Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act (S.C. 2017, c. 6)
Full Document:
Assented to 2017-05-16
PART 2Related Amendments (continued)
R.S., c. P-4Patent Act (continued)
43 Section 75 of the Act is replaced by the following:
Marginal note:Offences
75 (1) Every person is guilty of an indictable offence and is liable to a fine of not more than $200 or to imprisonment for a term of not more than three months, or to both, who
(a) without the consent of the patentee, marks in any way on anything made or sold by the person, and for the sole making or selling of which they are not the patentee, the name or any imitation of the name of any patentee for the sole making or selling of that thing;
(b) without the consent of the patentee, marks in any way on anything not purchased from the patentee, the words “Patent”, “Letters Patent”, “Queen’s (or King’s) Patent”, “Patented” or any word or words with a similar meaning, with the intent of counterfeiting or imitating the stamp, mark or device of the patentee, or of deceiving the public and inducing them to believe that the thing in question was made or sold by or with the patentee’s consent; or
(c) with intent to deceive the public, offers for sale as patented in Canada any article that is neither patented in Canada nor protected by a certificate of supplementary protection in Canada.
Marginal note:Certificate of supplementary protection
(2) Every person is guilty of an indictable offence and is liable to a fine of not more than $200 or to imprisonment for a term of not more than three months, or to both, who
(a) during the term of a certificate of supplementary protection, without the consent of the certificate’s holder, marks in any way on anything made or sold by the person, and for the sole making or selling of which they are not the holder of a certificate of supplementary protection, the name or any imitation of the name of any holder of a certificate of supplementary protection for the sole making or selling of that thing;
(b) after a certificate of supplementary protection has been issued and before the end of its term, without the consent of the certificate’s holder, marks in any way on anything not purchased from that holder the words “Certificate of Supplementary Protection”, “Protected by a Certificate of Supplementary Protection” or any words with a similar meaning, with the intent of counterfeiting or imitating that holder’s stamp, mark or device, or of deceiving the public and inducing them to believe that the thing in question was made or sold by or with that holder’s consent; or
(c) with the intent to deceive the public, offers for sale as protected by a certificate of supplementary protection in Canada any article that
(i) is neither patented in Canada nor protected by a certificate of supplementary protection in Canada, or
(ii) is patented in Canada but for which no certificate of supplementary protection has been issued.
44 Subsection 78(1) of the Act is replaced by the following:
Marginal note:Time limit deemed extended
78 (1) If any time limit or period of limitation specified under this Act, in respect of any business before the Patent Office, expires on a day when the Patent Office is closed for business, that time limit or period of limitation shall be deemed to be extended to the next day when the Patent Office is open for business.
Marginal note:1993, c. 2, s. 7
45 The heading “Patented Medicines” before section 79 of the Act is replaced by the following:
Patented or Protected Medicines
Marginal note:1993, c. 2. , s. 7
46 (1) The definition breveté ou titulaire d’un brevet in subsection 79(1) of the French version of the Act is replaced by the following:
- patentee
breveté ou titulaire d’un brevet La personne ayant pour le moment droit à l’avantage d’un brevet pour une invention liée à un médicament, ainsi que quiconque peut exercer tout droit d’un titulaire dans un cadre autre qu’une licence prorogée en vertu du paragraphe 11(1) de la Loi de 1992 modifiant la Loi sur les brevets. (patentee)
(2) Subsection 79(1) of the Act is amended by adding the following in alphabetical order:
- medicine
medicine includes a drug, as defined in section 104, and a medicinal ingredient; (médicament)
- 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:1993, c. 2, s. 7
47 (1) The portion of subsection 80(1) of the Act before paragraph (a) is replaced by the following:
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
Marginal note:1993, c. 2, s. 7
(2) Paragraph 80(1)(c) of the English version of the Act is replaced by the following:
(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;
Marginal note:1993, c. 2, s. 7
(3) The portion of subsection 80(2) of the Act before paragraph (a) is replaced by the following:
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
Marginal note:1993, c. 2, s. 7
(4) Paragraphs 80(2)(b) and (c) of the Act are replaced by the following:
(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;
Marginal note:1993, c. 2, s. 7
(5) Subsection 80(3) of the Act is replaced by the following:
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:1993, c. 2, s. 7
48 (1) Subsection 81(1) of the Act is replaced by the following:
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:1993, c. 2, s. 7
(2) Subsection 81(2) of the English version of the Act is replaced by the following:
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:1993, c. 2, s. 7
(3) Subsection 81(3) of the Act is replaced by the following:
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:1993, c. 2, s. 7
49 (1) Subsections 82(1) and (2) of the Act are replaced by the following:
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:1993, c. 2, s. 7
(2) Subsection 82(3) of the English version of the Act is replaced by the following:
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:1993, c. 2, s. 7
(3) Subsection 82(4) of the Act is replaced by the following:
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.
Marginal note:1993, c. 2, s. 7; 1994, c. 26, s. 54(F)
50 Section 83 of the Act is replaced by the following:
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:1993, c. 2, s. 7
51 (1) Subsections 84(1) and (2) of the Act are replaced by the following:
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:1993, c. 2, s. 7
(2) Subsection 84(3) of the English version of the Act is replaced by the following:
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.
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