Patent Act (R.S.C., 1985, c. P-4)

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: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: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: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: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: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.

Excessive Prices

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: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: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.

Marginal note:Factors to be considered

• 85 (1) In determining under section 83 whether a medicine is being or has been sold at an excessive price in any market in Canada, the Board shall take into consideration the following factors, to the extent that information on the factors is available to the Board:

  • (a) the prices at which the medicine has been sold in the relevant market;

  • (b) the prices at which other medicines in the same therapeutic class have been sold in the relevant market;

  • (c) the prices at which the medicine and other medicines in the same therapeutic class have been sold in countries other than Canada;

  • (d) changes in the Consumer Price Index; and

  • (e) such other factors as may be specified in any regulations made for the purposes of this subsection.

• Marginal note:Additional factors

  (2) Where, after taking into consideration the factors referred to in subsection (1), the Board is unable to determine whether the medicine is being or has been sold in any market in Canada at an excessive price, the Board may take into consideration the following factors:

  • (a) the costs of making and marketing the medicine; and

  • (b) such other factors as may be specified in any regulations made for the purposes of this subsection or as are, in the opinion of the Board, relevant in the circumstances.

• Marginal note: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.

Marginal note:Hearings to be public

• 86 (1) A hearing under section 83 shall be held in public unless the Board is satisfied on representations made by the person to whom the hearing relates that specific, direct and substantial harm would be caused to the person by the disclosure of information or documents at a public hearing, in which case the hearing or any part thereof may, at the discretion of the Board, be held in private.

• Marginal note:Notice of hearing to certain persons

  (2) The Board shall give notice to the Minister of Industry or such other Minister as may be designated by the regulations and to provincial ministers of the Crown responsible for health of any hearing under section 83, and each of them is entitled to appear and make representations to the Board with respect to the matter being heard.

Marginal note:Information, etc., privileged

• 87 (1) Subject to subsection (2), any information or document provided to the Board under section 80, 81 or 82 or in any proceeding under section 83 is privileged, and no person who has obtained the information or document pursuant to this Act shall, without the authorization of the person who provided the information or document, knowingly disclose the information or document or allow it to be disclosed unless it has been disclosed at a public hearing under section 83.

• Marginal note:Disclosure, etc.

  (2) Any information or document referred to in subsection (1)

  • (a) may be disclosed by the Board to any person engaged in the administration of this Act under the direction of the Board, to the Minister of Industry or such other Minister as may be designated by the regulations and to the provincial ministers of the Crown responsible for health and their officials for use only for the purpose of making representations referred to in subsection 86(2); and

  • (b) may be used by the Board for the purpose of the report referred to in section 100.

Sales and Expense Information

Marginal note: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.

• Marginal note: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.

• Marginal note:Compliance with order

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

• Marginal note:Information, etc., privileged

  (4) Subject to section 89, any information or document provided to the Board under subsection (1) or (2) is privileged, and no person who has obtained the information or document pursuant to this Act shall, without the authorization of the person who provided the information or document, knowingly disclose the information or allow it to be disclosed, except for the purposes of the administration of this Act.

Marginal note: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.

• Marginal note:Basis of report

  (2) The report shall be based on an analysis of information and documents provided to the Board under subsections 88(1) and (2) and of such other information and documents relating to the revenues and expenditures referred to in subsection 88(1) as the Board considers relevant but, subject to subsection (3), shall not be set out in a manner that would make it possible to identify a person who provided any information or document under subsection 88(1) or (2).

• Marginal note: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.

• 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.