Patent Act (R.S.C., 1985, c. P-4)

Marginal note:Proceedings

• 97 (1) All proceedings before the Board shall be dealt with as informally and expeditiously as the circumstances and considerations of fairness permit.

• Marginal note: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.

Marginal note: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.

• Marginal note:Interim orders, etc.

  (2) The Board may make interim orders or reserve further directions for an adjourned hearing of a matter.

• Marginal note:Rescission and variation

  (3) The Board may vary or rescind any order made by it and may re-hear any matter.

• Marginal note: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.

Marginal note: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.

• Marginal note: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.

• Marginal note: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  (3) Where an order of the Board that has been made an order of a court is varied or rescinded by a subsequent order of the Board, the subsequent order of the Board shall be made an order of the court in the manner described in subsection (1), and the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.

• Marginal note:Option to enforce

  (4) Nothing in this section prevents the Board from exercising any of its powers under this Act.

Marginal note:Report of Board

• 100 (1) The Board shall in each year submit to the Minister a report on its activities during the preceding year.

• Marginal note: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.

• Marginal note: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.

• Marginal note: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.

Regulations

Marginal note: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).

• Marginal note: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.

Meetings with Minister

Marginal note: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.

• Marginal note: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.

Agreements with Provinces

Marginal note: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.

Supplementary Protection for Inventions — Medicinal Ingredients

Interpretation

Marginal note:Definitions

104 The following definitions apply in this section and in sections 105 to 134.

authorization for sale

authorization for sale has the meaning assigned by regulations. (autorisation de mise en marché)

drug

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

Minister means the Minister of Health. (ministre)

Marginal note: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.

• Marginal note: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.

• Marginal note: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.

• Marginal note: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.

• Marginal note: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.

• Marginal note: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.

Application for Certificate of Supplementary Protection

Marginal note: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.

• Marginal note: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.

• Marginal note: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.

• Marginal note:Exception

  (4) Despite subsection (3), no application shall be filed within the prescribed period preceding the expiry of the term of the patent under section 44 without taking into account section 46.

• Marginal note: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.

• Marginal note:One patent per application

  (6) Each application is permitted to set out only one patent.

Marginal note:Information to be provided

• 107 (1) An applicant shall provide the Minister with any additional information that the Minister considers necessary.

• Marginal note: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.

Marginal note:Order of priority — same authorization for sale

• 108 (1) Subsections (2) to (4) apply in determining the priority of applications for a certificate of supplementary protection that set out the same authorization for sale.

• Marginal note:Patents granted on or before authorization for sale

  (2) An application setting out a patent that was granted on or before the day on which the authorization for sale was issued has the same priority as every other such application.

• Marginal note:Priority over patents granted after authorization for sale

  (3) An application setting out a patent that was granted on or before the day on which the authorization for sale was issued has priority over an application setting out a patent that is granted after that date.

• Marginal note:Patents granted after authorization for sale — priority

  (4) Priority among applications setting out patents that were granted after the day on which the authorization for sale was issued is established according to the date on which the patent was granted, with an earlier date having priority over a later date and patents granted on the same date having the same priority.