The FCA has released its reasons in the appeal of Justice
Rennie's Esomeprazole decision.1 In
Esomeprazole, Rennie J. found Astrazeneca's patent to
be invalid for failing to demonstrate, or soundly predict, the
promised utility. Rennie J. also undertook a thorough analysis of
the jurisprudence and arrived at the conclusion that the factual
basis and the line of reasoning underlying a sound prediction need
not be disclosed, except possibly in the case of patents that claim
a new use for an old compound. The FCA dismissed Astrazeneca's
Issues Relating to Construction of the Promise
The FCA decision dealt primarily with issues relating to the
promise. The patent at issue had both compound and use claims, not
unlike the patent at issue in the Celebrex decision. On
appeal, Astrazeneca argued that the claims must be assessed on a
claim by claim basis in assessing utility. Namely,
Astrazeneca's position on appeal was that a lower level of
utility should apply to the compound claims. Astrazeneca further
argued that the trial judge erred in accepting Apotex's
position that the promises were overarching (i.e. applying to each
claim). Finally, Astrazeneca argued that the promise should not
have been inconsistent with the inventive concept as determined,
attempting to apply the doctrine that one construction should be
given for all purposes.
The FCA agreed with Astrazeneca that "it is well settled
law that inutility must be assessed on a claim by claim
basis",2 and that promises are not necessarily
overarching (i.e. they can apply to only a subset of the
claims).3 However, the FCA held that the trial judge was
entitled to rely on the lis as framed between the parties,
and that the lis only contemplated an overarching
promise.4 Therefore, while Astrazeneca's legal
position that utility is to be assessed on a claim by claim basis
was correct, the failure to frame the issue of promise construction
before Rennie J. as a claim by claim issue was fatal on appeal.
The FCA also found that it was not an error of law for the
claimed utility to differ from the inventive
The (non)-Requirement for Disclosure in Cases of Sound
At trial, Rennie J. discussed the disparate requirements of
utility and sufficiency in considering whether there was a need in
Canadian patent law to disclose the factual basis and line of
reasoning in cases of sound prediction. In short, he looked at
whether a "heightened disclosure requirement" for sound
prediction cases was mandated by the Patent Act, and at
the impact of the Supreme Court of Canada's AZT
decision on this issue. After analyzing the jurisprudence and the
Patent Act, Rennie J. found that a disclosure of utility
can only be required where the invention (required to be disclosed
under section 27(3)(a)) is the patent's utility, such as in
AZT.6 As the instant patent claimed novel
compounds, Rennie J. found that no requirement existed for
AstraZeneca to disclose the studies it relies upon for a sound
prediction in the patent.7
This aspect of Rennie J.'s decision was not discussed in the
6 See paragraph 52 of the Supreme Court's decision: It
is important to reiterate that the only contribution made by
Glaxo/Wellcome in the case of AZT was to identify a new use. The compound
itself was not novel. [emphasis in original] (2002 SCC
7 Paragraph 141 of the trial decision
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