Status of Ongoing Proceedings

For information on how to obtain public transcripts of proceedings, please contact the Registrar, Guillaume Couillard, by phone at 613-954-8299 or by e-mail at Guillaume.Couillard@pmprb-cepmb.gc.ca.

Dates of Upcoming Hearings or Pre-Hearing Conferences

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Case Event Date / Location
Alexion Pharmaceuticals Inc.: Soliris Hearing January 16 to 19, and 23 to 27, 2017;
  • 333 Laurier Street West, 18th floor, Hearing room #1
    From 9:00 to 4:30
February 20 to 24, 2017;
  • 333 Laurier Street West, 18th floor, Hearing room #2
    From 9:00 to 4:30
February 27 to March 3, 2017
  • 333 Laurier Street West, 18th floor, Hearing room #1
    From 9:00 to 4:30

Matters before the Board

I. Allegations of excessive pricing

Patented Drug Product - Apo-Salvent CFC-Free
Patentee Indication / Use Date of Notice of Hearing / Status
Apotex Inc. Asthma July 8, 2008 / Ongoing
  • Decision pending
Patented Drug Product - Soliris
Patentee Indication / Use Date of Notice of Hearing / Status
Alexion Pharmaceuticals Inc. Paroxysmal Nocturnal
Hemoglobinuria

Atypical Hemolytic Uremic Syndrome
January 20, 2015 / Ongoing
  • Order of the Panel regarding the constitution of the Panel: February 1, 2017 (PDF - 111 kbNew
  • Order of the Panel regarding confidentiality: February 1, 2017 (PDF - 78 kbNew
  • Order of the Panel on Board Staff’s motion for production: January 24, 2017 (PDF - 63 kbNew
  • Order of the Panel on the Respondent’s motion for production: January 24, 2017 (PDF - 70 kbNew
  • Motion of the Respondent for the production of documents: January 23, 2017 (PDF - 33 kbNew
  • Motion of Board Staff for the production of documents: January 20, 2017 (PDF - 3.25 MBNew
  • Order of the Panel regarding BIOTEcanada second motion for intervention: January 18, 2017 (PDF - 62 kbNew
  • Motion of the Respondent with regard to the constitution of the Panel: January 13, 2017 (PDF - 28 kbNew
  • Motion of the Respondent to preclude Board Staff from entering into evidence IMS data: January 13, 2017 (PDF - 724 kbNew
  • Motion of the Respondent for an order permitting a witness to testify by videoconference: January 10, 2017 (PDF - 1.37 MBNew
  • Order of the Panel regarding the respondent’s motion for particulars: January 4, 2017 (PDF - 76 kbNew
  • Motion for Particulars of the Respondent: December 23, 2016 (PDF - 1.29 MBNew
  • Second motion of BIOTECanada to intervene: December 20, 2016 (PDF - 5.60 MBNew
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  • BIOTECanada submissions: June 15, 2016 (PDF - 1.67 MB
  • Supplementary reply of Board Staff to the Amended Statement of Allegations: August 11, 2016 (PDF - 1.53 MB
  • Respondent’s supplementary response to Board Staff’s amended Statement of Allegations: July 29, 2016 (PDF - 1313 kb
  • Order regarding scheduling: July 20, 2016 (PDF - 47 kb)
  • Decision of the Board on the motion of Board Staff to Amend the Statement of Allegation and Strike Certain Portions of Will-Say Statement: June 10, 2016 (PDF - 96 kb)
  • Order regarding BIOTECanada’s motion for leave to intervene: May 30, 2016 (PDF - 182 kb)
  • Board Staff motion to amend the statement of allegations and to strike portions of the witness statement of Barry Katsof: May 20, 2016 (PDF - 216 kb)
  • Motion for leave to intervene of BIOTECanada: May 18, 2016 (PDF - 3.90 MB)
  • Board Decision – Motion to Strike Evidence as Inadmissible: March 29, 2016 (PDF - 217 kb)
  • Reply of the Respondent pertaining to the Motion to Strike Evidence as Inadmissible: March 16, 2016 (PDF - 3.07 MB)
  • Written representations of Board Staff pertaining to the Motion to Strike Evidence as Inadmissible: March 8, 2016 (PDF - 12.4 MB)
  • Written representations of the Respondent pertaining to the Motion to Strike Evidence as Inadmissible: March 8, 2016 (PDF - 1.98 MB)
  • Notice of Motion of the Respondent to Strike Evidence as Inadmissible: February 26, 2016 (PDF - 1.05 MB)
  • Scheduling order of the Board: December 7, 2015 (PDF - 90 kb)
  • Surreply of the Respondent: December 4, 2015 (PDF - 687 kb)
  • Board Decision – Various Motions Related to Procedural Matters: November 24, 2015 (PDF - 177 kb)
  • Further written submissions of the Respondent (Board Staff's Motion to Strike Paragraphs 37 and 38 of the Amended Response): October 23, 2015 (PDF - 502 kb)
  • Reply of the Respondent (motion for disclosure): October 23, 2015 (PDF - 994 kb)
  • Reply of the Respondent (motion to strike portions of the amended reply of Board Staff): October 23, 2015 (PDF - 1.35 MB)
  • Reply of the respondent (motion to strike portions of the Minister of Health of B.C.’s further amended notice of appearance): October 23, 2015 (PDF - 1.71 MB)
  • Response of Board Staff (Motion of the Respondent for disclosure): October 19, 2015 (PDF - 2.66 MB)
  • Reply of Board Staff (Motion of Board Staff to strike portions of the Amended Response of the Respondent): October 19, 2015 (PDF - 4.44 MB)
  • Response of Board Staff (Motion of the Respondent to strike portions of the further Amended Notice of Appearance of the Minister of Health of B.C.): October 19, 2015 (PDF - 5.14 MB)
  • Response of Board Staff (Motion of the Respondent to strike portions of the amended reply of Board Staff): October 19, 2015 (PDF - 4.30 MB)
  • Response of the Minister of Health of B.C. (Motion of the Respondent to strike portions of the Further Amended Notice of Appearance of the Minister of Health of B.C.): October 19, 2015 (PDF - 446 kb)
  • Supplementary Written Representations of the Respondent in response to the Chairperson’s submissions: September 15, 2015 (PDF - 1.39 MB)
  • Board Decision – Motion Relating to Conflicts of Interest: October 5, 2015 (PDF - 241 kb)
  • Written submissions, responding to Alexion’s conflict of interest motion by counsel for Mary Catherine Lindberg: September 14, 2015 (PDF - 390 kb)
  • Responding Motion Record of Board Staff (Alleged Conflict of Isabel Jaen Raasch) : September 11, 2015 (PDF - 382 kb)
  • Written Representations of Board Staff (alleged conflict of Isabel Jaen Raasch): September 11, 2015 (PDF - 718 kb)
  • Written Representations of Board Staff in response to Alexion’s motion re: conflict of interest relating to Mary Catherine Lindberg: September 11, 2015 (PDF - 394 kb)
  • ALEXION'S WRITTEN REPRESENTATIONS (Board Staffs Motion to Strike Paragraphs 37 and 38 of the Amended Response and Alexion's Motion to Strike Paragraph 7 and the Amended Portion of Paragraph 9 of the Amended Reply): September 9, 2015 (PDF - 2 MB)
  • Chairperson’s Motion for leave to intervene: September 8, 2015 (PDF - 1 MB)
  • Written Submissions of the respondent: (Alexion’s Motion re: Strike Portions of the Further Amended Notice of Appearance Filed by the Minister of Health): September 2, 2015 (PDF - 3 MB)
  • Written Representations of the Respondent: Alexion’s motion re: Disclosure of documents: September 2, 2015 (PDF - 2 MB)
  • Written Representations of the Respondent: Alexion’s motion re: Conflicts of interest: September 2, 2015 (PDF - 2 MB)
  • Amended reply: September 1, 2015 (PDF - 393 kb)
  • Order regarding scheduling: August 5, 2015 (PDF - 782 kb)
  • Respondent’s motion pertaining to a conflict of interest: August 21, 2015 (PDF - 1.76 MB)
  • Respondent’s motion pertaining to the disclosure of documents: August 21, 2015 (PDF - 1.27 MB)
  • Respondent’s motion to strike portions of B.C. further amended notice of appearance: August 21, 2015 (PDF - 838 kb)
  • Affidavit of Anna Di Domenico: August 21, 2015 (PDF - 4.87 MB)
  • Amended respondent’s response: July 17, 2015 (PDF - 3.18 MB)
  • Amended Notice of Appearance:
    June 26, 2015 (PDF - 325 kb)
  • Order regarding particulars and regarding the calendar: June 23, 2015 (PDF - 183 kb)
  • Replies filed by the respondent
  • Written submissions filed by CLHIA: June 5, 2015 (PDF - 244 kb)
  • B.C. response to respondent’s Notice of Motion: June 5, 2015 (PDF - 2.27 MB)
  • Respondent’s written submissions in response to motion to intervene: May 29, 2015 (PDF - 1.58 MB)
  • Written Submissions on the Motion for Leave to Intervene: May 29, 2015 (PDF - 2.5 MB)
  • Order Regarding Scheduling: May 26, 2015 (PDF -183 Kb)
  • Written Submissions accompanying a Motion for Interlocutory Relief: May 22, 2015 (PDF - 1.7 MB)
  • Motion for Interlocutory Relief: May 15, 2015 (PDF - 7 MB)
  • Motion for leave to intervene: May 12, 2015 (PDF 370 Kb)
  • Order Regarding the Pre-Hearing Conference: May 1, 2015 (PDF 125 Kb)
  • Reply: April 10, 2015 (PDF 412 Kb)
  • Amended Notice of Appearance: April 2, 2015 (PDF 184 Kb)
  • Affidavit of Eric Lun: April 1, 2015 (PDF 1 MB)
  • Order Regarding Confidentiality: March 26, 2015 (PDF 184 Kb)
  • Order Regarding Scheduling: March 26, 2015 (PDF 186 Kb)
  • Objection to Amendment of Ministers’ Appearance: March 20, 2015 (PDF 620 Kb)
  • Request an Extension of the Deadline: March 17, 2015 (PDF 108 Kb)
  • Note to Parties Regarding Notice and Service: March 13, 2015 (PDF 179 Kb)
  • Order Regarding Scheduling: March 13, 2015 (PDF 181 Kb)
  • Request an Extension of the Deadline: March 11, 2015 (PDF 37.5 Kb)
  • Appearance by Minister: March 9, 2015 (PDF 60 Kb)
  • Response: March 9, 2015 (PDF 1,102 Kb)
  • Order Regarding Scheduling: February 13, 2015 (PDF 182 Kb)
  • Notice of Appearance: February 11, 2015 (PDF 42 Kb)
  • Request for an Extension to File the Response: February 10, 2015 (PDF 229 Kb)
  • Request an Extension of the Deadline: February 6, 2015 (PDF 35 Kb)
  • News Release: January 22, 2015
  • Statement of Allegations of Board Staff (PDF 27 Kb)
  • Notice of Hearing: January 20, 2015 (PDF 179 Kb)

II. Failure to File

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Patented Drug Product Indication / Use Patentee Issue Date of Notice of Hearing / Status
Oncaspar Acute Lymphoblastic Leukemia Baxalta Canada Corporation Failure to file (jurisdiction) March 22, 2016 / Ongoing
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Differin
Differin XP
TactuPump
TactuPump Forte
Acne Galderma Canada Inc. Failure to file (jurisdiction) February 23, 2016 / Ongoing
  • Board Order on the Merits: December 19, 2016 (PDF - 311 kbNew
  • Final submissions of Board Staff: September 19, 2016 (PDF - 1.01 MB)
  • Final submissions of the Respondent: September 19, 2016 (PDF - 6.10 MB)
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blank blank Apotex Inc. Failure to file (jurisdiction) March 3, 2008 / Ongoing

Judicial Review of Board Decisions and Appeals

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Patented Drug Product Indication / Use Patentee Issue Date of Notice of Hearing / Status
Soliris New Paroxysmal Nocturnal Hemoglobinuria

Atypical Hemolytic Uremic Syndrome
Alexion Pharmaceuticals Inc. Allegations of excessive pricing January 20, 2015
  • Application for judicial review filed at the Federal Court: November 3, 2015
ratio-Salbutamol HFA Asthma ratiopharm Inc. (now Teva Canada) Allegations of excessive pricing July 18, 2008

  • Application for leave to appeal filed at the Supreme Court of Canada: January 5, 2016

  • Decision rendered by the Federal Court of Appeal: November 6, 2015 (A-303-14)

  • Notice of Appeal filed at Federal Court of Appeal: June 25, 2014
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  • Decision issued: May 27, 2014 (2014 FC 502)
  • Judicial review heard by the Federal Court: November 4-6, 2013
  • Board Order: October 17, 2011
  • Board Decision: May 27, 2011
blank blank ratiopharm Inc. (now Teva Canada) Failure to file (jurisdiction) August 28, 2008

  • Application for leave to appeal filed at the Supreme Court of Canada: January 5, 2016

  • Decision rendered by the Federal Court of Appeal: November 6, 2015 (A-303-14)

  • Notice of Appeal filed at Federal Court of Appeal: June 25, 2014
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  • Decision issued: May 27, 2014 (2014 FC 502)
  • Judicial review heard by the Federal Court: November 4-6, 2013
  • Amended: October 17, 2011
  • Board Order: June 30, 2011
blank blank Sandoz Canada Inc. Failure to file (jurisdiction) March 8, 2010

  • Application for leave to appeal filed at the Supreme Court of Canada: January 5, 2016

  • Decision rendered by the Federal Court of Appeal: November 6, 2015 (A-302-14)

  • Notice of Appeal filed at Federal Court of Appeal: June 25, 2014
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  • Decision issued: May 27, 2014 (2014 FC 501)
  • Judicial review heard by the Federal Court: November 19-20, 2013
  • Re-issued: October 1, 2012
  • Board Order: August 1, 2012
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