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Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act (S.C. 2017, c. 6)

Assented to 2017-05-16

Marginal note:1993, c. 2, s. 7

  • 48 (1) Subsection 81(1) of the Act is replaced by the following:

    Marginal note: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.

  • Marginal note:1993, c. 2, s. 7

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

    • Marginal note: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.

  • Marginal note:1993, c. 2, s. 7

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

    • Marginal note: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.

Marginal note:1993, c. 2, s. 7

  • 49 (1) Subsections 82(1) and (2) of the Act are replaced by the following:

    Marginal note: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.

    • Marginal note: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.

  • Marginal note:1993, c. 2, s. 7

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

    • Marginal note: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.

  • Marginal note:1993, c. 2, s. 7

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

    • Marginal note: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.

Marginal note:1993, c. 2, s. 7; 1994, c. 26, s. 54(F)

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

Marginal note: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.

  • Marginal note: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.

  • Marginal note: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.

  • Marginal note: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.

  • Marginal note: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.

  • Marginal note: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.

  • Marginal note: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.

Marginal note:1993, c. 2, s. 7

  • 51 (1) Subsections 84(1) and (2) of the Act are replaced by the following:

    Marginal note: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.

    • Marginal note: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.

  • Marginal note:1993, c. 2, s. 7

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

    • Marginal note: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.

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