Sanofi-Aventis Canada Inc. v. Canada (Health)
The court upheld the Federal Court's conclusion that Riva's cross-reference submission was independently substantive and therefore engaged the PM(NOC) Regulations; Riva was required to serve and did serve a notice of allegation addressing the listed patents, so the prohibition order against Pharmascience did not bar...
Source-derived case information.
- Citation
- 2009 FCA 169
- Parties
- Appellant: Sanofi-Aventis Canada Inc.; Respondent: The Minister of Health; Respondent: The Attorney General of Canada; Respondent: Laboratoire Riva Inc.
- Court
- Federal Court of Appeal
- Jurisdiction
- Canada
- Judgment Date
- 26 May 2009
- Procedural Posture
- Judicial Review and Prohibition Proceeding Under Pm(noc) Regulations and the Patent Act / Appeal to the Federal Court of Appeal From Federal Court (hughes J.) Judgment Dismissing Sanofi's Application
- Outcome
- Appeal dismissed with costs.
- Legal Topics
- Notice of Compliance (noc), Pm(noc) Regulations, Abbreviated New Drug Submission (ands), Cross Reference Submissions, Prohibition Order, Generic Pharmaceuticals
- Source Language
- en
Source-derived case record
Summary, issues, holding and outcome
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Parties
Sanofi-Aventis Canada Inc.
Appellant
The Minister of Health
Respondent
The Attorney General of Canada
Respondent
Laboratoire Riva Inc.
Respondent
Procedural Posture
Judicial Review and Prohibition Proceeding Under Pm(noc) Regulations and the Patent Act / Appeal to the Federal Court of Appeal From Federal Court (hughes J.) Judgment Dismissing Sanofi's Application
Legal Issues
- 1 Whether a prohibition order against an original ANDS filer (Pharmascience) prevents an independent generic (Riva) from relying on that ANDS via cross-reference
- 2 Whether Riva's cross-reference submission circumvented the PM(NOC) Regulations
- 3 Whether Riva was required to and did serve Sanofi with a notice of allegation addressing the listed patents
Ratio Decidendi
The court upheld the Federal Court's conclusion that Riva's cross-reference submission was independently substantive and therefore engaged the PM(NOC) Regulations; Riva was required to serve and did serve a notice of allegation addressing the listed patents, so the prohibition order against Pharmascience did not bar Riva from obtaining a NOC, and Sanofi's challenge failed.
Court Disposition
Appeal dismissed with costs.
Orders
- Appeal dismissed with costs
Full Case Text
Judgment text and source record
1 paragraphs
Sanofi-Aventis Canada Inc. v. Canada (Health) Court (s) Database Federal Court of Appeal Decisions Date 2009-05-26 Neutral citation 2009 FCA 169 File numbers A-470-08 Decision Content Federal Court of Appeal CANADA Cour d'appel fédérale Date: 20090526 Docket: A-470-08 Citation: 2009 FCA 169 CORAM: LINDEN J.A. EVANS J.A. SHARLOW J.A. BETWEEN: SANOFI-AVENTIS CANADA INC. Appellant and THE MINISTER OF HEALTH, THE ATTORNEY GENERAL OF CANADA, and LABORATOIRE RIVA INC. Respondents Heard at Ottawa, Ontario, on May 26, 2009. Judgment delivered from the Bench at Ottawa, Ontario, on May 26, 2009. REASONS FOR JUDGMENT OF THE COURT BY: SHARLOW J.A. Federal Court of Appeal CANADA Cour d'appel fédérale Date: 20090526 Docket: A-470-08 Citation: 2009 FCA 169 CORAM: LINDEN J.A. EVANS J.A. SHARLOW J.A. BETWEEN: SANOFI-AVENTIS CANADA INC. Appellant and THE MINISTER OF HEALTH, THE ATTORNEY GENERAL OF CANADA, and LABORATOIRE RIVA INC. Respondents REASONS FOR JUDGMENT OF THE COURT (Delivered from the Bench at Ottawa, Ontario, on May 26, 2009) SHARLOW J.A. [1] This is an appeal of the judgment of Justice Hughes dismissing with costs the application of Sanofi-Aventis Canada Inc. for an order quashing the decision of the Minister of Health to issue a notice of compliance (NOC) to the respondent Laboratoire Riva Inc. for a generic version of 2.5, 5 and 10 mg ramipril capsules (2008 FC 1062). [2] Despite the able submissions of Mr. Gaikis, we have not been persuaded that Justice Hughes erred in law in deciding as he did. We agree with his decision, substantially for the reasons he gave. [3] Essentially, the argument for Sanofi is based on the premise that the abbreviated new drug submission (ANDS) originally filed by Pharmascience is so linked to the later prohibition order against Pharmascience that the order necessarily bars an independent generic drug producer, in this case Riva, from relying on the Pharmascience ANDS by using the technique of the “cross-reference” submission. We do not accept this argument. [4] Nor do we accept the submission of Sanofi that Riva has circumvented the PM (NOC) Regulations. Riva’s submission for a NOC, even though it was by way of cross-reference, was a submission of sufficient substance to engage the PM (NOC) Regulations, so that Riva was required independently to serve Sanofi with a notice of allegation addressing the listed patents. It did so, and successfully defended the resulting prohibition application commenced by Sanofi. [5] This appeal will be dismissed with costs. “K. Sharlow” J.A. FEDERAL COURT OF APPEAL NAMES OF COUNSEL AND SOLICITORS OF RECORD DOCKET: A-470-08 STYLE OF CAUSE: Sanofi-Aventis Canada Inc. v. The Minister of Health et al PLACE OF HEARING: Ottawa, Ontario DATE OF HEARING: May 26, 2009 REASONS FOR JUDGMENT OF THE COURT BY: (LINDEN, EVANS, SHARLOW J.J.A.) DELIVERED FROM THE BENCH BY: SHARLOW J.A. APPEARANCES: Gunars A. Gaikis Y. Lynn Ing FOR THE APPELLANT Arthur B. Renaud Rick Woyiwada FOR THE RESPONDENT Laboratoire Riva Inc. FOR THE RESPONDENT Minister of Health SOLICITORS OF RECORD: Smart & Biggar Toronto, Ontario FOR THE APPELLANT Bennett Jones LLP Toronto, Ontario John H. Sims, Q.C. Deputy Attorney General of Canada FOR THE RESPONDENT Laboratoire Riva Inc. FOR THE RESPONDENT Minister of Health