Patent Act (R.S.C., 1985, c. P-4)

Marginal note:Patents — filing date October 1, 1989 to before coming-into-force date

78.54 Subject to subsection 78.55(1) and section 78.56, any matter arising on or after the coming-into-force date in respect of a patent granted on the basis of an application whose filing date is on or after October 1, 1989 but before the coming-into-force date shall be dealt with and disposed of in accordance with the provisions of this Act, other than the definition filing date in section 2 and section 28.

Marginal note:Application of section 46 — item 31 of Schedule II to Patent Rules

• 78.55 (1) If the time, not including a period of grace, set out in item 31 of Schedule II to the Patent Rules to pay the applicable fee to maintain the rights accorded by a patent in effect ends before the coming-into-force date, section 46 as it read immediately before the coming-into-force date applies in respect of that fee.

• Marginal note:Application of section 46 — item 32 of Schedule II to Patent Rules

  (2) If the time, not including a period of grace, set out in item 32 of Schedule II to the Patent Rules to pay the applicable fee to maintain the rights accorded by a patent in effect ends before the coming-into-force date, section 46 as it read immediately before the coming-into-force date applies in respect of that fee.

Marginal note:Non-application of subsection 27.1(4) and section 73.1

78.56 Subsection 27.1(4) and section 73.1 do not apply to a patent that was granted before the coming-into-force date or to a reissued patent if the original patent was granted before that date.

Marginal note:Reissued patents

78.57 For greater certainty, for the purposes of sections 78.53 and 78.54, a reissued patent is considered to be issued on the basis of the original application.

Marginal note:Regulations

78.58 For greater certainty, a regulation made under subsection 12(1) applies to an application for a patent referred to in section 78.22, unless the regulation provides otherwise.

Marginal note:Payment of prescribed fees

• 78.6 (1) If, before the day on which this section comes into force, a person has paid a prescribed fee applicable to a small entity, within the meaning of the Patent Rules as they read at the time of payment, but should have paid the prescribed fee applicable to an entity other than a small entity and a payment equivalent to the difference between the two amounts is submitted to the Commissioner in accordance with subsection (2) either before or no later than twelve months after that day, the payment is deemed to have been paid on the day on which the prescribed fee was paid, regardless of whether an action or other proceeding relating to the patent or patent application in respect of which the fee was payable has been commenced or decided.

• Marginal note:Information to be provided

  (2) Any person who submits a payment to the Commissioner in accordance with subsection (1) is required to provide information with respect to the service or proceeding in respect of which the fee was paid and the patent or application in respect of which the fee was paid.

• Marginal note:No refund

  (3) A payment submitted in accordance with subsection (1) shall not be refunded.

• Marginal note:Action and proceedings barred

  (4) No action or proceeding for any compensation or damages lies against Her Majesty in right of Canada in respect of any direct or indirect consequence resulting from the application of this section.

• Marginal note:Application

  (5) For greater certainty, this section also applies to applications for patents mentioned in section 78.22.

Patented or Protected Medicines

Interpretation

Marginal note:Definitions

• 79 (1) In this section and in sections 80 to 103,

  Board

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

  Consumer Price Index

  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)

  medicine

  medicine includes a drug, as defined in section 104, and a medicinal ingredient; (médicament)

  Minister

  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

  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

  regulations means regulations made under section 101; (règlement)

  rights holder

  rights holder means, in respect of an invention pertaining to a medicine, a patentee and the person for the time being entitled to the benefit of a certificate of supplementary protection for that invention, and includes, if any other person is entitled to exercise rights in relation to the certificate, that other person in respect of those rights. (titulaire de droits)

• 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.

Pricing Information

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

• 80 (1) A rights holder for an invention pertaining to a medicine shall, as required by and in accordance with the regulations, provide the Board with the information and documents that 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, if that information is available to the rights holder in Canada or is within the knowledge or control of the rights holder;

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

  • (e) any other related matters.

• Marginal note:Former rights holder

  (2) Subject to subsection (3), a person who is a former rights holder for an invention pertaining to a medicine shall, as required by and in accordance with the regulations, provide the Board with the information and documents that 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 rights holder for the invention;

  • (c) the costs of making and marketing the medicine produced during that period, whether incurred before or after the patent was issued or the certificate of supplementary protection took effect, if 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, for a period of three or more years, been 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: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.