Patented Medicine Prices Review Board Rules of Practice and Procedure

SOR/2012-247

PATENT ACT

Registration 2012-11-23

Patented Medicine Prices Review Board Rules of Practice and Procedure

C.P. 2012-1547 2012-11-22

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 96(2)Footnote a of the Patent ActFootnote b, approves the making of the annexed Patented Medicine Prices Review Board Rules of Practice and Procedure by the Patented Medicine Prices Review Board.

The Patented Medicine Prices Review Board, pursuant to subsection 96(2)Footnote a of the Patent ActFootnote b, makes the annexed Patented Medicine Prices Review Board Rules of Practice and Procedure.

Ottawa, October 30, 2012

MARY CATHERINE LINDBERG
Chairperson of the Patented Medicine Prices Review Board

Interpretation

 The definitions in this section apply in these Rules.

Act

Loi

Act means the Patent Act. (Loi)

Chairperson

président

Chairperson means the Chairperson of the Board designated under subsection 93(1) of the Act. (président)

concerned minister

ministre intéressé

concerned minister means a federal Minister or a provincial minister referred to in subsection 86(2) of the Act, as the context requires. (ministre intéressé)

counsel

conseiller juridique

counsel means a member of the bar of a province. (conseiller juridique)

hearing

audience

hearing includes a conference held under these Rules. (audience)

party

partie

party means

  • (a) a respondent;

  • (b) Board Staff;

  • (c) a concerned minister; or

  • (d) a person who has been granted leave to intervene under Rule 20. (partie)

person

personne

person includes an unincorporated organization or entity. (personne)

respondent

intimé

respondent means a patentee, or a former patentee, against whom an order of the Board is proposed to be made under the Act. (intimé)

Secretary

secrétaire

Secretary means the Director of Board Secretariat or anyone acting on her or his behalf. (secrétaire)

Board

Marginal note:Composition of Board

 For the purposes of these Rules, the members assigned by the Chairperson under subsection 93(2) of the Act to deal with a matter constitute the Board.

Application

Marginal note:Application

 These Rules apply in respect of any proceeding before the Board.

Quorum

Marginal note:Quorum

 In any proceeding, a quorum of the Board consists of two members.

General

Marginal note:Defect in form or procedure
  •  (1) A proceeding or any part of a proceeding may not be defeated by reason only of a defect in form or procedure.

  • Marginal note:Unanticipated procedural matters

    (2) Any procedural matter or question that is not provided for in the Act, in these Rules or in any regulations made pursuant to the Act that arises in the course of any proceeding may be dealt with in any manner that the Board directs in order to ensure the fair and expeditious conduct of any proceeding.

  • Marginal note:Board discretion

    (3) For the purpose of ensuring the fair and expeditious conduct of any proceeding, the Board may vary, supplement or dispense with any requirement set out in these Rules.

Procedure and Evidence

Marginal note:Board powers
  •  (1) In relation to any proceeding, the Board may

    • (a) receive any evidence that it considers appropriate;

    • (b) take notice of facts that may be judicially noticed and of any generally recognized scientific or technical facts, information or opinions concerning patented medicines;

    • (c) add parties at any stage of the proceeding;

    • (d) permit the amendment of any document filed with the Secretary; and

    • (e) decide any question of procedure.

  • Marginal note:Directions — information, documents and facts

    (2) The Board may, at any time, direct

    • (a) that a party provide any information or documents, in paper or electronic format, that the Board considers concerned to any proceeding; and

    • (b) that a particular fact be established by affidavit.

  • Marginal note:Affidavits

    (3) All affidavits must be filed with the Secretary.

Marginal note:Witnesses appearing before Board

 Witnesses appearing before the Board must testify under oath or solemn affirmation and may be examined by the party calling the witness and cross-examined by parties adverse in interest.

Expert Witnesses

Marginal note:Admissibility of expert evidence
  •  (1) Expert witness evidence is not admissible in a proceeding before the Board in respect of any issue unless the issue has been raised in the pleadings or in a pre-hearing conference order or the expert witness evidence is called for the purpose of rebutting the evidence of an expert witness introduced by another party.

  • Marginal note:Maximum number

    (2) More than two expert witnesses may not be called by a party, per issue, without leave of the Board.

  • Marginal note:Report, declaration and availability

    (3) Every party who, in a proceeding before the Board, intends to introduce evidence given by an expert witness must

    • (a) file with the Secretary and serve on each of the parties in accordance with the Board’s schedule of events, an expert witness report that is supported by an affidavit and that must include

      • (i) a statement of the issues addressed in the report,

      • (ii) a description of the qualifications of the expert with respect to those issues,

      • (iii) the expert’s curriculum vitae attached to the report as a schedule,

      • (iv) the facts and assumptions on which the opinions in the report are based,

      • (v) a summary of the opinions expressed,

      • (vi) in the case of a report provided in response to another expert’s report, an indication of the points of agreement and of disagreement with the other expert’s opinions,

      • (vii) the reasons supporting each opinion expressed,

      • (viii) any literature or other documents specifically relied on in support of the opinions expressed,

      • (ix) a summary of the methodology on which the expert has relied;

    • (b) file with the Secretary and serve on each of the parties a signed Expert Witness Declaration in Form 1 set out in the schedule; and

    • (c) ensure that the expert witness is available for examination and cross-examination at the hearing.

  • Marginal note:Duration of examination in chief

    (4) Examination in chief of any expert witness may not, without the Board’s consent, exceed 90 minutes.

Time Limits

Marginal note:Computation of time
  •  (1) If a time limit set out in these Rules expires on a Saturday, Sunday or a holiday, the period is extended to the next business day.

  • Marginal note:Deemed service

    (2) Any document that is served after 5:00 p.m. at the local time for the recipient is deemed to be served at 9:00 a.m. on the next business day.

Notice and Service

Marginal note:Manner of service
  •  (1) Unless otherwise provided in these Rules, the giving of notice or the service of any document under these Rules must be effected

    • (a) by personal service in accordance with Rule 11;

    • (b) by courier, in which case service is deemed to have been made on the day of delivery of the document;

    • (c) by electronic transmission of a copy of the document to the address for service, in which case service is deemed to have been made on the day of transmission; or

    • (d)  in any other manner that the Board may direct.

  • Marginal note:Service of filed documents

    (2) If a document is required to be filed with the Board pursuant to these Rules or a direction of the Board, except in connection with ex parte motions, the person who files the document must, concurrently with the filing, serve a copy of the document on every person who is, at the time of service, a party to the proceeding.

  • Marginal note:Proof of service to be filed

    (3) Proof of service of any document that is required to be served must, at the request of the Board, be filed with the Secretary.

  • Marginal note:Service on respondent residing outside Canada

    (4) If these Rules require or permit giving notice to or the service of any document on a respondent who does not reside or carry on business at a specified address in Canada, the giving of notice or the service may be effected by giving notice to or serving the representative of the respondent who is appointed pursuant to section 29 of the Act.

 
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