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Patent Act (R.S.C., 1985, c. P-4)

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Act current to 2020-01-16 and last amended on 2019-10-30. Previous Versions

AMENDMENTS NOT IN FORCE

  • — 2017, c. 6, s. 45

    • 1993, c. 2, s. 7

      45 The heading “Patented Medicines” before section 79 of the Act is replaced by the following:

      Patented or Protected Medicines

  • — 2017, c. 6, s. 46

    • 1993, c. 2. , s. 7
      • 46 (1) The definition breveté ou titulaire d’un brevet in subsection 79(1) of the French version of the Act is replaced by the following:

        patentee

        breveté ou titulaire d’un brevet La personne ayant pour le moment droit à l’avantage d’un brevet pour une invention liée à un médicament, ainsi que quiconque peut exercer tout droit d’un titulaire dans un cadre autre qu’une licence prorogée en vertu du paragraphe 11(1) de la Loi de 1992 modifiant la Loi sur les brevets. (patentee)

      • (2) Subsection 79(1) of the Act is amended by adding the following in alphabetical order:

        medicine

        medicine includes a drug, as defined in section 104, and a medicinal ingredient; (médicament)

        rights holder

        rights holder means, in respect of an invention pertaining to a medicine, a patentee and the person for the time being entitled to the benefit of a certificate of supplementary protection for that invention, and includes, if any other person is entitled to exercise rights in relation to the certificate, that other person in respect of those rights; (titulaire de droits)

  • — 2017, c. 6, s. 47

    • 1993, c. 2, s. 7
      • 47 (1) The portion of subsection 80(1) of the Act before paragraph (a) is replaced by the following:

        • Pricing information, etc., required by regulations
          • 80 (1) A rights holder for an invention pertaining to a medicine shall, as required by and in accordance with the regulations, provide the Board with the information and documents that the regulations may specify respecting

      • 1993, c. 2, s. 7

        (2) Paragraph 80(1)(c) of the English version of the Act is replaced by the following:

        • (c) the costs of making and marketing the medicine, if that information is available to the rights holder in Canada or is within the knowledge or control of the rights holder;

      • 1993, c. 2, s. 7

        (3) The portion of subsection 80(2) of the Act before paragraph (a) is replaced by the following:

        • Former rights holder

          (2) Subject to subsection (3), a person who is a former rights holder for an invention pertaining to a medicine shall, as required by and in accordance with the regulations, provide the Board with the information and documents that the regulations may specify respecting

      • 1993, c. 2, s. 7

        (4) Paragraphs 80(2)(b) and (c) of the Act are replaced by the following:

        • (b) the price at which the medicine was sold in any market in Canada and elsewhere during the period in which the person was a rights holder for the invention;

        • (c) the costs of making and marketing the medicine produced during that period, whether incurred before or after the patent was issued or the certificate of supplementary protection took effect, if that information is available to the person in Canada or is within the knowledge or control of the person;

      • 1993, c. 2, s. 7

        (5) Subsection 80(3) of the Act is replaced by the following:

        • Limitation

          (3) Subsection (2) does not apply to a person who has not, for a period of three or more years, been entitled to the benefit of the patent or certificate of supplementary protection, as the case may be, or to exercise any rights in relation to the patent or certificate.

  • — 2017, c. 6, s. 48

    • 1993, c. 2, s. 7
      • 48 (1) Subsection 81(1) of the Act is replaced by the following:

        • Pricing information, etc. required by Board
          • 81 (1) The Board may, by order, require a rights holder or former rights holder for an invention pertaining to a medicine to provide the Board with information and documents respecting

            • (a) in the case of a rights holder, any of the matters referred to in paragraphs 80(1)(a) to (e);

            • (b) in the case of a former rights holder, any of the matters referred to in paragraphs 80(2)(a) to (e); and

            • (c) any other related matters that the Board may require.

      • 1993, c. 2, s. 7

        (2) Subsection 81(2) of the English version of the Act is replaced by the following:

        • Compliance with order

          (2) A rights holder or former rights holder in respect of whom an order is made under subsection (1) shall comply with the order within the time that is specified in the order or as the Board may allow.

      • 1993, c. 2, s. 7

        (3) Subsection 81(3) of the Act is replaced by the following:

        • Limitation

          (3) No order may be made under subsection (1) in respect of a former rights holder who, more than three years before the day on which the order is proposed to be made, ceased to be entitled to the benefit of the patent or certificate of supplementary protection, as the case may be, or to exercise any rights in relation to the patent or certificate.

  • — 2017, c. 6, s. 49

    • 1993, c. 2, s. 7
      • 49 (1) Subsections 82(1) and (2) of the Act are replaced by the following:

        • Notice of introductory price
          • 82 (1) A rights holder for an invention pertaining to a medicine who intends to sell the medicine in a market in Canada in which it has not previously been sold shall, as soon as practicable after determining the date on which the medicine will be first offered for sale in that market, notify the Board of its intention and of that date.

          • Pricing information and documents

            (2) If the Board receives a notice under subsection (1) from a rights holder or otherwise has reason to believe that a rights holder for an invention pertaining to a medicine intends to sell the medicine in a market in Canada in which the medicine has not previously been sold, the Board may, by order, require the rights holder to provide the Board with information and documents respecting the price at which the medicine is intended to be sold in that market.

      • 1993, c. 2, s. 7

        (2) Subsection 82(3) of the English version of the Act is replaced by the following:

        • Compliance with order

          (3) Subject to subsection (4), a rights holder in respect of whom an order is made under subsection (2) shall comply with the order within the time that is specified in the order or as the Board may allow.

      • 1993, c. 2, s. 7

        (3) Subsection 82(4) of the Act is replaced by the following:

        • Limitation

          (4) No rights holder shall be required to comply with an order made under subsection (2) prior to the 60th day preceding the date on which the rights holder intends to first offer the medicine for sale in the relevant market.

  • — 2017, c. 6, s. 50

    • 1993, c. 2, s. 7; 1994, c. 26, s. 54(F)

      50 Section 83 of the Act is replaced by the following:

      • Order re excessive prices
        • 83 (1) If the Board finds that a rights holder for an invention pertaining to a medicine is selling the medicine in any market in Canada at a price that, in the Board’s opinion, is excessive, the Board may, by order, direct the rights holder to cause the maximum price at which the rights holder sells the medicine in that market to be reduced to the level that the Board considers not to be excessive and that is specified in the order.

        • Order re excessive prices

          (2) Subject to subsection (4), if the Board finds that a rights holder for an invention pertaining to a medicine has, while a rights holder, sold the medicine in any market in Canada at a price that, in the Board’s opinion, was excessive, the Board may, by order, direct the rights holder to do any one or more of the following things that will, in the Board’s opinion, offset the amount of the excess revenues estimated by it to have been derived by the rights holder from the sale of the medicine at an excessive price:

          • (a) reduce the price at which the rights holder sells the medicine in any market in Canada, to the extent and for the period that are specified in the order;

          • (b) to the extent and for the period that are specified in the order, reduce the price at which the rights holder sells, in any market in Canada, any other medicine to which a patented invention, or invention protected by a certificate of supplementary protection, of the rights holder pertains;

          • (c) pay to Her Majesty in right of Canada an amount that is specified in the order.

        • Order re excessive prices

          (3) Subject to subsection (4), if the Board finds that a former rights holder for an invention pertaining to a medicine had, while a rights holder, sold the medicine in any market in Canada at a price that, in the Board’s opinion, was excessive, the Board may, by order, direct the former rights holder to do any one or more of the following things that will, in the Board’s opinion, offset the amount of the excess revenues estimated by it to have been derived by the former rights holder from the sale of the medicine at an excessive price:

          • (a) to the extent and for the period that are specified in the order, reduce the price at which the former rights holder sells, in any market in Canada, a medicine to which a patented invention, or invention protected by a certificate of supplementary protection, of the former rights holder pertains; or

          • (b) pay to Her Majesty in right of Canada an amount that is specified in the order.

        • If policy to sell at excessive price

          (4) If the Board, having regard to the extent and duration of the sales of the medicine at an excessive price, is of the opinion that the rights holder or former rights holder has engaged in a policy of selling the medicine at an excessive price, the Board may, by order, in lieu of any order it may make under subsection (2) or (3), as the case may be, direct the rights holder or former rights holder to do any one or more of the things referred to in that subsection that will, in the Board’s opinion, offset not more than twice the amount of the excess revenues estimated by it to have been derived by the rights holder or former rights holder from the sale of the medicine at an excessive price.

        • Excess revenues

          (5) In estimating the amount of excess revenues under subsection (2), (3) or (4), the Board shall not consider any revenues derived by a rights holder or former rights holder before December 20, 1991 or any revenues derived by a former rights holder after they ceased to be entitled to the benefit of the patent or certificate of supplementary protection, as the case may be, or to exercise any rights in relation to the patent or certificate.

        • Right to hearing

          (6) Before the Board makes an order under this section, it shall provide the rights holder or former rights holder with a reasonable opportunity to be heard.

        • Limitation period

          (7) No order may be made under this section in respect of a former rights holder who, more than three years before the day on which the proceedings in the matter commenced, ceased to be entitled to the benefit of the patent or certificate of supplementary protection, as the case may be, or to exercise any rights in relation to the patent or certificate.

  • — 2017, c. 6, s. 51

    • 1993, c. 2, s. 7
      • 51 (1) Subsections 84(1) and (2) of the Act are replaced by the following:

        • Compliance
          • 84 (1) A rights holder or former rights holder who is required by any order made under section 83 to reduce the price of a medicine shall commence compliance with the order within one month after the date of the order or within a greater period after that date that the Board determines is practical and reasonable, having regard to the circumstances of the rights holder or former rights holder.

          • Compliance

            (2) A rights holder or former rights holder who is directed by any order made under section 83 to pay an amount to Her Majesty shall pay that amount within one month after the date of the order or within a greater period after that date that the Board determines is practical and reasonable, having regard to the circumstances of the rights holder or former rights holder.

      • 1993, c. 2, s. 7

        (2) Subsection 84(3) of the English version of the Act is replaced by the following:

        • Debt due to Her Majesty

          (3) An amount payable by a rights holder or former rights holder to Her Majesty under any order made under section 83 constitutes a debt due to Her Majesty and may be recovered in any court of competent jurisdiction.

  • — 2017, c. 6, s. 52

    • 1993, c. 2, s. 7

      52 Subsection 85(3) of the Act is replaced by the following:

      • Research costs

        (3) In determining under section 83 whether a medicine is being or has been sold in any market in Canada at an excessive price, the Board shall not take into consideration research costs other than the Canadian portion of the world costs related to the research that led to the invention pertaining to that medicine or to the development and commercialization of that invention, calculated in proportion to the ratio of sales by the rights holder in Canada of that medicine to total world sales.

  • — 2017, c. 6, s. 53

    • 1993, c. 2, s. 7

      53 Subsections 88(1) and (2) of the Act are replaced by the following:

      • 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.

  • — 2017, c. 6, s. 54

    • 1993, c. 2, s. 7
      • 54 (1) Subsection 89(1) of the Act is replaced by the following:

        • 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.

      • 1993, c. 2, s. 7

        (2) Subsection 89(3) of the Act is replaced by the following:

        • 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.

  • — 2017, c. 6, s. 55

    • 1993, c. 2, s. 7

      55 Subsection 96(4) of the Act is replaced by the following:

      • 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.

  • — 2017, c. 6, s. 56

    • 1993, c. 2, s. 7

      56 Subsections 100(2) and (3) of the Act are replaced by the following:

      • 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.

  • — 2017, c. 6, s. 57

    • 1993, c. 2, s. 7
      • 57 (1) Paragraph 101(1)(d) of the English version of the Act is replaced by the following:

        • (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;

      • 1993, c. 2, s. 7

        (2) Paragraph 101(1)(h) of the English version of the Act is replaced by the following:

        • (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

  • — 2017, c. 6, s. 58

    • 1999, c. 26, s. 50

      58 Section 103 of the Act is replaced by the following:

      • 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.

  • — 2018, c. 27, s. 249

  • — 2018, c. 27, s. 250(1)

      • 250 (1) Paragraph 12(1)(j) of the Act is repealed.

  • — 2018, c. 27, s. 251

    • 251 Sections 15 and 16 of the Act are repealed.

  • — 2018, c. 27, s. 252

      • 252 (1) Paragraph 16.1(1)(a) of the Act is replaced by the following:

        • (a) it is between a patent agent and their client;

      • (2) Subsections 16.1(4) and (5) of the Act are replaced by the following:

        • Patent agents — country other than Canada

          (4) A communication between an individual who is authorized to act as the equivalent of a patent agent under the law of a country other than Canada and that individual’s client that is privileged under the law of that other country and that would be privileged under subsection (1) had it been made between a patent agent and their client is deemed to be a communication that meets the conditions set out in paragraphs (1)(a) to (c).

        • Individual acting on behalf of patent agent or client

          (5) For the purposes of this section, a patent agent or an individual who is authorized to act as the equivalent of a patent agent under the law of a country other than Canada includes an individual acting on their behalf and a client includes an individual acting on the client’s behalf.

  • — 2018, c. 27, s. 259(1), par. (5)(b)

    • 2014, c. 39
      • 259 (1) In this section, other Act means the Economic Action Plan 2014 Act, No. 2.

      • (5) If subsection 118(4) of the other Act comes into force before subsection 250(3) of this Act, then

        • (b) on the day on which section 249 of this Act comes into force, paragraph 12(1)(j.01) of the Patent Act is replaced by the following:

          • (j.01) respecting the circumstances in which an applicant, patentee or other person may or must be represented in business before the Patent Office by a patent agent whose licence is not suspended or by another person;

  • — 2018, c. 27, ss. 260(1) to (3)

    • 2014, c. 39 and 2015, c. 36
      • 260 (1) The following definitions apply in this section.

        first Act

        first Act means the Economic Action Plan 2014 Act, No. 2. (première loi)

        second Act

        second Act means the Economic Action Plan 2015 Act, No. 1. (deuxième loi)

      • (2) On the first day on which both section 139 of the first Act and section 251 of this Act are in force,

        • (a) paragraph 78.22(b) of the Patent Act is amended by striking out the reference to “15” and by making any grammatical changes that the circumstances require; and

        • (b) section 64 of the second Act, if it is not in force on that day, is amended by striking out the reference to “15” in the paragraph 78.22(b) that it enacts and by making any grammatical changes to that paragraph that the circumstances require.

      • (3) If subsection (2) produces its effects on the day on which section 64 of the second Act comes into force, then that section 64 is deemed to have come into force before that subsection produces its effects.

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