Date: 20050513
Docket: A-334-04
Citation: 2005 FCA 175
SEXTON J.A.
MALONE J.A.
BETWEEN:
ASTRAZENECA CANADA INC.
Appellant
and
MINISTER OF HEALTH
Respondent
Heard at Ottawa, Ontario, on April 12, 2005.
Judgment delivered at Ottawa, Ontario, May 13, 2005.
REASONS FOR JUDGMENT BY: MALONE J.A.
CONCURRED IN BY: NOËL J.A.
SEXTON J.A.
Date: 20050513
Docket: A-334-04
Citation: 2005 FCA 175
SEXTON J.A.
MALONE J.A.
BETWEEN:
ASTRAZENECA CANADA INC.
Appellant
and
MINISTER OF HEALTH
Respondent
REASONS FOR JUDGMENT
[1] This is an appeal of an order made by Heneghan J. of the Federal Court dated May 20, 2004 (and reported as 2004 FC 736), dismissing an application for judicial review brought by AstraZeneca Canada Inc. (AstraZeneca). The Applications Judge upheld the decision of the Minister of Health that AstraZeneca's Canadian Patent No. 2,186,037 (the '037 patent) was not to be included on the Patent Register maintained by the Minister where the supplemental new drug submission (SNDS) to which the patent related was made solely for the purpose of changing the name of the original drug manufacturer, Astra Pharma Inc.
[2] AstraZeneca is the successor corporation arising from the merger between Astra Pharma Inc. and Zeneca Pharma Inc. that took effect on January 1, 2000. The SNDS in issue would have replaced the name Astra Pharma Inc. as manufacturer with that of AstraZeneca.
[3] According to the Minister, AstraZeneca cannot add the '037 patent to the Patent Register under subsection 4(4) of the Patented Medicines (Notice of Compliance) Regulations, S.O.R./93-133 (the NOC Regulations). He argued that, using a contextual interpretation of the legislation, the phrase "submission for a notice of compliance" does not include every such submission, but only those submissions that have some meaning and significance in the context of the NOC Regulations. The Minister took the position that allowing AstraZeneca's application would render ineffective the requirements set out in subsections 4(4) and 4(5) of these Regulations.
[4] Following the reasoning of this Court in Hoffman-La Roche Limited v. The Minister of Health and The Attorney General of Canada, 2005 FCA 140, there is no justification for allowing a patent holder to enhance the advantages it obtains under the NOC Regulations as a result of a mere administrative change in the name of the manufacturer. As stated by Sharlow J.A. in Hoffman-La Roche at paragraph 25, a change in the name of a drug manufacturer is not relevant to the overall purposes of the NOC Regulations, which is preventing patent infringement.
[5] Accordingly, since a change in the manufacturer's name is not relevant to any potential claim for patent infringement, AstraZeneca cannot rely on such a submission in order to add the '037 patent to the Patent Register.
[6] I would dismiss the appeal with costs.
"B. Malone"
J.A.
"I agree
Marc Noël J.A."
"I agree
J. Edgar Sexton"
FEDERAL COURT OF APPEAL
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: A-334-04
Appeal from an Order of the Federal Court dated May 20, 2004
Federal Court File No.: T-1954-02
STYLE OF CAUSE: AztraZeneca Canada Inc. v. The Minister of Health
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: April 13, 2005
REASONS FOR JUDGMENT BY: Malone J.A.
CONCURRED IN BY: Noël J.A.
Sexton J.A.
DATED: May 13, 2005
APPEARANCES:
Mr. Gunars Gaikis
Ms. Nancy Pei FOR THE APPELLANT
Mr. Rick Woyiwada FOR THE RESPONDENT
SOLICITORS OF RECORD:
Smart & Biggar
Toronto, Ontario FOR THE APPELLANT
Mr. John Sims, Q.C.
Deputy Attorney General of Canada
Ottawa, Ontario FOR THE RESPONDENT