Patent Act (R.S.C., 1985, c. P-4)

Act current to 2017-11-06 and last amended on 2017-09-21. Previous Versions

Marginal note:Report of Board
  •  (1) The Board shall in each year submit to the Minister a report on its activities during the preceding year.

  • Marginal note:Idem

    (2) The report shall contain

    • (a) a summary of pricing trends in the pharmaceutical industry; and

    • (b) the name of each patentee in respect of whom an order was made under subsection 80(2) 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 patentee 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 patentee.

  • 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.

  • 1993, c. 2, s. 7.

Regulations

Marginal note:Regulations
  •  (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 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 such duties, in addition to those provided for in this Act, as 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 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.

  • 1993, c. 2, s. 7.

Meetings with Minister

Marginal note:Meetings with Minister
  •  (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.

  • 1993, c. 2, s. 7.

Agreements with Provinces

Marginal note:Agreements with provinces

 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 patentee or former patentee 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.

Supplementary Protection for Inventions — Medicinal Ingredients

Interpretation

Marginal note:Definitions

 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)

  • 2017, c. 6, s. 59.
Marginal note:Interpretation
  •  (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.

  • 2017, c. 6, s. 59.

Application for Certificate of Supplementary Protection

Marginal note:Application
  •  (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.

  • 2017, c. 6, s. 59.
 
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