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Sandoz’s LIPIDIL EZ non-infringement allegations justified

On June 15, 2012, Justice Zinn issued Judgments in two prohibition proceedings between Sandoz and Fournier in respect of fenofibrate tablets and Canadian Patent Nos. 2,372,576 (Court File No. T-991-10) and 2,487,054 (Court File No. T-1184-10). The ‘576 patent generally claims specific compositions of fenofibrate with a particle size less than 20 microns. The ‘054 patent is generally directed to formulations having a certain particle size having certain pharmacokinetic parameters in the fed and fasted state.  Both the ‘576 and ‘054 patents are listed on the Patent Register against Founier’s LIPIDIL EZ fenofibrate tablets.

fenofibrate

fenofibrate

The Federal Court’s recorded entries in both proceedings indicates that the result of the judicial review applications are “CONFIDENTIAL”. According to the Court’s recorded entries,  Justice Zinn has provided the parties in both matters until the end of business on Friday June 29, 2012 to inform the Court if any portions of the confidential reasons should be deleted or modified in the public versions thereof.

While Justice Zinn’s reasons remain confidential, Fournier has appealed the dismissal of the prohibition applications in respect of the ‘576 patent (Court File No. A-298-12) and the ‘054 patent (Court File No. A-299-12).

According to the redacted Notice of Appeal filed in A-298-12, Justice Zinn concluded that every one of Sandoz’s allegations of invalidity was not justified but he dismissed the prohibition proceeding because Fournier had failed to establish that Sandoz’s allegation of non-infringement was not justified.  In the Notice of Appeal, Fournier alleges that Justice Zinn’s finding on infringement arose from a deficiency in Sandoz’s Notice of Allegation, specifically that Sandoz “deliberately chose not to allege or ever commit to any particular particle size”.

According to the redacted Notice of Appeal filed in A-299-12, Fournier has asserted claims 10, 20, 27-28 and 38 of the ‘054 patent as they depend on claims 1-3. Justice Zinn found that Sandoz’s allegations of invalidity of the asserted claims were unjustified, but dismissed the application finding that Fournier had failed to establish, that Sandoz’s product infringes the ‘054 patent.

As of today, Health Canada’s NOC database does not indicate that Sandoz has received a NOC for its fenofibrate product.

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