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35886

Sanofi-Aventis, et al. v. Apotex Inc., et al.

(Federal) (Civil) (By Leave)

(Sealing order) (Certain information not available to the public)

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)
2015-05-01 Transcript received, 101 PAGES
2015-04-27 Appeal closed
2015-04-21 Formal judgment sent to the registrar of the court of appeal and all parties
2015-04-21 Judgment on appeal and notice of deposit of judgment sent to all parties
2015-04-20 Judgment on the appeal rendered, The appeal from the judgment of the Federal Court of Appeal, Numbers A-191-12, A-193-12, A-397-12 and A-474-12, 2014 FCA 68, dated March 14, 2014, was heard on April 20, 2015, and the Court on that day delivered the following judgment orally:

THE CHIEF JUSTICE — We are all of the view to dismiss the appeal substantially for the reasons of the majority of the Court of Appeal.
The appeal is dismissed with costs.
, CJ Abe Ro Cro Mo Ka Wa Ga Côt
Dismissed, with costs
2015-04-20 Hearing of the appeal, 2015-04-20, CJ Abe Ro Cro Mo Ka Wa Ga Côt
Judgment rendered
2015-04-20 General proceeding, Respondent Apotex Inc.
2015-04-20 General proceeding, Appellants Sanofi-Aventis
2015-04-20 Intervener's condensed book, (Book Form) Canadian Generic Pharmaceutical Association
2015-04-20 Respondent's condensed book, (Book Form) Apotex Inc.
2015-04-20 Appellant's condensed book, (Book Form) Sanofi-Aventis
2015-04-14 Appeal perfected for hearing
2015-04-08 Notice of appearance, H.B. Radomski, Andrew Brodkin, David Scrimger and Benjamin Hackett will be present at the hearing.
***6 reserved seats requested.
Apotex Inc.
2015-04-07 Notice of appearance, Allyson Whyte Nowak and Jason Markwell will be present at the hearing.
***3 reserved seats requested
Canada's Research-Based Pharmaceutical Companies
2015-04-07 Other book of authorities, (Book Form), Completed on: 2015-04-07 Apotex Inc.
2015-04-07 Reply factum on appeal, (Book Form), 4 more copies to come - rec'd April 8, 2015, Completed on: 2015-04-07, (Electronic version filed on 2015-04-08) Apotex Inc.
2015-04-07 Other book of authorities, (Book Form), Completed on: 2015-04-07 Sanofi-Aventis
2015-04-07 Reply factum on appeal, (Book Form), Completed on: 2015-04-07 Sanofi-Aventis
2015-04-07 Notice of appearance, Jonathan Stainsby, David W. Aitken and Devin Doyle will be present at the hearing.
*6 reserved seats requested
Canadian Generic Pharmaceutical Association
2015-04-07 Notice of appearance, Andrew J. Reddon, Steven G. Mason, David Tait and Sanjaya Mendis will be present at the hearing.
*6 reserved seats requested.
Sanofi-Aventis
2015-04-02 Order by, Ka, FURTHER TO THE ORDER dated March 6, 2015, granting leave to intervene to the Canadian Generic Pharmaceutical Association and Canada’s Research-Based Pharmaceutical Companies;
IT IS HEREBY FURTHER ORDERED THAT:
The interveners are each granted permission to present oral argument not exceeding ten (10) minutes at the hearing of the appeal.
Granted
2015-03-31 Intervener's book of authorities, (Book Form), Completed on: 2015-03-31 Canada's Research-Based Pharmaceutical Companies
2015-03-31 Intervener's factum, (Book Form), Completed on: 2015-04-01 Canada's Research-Based Pharmaceutical Companies
2015-03-31 Intervener's book of authorities, (Book Form), Completed on: 2015-03-31 Canadian Generic Pharmaceutical Association
2015-03-31 Intervener's factum, (Book Form), Completed on: 2015-03-31 Canadian Generic Pharmaceutical Association
2015-03-20 Respondent's book of authorities, (Book Form), Completed on: 2015-03-20 Apotex Inc.
2015-03-20 Respondent's factum, (Book Form), electronic filing form to come - rec'd March 26, 2015, Completed on: 2015-03-26 Apotex Inc.
2015-03-13 Appeal hearing scheduled, 2015-04-20, (previously tentatively scheduled for April 14, 2015)
Judgment rendered
2015-03-06 Order on motion for leave to intervene, (by KARAKATSANIS J.)
2015-03-06 Decision on the motion for leave to intervene, Ka, UPON APPLICATIONS by the Canadian Generic Pharmaceutical Association, Canada’s Research-Based Pharmaceutical Companies and Laboratoire Riva Inc. for leave to intervene in the above appeal;
AND THE MATERIAL FILED having been read;
IT IS HEREBY ORDERED THAT:
The motions for leave to intervene of the Canadian Generic Pharmaceutical Association and Canada’s Research-Based Pharmaceutical Companies are granted and the said interveners shall be entitled to each serve and file a factum not exceeding ten (10) pages in length on or before March 31, 2015.
The motion for leave to intervene by Laboratoire Riva Inc. is dismissed.
The requests to present oral argument are deferred to a date following receipt and consideration of the written arguments of the parties and the interveners.
The interveners are not entitled to raise new issues or to adduce further evidence or otherwise to supplement the record of the parties.
Pursuant to Rule 59(1)(a) of the Rules of the Supreme Court of Canada, the interveners shall pay to the appellants and respondent any additional disbursements occasioned to the appellants and respondent by their intervention.
The appellants and the respondent are permitted to serve and file a factum not exceeding ten (10) pages in reply to these interventions on or before April 7, 2014.
Allowed in part
2015-03-06 Submission of motion for leave to intervene, Ka
2015-02-27 Reply to the motion for leave to intervene, (Book Form), Completed on: 2015-02-27, (Electronic version filed on 2015-03-02) Canada's Research-Based Pharmaceutical Companies
2015-02-27 Reply to the motion for leave to intervene, (Letter Form), service to come - original and service rec'd March 03, 2015, Completed on: 2015-03-03, (Printed version filed on 2015-03-03) Laboratoire Riva Inc.
2015-02-25 Response to the motion for leave to intervene, (Book Form), Completed on: 2015-02-26, (Electronic version filed on 2015-02-26) Apotex Inc.
2015-02-25 Response to the motion for leave to intervene, (Letter Form), Completed on: 2015-02-25, (Electronic version filed on 2015-02-25) Sanofi-Aventis
2015-02-20 Intervener's book of authorities, (Book Form), Completed on: 2015-02-24, (Electronic version filed on 2015-02-20) Laboratoire Riva Inc.
2015-02-20 Notice of name, (Letter Form), (Electronic version filed on 2015-02-26) Canada's Research-Based Pharmaceutical Companies
2015-02-20 Certificate (on limitations to public access), (Letter Form), (Electronic version filed on 2015-02-26) Canada's Research-Based Pharmaceutical Companies
2015-02-20 Motion for leave to intervene, (Book Form), Completed on: 2015-02-20, (Electronic version filed on 2015-02-26) Canada's Research-Based Pharmaceutical Companies
2015-02-20 Motion for leave to intervene, (Book Form), Completed on: 2015-02-20, (Electronic version filed on 2015-02-24) Canadian Generic Pharmaceutical Association
2015-02-20 Motion for leave to intervene, (Book Form), service and fees to come. Proof of service and fee received 2015-02-24., Completed on: 2015-02-20, (Printed version filed on 2015-02-20) Laboratoire Riva Inc.
2015-02-12 Order on motion to dispense with printing
2015-02-12 Decision on motion to dispense with printing, Reg, UPON MOTION by the Appellants, SANOFI-AVENTIS, SANOFI-AVENTIS
DEUTSCHLAND GmbH and SANOFI-AVENTIS CANADA INC., for an Order pursuant to Rules 6, 35, 38, 41 and 47 of the Rules of the Supreme Court of Canada
IT IS HEREBY ORDERED THAT:
1. The Appellants will file 21 printed copies of Parts I and II of the Appellants' Record together with DVDs containing electronic versions only of Parts III and IV of the Appellants' Record;
2. The Appellants are excused from serving and filing printed copies of Parts III and IV of the Appellants' Record and permitted to serve and file these Parts III and IV in similar DVD format with the same numbering as these documents were filed in the Federal Court of Appeal;
3. The Appellants will serve and file one copy of the electronic version of the entire Appellants' Record, including Parts III and IV; and
4. Unless otherwise ordered herein, all other service and filing requirements set out in the Rules of the Supreme Court of Canada continues to apply to these proceedings.
Granted
2015-02-12 Submission of motion to dispense with printing, Reg
2015-02-04 Response to motion to dispense with printing, Completed on: 2015-02-04 Apotex Inc.
2015-01-30 Certificate of counsel (attesting to record) Sanofi-Aventis
2015-01-30 Certificate (on limitations to public access) Sanofi-Aventis
2015-01-30 Appellant's book of authorities, (3 volumes), Completed on: 2015-01-30 Sanofi-Aventis
2015-01-30 Appellant's record, Volumes 2, 4 to 8 are SEALED - 2 redacted copies of volumes 4 to 8 filed (8 volumes), Completed on: 2015-01-30 Sanofi-Aventis
2015-01-30 Appellant's factum, SEALED - 2 redacted copies filed, Completed on: 2015-01-30 Sanofi-Aventis
2015-01-30 Correspondence received from, (Letter Form), Appellants, re.: Rule 19.1 some of the Appellants' dcouments contain confidential material. Sanofi-Aventis
2015-01-30 Motion to dispense with printing, (Book Form), Completed on: 2015-01-30 Sanofi-Aventis
2015-01-29 Correspondence received from, (Letter Form), Appellants - Mr. Jeffrey Beedell will be agent Sanofi-Aventis
2014-12-19 Letter advising the parties of tentative hearing date and filing deadlines (Leave granted)
2014-12-19 Order by, Cro, IT IS HEREBY ORDERED THAT:
1. The appellants’ record, factum and book of authorities shall be served and filed on or before January 30, 2015.
2. Any person wishing to intervene in this appeal under Rule 55 of the Rules of the Supreme Court of Canada shall serve and file a motion for leave to intervene on or before February 20, 2015.
3. The appellants and respondent shall serve and file their responses, if any, to the motions for leave to intervene on or before February 25, 2015.
4. Replies to any responses to the motions for leave to intervene shall be served and filed on or before February 27, 2015.
5. The respondent’s record, factum and book of authorities shall be served and filed on or before March 20, 2015.
6. Any interveners granted leave to intervene under Rule 59 of the Rules of the Supreme Court of Canada shall serve and file their factum and book of authorities on or before March 31, 2015.
Granted
2014-11-28 Notice of appeal, Completed on: 2014-11-28, (Electronic version filed on 2014-12-03) Sanofi-Aventis
2014-10-31 Copy of formal judgment sent to Registrar of the Court of Appeal and all parties
2014-10-31 Judgment on leave sent to the parties
2014-10-30 Judgment of the Court on the application for leave to appeal, The motion for a sealing order is granted. The application for leave to appeal from the judgment of the Federal Court of Appeal, Numbers A-191-12, A-193-12, A-397-12 and A-474-12, 2014 FCA 68, dated March 14, 2014, is granted with costs in the cause.
Granted, with costs in the cause
2014-10-30 Decision on motion to seal
Granted
2014-10-06 All materials on application for leave submitted to the Judges, Abe Ro Mo
2014-10-06 Submission of motion to seal, Abe Ro Mo
2014-06-23 Book of authorities, (Book Form), submitted with the Reply Sanofi-Aventis
2014-06-23 Applicant's reply to respondent's argument, (Book Form), 1 more print copy to come - rec'd June 24, 2014, Completed on: 2014-06-24, (Electronic version filed on 2014-06-23) Sanofi-Aventis
2014-06-13 Certificate (on limitations to public access), (Letter Form) Apotex Inc.
2014-06-13 Respondent's response on the application for leave to appeal, (Book Form), submitted in 6 white sealed envelopes, Completed on: 2014-06-13 Apotex Inc.
2014-06-13 Motion to seal, (Book Form), Requesting an Order to Seal the Responding Memorandum of Argument of the Respondent and the affidavit of Howard Rosen., Completed on: 2014-06-13, (Electronic version filed on 2014-06-13) Apotex Inc.
2014-05-28 Notice of name, (Letter Form), Does not have a bilingual name Sanofi-Aventis
2014-05-14 Letter acknowledging receipt of a complete application for leave to appeal, FILE OPENED MAY 14, 2014
2014-05-13 Certificate (on limitations to public access), (Letter Form) Sanofi-Aventis
2014-05-13 Book of authorities, (Book Form) Sanofi-Aventis
2014-05-13 Application for leave to appeal, (Book Form), Service to come, (plus one more copy of the Application) REC'D 05-14-2014 - 2 Volumes, Completed on: 2014-05-15, (Electronic version filed on 2014-05-28) Sanofi-Aventis

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
Sanofi-Aventis Appellant Active
Sanofi-Aventis Deutschland GmbH and Sanofi-Aventis Canada Inc. Appellant Active

v.

Main parties - Respondents
Name Role Status
Apotex Inc. Respondent Active

And Between

Sub parties (1) - Appellants
Name Role Status
Sanofi-Aventis Appellant Active
Sanofi-Aventis Deutschland GmbH and Sanofi-Aventis Canada Inc. Appellant Active

v.

Sub parties (1) - Respondents
Name Role Status
Apotex Inc. Respondent Active

And Between

Sub parties (2) - Appellants
Name Role Status
Sanofi-Aventis Appellant Active
Sanofi-Aventis Deutschland GmbH and Sanofi-Aventis Canada Inc. Appellant Active

v.

Sub parties (2) - Respondents
Name Role Status
Apotex Inc. Respondent Active

And Between

Sub parties (3) - Appellants
Name Role Status
Sanofi-Aventis Appellant Active
Sanofi-Aventis Deutschland GmbH and Sanofi-Aventis Canada Inc. Appellant Active

v.

Sub parties (3) - Respondents
Name Role Status
Apotex Inc. Respondent Active

Other parties

Other parties
Name Role Status
Canadian Generic Pharmaceutical Association Intervener Active
Canada's Research-Based Pharmaceutical Companies Intervener Active

Counsel

Party: Sanofi-Aventis

Counsel
Andrew J. Reddon
McCarthy Tétrault LLP
Box 48, Suite 4700
Toronto Dominion Bank Tower
Toronto, Ontario
M5K 1E6
Telephone: (416) 362-1812
FAX: (416) 868-0673
Agent
Jeffrey W. Beedell
Gowling WLG (Canada) LLP
160 Elgin Street, Suite 2600
Ottawa, Ontario
K1P 1C3
Telephone: (613) 786-0171
FAX: (613) 563-9869
Email: jeff.beedell@gowlingwlg.com

Party: Sanofi-Aventis Deutschland GmbH and Sanofi-Aventis Canada Inc.

Counsel
Andrew J. Reddon
Steven G. Mason
David Tait
Sanjaya Mendis
McCarthy Tétrault LLP
Box 48, Suite 4700
Toronto Dominion Bank Tower
Toronto, Ontario
M5K 1E6
Telephone: (416) 362-1812
FAX: (416) 868-0673
Agent
Jeffrey W. Beedell
Gowling WLG (Canada) LLP
160 Elgin Street, Suite 2600
Ottawa, Ontario
K1P 1C3
Telephone: (613) 786-0171
FAX: (613) 563-9869
Email: jeff.beedell@gowlingwlg.com

Party: Apotex Inc.

Counsel
Harry B. Radomski
Andrew Brodkin
David Scrimger
Benjamin Hackett
Goodmans LLP
3400 - 333 Bay Street
Toronto, Ontario
M5H 2S7
Telephone: (416) 979-2211
FAX: (416) 979-1234
Email: hradomski@goodmans.ca
Agent
Dougald E. Brown
Nelligan O'Brien Payne LLP
1500 - 50 O'Connor St.
Ottawa, Ontario
K1P 6L2
Telephone: (613) 231-8210
FAX: (613) 788-3661
Email: dougald.brown@nelligan.ca

Party: Canadian Generic Pharmaceutical Association

Counsel
David W. Aitken
Devin Doyle
Aitken Klee LLP
100 Queen Street
Suite 300
Ottawa, Ontario
K1P 1J9
Telephone: (613) 903-5099
FAX: (613) 695-5854
Email: daitken@aitkenklee.com
Agent
Jonathan Stainsby
Aitken Klee LLP
100 Queen Street
Suite 300
Ottawa, Ontario
K1P 1J9
Telephone: (613) 903-5099
FAX: (613) 695-5854
Email: jstainsby@aitkenklee.com

Party: Canada's Research-Based Pharmaceutical Companies

Counsel
Allyson Whyte Nowak
Jason Markwell
Norton Rose Fulbright Canada LLP
Suite 3800, Royal Bank Plaza, South Tower
200 Bay Street - P.O. Box 84
Toronto, Ontario
M5J 2Z4
Telephone: (416) 216-4096
FAX: (416) 216-3930
Email: allyson.whytenowak@nortonrosefulbright.com

Summary

Keywords

None.

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.

(SEALING ORDER)

Intellectual property - Patents - Medicines - Generic manufacturer seeking damages under s. 8 of Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 after delayed market entry due to statutory stay occasioned by failed prohibition proceedings - Whether lower courts erred in interpreting s. 8 of the NOC Regulations as providing a damages framework that overcompensates claimants and leads to judicial inconsistencies; in selecting April 26, 2004 as the commencement date for the period of loss; and in awarding Apotex compensation for hypothetically losing unapproved HOPE sales

The Applicants (collectively, “Sanofi”) are the patentees and have the rights to a series of Canadian patents for the drug, ramipril, used in the treatment of hypertension. The original ‘087 patent issued in 1985 and was set to expire in 2002. In an effort to extend that patent protection, Sanofi obtained a further series of patents for different indications for ramipril and listed them on the Patent Register. Between 2003 and 2008, these “new” ramipril patents were challenged by Apotex Inc. and other generic manufacturers under the PM(NOC) Regulations. Sanofi applied for prohibition orders in each case, triggering the 24-month statutory stay that kept the generic competitors off the ramipril market during that period of time. Only one prohibition application was successful. Apotex received its NOC to market Apo-ramipril in December, 2006. Sanofi commenced separate unsuccessful infringement actions against both Apotex and the other generic manufacturers. Apotex then brought an action under s. 8 of the PM(NOC) Regulations, to claim damages for its net lost profits during the period of the statutory stay.

Lower court rulings

May 23, 2012
Federal Court

2012 FC 553, T-1357-09

Trial judge making key findings on evidence to allow parties to calculate damages suffered by Apotex pursuant to s. 8 of the PM(NOC) Regulations by reason of delayed market entry

June 22, 2012
Federal Court

T-1357-09

Apotex’s motion for reconsideration allowed; Liability judgment amended.

November 2, 2012
Federal Court

T-1357-09

Precise amount of s. 8 damages and post-judgment interest to be paid to Apotex determined after calculations by parties

March 14, 2014
Federal Court of Appeal

2014 FCA 68, A-191-12, A-193-12, A-397-12, A-474-12

Apotex’s appeal in A-191-12 allowed. Sanofi’s appeals in A-193-12 and A-397-12 dismissed. Sanofi’s appeal in A-474-12 allowed solely to facilitate redetermination of quantum of damages.

Memorandums of argument on application for leave to appeal

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 filing 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

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Factums on appeal

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.

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Date modified: 2025-02-27