Patented Medicines (Notice of Compliance) Regulations Matter Relating to a Methylphenidate Product
Janssen-Ortho Inc. v. Apotex Inc., 2010 FC 81 (Zinn, J.)

January 25, 2010

Neil Belmore for the Applicants, Janssen-Ortho Inc. and Alza Corporation
David Lederman and Daniel Cappe for the Respondent, Apotex Inc. (“Apotex”)

This decision relates to an application made pursuant to the Patented Medicines (Notice of Compliance) Regulations relating to a methylphenidate product.  In the applications, Apotex was required to file its evidence relating to validity before the Applicants were required to file their evidence.  The Applicants were required to file their evidence as to infringement before Apotex. 

The Applicants sought to have certain paragraphs and exhibits struck from Apotex’s evidence filed in response to the Applicants’ evidence on infringement.  The Applicants alleged that some of the evidence related to the invalidity of the patent rather than non-infringement.  The Applicants asserted that the paragraphs relating to invalidity violated the Court’s scheduling orders.  In the alternative, the Applicants sought to file reply evidence. 

Justice Zinn cited previous jurisprudence which held that motions to strike in Notice of Compliance (“NOC”) proceedings should be the exception and that complaints about the evidence are best left to the hearing judge.  Justice Zinn also held that in NOC proceedings, where the order of evidence has been reversed, parties ought not to file evidence in the second tranche that clearly and without question should have been filed in the first tranche.  However, the evidence about which a party complains must clearly and without question relate only to the issue on which the party has already filed its evidence. 

Justice Zinn examined each of the affidavits in questions, and in particular, the paragraphs which the Applicants alleged were directed to validity.  Justice Zinn found that paragraphs relating to ambiguity went to the interpretation of the patent.  Therefore, this evidence was acceptable as it did not relate only to invalidity.  Justice Zinn also refused to strike paragraphs relating to prior art as these paragraphs could relate to the Gilette defence, and hence, not solely to invalidity.  Other paragraphs relating to the construction of the patent were also not struck.  Paragraphs which had no obvious connection either to infringement or to the interpretation of the patent were struck. 

The Applicants sought to file reply evidence.  Rule 312(a) of the Federal Court Rules permits the Court to grant leave to file additional affidavits if the following four requirements are met: (a) The evidence to be adduced will serve the interests of justice; (b) The evidence will assist the Court; (c) The evidence will not cause substantial or serious prejudice to the other side; and (d) The evidence must not have been available at an earlier date.  Justice Zinn found that the Applicants had not demonstrated that some of the proposed evidence was not previously available or could not have been anticipated as relevant.  This evidence was not permitted to be filed.  Only the portion of the affidavit that could not have been reasonably anticipated could be filed in reply.

By: Jacqueline Chernys