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33951

Teva Canada Limited v. Pfizer Canada Inc., et al.

(Federal) (Civil) (By Leave)

(Sealing order)

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)
2014-02-12 Appeal closed
2014-02-12 Certificate of taxation issued to, David W. Aitken
2014-02-12 Decision on the bill of costs, in the amount of $23,626.44, DeRg
2014-02-12 Submission of the bill of costs, DeRg
2013-12-23 Reply to the bill of costs, Completed on: 2013-12-23 Teva Canada Limited
2013-12-16 Response to the bill of costs, (Letter Form), Completed on: 2013-12-16 Pfizer Canada Inc.
2013-12-04 Bill of costs, Completed on: 2013-12-05 Teva Canada Limited
2013-06-04 Formal judgment sent to the registrar of the court of appeal and all parties
2013-06-04 Decision on the motion for a re-hearing of the appeal, see decision of 04-06-2013.
2013-06-04 Order on motion to vary pronouncement / order, and for re-hearing (By the COURT)
2013-06-04 Decision on motion to vary pronouncement / order, and for re-hearing, UPON APPLICATION by Pfizer Canada Inc., Pfizer Inc., Pfizer Ireland Pharmaceuticals and Pfizer Research and Development Company N.V./S.A. for a modification of the judgment and reasons of the Court in this appeal or alternatively for a re-hearing;
AND UPON APPLICATION by Teva Canada Limited to modify the judgment of the Court to allow the appeal with costs in this Court and in the courts below;
AND THE MATERIAL FILED having been read;
IT IS HEREBY ORDERED THAT:
The motion of Pfizer Canada Inc., Pfizer Inc., Pfizer Ireland Pharmaceuticals and Pfizer Research and Development Company N.V./S.A. is granted in part as follows:
1. After the first sentence of the reasons of the judgment of the Court rendered on November 8, 2012, the following sentence is added: “On August 24, 2007, Pfizer brought an application before the Federal Court under s. 55.2(4) of the Patent Act, R.S.C. 1985, c. P-4, and under s. 6(1) of the Patent Medicines (Notice of Compliance) Regulations, SOR/93-133 (“Regulations”), for an order prohibiting the Minister of Health from issuing Teva a Notice of Compliance (“NOC”) for its generic version of Viagra.”
2. At paragraph 83, the last sentence is replaced by the following: ''Therefore, I find that the appellant has established its allegation under ss. 5(1)(b)(iii) and 5(3) of the Regulations that Patent ’446 is not valid.”
3. At paragraph 87, the last sentence is replaced by the following: “Therefore, in the light of the remedy in Pioneer Hi-Bred, as I mentioned above, I hold that Teva has established its allegation that Patent ’446 is not valid.”
4. At paragraph 91, the first sentence is replaced by the following: “Therefore, I would allow the appeal with costs and hold that Teva established its allegation that Patent 2,163,446 is not valid, and dismiss Pfizer’s application for an order of prohibition under s. 6(1) of the Regulations”.
5. The formal order is amended to read as follows: “The appeal from the judgment of the Federal Court of Appeal, Number A-292-09, 2010 FCA 242, dated September 24, 2010, heard on April 18, 2012, is allowed with costs and Teva having established its allegation that Patent 2,163,446 is not valid, the application of Pfizer for an order of prohibition under s. 55.2(4) of the Patent Act, R.S.C. 1985, c. P-4, and s. 6 of the Patent Medicines (Notice of Compliance) Regulations, SOR/93-133, is dismissed”, and;
IT IS FURTHER ORDERED THAT:
6. The Court grants Teva’s motion to amend the formal order of the Court by adding after the word “allowed”, the words “with costs in this Court and in the courts below”, in both the formal order and paragraph 91 of the reasons.
7. There will be no costs on these motions
Allowed in part, without costs
2013-05-29 Correspondence received from, David W. Aitken dated May 29/13 re: change of address Teva Canada Limited
2012-12-19 All material on motion for a re-hearing of the appeal submitted to Justices
2012-12-19 Submission of motion to vary pronouncement / order
2012-12-13 Response to motion to vary pronouncement / order, (Letter Form), from Andrew Shaughnessy dated Dec. 13/12 (submitted to the Court Dec. 19/12), Completed on: 2012-12-13 Pfizer Canada Inc.
2012-12-10 Appellant's book of authorities, (Book Form), (on Motion to Vary) (submitted to the Court Dec. 19/12), Completed on: 2012-12-10 Teva Canada Limited
2012-12-10 Motion to vary pronouncement / order, (Book Form), Motion to amend judgment (Rules 76 & 81) (submitted to the Court Dec. 19/12), Completed on: 2012-12-10 Teva Canada Limited
2012-12-05 Response to the motion for a re-hearing of the appeal, (Letter Form), from Patrick S. Smith dated Dec. 5/12 re supports Pfizer's motion (submitted to the Court Dec. 19/12), Completed on: 2012-12-05 Canada's Research-Based Pharmaceutical Companies
2012-12-04 Respondent's book of authorities, (Book Form), (on motion for Re-Hearing) (submitted to the Court Dec. 19/12), Completed on: 2012-12-04 Pfizer Canada Inc.
2012-12-04 Reply to the response to the motion for a re-hearing of the appeal, (Book Form), (submitted to the Court Dec. 19/12) Pfizer Canada Inc.
2012-12-03 Correspondence received from, Andrew Shaughnessy dated Dec. 3/12 re will be filing a reply on or before Dec. 11/12 Pfizer Canada Inc.
2012-11-26 Response to the motion for a re-hearing of the appeal, (Letter Form), from Jonathan Stainsby dated Nov. 26/12 re supports Teva's position (submitted to the Court Dec. 19/12), Completed on: 2012-11-26 Canadian Generic Pharmaceutical Association
2012-11-26 Appellant's book of authorities, (Book Form), (on motion for Re-Hearing) (submitted to the Court Dec. 19/12), Completed on: 2012-11-26 Teva Canada Limited
2012-11-26 Response to the motion for a re-hearing of the appeal, (Book Form), (submitted to the Court Dec. 19/12), Completed on: 2012-11-26 Teva Canada Limited
2012-11-19 Response to the motion for a re-hearing of the appeal, (Letter Form), from Christopher Rupar dated Nov. 19/12 (submitted to the Court Dec. 19/12), Completed on: 2012-11-19 Minister of Health
2012-11-13 Respondent's book of authorities, (Book Form), (on motion for Re-Hearing) (submitted to the Court Dec. 19/12), Completed on: 2012-11-13 Pfizer Canada Inc.
2012-11-09 Motion for a re-hearing of the appeal, (Book Form), (and/or amending the judgment) (submitted to the Court Dec. 19/12), Completed on: 2012-11-09 Pfizer Canada Inc.
2012-11-09 Formal judgment sent to the registrar of the court of appeal and all parties
2012-11-09 Judgment on appeal and notice of deposit of judgment sent to all parties
2012-11-08 Correspondence received from, Andrew Shaughnessy dated Nov 8/12 re: will be filing a motion under rule 80 Pfizer Canada Inc.
2012-11-08 Judgment on the appeal rendered, CJ LeB De Abe Ro Cro Mo, The appeal from the judgment of the Federal Court of Appeal, Number A-292-09, 2010 FCA 242, dated September 24, 2010, heard on April 18, 2012, is allowed with costs and Patent 2,163,446 is declared void.
Allowed, with costs
2012-05-03 Transcript received, (81 pages)
2012-04-18 Judgment reserved OR rendered with reasons to follow
2012-04-18 Hearing of the appeal, 2012-04-18, CJ LeB De Abe Ro Cro Mo
Judgment reserved
2012-04-18 Intervener's condensed book, (14 copies) distributed in Court Canada's Research-Based Pharmaceutical Companies
2012-04-18 Intervener's condensed book, (14 copies) distributed in Court Canadian Generic Pharmaceutical Association
2012-04-18 Respondent's condensed book, (14 copies) distributed in Court Pfizer Canada Inc.
2012-04-18 Appellant's condensed book, (14 copies) distributed in Court Teva Canada Limited
2012-04-18 Acknowledgement and consent for video taping of proceedings, from all parties
2012-04-17 Supplemental document, Second supplemental book of authorities, Completed on: 2012-04-17 Teva Canada Limited
2012-03-29 Notice of appearance, Jonathan Stainsby and Andrew Skodyn will be present at hearing Canadian Generic Pharmaceutical Association
2012-03-20 Supplemental document, Supplemental book of authorities, Completed on: 2012-03-20 Pfizer Canada Inc.
2012-03-19 Reply factum on appeal, Pursuant to the Order of Justice Rothstein dated March 7, 2012., Completed on: 2012-03-19 Pfizer Canada Inc.
2012-03-19 Supplemental document, Supplemental book of authorities (24 copies), Completed on: 2012-03-19 Teva Canada Limited
2012-03-19 Reply factum on appeal, Pursuant to the Order of Justice Rothstein dated March 7, 2012., Completed on: 2012-03-19 Teva Canada Limited
2012-03-19 Correspondence received from, 1 reserved seat rquested Canada's Research-Based Pharmaceutical Companies
2012-03-19 Notice of appearance, Patrick Smith and Jane Clark will be present at the hearing. Canada's Research-Based Pharmaceutical Companies
2012-03-14 Notice of appearance, Andrew Shaughnessy, Andrew Bernstein and Yael Bienenstock will be present at the hearing. Pfizer Canada Inc.
2012-03-14 Correspondence received from, 6 reserved seats requested Pfizer Canada Inc.
2012-03-09 Notice of hearing sent to parties
2012-03-09 Correspondence received from, Marcus Klee dated March 9/12 in response to Mr. Crane's letter of March 8/12 Teva Canada Limited
2012-03-09 Appeal hearing scheduled, 2012-04-18, (Early start 9:00a.m.)
Judgment reserved
2012-03-08 Correspondence received from, Brian A. Crane, Q.C. dated March 8/12 re reconsideration of the order Pfizer Canada Inc.
2012-03-07 Order on motion to strike out, (BY ROTHSTEIN J.)
2012-03-07 Decision on motion to strike out, Ro, UPON APPLICATION by the appellant for:
1) An order striking the last two sentences of paragraph 6; paragraphs 9, 10, 11; Figure 3; paragraphs 12(2), 12(3), 16, 17, 18, 19, 20, 21; the first four sentences of paragraph 22; paragraph 23; and the fourth sentence of paragraph 24 from the factum filed by the intervener, Canada’s Research-Based Pharmaceutical Companies;
2) Permission to file a reply factum, not exceeding five pages, to address the issues of foreign law, harmonization and Canada’s international treaty obligations and an additional 5 minutes for oral argument;
AND THE MATERIAL FILED having been read;
IT IS HEREBY ORDERED THAT:
1) The motion to strike is granted with costs payable by the intervener Canada’s Research-Based Pharmaceutical Companies;
2) The appellant and the respondents Pfizer are both granted permission to file a reply factum, not exceeding 5 pages, to address the issues of foreign law, harmonization and Canada’s international treaty obligations on or before March 19, 2012;
3) The request for additional time for oral argument is denied
Allowed in part, with costs
2012-03-07 Submission of motion to strike out, Ro
2012-02-27 Reply to motion to strike out, (bookform), Completed on: 2012-02-27 Teva Canada Limited
2012-02-17 Response to motion to strike out, (Letter Form), from Andrew Bernstein dated Feb. 17/12, Completed on: 2012-02-17 Pfizer Canada Inc.
2012-02-17 Response to motion to strike out, (bookform), Completed on: 2012-02-17 Canada's Research-Based Pharmaceutical Companies
2012-02-08 Motion to strike out, paragraphs end sentences in the Canada's Research-Based Pharmaceutical Companies intervener's factum (joint with motion to file a reply factum not exceeding 5 pages) (bookform), Completed on: 2012-02-08 Teva Canada Limited
2012-01-25 Correspondence (sent by the Court) to, parties on the date of the hearing of the appeal (sent by fax)
2012-01-25 Order on motion to adjourn the hearing of the appeal, (BY THE CHIEF JUSTICE)
2012-01-25 Decision on motion to adjourn the hearing of the appeal, CJ, UPON APPLICATION by the respondents Pfizer for an order that the hearing of this matter scheduled for Monday, February 7, 2012, be traversed to the Spring session.
AND THE MATERIAL FILED having been read;
IT IS HEREBY ORDERED THAT:
1) The motion is granted.
2) This appeal, which has been scheduled to be heard on February 7, 2012, shall be traversed to a date to be set by the Registrar during the 2012 Spring session
Granted
2012-01-25 Submission of motion to adjourn the hearing of the appeal, CJ
2012-01-24 Response to the motion to adjourn the hearing of the appeal, (by email), Completed on: 2012-01-24 Teva Canada Limited
2012-01-24 Motion to adjourn the hearing of the appeal, and traversing the hearing to the appeal to the Spring Session, Completed on: 2012-01-24 Pfizer Canada Inc.
2012-01-24 Order by, De, FURTHER TO THE ORDER dated November 7, 2011, granting leave to intervene to the Canadian Generic Pharmaceutical Association and the Canada's Research-Based Pharmaceutical Companies;
IT IS HEREBY FURTHER ORDERED THAT the said interveners are each granted permission to present oral argument not exceeding ten (10) minutes at the hearing of the appeal.
Granted
2012-01-20 Intervener's book of authorities, REVISED in accordance with March 7, 2012 Order - Filed on March 9, 2012, Completed on: 2012-01-20 Canada's Research-Based Pharmaceutical Companies
2012-01-20 Intervener's factum, REVISED in accordance with March 7, 2012 Order - Filed on March 9, 2012 (Sent to the Court on March 13, 2012), Completed on: 2012-01-20 Canada's Research-Based Pharmaceutical Companies
2012-01-20 Intervener's book of authorities, Completed on: 2012-01-20 Canadian Generic Pharmaceutical Association
2012-01-20 Intervener's factum, Completed on: 2012-01-20 Canadian Generic Pharmaceutical Association
2012-01-18 Correspondence received from, Caroline Etter rec'd by e-mail re: request for 7 reserved seats Canadian Generic Pharmaceutical Association
2012-01-16 Correspondence received from, 6 reserved seats rquested Teva Canada Limited
2012-01-16 Notice of appearance, David AItken, Markus Klee and Ildiko Mehes will be present at the hearing. Teva Canada Limited
2011-12-16 Notice of appearance, Patrick Smith and Jane Clark will be present at the hearing. Canada's Research-Based Pharmaceutical Companies
2011-12-15 Correspondence received from, Gowling by email, re.: request for 1 reserved seat at the hearing Canada's Research-Based Pharmaceutical Companies
2011-12-15 Correspondence received from, Gowling by email, re.: request for 6 reserved seats at the hearing Pfizer Canada Inc.
2011-12-15 Notice of appearance, Andrew Shaughnessy, Andrew Bernstein and Yael Bienenstock will be present at the hearing. Pfizer Canada Inc.
2011-12-08 Notice of hearing sent to parties
2011-11-07 Order on motion for leave to intervene, (BY DESCHAMPS J.)
2011-11-07 Decision on the motion for leave to intervene, De, UPON APPLICATIONS by BIOTECanada, the Canadian Generic Pharmaceutical Association and the Canada's Research-Based Pharmaceutical Companies 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 the Canada's Research-Based Pharmaceutical Companies are granted and the said interveners shall be entitled to serve and file a factum not to exceed 10 pages in length.
The motion for leave to intervene of BIOTECanada is dismissed.
The request to present oral argument is deferred to a date following receipt and consideration of the written arguments of the parties and the interveners.
The interveners shall not be 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 appellant and respondents any additional disbursements occasioned to the appellant and respondents by their intervention
Allowed in part
2011-11-07 Submission of motion for leave to intervene, De
2011-10-31 Respondent's book of authorities, Completed on: 2011-10-31 Pfizer Canada Inc.
2011-10-31 Respondent's record, Completed on: 2011-10-31 Pfizer Canada Inc.
2011-10-31 Respondent's factum, Completed on: 2011-10-31 Pfizer Canada Inc.
2011-10-20 Appeal perfected for hearing
2011-10-17 Order on motion to extend time
2011-10-17 Decision on motion to extend time, Reg, to serve and file the Respondent's factum and book of authorities to Oct. 31/11
Granted
2011-10-17 Submission of motion to extend time, Reg
2011-10-11 Response to the motion for leave to intervene, (Letter Form), from Andrew Bernstein dated Sept. 29/11 (by all interveners), Completed on: 2011-10-11 Pfizer Canada Inc.
2011-10-07 Response to motion to extend time, included in the motion for extension of time (by the respondent), Completed on: 2011-10-07 Teva Canada Limited
2011-10-07 Motion to extend time, to serve and file the Respondent's factum and book of authorities to Oct. 31/11, Completed on: 2011-10-07 Pfizer Canada Inc.
2011-10-07 Reply to the motion for leave to intervene, (Letter Form), from Adrienne blanchard dated Oct. 7/11, Completed on: 2011-10-07 Canada's Research-Based Pharmaceutical Companies
2011-10-06 Reply to the motion for leave to intervene, (bookform), Completed on: 2011-10-06 Canadian Generic Pharmaceutical Association
2011-10-03 Response to the motion for leave to intervene, (of all the interveners except Canadian generic), Completed on: 2011-10-03 Teva Canada Limited
2011-09-22 Intervener's book of authorities, On motion, Completed on: 2011-09-22 Canada's Research-Based Pharmaceutical Companies
2011-09-22 Motion for leave to intervene, Bookform, Completed on: 2011-09-22 Canada's Research-Based Pharmaceutical Companies
2011-09-22 Motion for leave to intervene, Bookform, Completed on: 2011-09-22 BIOTECanada
2011-09-21 Motion for leave to intervene, Bookform, Completed on: 2011-09-21 Canadian Generic Pharmaceutical Association
2011-08-25 Appellant's record, (SEALED Vol. 1 to 11) 2 redacted version filed - CD rec'd Sept. 28/11), Completed on: 2011-09-29 Teva Canada Limited
2011-08-25 Appellant's book of authorities, (Vol. 1 and 2 ), Completed on: 2011-09-29 Teva Canada Limited
2011-08-25 Appellant's factum, (New CD rec'd sept. 22/11), Completed on: 2011-10-03 Teva Canada Limited
2011-07-21 Letter advising the parties of tentative hearing date and filing deadlines (Leave granted)
2011-06-02 Notice of appeal, Completed on: 2011-06-02 Teva Canada Limited
2011-05-26 Correspondence received from, Teza Lwin dated May 26, 2011. Re: Will not be participating in the appeal Minister of Health
2011-05-06 Copy of formal judgment sent to Registrar of the Court of Appeal and all parties
2011-05-06 Judgment on leave sent to the parties
2011-05-05 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-292-09, 2010 FCA 242, dated September 24, 2010, is granted with costs in the cause.
Granted, with costs in the cause
2011-03-28 All materials on application for leave submitted to the Judges, (revised from Bi, Fi, Ro) to, Bi Ro Cro
2011-01-19 Applicant's reply to respondent's argument, Completed on: 2011-01-19 Teva Canada Limited
2011-01-10 Book of authorities Pfizer Canada Inc.
2011-01-10 Respondent's response on the application for leave to appeal, Completed on: 2011-01-10 Pfizer Canada Inc.
2011-01-10 Correspondence received from, Marcus Klee dated January 10, 2011. Re: Insert page 37 of the reasons for judgment at page 127a of the application Teva Canada Limited
2010-11-25 Respondent's response on the application for leave to appeal, (Letter Form), Teza Lwin dated November 24, 2010. Re: Will not be filing a response, Completed on: 2010-11-25 Minister of Health
2010-11-24 Letter acknowledging receipt of a complete application for leave to appeal
2010-11-23 Book of authorities Teva Canada Limited
2010-11-23 Application for leave to appeal, Page 127a was inserted in all books on January 10, 2011, Completed on: 2010-11-23 Teva Canada Limited

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
Teva Canada Limited Appellant Active

v.

Main parties - Respondents
Name Role Status
Pfizer Canada Inc. Respondent Active
Pfizer Inc., Pfizer Ireland Pharmaceuticals, Pfizer Research and Development Company N.V./S.A. Respondent Active
Minister of Health 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: Teva Canada Limited

Counsel
David W. Aitken
Marcus Klee
Ildiko Mehes
Brad Jenkins
Aitken Klee LLP
160 Elgin Street
Suite 2404
Ottawa, Ontario
K2P 2P7
Telephone: (613) 695-5858
FAX: (613) 695-5854
Email: daitken@aitkenklee.com

Party: Pfizer Canada Inc.

Counsel
Andrew Shaughnessy
Andrew Bernstein
Emily Kirkpatrick
Yael Bienenstock
Torys LLP
3000 - 79 Wellington Street West
Box 270, TD Centre
Toronto, Ontario
M5K 1N2
Telephone: (416) 865-7380
FAX: (416) 865-7380
Email: ashaughnessy@torys.com
Agent
Brian A. Crane, Q.C.
Gowling WLG (Canada) LLP
2600 - 160 Elgin St
Box 466 Station D
Ottawa, Ontario
K1P 1C3
Telephone: (613) 233-1781
FAX: (613) 563-9869
Email: brian.crane@gowlingwlg.com

Party: Pfizer Inc., Pfizer Ireland Pharmaceuticals, Pfizer Research and Development Company N.V./S.A.

Counsel
Andrew Shaughnessy
Andrew Bernstein
Emily Kirkpatrick
Yael Bienenstock
Torys LLP
3000 - 79 Wellington Street West
Box 270, TD Centre
Toronto, Ontario
M5K 1N2
Telephone: (416) 865-7380
FAX: (416) 865-7380
Email: ashaughnessy@torys.com
Agent
Brian A. Crane, Q.C.
Gowling WLG (Canada) LLP
2600 - 160 Elgin St
Box 466 Station D
Ottawa, Ontario
K1P 1C3
Telephone: (613) 233-1781
FAX: (613) 563-9869
Email: brian.crane@gowlingwlg.com

Party: Minister of Health

Counsel
Eric Peterson
Attorney General of Canada
The Exchange Tower, Box 36
3400 - 130 King Street West
Toronto, Ontario
M5X 1K6
Telephone: (416) 952-6334
FAX: (416) 973-5004
Email: eric.peterson@justice.gc.ca
Agent
Christopher M. Rupar
Attorney General of Canada
50 O'Connor Street, Suite 500, Room 557
Ottawa, Ontario
K1P 6L2
Telephone: (613) 670-6290
FAX: (613) 954-1920
Email: christopher.rupar@justice.gc.ca

Party: Canadian Generic Pharmaceutical Association

Counsel
Jonathan Stainsby
Andrew Skodyn
Heenan Blaikie LLP
333 Bay Street, Suite 2900
P.O. Box 2900
Toronto, Ontario
M5H 2T4
Telephone: (416) 360-6336
FAX: (416) 360-8425
Email: jstainsby@heenan.ca
Agent
Mark C. Power
Heenan Blaikie LLP
55 Metcalfe Street
Suite 300
Ottawa, Ontario
K1P 6L5
Telephone: (613) 236-7908
FAX: (866) 296-8395
Email: mpower@heenan.ca

Party: Canada's Research-Based Pharmaceutical Companies

Counsel
Patrick S. Smith
Jane Clark
Henry S. Brown, Q.C.
Gowling WLG (Canada) LLP
Suite 2600
160 Elgin Street
Ottawa, Ontario
K1P 1C3
Telephone: (613) 786-0245
FAX: (613) 563-9869
Email: patrick.smith@gowlingwlg.com
Agent
Henry S. Brown, Q.C.
Gowling WLG (Canada) LLP
2600 - 160 Elgin St
P.O. Box 466, Stn "D"
Ottawa, Ontario
K1P 1C3
Telephone: (613) 233-1781
FAX: (613) 788-3433
Email: henry.brown@gowlings.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.


Patents — Medicines — Construction of patents — Disclosure — Sufficiency of disclosure — Whether guidance is needed on the law of sufficiency of disclosure — Whether an allegation of insufficiency is at the “heart of the patent system” or a “technical attack” — Whether the Federal Court of Appeal has confused the Consolboard questions — Whether the Federal Court of Appeal condones the imposition of a research project — Whether the Federal Court of Appeal’s “claim based” approach rewrites the law of sufficiency of disclosure — Whether the Federal Court of Appeal confuses disclosure of invention with “best mode” — Whether the Federal Court of Appeal imposes a crippling “wait and see” regime on generic manufacturers.

In 1994, Pfizer applied for a patent for a range of compounds, of which it claimed that one compound was effective for the oral treatment of erectile dysfunction. It received Patent 2,163,446 on July 7, 1998. Patent ’446 expires in 2014.

The disclosure explains that the invention concerns the use of a compound of formula (I) or a salt thereof as a medicament for the treatment of erectile dysfunction. Claim 1 sets out formula (I), which produces 260 quintillion possible compounds. Claims 2 5 are for successively smaller ranges of compounds of formula (I), with Claim 5 being narrowed to a range of nine compounds. Claims 6 and 7 refer to one compound each. Neither the disclosure nor the claims disclose that Claim 7 contains the effective compound, that sildenafil is that compound, or that it is the only active compound sold commercially under the trade name Viagra. Nor does it disclose that the remaining compounds in the patent had not been found to treat erectile dysfunction.

Novopharm, now Teva, applied for a Notice of Compliance to produce a generic version of Viagra, alleging that the patent was invalid for obviousness, lack of utility, and insufficient disclosure. The Federal Court judge found that the patent was not obvious, had utility, and did not fail to adequately disclose the invention. He prohibited the Minister from issuing the requested Notice of Compliance. The Federal Court of Appeal dismissed an appeal.

Lower court rulings

June 18, 2009
Federal Court

T-1566-07, 2009 FC 638

Appliction allowed; Minister of Health prohibited from issuing Notice of Complicance for a generic version of Viagra until patent 2, 163,446 expires
September 24, 2010
Federal Court of Appeal

A-292-09, 2010 FCA 242

Appeal dismissed with costs

Memorandums of argument on application for leave to appeal

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Date modified: 2025-02-27