Patent Act (R.S.C., 1985, c. P-4)

Marginal note:Pricing information, etc., required by regulations

• 80. (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.

Marginal note:Pricing information, etc. required by Board

• 81. (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.