Case: Apotex Inc. v. Pfizer Ireland Pharmaceuticals

Drug:VIAGRA (sildenafil citrate)

Nature of Case:Patent impeachment action - s. 60(1) of the Patent Act

Successful Party:Pfizer Ireland Pharmaceuticals

Date of Decision:September 29, 2010  

Summary:

On September 29, 2010, Justice Hughes of the Federal Court dismissed an appeal by Apotex seeking to strike allegations of issue estoppel, collateral estoppel, comity and abuse of process (the "Abuse Allegations") from Pfizer's Statement of Defence in an impeachment action. Ogilvy Renault represented Pfizer at the appeal.

Pfizer successfully brought a prohibition application against Apotex under the PM(NOC) Regulations in respect of Canadian Patent No. 2,163,446, and was similarly successful on appeal. Apotex subsequently commenced a patent impeachment action in respect of the same patent raising almost the identical allegations of invalidity it had raised in the PM(NOC) proceeding.

Apotex brought a motion to strike the Abuse Allegations from Pfizer's Statement of Defence on the basis that they had no chance of success. Apotex's motion was dismissed by Prothonotary Aalto by Order dated June 11, 2010, as it was not clear that Pfizer's defence was bereft of any chance of success (see PIB dated June 16, 2010).

Apotex appealed from the Prothonotary's Order. Hughes J. held that "the issue on this appeal concerns the effect, if any, of a final decision brought by way of application under the Patented Medicines (Notice of Compliance) Regulations on proceedings brought by way of an action under the Patent Act for a declaration of invalidity of the same patent(s) considered in the NOC application." The Court noted that a party seeking to strike an allegation from a pleading must meet the "high threshold" of demonstrating that it is plain and obvious that the defence cannot succeed at trial. Hughes J. reviewed the jurisprudence and noted that "issues as to issue estoppel, comity, collateral estoppel, and abuse of process had not been raised or fully argued in any previous case, particularly as they relate to evidentiary findings and findings as to legal issues that were fully argued." Since these issues had not been "squarely raised previously", it was not "sufficiently plain and obvious" that they should be struck out. Hughes J. held that if "Apotex is ultimately successful on the issue", then there could be "cost implications". The Court struck Pfizer's defence of res judicata, on consent, based on jurisprudence from the Federal Court of Appeal. Pfizer was given 10 days to file an Amended Statement of Defence.

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LINK TO DECISION: The decision is not yet available on the Federal Court website, however, the decision will have the following neutral citation: Apotex Inc. v. Pfizer Ireland Pharmaceuticals, 2010 FC 968.