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Case information

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38336

Apotex Inc. v. Minister of Health, et al.

(Federal) (Civil) (By Leave)

Docket

Judgments on applications for leave to appeal are rendered by the Court, but are not necessarily unanimous.

List of proceedings
Date Proceeding Filed By
(if applicable)
2019-02-26 Close file on Leave
2019-02-22 Copy of formal judgment sent to Registrar of the Court of Appeal and all parties
2019-02-22 Judgment on leave sent to the parties
2019-02-21 Judgment of the Court on the application for leave to appeal,
The application for leave to appeal from the judgment of the Federal Court of Appeal, Number A-137-17, 2018 FCA 147, dated August 2, 2018, is dismissed with costs.
Dismissed, with costs
2019-01-21 All materials on application for leave submitted to the Judges, for consideration by the Court
2018-11-15 Applicant's reply to respondent's argument, (Book Form), Completed on: 2018-11-15 Apotex Inc.
2018-11-05 Certificate (on limitations to public access), (Letter Form) Minister of Health
2018-11-05 Notice of name, (Letter Form) Minister of Health
2018-11-05 Respondent's response on the application for leave to appeal, (Book Form), Completed on: 2018-11-05 Minister of Health
2018-10-05 Letter acknowledging receipt of a complete application for leave to appeal, FILE OPENED: 05/10/2018
2018-10-01 Notice of name, (Letter Form) Apotex Inc.
2018-10-01 Certificate (on limitations to public access), (Letter Form), Form 23A Apotex Inc.
2018-10-01 Application for leave to appeal, (Book Form), Completed on: 2018-10-01 Apotex Inc.

Parties

Please note that in the case of closed files, the “Status” column reflects the status of the parties at the time of the proceedings. For more information about the proceedings and about the dates when the file was open, please consult the docket of the case in question.

Main parties

Main parties - Appellants
Name Role Status
Apotex Inc. Applicant Active

v.

Main parties - Respondents
Name Role Status
Minister of Health Respondent Active
Attorney General of Canada Respondent Active

Counsel

Party: Apotex Inc.

Counsel
Names
Harry B. Radomski
Nando De Luca
Julie Rosenthal
Daniel Cohen
Contact information
Goodmans LLP
Bay Adelaide Centre
333 Bay Street, Suite 3400
Toronto, Ontario
M5H 2S7
Telephone: (416) 597-4142
Email: hradomski@goodmans.ca
Agent
Name
Christopher Rootham
Contact information
Nelligan O'Brien Payne LLP
50 O'Connor Street
Suite 1500
Ottawa, Ontario
K1P 6L2
Telephone: (613) 238-8080
FAX: (613) 238-2098
Email: christopher.rootham@nelligan.ca

Party: Minister of Health

Counsel
Names
Glynis Evans
Laura Tausky
Contact information
Department of Justice
The Exchange Tower, 130 King St. West
Suite 3400, Box 36
Toronto, Ontario
M5X 1K6
Telephone: (416) 954-9025
FAX: (416) 973-0809
Email: glynis.evans@justice.gc.ca
Agent
Name
Christopher Rupar
Contact information
Department of Justice
50 O'Connor Street
Suite 500
Ottawa, Ontario
K1A 0H8
Telephone: (613) 670-6290
FAX: (613) 954-1920
Email: christopher.rupar@justice.gc.ca

Party: Attorney General of Canada

Counsel
Names
Glynis Evans
Laura Tausky
Contact information
Department of Justice
The Exchange Tower, 130 King St. West
Suite 3400, Box 36
Toronto, Ontario
M5X 1K6
Telephone: (416) 954-9025
FAX: (416) 973-0809
Email: glynis.evans@justice.gc.ca
Agent
Name
Christopher Rupar
Contact information
Department of Justice
50 O'Connor Street
Suite 500
Ottawa, Ontario
K1A 0H8
Telephone: (613) 670-6290
FAX: (613) 954-1920
Email: christopher.rupar@justice.gc.ca

Summary

Keywords

Administrative law – Judicial review – Evidence – Adverse inference – Judge reviewing decision of Health Canada to require further information on safety and efficacy of drug manufactured in facility with data integrity concerns – Applicant arguing reviewing judge failing to make appropriate adverse inferences regarding decision under review – What is the proper test to be applied as to when an adverse inference should and must be drawn?

Summary

Case summaries are prepared by the Office of the Registrar of the Supreme Court of Canada (Law Branch). Please note that summaries are not provided to the Judges of the Court. They are placed on the Court file and website for information purposes only.

Apotex Inc. successfully obtained judgments quashing two decisions of Health Canada relating to manufacturing facilities in India owned by Apotex affiliates: the decision in September 2014 to impose an import ban on drug products produced in those facilities, and the decision in August 2015 to vary the terms and conditions of the licences for the facilities. The first decision was quashed on the basis that, in imposing the import ban, the Minister of Health acted for an improper purpose, motivated by the Minister’s desire to relieve political pressure. The second decision was quashed on the basis that it was interconnected with the first decision and tainted by the same improper purpose. Apotex also sought judicial review of a third decision by Health Canada made in the fall of 2015, to refuse to end a requirement put in place through another decision made in November 2014. The November 2014 decision was that regulatory approval would not be granted for products manufactured in or containing active pharmaceutical ingredients sourced from the two facilities in India unless Health Canada was provided with additional information confirming the integrity of test data from those facilities. Apotex argued that this decision, too, was tainted by the Minister’s improper purpose in the first two quashed decisions. The reviewing judge dismissed Apotex’s application for judicial review. This decision was upheld on appeal.

Lower court rulings

March 27, 2017
Federal Court

2017 FC 315, T-1915-15

Applicant’s application for judicial review dismissed

August 2, 2018
Federal Court of Appeal

2018 FCA 147, A-137-17

Applicant’s appeal dismissed.

Filed documents

The memorandums of argument on an application for leave to appeal will be posted here 30 days after leave to appeal has been granted unless they contain personal information, information that is subject to a publication ban, or any other information that is not part of the public record. You may also obtain copies of the memorandum by filling out the Request for Court records form or by contacting the Court’s Records Centre either by email at records-dossiers@scc-csc.ca or by telephone at 613‑996‑7933 or at 1‑888‑551‑1185.

If you have questions about a memorandum of argument or want to use a memorandum of argument, please contact the author of the memorandum of argument directly. Their name appears at the end of the memorandum of argument. The contact information for counsel is found in the “Counsel” tab of this page.

Downloadable PDFs

Not available

The factums of the appellant, the respondent and the intervener will be posted here at least 2 weeks before the hearing unless they contain personal information, information that is subject to a publication ban, or any other information that is not part of the public record. You may also obtain copies of factums by filling out the Request for Court records form or by contacting the Court’s Records Centre either by email at records-dossiers@scc-csc.ca or by telephone at 613‑996‑7933 or at 1‑888‑551‑1185.

If you have questions about a factum or want permission to use a factum, please contact the author of the factum directly. Their contact information appears on the first page of each factum.

Downloadable PDFs

Not available

The condensed books of the appellant, the respondent and the intervener will be posted here upon receipt of the electronic version, 2 days prior to the scheduled appeal hearing. You may also obtain copies of condensed books by filling out the Request for Court records form or by contacting the Court’s Records Centre either by email at records-dossiers@scc-csc.ca or by telephone at 613‑996‑7933 or at 1‑888‑551‑1185.

If you have questions about a condensed book or want permission to use a condensed book, please contact the author of the condensed book directly. Their contact information appears on the first page of each condensed book.

Downloadable PDFs

Not available

Webcasts

Not available.

Date modified: 2025-05-21