Cancel the Date: Federal Court Vacates Novel Bifurcation for Section 8 Start Date

On September 15, 2014 Prothonotary Aalto granted Pfizer’s motion to amend its pleadings and in doing so vacated a bifurcation order that bifurcated the start date issue from the rest of Apotex’s section 8 claim.

This motion arose in the context of Apotex’s claim for section 8 damages relating to Pfizer’s atorvastatin product, marketed under the brand Lipitor. In a novel order the start date issue was bifurcated from the remaining issues (see our previous post here). The start date issue arose because Apotex developed two atorvastatin products. The Minister of Health certified patent hold dates of May 15, 2007 and February 22, 2010 for Apotex’s first and second atorvastatin products, respectively. Apotex received Notices of Compliance for both products on May 19, 2010 but only marketed the second product.

Amongst the proposed amendments, Pfizer sought to amend its defence to plead that Apotex’s 2006 NOAs have no legal effect because they failed to include information required by the PM(NOC) Regulations. Pfizer also sought amendments related to Apotex’s decision to market only the second of its generic atorvastatin products arguing this election disentitles Apotex to damages for the longer period associated with the product it chose not to market.

After reviewing the jurisprudence dealing with motions to amend, Prothonotary Aalto considered Apotex’s argument that the proposed amendments did not amount to a recognized defence to a section 8 damages claim. Prothonotary Aalto stated that section 8 damage cases are an evolving area of law and one should not arbitrarily close the door to possible defences without the benefit of a full record before a trial judge.

Prothonotary Aalto found that the proposed amendments should be granted as they were not so radical as to amount to a new and different case and any prejudice to Apotex could be compensated by way of remedy. Prothonotary Aalto noted that all proposed amendments alter the scope of the start date issue, making it virtually impossible for the issue to be determined as originally contemplated. Thus, in addition to granting Pfizer motion to amend, Prothonotary Aalto vacated the bifurcation order and ordered that the trial shall commence on April 4, 2016 on all issues, subject to the discretion of the trial judge.

A copy of Prothonotary Aalto’s Order and Reasons may be found here.