On November 2, 2011 the Federal Court of Appeal, from the bench, dismissed appeals brought from the decision of Madam Justice Snider (2009 FC 676) involving Canadian Letters Patent No. 1,341,206 and the drug ramipril (brand name AltaceTM). On November 2, 2011, the Federal Court of Appeal (2011 FCA 300) dismissed the appeals brought by Sanofi-Aventis Canada Inc. and Schering Corporation from the bench. The Court upheld Justice Snider’s judgment, which had invalidated the claims in issue of the 206 patent. Justice Snider had found that the inventors did not have a sound prediction of the utility of the compounds in the claims at issue and, on that basis, found that the patent was invalid.
The Court found that Justice Snider had correctly articulated and applied the legal test for sound prediction to the facts and evidence led at trial. Accordingly, the Federal Court of Appeal affirmed and upheld the declaration of the invalidity of the ramipril patent.
Having succeeded on behalf of its client, Teva, in a 37 day trial back in 2009, the Heenan Blaikie team has now had the Federal Court of Appeal confirm that victory. Ramipril had sales in excess of $350 million a year in 2006 when the generic companies gained entry into the market.
This is an important decision. It affirms that the doctrine of sound prediction, as expressed by the Supreme Court of Canada in Apotex Inc. v. Wellcome Foundation (“AZT”). The doctrine of sound prediction requires that where the utility of an invention has not been shown or demonstrated as of the filing date, the patent will be held invalid unless the investors had a “sound prediction” of that utility, requiring that they had a factual basis and sound line of reasoning for their prediction of utility and that both the factual basis and line of reasoning were disclosed in the patent.
The Federal Court of Appeal decision also affirms that proposition that where a patent promises a utility (in this case, Justice Snider had found that the patent promised in vitro and in vivo utility for the claimed compounds), the patentee will have to have had a sound prediction of that promise. Simply put, all of the promises that are made in a patent must be met or the patent will be found to be invalid.