2009 fc 914; ezetimibe; September 15, 2009

The Prothonotary hasd dismissed Novopharm's motion for leave to file reply evidence. The motions judge partially overturned that order.

Novopharm had sent a NOA that was very broad and alleged some 223 pieces of prior art. Merck Frosst started a proceeding by way of an Application. The order of evidence was reversed, resulting in Novopharm filing its evidence relating to validity first.

The Court held that its job is to determine, on an objective analysis, whether the proposed reply evidence could reasonably have been anticipated as relevant. The Court then found that the generic company does not need to speculate as to every piece of evidence that an Applicant may choose to put forward. Where the Applicant is not merely challenging the generic company's expert but rather is raising new matters with different science, authorities and assumptions, then reply evidence from the generic may be appropriate.

The Court refused to allow reply evidence to be filed where the Applicant's witnesses were merely considering other parts of documents that Novopharm's witnesses had commented upon. However, when Merck Frosst's witnesses were raising new issues, reply evidence was allowed.

The full text of the decision can be found at: http://decisions.fct-cf.gc.ca/en/2009/2009fc914/2009fc914.html