Patent Act

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.