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On July 5, 2012, the Federal Court of Canada contemporaneously
released public reasons in two matters (Court File Nos. T-991-10
and T-1184-10) involving Fournier, Sandoz and the drug
fenofibrate. As
previously reported, Justice Zinn had dismissed both
prohibition application on the basis that Fournier had failed to
discharge the burden of demonstrating, on a balance of
probabilities, that Sandoz's allegation of non infringement was
not justified.
The applications involved Canadian Patent No. 2,372,576 and
2,487,054. The asserted claims of the patents require, among
other things, a composition having fenofibrate particles of a
maximum size (the '576 patent) or size distributions (the
'054 patent) .
Prior to the hearing of the applications, the Court ordered that
some evidence provided in one proceeding could be referenced in the
other proceeding In both matters. All of the parties'
submissions relied on evidence in respect of an earlier dispersion
of fenofibrate used to manufacture Sandoz's ultimate tablets or
a later redispersion of the tablets in an appropriate media.
No direct specific evidence of the particle size of the
fenofibrate in Sandoz's proposed tablets was provided by any
party, notwithstanding expert evidence that a certain
analytical technique would have determined the particle size
in the Sandoz's proposed tablets.
Justice Zinn dismissed both prohibition applications on the
basis that Fournier had failed to demonstrate, on a balance of
probabilities, that Sandoz 's allegations of non-infringement
were not justified, concluding:
T-991-10
[91] Accordingly, there is no evidence from which the Court can
conclude, on the balance of probabilities, that the particle size
of the fenofibrate is less than 10 µm or less than 20
µm or indeed less than any number. We do not know what
size most of the fenofibrate particles are less than; all we know
is that the D90 is at least [ ...] and from that evidence we
cannot deduce the D99 of the fenofibrate. Quite simply, we
have not been provided with the evidence from Fournier that is
required in order to be able to conclude that the size of the
fenofibrate particles in the Sandoz Tablet infringes that set out
in the '596 Patent.
T-1184-10
[129] I cannot conclude that Fournier has established, on the
balance of probabilities, that the particle size of the fenofibrate
in the dispersion that is disclosed in the Sandoz ANDS reflects the
size of the fenofibrate particles in the Sandoz Tablet. The
evidence of Dr. Muzzio and Dr. Fairhurst is not supported by any
reference to scientific literature or study. I prefer the
evidence of Dr. Serajuddin and Dr. Leclair, which is supported by
US '986 Patent, and which shows that a solid spray granulated
nanoparticulate composition or tablet redisperses to a particle
size of the active agent that is larger than its particle size in
the dispersion prior to incorporation into a solid dose form.
A copy of the Public Reasons for Judgment and Judgment in
T-911-10 may be found
here.
A copy of the Public Reasons for Judgment and Judgment in
T-1184-10 may be found
here.
According to Health Canada'sNOC
database, Sandoz Fenofibrate E has not yet received an NOC.
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