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29823

Biolyse Pharma Corporation v. Bristol-Myers Squibb Company, 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)
2005-07-18 Record returned to the Registrar of the Court of Appeal
2005-06-01 Appeal closed
2005-05-20 Judgment on appeal and notice of deposit of judgment sent to all parties
2005-05-19 Judgment on the appeal rendered, CJ Ma Ba Bi LeB De F Abe Cha, The appeal from the judgment of the Federal Court of Appeal, Number A-697-02, dated April 7, 2003, heard on November 5, 2004 is allowed with costs throughout, Major, Bastarache and Charron JJ. dissenting.
Allowed, with costs
2005-02-02 Appeal court record, (1 box - Confidential)
2004-12-14 Correspondence received from, F.B. (Rick) Woyiwada dated Dec. 14/04 with Proposed Regulations (sent to the Court Dec. 17/04) Attorney General of Canada
2004-12-14 Correspondence received from, Henry S. Brown, Q.C. dated Dec. 14/04 in response to Mr. McCourt's letter (sent to the Court Dec. 17/04) Bristol-Myers Squibb Company
2004-12-08 Correspondence received from, Marie-France Major dated Dec. 8/04 in response to Mr. McCourt's letter (sent to the Court Dec. 17/04) Biolyse Pharma Corporation
2004-12-07 Correspondence received from, F.B. (Rick) Woyiwada dated Dec. 7/04 in response to Mr. McCourt's letter (sent to the Court Dec. 17/04) Attorney General of Canada
2004-11-25 Correspondence received from, Conor D.M. McCourt dated Nov. 24/04 re: nicoderm and nicotrol (sent to the Court Dec. 17/04) Pfizer Canada Inc.
2004-11-24 Certificate of taxation issued to, Lang, Michener
2004-11-23 Decision on the bill of costs, taxed at the amount of $470.74
2004-11-23 Transcript received, (80 pages)
2004-11-22 Response to the bill of costs, (Letter Form), from H. Brown dated Nov. 22, 2004 re: consent - bill of costs by Can. Generic, Completed on: 2004-11-22 Bristol-Myers Squibb Company
2004-11-18 Submission of the bill of costs, re: intervener
2004-11-05 Judgment reserved OR rendered with reasons to follow
2004-11-05 Hearing of the appeal, 2004-11-05, CJ Ma Ba Bi LeB De F Abe Cha
Judgment reserved
2004-11-05 Hearing of miscellaneous motion, 2004-11-05, CJ Ma Ba Bi LeB De F Abe Cha
Decision reserved
2004-11-05 Submission of miscellaneous motion, 2004-11-05, submitted during hearing., CJ Ma Ba Bi LeB De F Abe Cha
Decision reserved
2004-11-05 Respondent's condensed book, 14 copies - submitted in court Bristol-Myers Squibb Company
2004-11-05 Appellant's condensed book, 14 copies - submitted in court. Biolyse Pharma Corporation
2004-11-03 Correspondence (sent by the Court) to, P. Smith c.c. parties re: acknowledge receipt of his letter dated Nov. 2, 2004 - returning his reply to the motion to admit new evidence
2004-11-02 Correspondence received from, P. Smith dated Nov. 2, 2004 (fax copy) re: withdraw the written reply to the motion to adduce new evidence Bristol-Myers Squibb Company
2004-11-01 Correspondence received from, H. Brown dated Nov. 1, 2004 re: enclosing Schedule "A" omitted in BMS's factum - ref. in par. 15 (sent to the judges on November 2, 2004) - 24 copies Bristol-Myers Squibb Company
2004-10-28 Notice of appearance, Mr. Andrew J. Roman will be present at hearing and his argument will be 45 minutes and 20 minutes for the reply. Biolyse Pharma Corporation
2004-10-27 Response to miscellaneous motion, (sent to the judges on Oct. 28, 2004), Completed on: 2004-10-27 Canadian Generic Pharmaceutical Association (CGPA)
2004-10-25 Notice of appearance, The Attorney General of Canada does not intend to participate in the appeal hearing. Attorney General of Canada
2004-10-20 Book of authorities, (Supplemental Book of Authorities), Completed on: 2004-10-20 Pfizer Canada Inc.
2004-10-18 Notice of miscellaneous motion, (under s. 62(3) of the Supreme Court Act) - 14 copies of vol. 1 and 2 - book form (ref. to Major's order dated Sept. 21, 2004) - sent to the judges on Oct. 28, 2004, Completed on: 2004-10-21 Bristol-Myers Squibb Company
2004-10-12 Response to the bill of costs, (Letter Form), from H. Brown dated Oct. 12, 2004 re: in reference to Justice Major dated Sept. 21, 2004 - costs, Completed on: 2004-10-12 Bristol-Myers Squibb Company
2004-09-24 Bill of costs, Completed on: 2004-09-24 Canadian Generic Pharmaceutical Association (CGPA)
2004-09-23 Correspondence received from, H. Brown dated September 22, 2004 (fax copy) re: responding to E. Hore's letter dated September 22, 2004 Bristol-Myers Squibb Company
2004-09-22 Correspondence received from, E. Hore dated Sept. 22, 2004 (fax copy) re: Justice Major's order dated Aug. 17, 2004 Canadian Generic Pharmaceutical Association (CGPA)
2004-09-21 Appellant's book of authorities, (Supplemental Book of Authorities), Completed on: 2004-09-21 Biolyse Pharma Corporation
2004-09-21 Correspondence received from, Lang Michener advises that Michelle Wong is no longer co-counsel for the appellants. Biolyse Pharma Corporation
2004-09-21 Order on miscellaneous motion, (BY MAJOR J.)
2004-09-21 Decision on miscellaneous motion, Ma, UPON APPLICATION by the respondents, Bristol-Myers Squibb Company and Bristol-Myers Squibb Canada Inc., for an order admitting as new evidence the Affidavit of Noëlle-Dominique Willems and allowing the respondents to file a reply factum to the new evidence and factum filed by the intervener Canadian Generic Pharmaceutical Association;
AND HAVING READ the material filed;
IT IS HEREBY ORDERED THAT:
The motion is dismissed with costs without prejudice to the respondents, Bristol-Myers Squibb Company and Bristol-Myers Squibb Canada Inc., to renew the application at the hearing of the appeal, subject to the condition that the time used for the application will count against the one hour allotted for the appeal.
Dismissed, with costs
2004-09-21 Order by, Ma, UPON APPLICATION by the Pfizer Canada Inc., for leave to intervene in the above appeal and pursuant to the order of June 9, 2004;
IT IS ORDERED THAT the said intervener is granted permission to present oral argument not exceeding fifteen (15) minutes at the hearing of the appeal.

Granted
2004-09-17 Reply to miscellaneous motion, (Letter Form), from Henry S. Brown, Q.C. dated 09/17/04, Completed on: 2004-09-17 Bristol-Myers Squibb Company
2004-09-13 Certificate of taxation issued to, Gowlings
2004-09-13 Decision on the bill of costs, taxed at the amount of $512.21, Reg
2004-09-10 Submission of the bill of costs, Reg
2004-09-09 Response to miscellaneous motion, Completed on: 2004-09-09 Canadian Generic Pharmaceutical Association (CGPA)
2004-09-08 Submission of miscellaneous motion, Ma
2004-09-03 Response to the bill of costs, Completed on: 2004-09-03 Canadian Generic Pharmaceutical Association (CGPA)
2004-09-03 Bill of costs, (ref. to Justice Major's order dated Aug. 17, 2004), Completed on: 2004-09-16 Bristol-Myers Squibb Company
2004-09-03 Reply to miscellaneous motion, (Letter Form), from H.S. Brown, Q.C. (by fax), Completed on: 2004-09-03 Bristol-Myers Squibb Company
2004-09-01 Response to miscellaneous motion, (Letter Form), M.-F. Major, Completed on: 2004-09-01 Biolyse Pharma Corporation
2004-08-30 Notice of miscellaneous motion, to admit new evidence and file a reply factum to Canadian Generic Pharmaceutical Association's factum (book form), Completed on: 2004-09-10 Bristol-Myers Squibb Company
2004-08-20 E-filing e-mail confirmation, re: book of authorities
2004-08-20 E-filing e-mail confirmation, re: intervener's record
2004-08-20 E-filing e-mail confirmation, re: factum
2004-08-19 Correspondence received from, e-mail from Lang Michener dated 08/19/04 re: disregard first electronic version Canadian Generic Pharmaceutical Association (CGPA)
2004-08-19 Book of authorities, (see order of 08/17/04), Completed on: 2004-08-19 Canadian Generic Pharmaceutical Association (CGPA)
2004-08-19 Supplemental document, intervener's record (see orders of 06/09/04 and 08/17/04) Canadian Generic Pharmaceutical Association (CGPA)
2004-08-19 Intervener's factum, (see order of 08/17/04), Completed on: 2004-08-19 Canadian Generic Pharmaceutical Association (CGPA)
2004-08-17 Order on motion to extend time
2004-08-17 Decision on motion to extend time, Ma, 1) The motion to extend the time to serve and file the factum, affidavit and book of authorities of the Canadian Generic Pharmaceutical Association to August 20, 2004 is granted.
2) The request to present oral argument is dismissed.
3) Costs of this application are awarded to the respondents to be paid by the intervener Canadian Generic Pharmaceutical Association.
Allowed in part
2004-08-16 Submission of motion to extend time, Ma
2004-08-09 Reply to motion to extend time, Completed on: 2004-08-09 Canadian Generic Pharmaceutical Association (CGPA)
2004-08-06 Correspondence received from, Steve Grace re: Conor McCourt should be substituted for Andrew Shaughnessy on the covers of the factum and authorities Pfizer Canada Inc.
2004-08-04 Book of authorities, Completed on: 2004-08-04 Pfizer Canada Inc.
2004-08-04 Intervener's factum, Completed on: 2004-08-04 Pfizer Canada Inc.
2004-08-04 Response to motion to extend time, Completed on: 2004-08-04 Bristol-Myers Squibb Company
2004-08-04 Correspondence received from, Marie-France Major re: act as agent for the intervener Canadian Generic Pharmaceutical Association Canadian Generic Pharmaceutical Association (CGPA)
2004-08-03 Notice of hearing sent to parties
2004-07-23 Respondent's record, (4 vols.), Completed on: 2004-07-23 Bristol-Myers Squibb Company
2004-07-23 Respondent's book of authorities, Completed on: 2004-07-23 Bristol-Myers Squibb Company
2004-07-23 Respondent's factum, Completed on: 2004-07-23 Bristol-Myers Squibb Company
2004-07-21 Correspondence received from, Marie-France Major dated 07/21/04 re: replacement for tabs 4(e) to 4(k) and a revised table of contents of the Appellant's record Biolyse Pharma Corporation
2004-07-15 Appeal hearing scheduled, 2004-11-05, (Previously Oct. 6/04 - Nov. 10/04 - Oct. 13/04)
Judgment reserved
2004-07-12 Motion to extend time, to file the factum to August 20, 2004 and to present oral argument (fax copy)(original received on July 14, 2004), Completed on: 2004-07-14 Canadian Generic Pharmaceutical Association (CGPA)
2004-06-09 Order on motion for leave to intervene, (BY ARBOUR J.)
2004-06-09 Decision on the motion for leave to intervene, Arb, UPON APPLICATIONS by the Canadian Generic Pharmaceutical Association and the Pfizer Canada Inc., for leave to intervene in the above appeal;
AND HAVING READ the material filed;
IT IS HEREBY ORDERED THAT:
1) The motion for leave to intervene of the applicant, the Canadian Generic Pharmaceutical Association, is granted and the applicant shall be entitled to adduce evidence in the form of the affidavit of James Keon similar to that filed in support of this motion, excluding the portions relevant only to this motion.
The applicant, the Canadian Generic Pharmaceutical Association, shall be entitled to serve and file a factum not to exceed 20 pages in length.
The requests to present oral argument is deferred to a date following receipt and consideration of the written arguments of the parties and the intervener.
Pursuant to Rule 59(1)(a) the intervener shall pay to the appellant and respondents any additional disbursements occasioned to the appellant and respondents by their intervention.
2) The motion for leave to intervene of the applicant, the Pfizer Canada Inc., is granted and the applicant shall be entitled to serve and file a factum not to exceed 20 pages in length.
The requests to present oral argument is deferred to a date following receipt and consideration of the written arguments of the parties and the intervener.
The intervener 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) the intervener shall pay to the appellant and respondents any additional disbursements occasioned to the appellant and respondents by their intervention.
Granted
2004-06-07 Submission of motion for leave to intervene, Arb
2004-06-01 Reply to the motion for leave to intervene, to Bristol-Myers (bookform), Completed on: 2004-06-01 Pfizer Canada Inc.
2004-05-28 Response to the motion for leave to intervene, (Letter Form), from F.B. Woyiwada dated 05/28/04, Completed on: 2004-05-28 Attorney General of Canada
2004-05-27 Correspondence received from, Lang Michener re: documents that have been struck as per Order of Bastarache J. Biolyse Pharma Corporation
2004-05-27 Response to the motion for leave to intervene, (bookform), Completed on: 2004-06-07 Bristol-Myers Squibb Company
2004-05-26 Reply to the motion for leave to intervene, to Biolyse (bookform), Completed on: 2004-05-26 Pfizer Canada Inc.
2004-05-20 Response to the motion for leave to intervene, Completed on: 2004-05-20 Biolyse Pharma Corporation
2004-05-17 Motion for leave to intervene, (joint with an extension of time)(bookform), Completed on: 2004-05-17 Pfizer Canada Inc.
2004-05-13 Order on motion to strike out, (BY BASTARACHE J.)
2004-05-13 Decision on motion to strike out, Ba, UPON APPLICATION by the respondents, Bristol-Myers Squibb Company and Bristol-Myers Squibb Canada Inc., for an order striking certain documents from the appellant's record, book of authorities and factum;
AND UPON A CONDITIONAL APPLICATION by the appellant for an order admitting new evidence;
AND HAVING READ the material filed;
IT IS HEREBY ORDERED THAT:
1) The respondent's motion to strike portions of the appellant's record, book of authorities and factum is granted, with costs. There is no general justification for supplementing the record on the basis that new material is not contentious or simply presented as further background information to support new arguments. There is also no justification for supplementing the record on the basis that new material is simply in the nature of legislative facts.
2) The conditional motion to adduce certain material, which has been struck, as fresh evidence is denied. At this late stage, such motion must establish why the material could not have been produced earlier, why it is necessary to inform the Court fully, and in what way it is required to support the arguments of the party seeking its admission.
IT IS THEREFORE HEREBY ORDERED THAT:
1) the documents found at Tabs 3B, 4L, 4M, 4N, 4O, 4P and 4Q of Volume II of the appellant's record, be struck;
2) the documents found at Tabs 13, 14 and 17 of the appellant's book of authorities, be struck;
3) the alleged facts in the appellant's factum, at paragraphs 15, 16, 17, 18, 51, 58, 99, 105, 106 and 107, relying on the documents referred to in a) and b), together with the citations in support, be struck;
4) unsupported allegations of fact in the appellant's factum contained in paragraphs 1, 3 and 28, be struck;
5) the appellant shall serve and file its factum, record and authorities without the passages and material struck on or before May 28, 2004;
6) the respondents shall serve and file their factum eight weeks after receipt of the appellant's amended factum and record.
Granted, with costs
2004-05-11 Submission of motion to strike out, Ba
2004-05-11 Reply to motion to strike out, (reply to SUR-REPLY), Completed on: 2004-05-11 Biolyse Pharma Corporation
2004-05-10 Appeal perfected for hearing
2004-05-07 Reply to motion to strike out, SUR-REPLY to the motion to admit new evidence, Completed on: 2004-05-13 Bristol-Myers Squibb Company
2004-05-05 Reply to motion to strike out, and to introduce new materials, Completed on: 2004-05-05 Biolyse Pharma Corporation
2004-05-05 Reply to the motion for leave to intervene, Completed on: 2004-05-05 Canadian Generic Pharmaceutical Association (CGPA)
2004-04-29 Response to the motion for leave to intervene, by CGPA (bookform), Completed on: 2004-05-03 Bristol-Myers Squibb Company
2004-04-29 Reply to motion to strike out, (bookform)(joint with response to admit new evidence), Completed on: 2004-05-03 Bristol-Myers Squibb Company
2004-04-29 Response to the motion for leave to intervene, (Letter Form), from F.B. Woyiwada dated 04/29/04 (joint with response to motion to strike), Completed on: 2004-04-29 Attorney General of Canada
2004-04-29 Response to motion to strike out, (Letter Form), from F.B. Woyiwada dated 04/29/04 (joint with response to CGPA intervention), Completed on: 2004-04-29 Attorney General of Canada
2004-04-21 Response to the motion for leave to intervene, by CGPA, Completed on: 2004-04-21 Biolyse Pharma Corporation
2004-04-19 Response to motion to strike out, joint with a conditional motion to adduce additional evidence (bookform), Completed on: 2004-04-19 Biolyse Pharma Corporation
2004-04-14 Book of authorities, on intervention (bookform), Completed on: 2004-04-14 Canadian Generic Pharmaceutical Association (CGPA)
2004-04-13 Motion for leave to intervene, Completed on: 2004-04-13 Canadian Generic Pharmaceutical Association (CGPA)
2004-04-08 Motion to strike out, portions of the apellants' record, authorities & factum (bookform), Completed on: 2004-04-08 Bristol-Myers Squibb Company
2004-03-15 Appellant's book of authorities, Pursuant to the order of Bastarache J. dated May 13/04 - Tab 13, 14 and 17 have been removed on May 28/04, Completed on: 2004-03-15 Biolyse Pharma Corporation
2004-03-15 Appellant's record, (Volumes 1 and 2) Pursuant to the order of Bastarache J. dated May 13 - Doc. 3B, 4L, 4M, 4N, 4O, 4P and 4Q have been removed from Vol. 2 on May 28/04, Completed on: 2004-03-15 Biolyse Pharma Corporation
2004-03-15 Appellant's factum, AMENDED FACTUM filed May 28, 2004 as per order of Bastarache J. dated May 13, 2004. (served May 28/04 and rec'd June 3/04), Completed on: 2004-03-15 Biolyse Pharma Corporation
2003-12-22 Notice of appeal, Completed on: 2003-12-22 Biolyse Pharma Corporation
2003-12-19 Letter advising the parties of tentative hearing date and filing deadlines (Leave granted)
2003-11-21 Judgment on leave sent to the parties
2003-11-20 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-697-02, dated April 7, 2003, is granted with costs to the applicant in any event of the cause.
Granted, with costs to the applicant(s) in any event of the cause
2003-10-06 All materials on application for leave submitted to the Judges, Ia Bi Arb
2003-09-23 Correspondence received from, E. Meehan dated Sept. 23, 2003 re: objection to Gowlings's letter dated Sept. 10, 2003 Biolyse Pharma Corporation
2003-09-11 Correspondence received from, Gowlings dated Sept. 10, 2003 (fax copy) re: requesting to expedite the leave application Bristol-Myers Squibb Company
2003-08-11 Applicant's reply to respondent's argument, Completed on: 2003-09-10 Biolyse Pharma Corporation
2003-07-24 Book of authorities Bristol-Myers Squibb Company
2003-07-24 Respondent's response on the application for leave to appeal, Completed on: 2003-07-24 Bristol-Myers Squibb Company
2003-07-24 Respondent's response on the application for leave to appeal, (Letter Form), from F. Woyiwada dated July 24, 2003 (fax copy) re: takes no position, Completed on: 2003-07-24 Attorney General of Canada
2003-07-23 Letter acknowledging receipt of a complete application for leave to appeal
2003-07-10 Correspondence received from, A. Roman dated July 9, 2003 (fax copy) re: no ban Biolyse Pharma Corporation
2003-06-20 Application for leave to appeal, Completed on: 2003-07-23 Biolyse Pharma Corporation
2003-06-06 Notice of application for leave to appeal Biolyse Pharma Corporation

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
Biolyse Pharma Corporation Applicant Active

v.

Main parties - Respondents
Name Role Status
Bristol-Myers Squibb Company Respondent Active
Bristol-Myers Squibb Canada Inc. and the Respondent Active
Attorney General of Canada Respondent Active

Other parties

Other parties
Name Role Status
Canadian Generic Pharmaceutical Association (CGPA) Intervener Active
Pfizer Canada Inc. Intervener Active

Counsel

Party: Biolyse Pharma Corporation

Counsel
Andrew J. Roman
Miller Thomson
2500 - 20 Queen St. W.
Toronto, Ontario
M5H 3S1
Telephone: (416) 595-8604
FAX: (416) 595-8695
Email: aroman@millerthomson.ca
Agent
Eugene Meehan, Q.C.
Lang Michener
300 - 50 O'Connor St
Ottawa, Ontario
K1P 6L2
Telephone: (613) 232-7171
FAX: (613) 231-3191
Email: emeehan@langmichener.ca

Party: Bristol-Myers Squibb Company

Counsel
Anthony G. Creber
Patrick S. Smith
Gowling WLG (Canada) LLP
Suite 2600, Box 466
160 Elgin Street - Stn. D.
Ottawa, Ontario
K1P 1C3
Telephone: (613) 232-1781
FAX: (613) 563-9869
Email: Anthony.creber@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

Party: Bristol-Myers Squibb Canada Inc. and the

Counsel
Anthony G. Creber
Patrick S. Smith
Gowling WLG (Canada) LLP
Suite 2600, Box 466
160 Elgin Street - Stn. D.
Ottawa, Ontario
K1P 1C3
Telephone: (613) 232-1781
FAX: (613) 563-9869
Email: Anthony.creber@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

Party: Attorney General of Canada

Counsel
Frederick B. Woyiwada
Attorney General of Canada
284 Wellington Street, 11th Floor
Ottawa, Ontario
K1A 0H8
Telephone: (613) 941-2353
FAX: (613) 954-1920
Email: Frederick.Woyiwada@justice.gc.ca

Party: Canadian Generic Pharmaceutical Association (CGPA)

Counsel
Edward Hore
Hazzard & Hore
141 Adelaide Street West
Suite 1002
Toronto, Ontario
M5H 3L5
Telephone: (416) 868-1340
FAX: (416) 868-1468
Email: edhore@hazzardandhore.com
Agent
Marie-France Major
Lang Michener
300 - 50 O'Connor Street
Ottawa, Ontario
K1P 6L2
Telephone: (613) 232-7171
FAX: (613) 231-3191
Email: mmajor@langmichener.ca

Party: Pfizer Canada Inc.

Counsel
Sheila R. Block
Conor McCourt
John Terry
Torys
Suite 3000, 79 Wellington Street West
P.O. Box 270, Toronto Dominion Centre
Toronto, Ontario
M5K 1N2
Telephone: (416) 865-7319
FAX: (416) 865-7380
Email: sblock@torys.com
Agent
Stephen J. Grace
Maclaren Corlett
Suite 1625
50 O'Connor Street
Ottawa, Ontario
K1P 6L2
Telephone: (613) 233-1146
FAX: (613) 233-7190
Email: sgrace@macorlaw.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.

The Appellant is a small pharmaceutical company based in St. Catherine’s Ontario that has developed a new method of producing the drug, paclitaxel, from a novel source. Paclitaxel is a drug used in the treatment of breast, ovarian and non-small-cell lung cancer. The corporate Respondents (the “Respondents”) are large pharmaceutical companies that owned two patents for injectable paclitaxel solutions, derived from the bark of the yew tree (taxus brevifolia), and marketed under the name “Taxol”. The Appellant derived its paclitaxel from the twigs and needles of the Canadian yew bush (taxus canadensis) and marketed its product under the name “PACLITAXEL for injection.” When the Appellant developed its product, the Minister of Health (the “Minister”) advised it to file a New Drug Submission (“NDS”) rather than an Abbreviated New Drug Submission (“ANDS”) because the Appellant’s proposed drug emanated from a novel botanical source. The Appellant submitted an NDS for its injectable paclitaxel solution in the same dosage as Bristol’s medication. It conducted clinical trials and submitted this data, along with data from the public domain regarding the safety and efficacy of the product.

The Minister issued a Notice of Compliance (“NOC”) to the Appellant in relation to 6mg/ml PACLITAXEL for injection, having determined that s. 5 of the Patented Medicines (NOC) Regulations (the “Regulations”), SOR/93-133 was not engaged as the Appellant did not compare its drug or make reference to another drug in order to demonstrate bioequivalence.. As a result, the Appellant was not required to send a Notice of Allegation (“NOA”) to the Respondents. Having received the NOC, the Appellant began to sell and advertise its product.

The Respondents applied for judicial review of a decision of the Minister to issue a NOC to the Appellant pursuant to the Regulations. The Respondents submitted that they should have received an NOA before the NOC was issued. They further submitted that the Minister had erred when he issued the NOC and when he decided that the NOA was not necessary. The Respondents successfully applied for judicial review of the decision to issue the NOC and for an order quashing the NOC. The decision was upheld on appeal by the Federal Court of Appeal.

Lower court rulings

December 20, 2002
Federal Court of Canada, Trial Division


Appellant's motion for stay of proceedings granted

April 7, 2003
Federal Court of Appeal

A-697-02

Appellant's appeal dismissed

Memorandums of argument on application for leave to appeal

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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

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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.

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Webcasts

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Date modified: 2025-05-13