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Canada: Pharma in brief

Federal Court Considers a Patent Disclaimer Filed After the Receipt of a Notice of Allegation

November 10, 2009

Case: sanofi-aventis Canada Inc. v. Hospira Healthcare Corporation (Federal Court - Zinn J.)
DRUG: TAXOTERE (docetaxel)
Nature of Case: NOC Regulations: s. 6 Prohibition Proceedings
Successful Party: Hospira Healthcare Corporation
Date of Decision: October 22, 2009

Summary:

On October 22, 2009, Justice Zinn of the Federal Court dismissed sanofi-aventis Canada Inc.'s application for an order of prohibition. In doing so, Justice Zinn considered several issues relating to disclaimers including: the date at which a Notice of Allegation (an "NOA") is to be assessed; the evidence required to demonstrate the validity of a disclaimer; and the effect of an invalid disclaimer.

On October 15, 2008, Hospira Healthcare Corporation ("Hospira") sent a Notice of Allegation (an "NOA") to sanofi-aventis Canada Inc. ("sanofi") in respect of Canadian Patent No. 2,102,778 (the "'778 Patent") and three other patents relating to TAXOTERE. In the NOA, Hospira alleged that the '778 Patent was invalid for double patenting in light of Canadian Patent No. 2,102,777, which is also owned by sanofi and listed on the Patent Register in respect of TAXOTERE. sanofi subsequently filed a disclaimer in respect of the '778 Patent on the basis that "there was potential overlap in the scope of the claims of these two patents." Shortly after filing the disclaimer, sanofi commenced the prohibition application based upon only '778 Patent as disclaimed.

Hospira argued that the Court should consider the '778 Patent as it read on the date the NOA was served and not as it read after the disclaimer was filed. In making this argument, Hospira relied on three recent cases: Bristol-Myers Squibb Canada Co. v. Apotex Inc., 2009 FC 137 ("BMS"); Abbott Laboratories v. Sandoz Canada Inc., 2009 FC 648 ("Abbott"); and Janssen-Ortho Inc. v. Apotex Inc., 2009 FC 650, aff'd 2009 FC 783 ("Janssen-Ortho"). sanofi, in contrast, relied upon the Supreme Court of Canada's decision in Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare), [1998] 2 S.C.R. 198 ("Merck") and argued that the Court should assess the allegations contained in the NOA as of the date of the hearing and thus should consider the '778 Patent as disclaimed. sanofi argued that BMS, Abbott and Janssen-Ortho would have been decided differently had the Merck decision been considered in those proceedings.

Justice Zinn reviewed the case law and followed the decision in Merck, holding that the justification for an NOA is to be assessed as of the date of hearing and not at the date of service of the NOA. Justice Zinn also held that the decisions in BMS, Abbott and Janssen-Ortho should not be followed.

Justice Zinn then found that the disclaimer was invalid as sanofi failed to prove that the overclaiming in the '778 Patent was the result of an accident, inadvertence or mistake. At a minimum, Zinn J. held that sanofi should have admitted that the claims were too broad and explained how the overclaiming occurred in order to prove that the drafting was by mistake, accident or inadvertence and with no wilful intent to defraud the public. Since sanofi's affiants made no such admissions, sanofi failed to meet its burden of proof establishing that the disclaimer was valid.

Finally, Zinn J. held "that having filed a disclaimer the patentee [sanofi] cannot appropriately also rely on the patent as it read before the disclaimer. The filing of the disclaimer is an admission that the patent as filed was over broad and this admission is not affected by a subsequent finding that the disclaimer was not valid."

LINK TO DECISION:

The decision has not yet been posted on the Federal Court website. However, the decision has been assigned the following neutral citation: sanofi-aventis Canada Inc. v. Hospira Healthcare Corporation, 2009 FC 1077.

The purpose of this document is to provide information as to developments in the law. It does not contain a full analysis of the law nor does it constitute an opinion of Ogilvy Renault LLP or any member of the firm on the points of law discussed.

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