Free Trade Area of the Americas - FTAA

 
Ministerial
Declarations
Trade Negotiations
Committee
Negotiating
Groups
Special
Committees
Business
Facilitation
Civil
Society
Trade&Tariff
Database
Hemispheric
Cooperation
Program

Home Countries Sitemap A-Z list Governmental Contact Points

 
 

INTELLECTUAL PROPERTY RIGHTS

NATIONAL LEGISLATION - CANADA

Patent Act


TRANSITIONAL PROVISIONS

Patent applications filed before October 1, 1989

78.1 (1) Applications for patents in Canada filed before October 1, 1989 shall
be dealt with and disposed of in accordance with the provisions of this Act as
they read immediately before that date and section 38.1 as it read immediately
after this section came into force.

Patents issued before October 1, 1989

(2) Subject to section 78.5, any matter arising on or after October 1, 1989 in
respect of a patent issued before that date shall be dealt with and disposed of
in accordance with the provisions of this Act as they read immediately before
that date and section 38.1 as it read immediately after this section came into
force.

1993, c. 15, s. 55.

Patents issued on or after October 1, 1989 on the basis of previously filed
applications

78.2 Subject to section 78.5, any matter arising on or after October 1, 1989 in
respect of a patent issued on or after that date on the basis of an application
filed before that date, shall be dealt with and disposed of in accordance with
the provisions of this Act, other than section 46, as they read immediately
before that date, and with sections 38.1, 45, 46 and 48.1 to 48.5 as they read
immediately after this section came into force.

1993, c. 15, s. 55.

Previous version of section 43 applies

78.3 (1) Where a conflict, as defined in section 43 as it read immediately
before October 1, 1989, exists between an application for a patent in Canada
filed before October 1, 1989 (the "earlier application") and an application for
a patent in Canada filed on or after that date (the "later application") and

(a) the later application is filed by a person who is entitled to protection
under the terms of any treaty or convention relating to patents to which Canada
is a party and who has previously regularly filed in or for any other country
that by treaty, convention or law affords similar protection to citizens of
Canada an application for a patent describing the same invention,

(b) the later application is filed within twelve months after the filing of the
previously regularly filed application,

(c) the applicant in the later application has made a request for priority in
respect of that application on the basis of the previously regularly filed
application, and

(d) the earlier application is filed after the filing of the previously
regularly filed application,

the applicant having the earlier date of invention shall be entitled to a patent
and the applications shall be dealt with and disposed of in accordance with
section 43, as it read immediately before October 1, 1989.

Exception

(2) Subsection (1) does not apply if

(a) the earlier application is filed by a person who is entitled to protection
under the terms of any treaty or convention relating to patents to which Canada
is a party and who has previously regularly filed in or for any other country
that by treaty, convention or law affords similar protection to citizens of
Canada an application for a patent describing the same invention;

(b) the earlier application is filed within twelve months after the filing of
the previously regularly filed application mentioned in paragraph (a);

(c) the applicant in the earlier application has made a request for priority in
respect of that application on the basis of the previously regularly filed
application mentioned in paragraph (a); and

(d) the previously regularly filed application mentioned in paragraph (a) was
filed before the filing of the previously regularly filed application mentioned
in subsection (1).

1993, c. 15, s. 55.

Patent applications filed on or after October 1, 1989

78.4 (1) Applications for patents in Canada filed on or after October 1, 1989,
but before this section came into force, shall be dealt with and disposed of in
accordance with

(a) subsection 27(2) as it read immediately before this section came into force;
and

(b) the provisions of this Act, including subsection 27(2), as they read
immediately after this section came into force.

Patents issued on or after October 1, 1989

(2) Any matter arising in respect of a patent issued on the basis of an
application filed on or after October 1, 1989, but before this section came into
force, shall be dealt with and disposed of in accordance with

(a) subsection 27(2) as it read immediately before this section came into force;
and

(b) the provisions of this Act, including subsection 27(2), as they read after
this section came into force and as amended from time to time.

1993, c. 15, s. 55.

Application

78.5 The provisions of this Act that apply as provided in subsection 78.1(2) and
section 78.2 shall be read subject to any amendments to this Act coming into
force

(a) after October 1, 1989 and before this section came into force; or

(b) after this section came into force.

1993, c. 15, s. 55.

PATENTED MEDICINES

Interpretation

Definitions

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

"Board" « Conseil »

"Board" means the Patented Medicine Prices Review Board continued by section 91;

"Consumer Price Index" « indice des prix à la consommation »

"Consumer Price Index" means the Consumer Price Index published by Statistics
Canada under the authority of the Statistics Act;

"Minister" « ministre »

"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;

"patentee" « breveté » ou « titulaire d'un brevet »

"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;

"regulations" « règlement »

"regulations" means regulations made under section 101.

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.

1993, c. 2, s. 7; 1996, c. 8, s. 32.

Pricing Information

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.

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.

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.

1993, c. 2, s. 7.

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.

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.

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.

1993, c. 2, s. 7.

Notice of introductory price

82. (1) A patentee of 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.

Pricing information and documents

(2) Where the Board receives a notice under subsection (1) from a patentee or
otherwise has reason to believe that a patentee of 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
patentee to provide the Board with information and documents respecting the
price at which the medicine is intended to be sold in that market.

Compliance with order

(3) Subject to subsection (4), a patentee in respect of whom an order is made
under subsection (2) shall comply with the order within such time as is
specified in the order or as the Board may allow.

Limitation

(4) No patentee shall be required to comply with an order made under subsection
(2) prior to the sixtieth day preceding the date on which the patentee intends
to first offer the medicine for sale in the relevant market.

1993, c. 2, s. 7.

Excessive Prices

Order re excessive prices

83. (1) Where the Board finds that a patentee of 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 patentee to
cause the maximum price at which the patentee sells the medicine in that market
to be reduced to such level as the Board considers not to be excessive and as is
specified in the order.

Idem

(2) Subject to subsection (4), where the Board finds that a patentee of an
invention pertaining to a medicine has, while a patentee, 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 patentee to do any one or more of the following
things as will, in the Board's opinion, offset the amount of the excess revenues
estimated by it to have been derived by the patentee from the sale of the
medicine at an excessive price:

(a) reduce the price at which the patentee sells the medicine in any market in
Canada, to such extent and for such period as is specified in the order;

(b) reduce the price at which the patentee sells one other medicine to which a
patented invention of the patentee pertains in any market in Canada, to such
extent and for such period as is specified in the order; or

(c) pay to Her Majesty in right of Canada an amount specified in the order.

Idem

(3) Subject to subsection (4), where the Board finds that a former patentee of
an invention pertaining to a medicine had, while a patentee, 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 patentee to do any one or more of the
following things as will, in the Board's opinion, offset the amount of the
excess revenues estimated by it to have been derived by the former patentee from
the sale of the medicine at an excessive price:

(a) reduce the price at which the former patentee sells a medicine to which a
patented invention of the former patentee pertains in any market in Canada, to
such extent and for such period as is specified in the order; or

(b) pay to Her Majesty in right of Canada an amount specified in the order.

Where policy to sell at excessive price

(4) Where 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 patentee or
former patentee 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 patentee or former
patentee to do any one or more of the things referred to in that subsection as
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 patentee or former
patentee from the sale of the medicine at an excessive price.

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 patentee or former
patentee before December 20, 1991 or any revenues derived by a former patentee
after the former patentee ceased to be entitled to the benefit of the patent or
to exercise any rights in relation to the patent.

Right to hearing

(6) Before the Board makes an order under this section, it shall provide the
patentee or former patentee with a reasonable opportunity to be heard.

Limitation period

(7) No order may be made under this section in respect of a former patentee 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 to exercise any
rights in relation to the patent.

1993, c. 2, s. 7; 1994, c. 26, s. 54(F).

Compliance

84. (1) A patentee or former patentee 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 such greater period
after that date as the Board determines is practical and reasonable, having
regard to the circumstances of the patentee or former patentee.

Idem

(2) A patentee or former patentee 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 such greater period after that date
as the Board determines is practical and reasonable, having regard to the
circumstances of the patentee or former patentee.

Debt due to Her Majesty

(3) An amount payable by a patentee or former patentee 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.

1993, c. 2, s. 7.

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.

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.

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 patentee in Canada of that medicine to
total world sales.

1993, c. 2, s. 7.

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.

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.

1993, c. 2, s. 7; 1995, c. 1, s. 62.

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.

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.

1993, c. 2, s. 7; 1995, c. 1, s. 62.

Sales and Expense Information

Sales and expense information, etc., to be provided

Continue with: PATENTED MEDICINES

 

Return to National Legislation page

 
countries sitemap a-z list governmental contact points