Right of Reply When Evidence Not Anticipated
AstraZeneca Canada Inc., AstraZeneca AB and Shionogi Seiyaku Kabushiki Kaisha v. Novopharm Limited and The Minister of Health 2009 FC 902 (Aalto, P.)

July 23, 2009

Gunars A. Gaikis and Ursula Wojtyra for the Applicants, AstraZeneca Canada Inc. et al. (“AstraZeneca”)
Jonathan Stainsby and Lesley Caswell for the Respondent, Novopharm Limited (“Novopharm”)

The Applicants, AstraZeneca, sought an order pursuant to the PM(NOC) Regulations prohibiting the Minister of Health from issuing a NOC to the Respondent, Novopharm, in respect of rosuvastatin calcium tablets until the expiration of Canadian Patent Nos. 2,072,945 (the ‘945 Patent) and 2,313,783.

The primary issue considered by the Court was the right of Novopharm to file reply evidence. Novopharm sought to file reply affidavits of three expert witnesses who had each filed affidavits in chief pursuant to an order reversing the evidence on invalidity.

Novopharm argued that the affidavits were required because the Notice of Application was bereft of any relevant facts to permit Novopharm to know the case it has to meet; there was no information in the Notice as to why the ‘945 Patent is not a selection patent, the nature of any special advantage of rosuvastatin over other statins disclosed in an earlier genus patent, and why the ‘945 Patent is not anticipated or obvious.

AstraZeneca argued that Novopharm had not demonstrated the need to serve reply evidence, that such evidence is an attempt to split its case, that the evidence is repetitive and duplicative of evidence already given, that much of it should have been part of the evidence in chief, that such reply evidence should be dealt with on cross-examination of the AstraZeneca’s experts, and that it was available at an earlier date.

The Court held that while there is no automatic right of reply in proceedings under the Regulations, where a party raises an issue or puts forward evidence that is new or unanticipated to the other party, then that party ought to have the right of reply.

The Court was satisfied that the reply evidence would assist the court, serve the interests of justice, and not cause substantial or serious prejudice to the other side. In considering whether evidence was available at an earlier date, the Court held that the evidence must be known to be relevant and required.

The Court held that the fact that a party may baldly state they did not anticipate evidence will not be sufficient to permit reply evidence to be filed. Novopharm, in an affidavit in support of the motion, had provided specific details of the reply evidence and why it was not anticipated. This was considered sufficient to meet the required tests for reply evidence.

Novopharm was granted leave to file the majority of its reply evidence. The balance of the motion was dismissed with costs.

By: Clare McCurley, Deeth Williams Wall LLP