Court Affirms Prothonotary’s Decision Refusing to Strike Out Affidavit Evidence and Refusing to Allow Filing of Reply Evidence During PM(NOC) Proceedings
AstraZeneca Canada Inc. v. Apotex Inc., 2010 FC 65 (Hughes, J.)

January 20, 2010

Yoon Kang and Tracey Stott for the Applicant, AstraZeneca Canada Inc.
Andrew Brodkin and Daniel Cappe for the Respondent, Apotex Inc.

In a motion brought by AstraZeneca during Patented Medicines (Notice of Compliance) (“PM(NOC)”) proceedings, AstraZeneca appealed a decision of a prothonotary in which the prothonotary: (1) refused to strike out certain Apotex affidavit evidence (the “Hems Affidavit”); and (2) refused to permit AstraZeneca to file an affidavit (the “Davies Affidavit”) by way of reply evidence.

The Court affirmed the prothonotary’s decision with respect to both the Hems Affidavit and the Davies Affidavit.

As a preliminary matter, the Court noted that there was no provision in the Federal Court Rules for striking out evidence before the hearing of an application or for allowing evidence to be filed in reply to evidence filed by a respondent in application proceedings.  The Court further noted that while court orders to such effect were sometimes granted, they were exceptional and determined on a case-by-case basis.

With respect to the Hems Affidavit, AstraZeneca took the position that the Hems Affidavit constituted a withdrawal of certain statements made by Apotex in its Notice of Allegation, the effect of which would prejudice AstraZeneca, particularly were Apotex to make a section 8 claim under the PM(NOC) Regulations.  The Court concluded that this potential prejudice was entirely speculative.  Furthermore, the Court concluded that Apotex was not changing its Notice of Allegation by virtue of filing the Hems Affidavit; instead, Apotex was removing one of the grounds for the allegations as to non-infringement, and was simplifying the case by narrowing the issues for determination by the Court.  Consequently, the Court affirmed the prothonotary’s refusal to strike out the Hems Affidavit, commenting that any ramifications as to a Section 8 claim under the PM(NOC) Regulations could be argued by AstraZeneca at a later time, if necessary.

With respect to the Davies Affidavit, AstraZeneca argued that it addressed two matters: first, the propriety of certain tests, said to replicate prior art, that was put in evidence by Apotex; and second, an “optical purity” issue that AstraZeneca argued was not put into play initially in Apotex’s Notice of Allegation.  As to the propriety matter, AstraZeneca argued that it  was caught by surprise and could not have anticipated Apotex’s evidence. The Court disagreed on the bases that AstraZeneca had known the order in which evidence was to be presented in the proceedings by virtue of a previous order of the prothonotary, and that if AstraZeneca was caught by surprise, there was no evidence that indicated this before the prothonotary.  As to whether Apotex had gone beyond the allegations made in its Notice of Allegation, the Court held that AstraZeneca was free to make this argument at the hearing of its applications.  It determined that this argument was one of law, and consequently, there was no need for AstraZeneca to rely on the Davies Affidavit.

By: Roch Ripley, Gowling Lafleur Henderson LLP