On July 2, 2014, Mr. Justice Rennie of the Federal Court
released his judgment and reasons in Astrazeneca Canada Inc v.
Apotex Inc., 2014 FC 638 dismissing AstraZeneca's
action for infringement and granting Apotex's counterclaim for
a declaration that Canadian Patent 2,139,653 (the
"'653 Patent") is invalid. This
patent relates to AstraZeneca's successful drug
Justice Rennie found the invention of the '653 Patent was
novel and non-obvious, but nevertheless invalidated the patent for
promising an improved therapeutic profile which
was not soundly predicted.
While Justice Rennie canvassed a number of legal issues, his
holding regarding the so-called "enhanced disclosure"
requirement for sound prediction is particularly interesting as it
represents a landmark ruling in the evolution of sound prediction
law in Canada. His analysis on the issue is found at paragraphs
139-161 of the decision.
Assuming any disclosure requirement exists at all in respect of
sound prediction – which Justice Rennie viewed as
questionable in light of the Supreme Court of Canada's recent
ruling in the Viagra case – he held that it
is restricted to "new use" patents.
Following the Supreme Court's decision in Apotex Inc. v.
Wellcome Foundation Ltd., 2002 SCC 77
("AZT"), and in respect of
utility based on sound prediction, the Federal Court of Appeal
recognised a general "heightened obligation to disclose
the underlying facts and the line of reasoning for inventions that
comprise the prediction" (Elli Lilly Canada Inc v
Apotex Inc, 2009 FCA 97 at para 14,
"Raloxifene"; see also
Lilly and Company v. Teva Canada Limited, 2011 FCA 220,
Some have viewed this nebulous enhanced disclosure obligation as
applying to all types of patented inventions where any aspect of
utility is based on a prediction.
In this case, however, Justice Rennie disagreed with the view
that AZT suggests an enhanced disclosure requirement
in all cases of prediction for two primary
Justice Binnie described that while generally inventors do not
need provide a theory of why the invention works, in the "sort
of case" of AZT, sound prediction is to some extent
the quid pro quo the applicant offers in exchange for the
patent monopoly (AZT, para. 70). Justice Rennie reasoned
that Justice Binnie's reference in AZT to this
"sort of case" clearly meant he was
referring to a subset of sound prediction cases. In other words,
this suggests there are other sorts of cases where the sound
prediction is not the quid pro quo offered by the
patentee, for which presumably there is no heighted disclosure
Principally, Justice Rennie further reasoned, that where a
new use is patented for an old compound (as in the
AZT case) "there may be an enhanced
disclosure requirement because utility is the only thing being
offered in exchange for the patent monopoly since the compound
itself was previously disclosed".
As support for his interpretation of AZT, Justice
Rennie found his views consistent with Justice Gauthier's
recent concurring reasons in the FCA's
"Plavix" decision (Sanofi-Aventis v.
Apotex Inc., 2013 FCA
186 at para. 135).
His analysis is also grounded by the Patent Act, as
utility (section 2) and disclosure (section 27(3)) are addressed
separately, suggesting there is no statutory basis for combining
the two to create a disclosure requirement for utility, even when
it is based on a prediction.
Finally, Justice Rennie concluded that Justice Lebel's
remarks (albeit obiter) in Viagra
overturn previous FCA jurisprudence (such as for example,
Raloxifene and Atomoxetine) in so far as it might
have required enhanced disclosure in all sound prediction
The Supreme Court may have the last word:
Justice Rennie's decision highlights the notion that the level
of disclosure required in patents where the invention's utility
is based on a sound prediction, has deviated from what was intended
by AZT. With the Supreme Court set to hear the
Plavix appeal this Fall (for which sound prediction and
disclosure are main issues), that Court may soon be writing the
governing decision on sound prediction law in Canada.
A recent Saskatchewan Court of Queen's Bench decision allowed a court-appointed receiver to sell and transfer intellectual property rights free and clear of encumbrances, finding that a license to use improvements of an invention was a contractual interest and not a property interest.
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