Apotex Inc v Wellcome Foundation Ltd / AZT 2002 SCC 77, aff’g [2001] 1 FC 495 (FCA), var’g
T-3197-90, 79 CPR (3d) 193 (FC) Wetston J
1,238,277
The law of utility has become much quieter since AstraZeneca 2017 SCC 36, so I’ve been
spending some time reviewing the case law to see where we have ended up. One issue that
remains contentious relates to the enhanced disclosure requirement that arises when utility is
established on the basis of a sound prediction. In Wellcome / AZT 2002 SCC 77 at paragraph 70
the SCC remarked that:
Normally, it is sufficient if the specification provides a full, clear and exact description of
the nature of the invention and the manner in which it can be practised. It is generally not
necessary for an inventor to provide a theory of why the invention works. Practical
readers merely want to know that it does work and how to work it. In this sort of case,
however, the sound prediction is to some extent the quid pro quo the applicant offers in
exchange for the patent monopoly.
This suggests that something other than the normal disclosure is required, though the SCC did
not go on to explain what that might be. This passage has been interpreted as requiring a
heightened disclosure requirement in the case of a sound prediction, such that the factual basis
for the prediction must be disclosed, or at least referred to, in the patent itself: Raloxifene 2011
FCA 220 [46]-[47] aff’g 2010 FC 915 [116]-[17]. This enhanced disclosure requirement is
substantively controversial: see Gauthier JA’s remarks in Clopidogrel 2013 FCA 186 [132] and
Rennie J’s remarks in Nexium 2014 FC 638 [158-59]. Even parsing the SCC’s statement is not
easy: see Rennie J’s careful discussion in Nexium [139-60] arguing that “this sort of case” refers
to a new use, not sound prediction generally.
In this post, I am not going to tackle either the interpretation of paragraph 70 or the substantive
merits of an enhanced disclosure requirement. Instead, I will focus on a purely factual point. The
reason the SCC gave for not elaborating further is that the precise disclosure requirements “do
not arise for decision in this case because both the underlying facts (the test data) and the line of
reasoning (the chain terminator effect) were in fact disclosed, and disclosure in this respect did
not become an issue between the parties” [70, my emphasis]. Similarly, the SCC said that “[t]he
trial judge has found that the inventors possessed and disclosed in the patent both the factual data
on which to base a prediction,” as well as the line of reasoning necessary to support a sound
prediction [75, my emphasis]. In this post I will show that the SCC’s statement that the
underlying facts supporting the sound prediction “were in fact disclosed,” is, in fact, false.
This is a purely factual point, involving a comparison between what was disclosed in the patent
with the evidence that was found to support a sound prediction. The bulk of this post is devoted
to supporting my claim that the factual basis was not disclosed by going through the decision and
the patent in rather pedantic detail. It may seem at times that I am belabouring the obvious, but
since I am arguing that the SCC made a factual error, I would like to be clear as to the basis for
my assertion. I’ll finish by considering the doctrinal implications of this observation.
I should stress that I am not disagreeing with any of the key holdings in AZT. I am arguing that
the SCC’s statement at [70] was based on a factually erroneous premise; but that statement was
expressly obiter. Given that the remarks were obiter, it is understandable that the SCC was
perhaps not as careful in dealing with the issue as it might have been. An obiter comment of this
type is clearly not binding in any event: R v Henry 2005 SCC 76 [57]. My argument is that the
underlying factual error is one more reason for not placing significant weight on this obiter
comment in the future development of the law on this point.
