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LIPIDIL EZ – Absence of evidence of direct specific infringement sinks prohibition applications

Fenofibrate

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.

As previously reported, Fournier has appealed both Judgments.

According to  Health Canada’s NOC database,  Sandoz Fenofibrate E has not yet  received an NOC.