Federal Court Clarifies Disclosure Requirement For Sound Prediction

In Astrazeneca Canada Inc v Apotex Inc, 2014 FC 638, Justice Rennie of the Federal Court ruled that the sound prediction of the utility of a patent does not require the disclosure of a factual basis and a sound line of reasoning in the patent itself unless the patent is directed to a new use. AstraZeneca is the holder of Canadian patent 2,139,653 (the ‘653 Patent) relating to Esomeprazole, a successful drug used to treat gastric acid conditions including reflux esophagitis, sold under the name NEXIUM®. In a prior proceeding under the PM(NOC) Regulations, AstraZeneca was unsuccessful in prohibiting Apotex from selling generic Esomeprazole, which allowed Apotex to sell it. AstraZeneca then brought this infringement proceeding to seek damages for sales by Apotex, and Apotex counterclaimed, seeking to invalidate the ‘653 patent. The Court declared the ‘653 Patent to be invalid for lack of utility on the basis that it failed to soundly predict an improved therapeutic profile that had been promised in the disclosure. The Court interpreted the statement “(the compounds) will give an improved therapeutic profile such as a lower degree of interindividual variation” to be a promise. The Court went on to hold that the promise was not soundly predicted, on the basis that the data from AstraZeneca’s studies on three human livers and six plasma re-analyses provided an insufficient factual basis to support the prediction across the entire patient population. In Justice Rennie’s analysis, he established that the requirement of a “proper disclosure” of a factual basis and sound line of reasoning in the patent applies only to the sound prediction of the utility of new uses, on the basis that utility is the only thing being offered in exchange for a patent monopoly in those cases. In support of his conclusion, Justice Rennie relied on Apotex Inc v Wellcome Foundation, 2002 SCC 77 (AZT) and Sanofi-Aventis v Apotex Inc, 2013 FCA 186 (Plavix case), and the separation of the disclosure and utility requirements under the Patent Act. Justice Rennie’s decision provides some clarification on the disclosure requirements in respect of sound prediction and the meaning of an “explicit” promise, although these issues are likely to be revisited on appeal. It will also be interesting to compare Justice Rennie’s analysis with the Supreme Court of Canada’s analysis of similar issues in the upcoming appeal of the Plavix case, which is expected to be heard later this year. Summary by: Darren Hall