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Utility - The Heightened Disclosure Pendulum Swings Again

March 14, 2016

By Melanie Szweras and R. Scott MacKendrick

The Federal Court of Canada has once again waivered on what is required in order to satisfy utility based on sound prediction. In Eli Lilly Canada Inc. v. Hospira Healthcare Corporation et al., 2016 FC 47, the Court has backtracked on the progress that was recently made by patentees in relation to sound prediction but has maintained the easing of the promise of the patent doctrine.

The case was brought as an application under the Patented Medicines (Notice of Compliance) Regulations, as occurs for many pharmaceutical cases in Canada. Eli Lilly sought to prevent Hospira from obtaining a notice of compliance for a generic version of the drug pemetrexed disodium (pemetrexed), which is marketed by Lilly as ALIMTA®. Although a number of issues were raised, the Court ultimately only dealt with sound prediction of utility.

The claims at issue related to a class of compounds, many of which were not specifically disclosed nor made or tested before the filing date, including pemetrexed. Thus, to fulfill Canada’s current approach to utility, there must have been a sound prediction of utility at the filing date.

Prior to embarking on the issue of whether there was a sound prediction at the filing date, the Court first had to determine the promised utility from which to measure whether a sound prediction existed. Not surprisingly, the parties had very divergent positions on the patent’s promised utility. Lilly pushed for a position requiring only a “scintilla” of utility reminiscent of the requirement stated by the Supreme Court of Canada in Consolboard v. McMillani. In particular, Lilly pushed for the promise to be that the compound claims had some antifolate activity in vitro. In contrast, Hospira argued for a heightened promise of utility, pressing the Court to accept that the promise of utility encompassed in vivo antitumour activity and had some advantage over methotrexate – an earlier treatment – or that all the claimed compounds had toxicities specific to tumor cells. The Court rejected both positions, deciding that the promise fell between the two, requiring the use of the compounds as antitumour agents.

In arriving at the promise, the Court rejected Lilly’s argument that there should be no heightened promise of utility for compound claims since there was no asserted utility in the claim language. The Court stated that to limit the utility to the bare requirement offered by Lilly would ignore clear and unambiguous language in the specification. In making this statement, the Court quoted the opening sentence of the patent, which reads “This invention relates to the novel pyrrolopyrimidine derivatives which are useful as anti-tumour agents, the production and utilization thereof” [emphasis in the decision]. The Court also rejected the heightened promise advocated by Hospira. In doing so, the Court held that highly subjective and qualitative references to “excellent” or “remarkable” would not be included within the promise. The Court, following earlier language from the Federal Court of Appeal in Sanofi-Aventis v Apotexii, accordingly confirmed that a promise “must be clearly and unequivocally found in the express language of the specification”.

Having arrived at the promise of utility, the Court then endeavoured to consider whether there was a sound prediction that the claimed compounds be antitumour agents. As always, the Court started the analysis by considering the oft quoted test for sound prediction from the Apotex v Wellcome (AZT) Supreme Court of Canada decisioniii, which requires a factual basis for the prediction, an articulate and sound line of reasoning from which the desired result can be inferred, and proper disclosure. There have been numerous decisions since AZT that have contemplated, and in some ways arguably debated, what the patentee must disclose to the public where utility is predicated on a sound prediction in order to meet the “proper disclosure” part of the test.

In reviewing some of the decisions on the disclosure requirement, the Court favoured that the factual basis and sound line of reasoning must be disclosed within the application as filed, relying on past decisions including the AZT case and, as well, as endorsed by the Federal Court of Appeal in Eli Lilly v Apotexiv and Eli Lilly v Novopharmv. The Court did recognize, however, the recent Federal Court of Appeal proviso from Bell Helicopter Textron v Eurocoptervi that there is no requirement to disclose that which is part of the common general knowledge of the skilled person.

Unfortunately, this decision pulls the heightened disclosure yardsticks back somewhat. At least some of decisions were questioning or moving on the heightened disclosure requirement for sound prediction. The Court recognized this, stating that “the issue of what the patentee must disclose to the public where utility is predicted remains somewhat controversial”. The Court specifically mentioned Justice Gauthier’s concurring reasons in Sanofi-Aventis v Apotexvii, where she questioned the general requirement for heightened disclosure in sound prediction cases. The Court also mentioned Justice Rennie (as he then was) limiting, in Astrazeneca v Apotexviii, the disclosure requirement to new use patents.ix

The Court had “some sympathy for Justice Rennie’s and Justice Gauthier’s views”, but was “not persuaded that the state of the law on this issue has changed”. It appears that the Court felt bound by the earlier Supreme Court of Canada AZT decision.

With the heightened disclosure approach decided, it did not take long for the Court to find that a sound line of reasoning could not be found in the patent.

The Court stated that it could not agree “that a person of skill would have made a prediction of utility for the thousands of untested compounds included in the asserted claims”.  And, referring to the AZT decision, the Court expressed concern that this patent attempted to “monopolize … a huge class of compounds on the strength of its highly discrete test data”, seeing it as “a clear case of over-reaching”.

It will be interesting to see whether the Supreme Court of Canada also weighs in on what this Court described as the “somewhat controversial” heightened disclosure sound prediction requirement when Supreme Court of Canada considers the so called “promise doctrine” in AstraZeneca Canada v Apotex, likely early in 2017.x

i [1981] 1 SCR 504
ii 2013 FCA 186
iii 2002 SCC 77
iv 2009 FCA 97
v 2010 FCA 197
vi 2013 FCA 261
vii 2013 FCA 186
viii 2014 FC 638
ix In fact, in a more recent decision, in Gilead Sciences v Idenix Pharmaceuticals (2015 FC 1156), the Court confirmed that for a new composition, there is no requirement to specifically disclose the utility in the application. A specific utility must, however, be disclosed in patents claiming a new use of a known compound

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Melanie Szweras Melanie Szweras
B.Sc., Ph.D. (Genetics), LL.B.
416.957.1678  email Melanie Szweras
R. Scott MacKendrick R. Scott MacKendrick
B.A.Sc. (Chem. Eng.), LL.B.
416.957.1675  email R. Scott MacKendrick