Merits of a 55.2 proceeding; 2009 FC 320; raloxifene; March 26, 2009

The Court dismissed the application for prohibition on the basis that the allegations of anticipation, obviousness, claims broader and Gillette defence are justified. The allegation as to non-infringement was not justified, however, that did not effect the outcome of the proceeding.

A preliminary motion was brought to strike the evidence of one of the witnesses for Apotex as when he drafted his affidavit, he was an employee of a company related to Apotex, and when he was cross-examined on his affidavit he was an employee of Apotex' counsel of record. This motion was dismissed for a number of reasons, including that there was no evidence that any of his connections caused him to be biased or influenced the results of his testing. Furthermore, the motion was brought just before hearing, with no reservation of rights to do so. The Court found that the evidence was in the record and nobody was taken by surprise.

The Court found that there had been no abuse in continuing with the Apotex proceeding when a Novopharm proceeding was pending as the decision in the Novopharm proceeding was not rendered until after the hearing in the Apotex proceeding. However, the Court did consider that comity should apply and found that there was no reason to arrive at a result different from that in the Novopharm proceeding. Thus, the allegations as to invalidity based on anticipation and obviousness were justified.

The Court then considered additional allegations made by Apotex and found the allegation as to be overbreadth to be justified. Furthermore, the Court found that on a balance of probabilities, Apotex' process is not different than the process of one of the prior art patents found to anticipate the patent at issue. Thus, although a simple allegation of non-infringement would fail, Apotex' Gillette defence is justified.

The full text of the decision can be found at:

http://decisions.fct-cf.gc.ca/en/2008/2009fc320/2009fc320.html