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Patented Medicine Prices Review Board Rules of Practice and Procedure (SOR/2012-247)

Regulations are current to 2022-05-02 and last amended on 2021-06-30. Previous Versions

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

Act means the Patent Act. (Loi)

Chairperson

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

concerned minister

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

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

hearing

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

party

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

person includes an unincorporated organization or entity. (personne)

respondent

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

Secretary

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 or protected 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.

Personal Service

Marginal note:Personal service

 Personal service of a document must be effected by leaving a copy of the document

  • (a) in the case of service on an individual, with that individual;

  • (b) in the case of service on a partnership, with one of the partners;

  • (c) in the case of service on a corporation, with an officer or director of the corporation;

  • (d) in the case of service on a concerned minister, with the concerned minister or the person apparently in charge of the office; or

  • (e) if counsel has filed a notice of appearance on behalf of a person referred to in any of paragraphs (a) to (d), with counsel.

Address for Service

Marginal note:Address for service

 The address for service for a party is

  • (a) if there is counsel of record for the party, the business address of counsel as shown on the last document filed by counsel;

  • (b) if a party is unrepresented,

    • (i) in the case of a concerned minister, the address of the concerned minister’s office, or

    • (ii) in the case of any other person, the address of the person as shown on the notice of hearing; and

  • (c) if a notice of change of address for service has been filed with the Board, the new address.

Counsel

Marginal note:Notice of appearance

  •  (1) Counsel must file a notice of appearance with the Secretary before representing a party before the Board.

  • Marginal note:Beginning of representation

    (2) A party is represented by counsel before the Board beginning on the date of filing of the notice of appearance.

  • Marginal note:Notice of change of counsel

    (3) A person may change counsel by filing a notice of change of counsel with the Board, together with proof of service of that notice on counsel and on all other parties.

  • Marginal note:Notice of withdrawal of counsel

    (4) Counsel may withdraw from a proceeding by filing with the Board a notice of withdrawal, together with proof of service of that notice on all parties.

  • Marginal note:Any party that is not an individual

    (5) Any party that is not an individual must be represented by counsel in all proceedings.

Filing

Marginal note:Manner of filing

  •  (1) The filing of a document with the Board must be effected

    • (a) by personal service of the document on the Secretary;

    • (b) by delivery of the document by courier or by registered or certified mail to the Secretary; or

    • (c) by transmitting the document electronically to the Secretary.

  • Marginal note:Electronic filing

    (2) Any documents that are filed with the Board electronically must meet the following requirements:

    • (a) the electronic and paper versions of documents must have the same cover page, table of contents and page numbers;

    • (b) the filename of an electronic document must include the name of either the patented or protected medicine or the company if the hearing does not relate to a specific patented or protected medicine, the name of the party filing the document, the title of the document and the date which appears on the document or must meet alternative requirements, if any, set out by the Secretary; and

    • (c) documents must be filed as PDF (Portable Document Format) documents or in any format authorized by the Secretary.

  • Marginal note:Deemed filing date

    (3) The date of receipt marked by the Secretary on a document is deemed to be the date on which the document was filed with the Secretary.

  • Marginal note:Copies

    (4) Three paper copies of any document that is served by a party must be filed with the Secretary. If the document is filed electronically, the three copies must be filed with the Secretary within 48 hours of electronic filing.

  • Marginal note:Confirmation of filing

    (5) On the request of a party or any interested person filing a document with the Secretary, the Secretary must provide the party or interested person with confirmation of that filing.

  • Marginal note:Confidential documents

    (6) If a party files a document with the Board that contains confidential information, it must ensure that “CONFIDENTIAL/CONFIDENTIEL” appears prominently on the cover and pages of the document which contain confidential information.

Notice of Hearing

Marginal note:Signed notice of hearing

  •  (1) Proceedings are initiated by issuance of a notice of hearing signed by the Secretary.

  • Marginal note:Personal service

    (2) A notice of hearing must be served personally on the respondent, all concerned ministers and on any other person that the Board may direct, in accordance with Rule 11.

  • Marginal note:Statement of allegation or notice of application

    (3) A notice of hearing must be accompanied by

    • (a) in the case of an allegation of a patented or protected medicine sold at an excessive price, a statement of allegation set out in consecutively numbered paragraphs containing the material facts, the allegations and the order sought by Board Staff in the proceeding; or

    • (b) in the case of an allegation of a failure to provide information and documents related to a patented or protected medicine, a notice of application set out in consecutively numbered paragraphs containing a statement of the relief sought by Board Staff, the grounds for the relief and the material facts on which Board Staff intends to rely.

 
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