GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Patent Act — P-4 87
Information, etc., privileged 87 (1) Subject to subsection (2), any information or document provided to the Board under section 80, 81 or 82 or in any proceeding under section 83 is privileged, and no person who has obtained the information or document pursuant to this Act shall, without the authorization of the person who provided the information or document, knowingly disclose the information or document or allow it to be disclosed unless it has been disclosed at a public hearing under section 83. Disclosure, etc. (2) Any information or document referred to in subsection (1) (a) may be disclosed by the Board to any person engaged in the administration of this Act under the direction of the Board, to the Minister of Industry or such other Minister as may be designated by the regulations and to the provincial ministers of the Crown responsible for health and their officials for use only for the purpose of making representations referred to in subsection 86(2); and (b) may be used by the Board for the purpose of the report referred to in section 100. 1993, c. 2, s. 7; 1995, c. 1, s. 62
Patent Act — P-4 88
Sales and expense information, etc., to be provided 88 (1) A rights holder for an invention pertaining to a medicine shall, as required by and in accordance with the regulations, or as the Board may, by order, require, provide the Board with the information and documents that the regulations or the order may specify respecting (a) the identity of the licensees in Canada of the rights holder; (b) the revenue of the rights holder, and details of the source of the revenue, whether direct or indirect, from sales of medicine in Canada; and (c) the expenditures made by the rights holder in Canada on research and development relating to medicine. Additional information (2) If the Board believes on reasonable grounds that any person has information or documents pertaining to the value of sales of medicine in Canada by a rights holder or the expenditures made by a rights holder in Canada on research and development relating to medicine, the Board may, by order, require the person to provide the Board with any of the information or documents that are specified in the order, or with copies of them. Compliance with order (3) A person in respect of whom an order is made under subsection (1) or (2) shall comply with the order within such time as is specified in the order or as the Board may allow. Information, etc., privileged (4) Subject to section 89, any information or document provided to the Board under subsection (1) or (2) is privileged, and no person who has obtained the information or document pursuant to this Act shall, without the authorization of the person who provided the information or document, knowingly disclose the information or allow it to be disclosed, except for the purposes of the administration of this Act. 1993, c. 2, s. 7 2017, c. 6, s. 53
Patent Act — P-4 89
Report 89 (1) The Board shall in each year submit to the Minister a report setting out (a) the Board’s estimate of the proportion, as a percentage, that the expenditures of each rights holder in Canada in the preceding year on research and development relating to medicine is of the revenues of those rights holders from sales of medicine in Canada in that year; and (b) the Board’s estimate of the proportion, as a percentage, that the total of the expenditures of rights holders in Canada in the preceding year on research and development relating to medicine is of the total of the revenues of those rights holders from sales of medicine in Canada in that year. Basis of report (2) The report shall be based on an analysis of information and documents provided to the Board under subsections 88(1) and (2) and of such other information and documents relating to the revenues and expenditures referred to in subsection 88(1) as the Board considers relevant but, subject to subsection (3), shall not be set out in a manner that would make it possible to identify a person who provided any information or document under subsection 88(1) or (2). Exception (3) The Board shall, in the report, identify the rights holders in respect of whom an estimate referred to in subsection (1) is given in the report, and may, in the report, identify any person who has failed to comply with subsection 88(1) or (2) at any time in the year in respect of which the report is made. Tabling of report (4) The Minister shall cause a copy of the report to be laid before each House of Parliament on any of the first thirty days on which that House is sitting after the report is submitted to the Minister. 1993, c. 2, s. 7 2017, c. 6, s. 54
Patent Act — P-4 90
Inquiries 90 The Board shall inquire into any matter that the Minister refers to the Board for inquiry and shall report to the Minister at the time and in accordance with the terms of reference established by the Minister. 1993, c. 2, s. 7
Patent Act — P-4 91
Establishment 91 (1) The Patented Medicine Prices Review Board is hereby continued, and shall consist of not more than five members to be appointed by the Governor in Council. Tenure (2) Each member of the Board shall hold office during good behaviour for a period of five years, but may be removed at any time by the Governor in Council for cause. Reappointment (3) A member of the Board, on the expiration of a first term of office, is eligible to be reappointed for one further term. Acting after expiration of appointment (4) A person may continue to act as a member of the Board after the expiration of the person’s term of appointment in respect of any matter in which the person became engaged during the term of appointment. Remuneration and expenses (5) The members of the Board shall be paid such remuneration as may be fixed by the Governor in Council and are entitled to be paid reasonable travel and living expenses incurred by them in the course of their duties under this Act while absent from their ordinary place of residence. 1993, c. 2, s. 7
Patent Act — P-4 92
Advisory panel 92 (1) The Minister may establish an advisory panel to advise the Minister on the appointment of persons to the Board, which panel shall include representatives of the provincial ministers of the Crown responsible for health, representatives of consumer groups, representatives of the pharmaceutical industry and such other persons as the Minister considers appropriate to appoint. Consultation (2) The Minister shall consult with an advisory panel established under subsection (1) for the purpose of making a recommendation to the Governor in Council with respect to the appointment of a person to the Board. 1993, c. 2, s. 7
Patent Act — P-4 93
Chairperson and Vice-chairperson 93 (1) The Governor in Council shall designate one of the members of the Board to be Chairperson of the Board and one of the members to be Vice-chairperson of the Board. Duties of Chairperson (2) The Chairperson is the chief executive officer of the Board and has supervision over and direction of the work of the Board, including (a) the apportionment of the work among the members thereof and the assignment of members to deal with matters before the Board and to sit at hearings of the Board and to preside at hearings or other proceedings; and (b) generally, the conduct of the work of the Board, the management of its internal affairs and the duties of its staff. Duties of Vice-chairperson (3) If the Chairperson is absent or incapacitated or if the office of Chairperson is vacant, the Vice-chairperson has all the powers and functions of the Chairperson during the absence, incapacity or vacancy. 1993, c. 2, s. 7
Patent Act — P-4 94
Staff 94 (1) Such officers and employees as are necessary for the proper conduct of the work of the Board shall be appointed in accordance with the Public Service Employment Act . Idem (2) Persons appointed under subsection (1) shall be deemed to be employed in the public service for the purposes of the Public Service Superannuation Act . Technical assistance (3) The Board may engage on a temporary basis the services of persons having technical or specialized knowledge to advise and assist in the performance of its duties and, with the approval of the Treasury Board, the Board may fix and pay the remuneration and expenses of those persons. 1993, c. 2, s. 7; 2003, c. 22, s. 225(E)
Patent Act — P-4 95
Principal office 95 (1) The principal office of the Board shall be in the National Capital Region described in the schedule to the National Capital Act . Meetings (2) The Board may meet at such times and places in Canada as the Chairperson deems advisable. 1993, c. 2, s. 7
Patent Act — P-4 96
General powers, etc. 96 (1) The Board has, with respect to the attendance, swearing and examination of witnesses, the production and inspection of documents, the enforcement of its orders and other matters necessary or proper for the due exercise of its jurisdiction, all such powers, rights and privileges as are vested in a superior court. Rules (2) The Board may, with the approval of the Governor in Council, make general rules (a) specifying the number of members of the Board that constitutes a quorum in respect of any matter; and (b) for regulating the practice and procedure of the Board. By-laws (3) The Board may make by-laws for carrying out the work of the Board, the management of its internal affairs and the duties of its staff. Guidelines (4) Subject to subsection (5), the Board may issue guidelines with respect to any matter within its jurisdiction but such guidelines are not binding on the Board or any rights holder or former rights holder. Consultation (5) Before the Board issues any guidelines, it shall consult with the Minister, the provincial ministers of the Crown responsible for health and such representatives of consumer groups and representatives of the pharmaceutical industry as the Minister may designate for the purpose. Non-application of Statutory Instruments Act (6) The Statutory Instruments Act does not apply to guidelines issued under subsection (4). 1993, c. 2, s. 7 2017, c. 6, s. 55
Patent Act — P-4 97
Proceedings 97 (1) All proceedings before the Board shall be dealt with as informally and expeditiously as the circumstances and considerations of fairness permit. Differences of opinion among members (2) In any proceedings before the Board, (a) in the event of a difference of opinion among the members determining any question, the opinion of the majority shall prevail; and (b) in the event of an equally divided opinion among the members determining any question, the presiding member may determine the question. 1993, c. 2, s. 7
Patent Act — P-4 98
Orders 98 (1) The Board may, in any order, direct (a) that the order or any portion thereof shall come into force at a future time, on the happening of a contingency, event or condition specified in the order or on the performance to the satisfaction of the Board, or a person named by it, of any terms specified in the order; and (b) that the whole or any portion of the order shall have effect for a limited time or until the happening of a specified event. Interim orders, etc. (2) The Board may make interim orders or reserve further directions for an adjourned hearing of a matter. Rescission and variation (3) The Board may vary or rescind any order made by it and may re-hear any matter. Certificates (4) Where any person satisfies the Board that the Board would not have sufficient grounds to make an order under section 83 in respect of the person, the Board may, after the person pays any fees required to be paid by the regulations, issue to the person a certificate to that effect, but no certificate is binding on the Board. 1993, c. 2, s. 7
Patent Act — P-4 99
Enforcement of orders 99 (1) Any order of the Board may be made an order of the Federal Court or any superior court of a province and is enforceable in the same manner as an order of the court. Procedure (2) To make an order of the Board an order of a court, the usual practice and procedure of the court in such matters may be followed or, in lieu thereof, the Board may file with the registrar of the court a certified copy of the Board’s order, and thereupon the order becomes an order of the court. Effect of variation or rescission (3) Where an order of the Board that has been made an order of a court is varied or rescinded by a subsequent order of the Board, the subsequent order of the Board shall be made an order of the court in the manner described in subsection (1), and the order of the court shall be deemed to have been varied or rescinded accordingly. Option to enforce (4) Nothing in this section prevents the Board from exercising any of its powers under this Act. 1993, c. 2, s. 7
Patent Act — P-4 100
Report of Board 100 (1) The Board shall in each year submit to the Minister a report on its activities during the preceding year. Contents (2) The report shall contain (a) a summary of pricing trends in the pharmaceutical industry; and (b) the name of each rights holder and former rights holder in respect of whom an order was made under subsection 81(1) or 82(2) or section 83 during the year and a statement as to the status of the matter in respect of which the order was made. Report summary (3) The summary referred to in paragraph (2)(a) may be based on information and documents provided to the Board by any rights holder or former rights holder under section 80, 81 or 82 or in any proceeding under section 83, but shall not be set out in a manner that would make it possible to identify that rights holder or former rights holder. Tabling of report (4) The Minister shall cause a copy of the report to be laid before each House of Parliament on any of the first thirty days on which that House is sitting after the report is submitted to the Minister. 1993, c. 2, s. 7 2017, c. 6, s. 56
Patent Act — P-4 101
Regulations 101 (1) Subject to subsection (2), the Governor in Council may make regulations (a) specifying the information and documents that shall be provided to the Board under subsection 80(1) or (2) or 88(1); (b) respecting the form and manner in which and times at which such information and documents shall be provided to the Board and imposing conditions respecting the provision of such information and documents; (c) specifying a period for the purposes of subsection 80(2); (d) specifying factors for the purposes of subsection 85(1) or (2), including factors relating to the introductory price of any medicine to which a patented invention, or invention protected by a certificate of supplementary protection, pertains; (e) designating a Minister for the purposes of subsection 86(2) or paragraph 87(2)(a); (f) defining, for the purposes of sections 88 and 89, the expression research and development ; (g) requiring fees to be paid before the issue of any certificate referred to in subsection 98(4) and specifying those fees or the manner of determining those fees; (h) requiring or authorizing the Board to perform the duties, in addition to those provided for in this Act, that are specified in the regulations, including duties to be performed by the Board in relation to the introductory price of any medicine to which a patented invention, or invention protected by a certificate of supplementary protection, pertains; and (i) conferring on the Board such powers, in addition to those provided for in this Act, as will, in the opinion of the Governor in Council, enable the Board to perform any duties required or authorized to be performed by it by any regulations made under paragraph (h). Recommendation (2) No regulations may be made under paragraph (1)(d), (f), (h) or (i) except on the recommendation of the Minister, made after the Minister has consulted with the provincial ministers of the Crown responsible for health and with such representatives of consumer groups and representatives of the pharmaceutical industry as the Minister considers appropriate. 1993, c. 2, s. 7 2017, c. 6, s. 57(E)
Patent Act — P-4 102
Meetings with Minister 102 (1) The Minister may at any time convene a meeting of the following persons: (a) the Chairperson and such members of the Board as the Chairperson may designate; (b) the provincial ministers of the Crown responsible for health or such representatives as they may designate; (c) such representatives of consumer groups and representatives of the pharmaceutical industry as the Minister may designate; and (d) such other persons as the Minister considers appropriate. Agenda (2) The participants at a meeting convened under subsection (1) shall consider such matters in relation to the administration or operation of sections 79 to 101 as the Minister may determine. 1993, c. 2, s. 7
Patent Act — P-4 103
Agreements with provinces 103 The Minister may enter into agreements with any province respecting the distribution of, and may pay to that province out of the Consolidated Revenue Fund, amounts received or collected by the Receiver General under section 83 or 84 or in respect of an undertaking given by a rights holder or former rights holder that is accepted by the Board in lieu of holding a hearing or making an order under section 83, less any costs incurred in relation to the collection and distribution of those amounts. 1993, c. 2, s. 7; 1994, c. 26, s. 55(F); 1999, c. 26, s. 50 2017, c. 6, s. 58
Patent Act — P-4 104
Definitions 104 The following definitions apply in this section and in sections 105 to 134 . authorization for sale has the meaning assigned by regulations. ( autorisation de mise en marché ) drug means a substance or a mixture of substances manufactured, sold or represented for use in (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals; or (b) restoring, correcting or modifying organic functions in human beings or animals. ( drogue ) Minister means the Minister of Health. ( ministre ) 2017, c. 6, s. 59
Patent Act — P-4
authorization for sale has the meaning assigned by regulations. ( autorisation de mise en marché )
Patent Act — P-4 (a)
drug means a substance or a mixture of substances manufactured, sold or represented for use in (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals; or (b) restoring, correcting or modifying organic functions in human beings or animals. ( drogue )
Patent Act — P-4
Minister means the Minister of Health. ( ministre )
Patent Act — P-4 105
Interpretation 105 (1) For the purposes of this section and sections 106 to 134 , if a patent is reissued under section 47, it is deemed to have been granted on the day on which the original patent was granted and its application filing date is deemed to be the day on which the application for the original patent was filed. Human and veterinary uses (2) For the purposes of this section and sections 106 to 134 , a medicinal ingredient or combination of medicinal ingredients contained in a drug authorized for human use and a medicinal ingredient or combination of medicinal ingredients contained in a drug authorized for veterinary use are to be treated as different medicinal ingredients or different combinations of medicinal ingredients, as the case may be. Same medicinal ingredient — human use (3) If medicinal ingredients contained in drugs authorized for human use differ from each other only with respect to a prescribed variation, they are to be treated as the same medicinal ingredient for the purposes of this section and sections 106 to 134 . Same medicinal ingredient — veterinary use (4) If medicinal ingredients contained in drugs authorized for veterinary use differ from each other only with respect to a prescribed variation, they are to be treated as the same medicinal ingredient for the purposes of this section and sections 106 to 134 . Same combination — human use (5) If combinations of medicinal ingredients contained in drugs authorized for human use differ from each other only with respect to a variation in the ratio between those ingredients, they are to be treated as the same combination of medicinal ingredients for the purposes of this section and sections 106 to 134 . Same combination — veterinary use (6) If combinations of medicinal ingredients contained in drugs authorized for veterinary use differ from each other only with respect to a variation in the ratio between those ingredients, they are to be treated as the same combination of medicinal ingredients for the purposes of this section and sections 106 to 134 . 2017, c. 6, s. 59
Patent Act — P-4 106
Application 106 (1) On the payment of the prescribed fee, a patentee may apply to the Minister for a certificate of supplementary protection for a patented invention if all of the following conditions are met: (a) the patent is not void and it meets any prescribed requirements; (b) the filing date for the application for the patent is on or after October 1, 1989; (c) the patent pertains in the prescribed manner to a medicinal ingredient, or combination of medicinal ingredients, contained in a drug for which an authorization for sale of the prescribed kind was issued on or after the day on which this section comes into force; (d) the authorization for sale is the first authorization for sale that has been issued with respect to the medicinal ingredient or the combination of medicinal ingredients, as the case may be; (e) no other certificate of supplementary protection has been issued with respect to the medicinal ingredient or the combination of medicinal ingredients, as the case may be; (f) if an application for a marketing approval, equivalent to an authorization for sale, was submitted in a prescribed country with respect to the medicinal ingredient or combination of medicinal ingredients, as the case may be, before the application for the authorization for sale was filed with the Minister, the application for the authorization for sale was filed before the end of the prescribed period that begins on the day on which the first such application for a marketing approval was submitted. Issuance — paragraph (1)(e) (2) Another certificate of supplementary protection is considered to have been issued for the purposes of paragraph (1)(e) even if that other certificate is subsequently held to be invalid or void or it never takes effect or ceases to have effect. When application to be filed (3) An application for a certificate of supplementary protection shall be filed with the Minister before the end of the prescribed period that begins on (a) the day on which the authorization for sale is issued, if the patent is granted on or before that day; or (b) the day on which the patent is granted, if the patent is granted after the day on which the authorization for sale is issued. Exception (4) Despite subsection (3), no application shall be filed within the prescribed period preceding the expiry of the term of the patent referred to in section 44 without taking into account section 46. Contents of application (5) An application for a certificate of supplementary protection shall (a) set out the number, as recorded in the Patent Office, of the patent — as well as the medicinal ingredient or combination of medicinal ingredients and the number of the authorization for sale — in relation to which the certificate is sought; (b) if paragraph (1)(f) applies with respect to the application, specify the day on which the first application for a marketing approval that is equivalent to an authorization for sale was made and the country in which that application was made; and (c) set out any prescribed information. One patent per application (6) Each application is permitted to set out only one patent. 2017, c. 6, s. 59 2023, c. 26, s. 497
Patent Act — P-4 107
Information to be provided 107 (1) An applicant shall provide the Minister with any additional information that the Minister considers necessary. Refusal (2) Whenever the Minister is satisfied that any of the requirements set out in section 106 are not met with respect to an application for a certificate of supplementary protection, the Minister may refuse the application. The Minister shall notify the applicant of a refusal and of the grounds for it. 2017, c. 6, s. 59