactive at the level tested. The Court also found that there was nothing in the literature that could have been used to predict the activities of these compounds or provide a sound line of reasoning.

The Court then went on to consider the disclosure element of sound prediction test and found there was no proper disclosure as there was no data included, no reference to publications in the art or other work done by the inventors that might disclose a sound line of reasoning in drawing its conclusions.

The Court, however, dismissed Apotex’ allegation that there was a lack of sound prediction of the methodology for making a particular compound. This was seen as merely another attempt to circumvent the date for a sufficiency allegation. The Court clearly found that as of the relevant date, the date of publication, the patent disclosure was sufficient.

The Court, in its obviousness analysis, determined the inventive concept and held that it would have been obvious to try. The Court concluded that the skilled person would consider that the claimed compounds ought to work. Thus the invention was held to be obvious.

The Court dismissed Apotex’ allegations as to best mode. This obligation to disclose the best mode only arises in the case of a patent to a machine. The allegations as to double patenting were also dismissed, as the priority filing date of the patent at issue is earlier than that of the alleged patent for double patenting. In addition, the Court recognized consistent jurisprudence that states that double patenting can only arise where the two patents are held by the same party. The argument as to the Gillette Defence was also dismissed. The Court found that absent a conclusion of anticipation, the Gillette Defence is not available. Finally, the Court dismissed Apotex’ allegations that Schering was not the first to invent ramipril.