Patent Act (R.S.C., 1985, c. P-4)

Act current to 2017-10-13 and last amended on 2017-09-21. Previous Versions

Patented Medicines

Interpretation

Marginal note:Definitions
  •  (1) In this section and in sections 80 to 103,

    Board

    Conseil

    Board means the Patented Medicine Prices Review Board continued by section 91; (Conseil)

    Consumer Price Index

    indice des prix à la consommation

    Consumer Price Index means the Consumer Price Index published by Statistics Canada under the authority of the Statistics Act; (indice des prix à la consommation)

    Minister

    ministre

    Minister means the Minister of Health or such other Member of the Queen’s Privy Council for Canada as is designated by the Governor in Council as the Minister for the purposes of this section and sections 80 to 103; (ministre)

    patentee

    breveté ou titulaire d’un brevet

    patentee, in respect of an invention pertaining to a medicine, means the person for the time being entitled to the benefit of the patent for that invention and includes, where any other person is entitled to exercise any rights in relation to that patent other than under a licence continued by subsection 11(1) of the Patent Act Amendment Act, 1992, that other person in respect of those rights; (breveté ou titulaire d’un brevet)

    regulations

    règlement

    regulations means regulations made under section 101. (règlement)

  • Marginal note:Invention pertaining to a medicine

    (2) For the purposes of subsection (1) and sections 80 to 101, an invention pertains to a medicine if the invention is intended or capable of being used for medicine or for the preparation or production of medicine.

  • 1993, c. 2, s. 7;
  • 1996, c. 8, s. 32.

Pricing Information

Marginal note:Pricing information, etc., required by regulations
  •  (1) A patentee of an invention pertaining to a medicine shall, as required by and in accordance with the regulations, provide the Board with such information and documents as the regulations may specify respecting

    • (a) the identity of the medicine;

    • (b) the price at which the medicine is being or has been sold in any market in Canada and elsewhere;

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

    • (d) the factors referred to in section 85; and

    • (e) any other related matters.

  • Marginal note:Idem

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

    • (a) the identity of the medicine;

    • (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 patentee of the invention;

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

    • (d) the factors referred to in section 85; and

    • (e) any other related matters.

  • Marginal note:Limitation

    (3) Subsection (2) does not apply to a person who has not been entitled to the benefit of the patent or to exercise any rights in relation to the patent for a period of three or more years.

  • 1993, c. 2, s. 7.
Marginal note:Pricing information, etc. required by Board
  •  (1) The Board may, by order, require a patentee or former patentee of an invention pertaining to a medicine to provide the Board with information and documents respecting

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

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

    • (c) such other related matters as the Board may require.

  • Marginal note:Compliance with order

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

  • Marginal note:Limitation

    (3) No order may be made under subsection (1) in respect of a former patentee 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 to exercise any rights in relation to the patent.

  • 1993, c. 2, s. 7.
Marginal note:Notice of introductory price
  •  (1) A patentee of 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) Where the Board receives a notice under subsection (1) from a patentee or otherwise has reason to believe that a patentee of 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 patentee 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:Compliance with order

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

  • Marginal note:Limitation

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

  • 1993, c. 2, s. 7.

Excessive Prices

Marginal note:Order re excessive prices
  •  (1) Where the Board finds that a patentee of 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 patentee to cause the maximum price at which the patentee sells the medicine in that market to be reduced to such level as the Board considers not to be excessive and as is specified in the order.

  • Marginal note:Idem

    (2) Subject to subsection (4), where the Board finds that a patentee of an invention pertaining to a medicine has, while a patentee, 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 patentee to do any one or more of the following things as will, in the Board’s opinion, offset the amount of the excess revenues estimated by it to have been derived by the patentee from the sale of the medicine at an excessive price:

    • (a) reduce the price at which the patentee sells the medicine in any market in Canada, to such extent and for such period as is specified in the order;

    • (b) reduce the price at which the patentee sells one other medicine to which a patented invention of the patentee pertains in any market in Canada, to such extent and for such period as is specified in the order; or

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

  • Marginal note:Idem

    (3) Subject to subsection (4), where the Board finds that a former patentee of an invention pertaining to a medicine had, while a patentee, 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 patentee to do any one or more of the following things as will, in the Board’s opinion, offset the amount of the excess revenues estimated by it to have been derived by the former patentee from the sale of the medicine at an excessive price:

    • (a) reduce the price at which the former patentee sells a medicine to which a patented invention of the former patentee pertains in any market in Canada, to such extent and for such period as is specified in the order; or

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

  • Marginal note:Where policy to sell at excessive price

    (4) Where 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 patentee or former patentee 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 patentee or former patentee to do any one or more of the things referred to in that subsection as 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 patentee or former patentee 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 patentee or former patentee before December 20, 1991 or any revenues derived by a former patentee after the former patentee ceased to be entitled to the benefit of the patent or to exercise any rights in relation to the patent.

  • Marginal note:Right to hearing

    (6) Before the Board makes an order under this section, it shall provide the patentee or former patentee 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 patentee 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 to exercise any rights in relation to the patent.

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