INTELLECTUAL PROPERTY RIGHTS

NATIONAL LEGISLATION - CANADA

Patent Act

PATENTED MEDICINES (continued)

Report of Board

100. (1) The Board shall in each year submit to the Minister a report on its
activities during the preceding year.

Idem

(2) The report shall contain

(a) a summary of pricing trends in the pharmaceutical industry; and

(b) the name of each patentee in respect of whom an order was made under
subsection 80(2) during the year and a statement as to the status of the matter
in respect of which the order was made.

Report summary

(3) The summary referred to in paragraph (2)(a) may be based on information and
documents provided to the Board by any patentee under section 80, 81 or 82 or in
any proceeding under section 83, but shall not be set out in a manner that would
make it possible to identify that patentee.

Tabling of report

(4) The Minister shall cause a copy of the report to be laid before each House
of Parliament on any of the first thirty days on which that House is sitting
after the report is submitted to the Minister.

1993, c. 2, s. 7.

Regulations

Regulations

101. (1) Subject to subsection (2), the Governor in Council may make regulations

(a) specifying the information and documents that shall be provided to the Board
under subsection 80(1) or (2) or 88(1);

(b) respecting the form and manner in which and times at which such information
and documents shall be provided to the Board and imposing conditions respecting
the provision of such information and documents;

(c) specifying a period for the purposes of subsection 80(2);

(d) specifying factors for the purposes of subsection 85(1) or (2), including
factors relating to the introductory price of any medicine to which a patented
invention pertains;

(e) designating a Minister for the purposes of subsection 86(2) or paragraph
87(2)(a);

(f) defining, for the purposes of sections 88 and 89, the expression "research
and development";

(g) requiring fees to be paid before the issue of any certificate referred to in
subsection 98(4) and specifying those fees or the manner of determining those
fees;

(h) requiring or authorizing the Board to perform such duties, in addition to
those provided for in this Act, as are specified in the regulations, including
duties to be performed by the Board in relation to the introductory price of any
medicine to which a patented invention pertains; and

(i) conferring on the Board such powers, in addition to those provided for in
this Act, as will, in the opinion of the Governor in Council, enable the Board
to perform any duties required or authorized to be performed by it by any
regulations made under paragraph (h).

Recommendation

(2) No regulations may be made under paragraph (1)(d), (f), (h) or (i) except on
the recommendation of the Minister, made after the Minister has consulted with
the provincial ministers of the Crown responsible for health and with such
representatives of consumer groups and representatives of the pharmaceutical
industry as the Minister considers appropriate.

1993, c. 2, s. 7.

Meetings with Minister

Meetings with Minister

102. (1) The Minister may at any time convene a meeting of the following
persons:

(a) the Chairperson and such members of the Board as the Chairperson may
designate;

(b) the provincial ministers of the Crown responsible for health or such
representatives as they may designate;

(c) such representatives of consumer groups and representatives of the
pharmaceutical industry as the Minister may designate; and

(d) such other persons as the Minister considers appropriate.

Agenda

(2) The participants at a meeting convened under subsection (1) shall consider
such matters in relation to the administration or operation of sections 79 to
101 as the Minister may determine.

1993, c. 2, s. 7.

Agreements with Provinces

Agreements with provinces

103. The Minister may enter into agreements with any province respecting the
distribution to that province of amounts received or collected by the Receiver
General under section 84, less any costs incurred in relation to the collection
and distribution of those amounts.

1993, c. 2, s. 7; 1994, c. 26, s. 55(F).

RELATED PROVISIONS

-                 R.S., 1985, c. 33 (3rd Supp.), ss. 31 and 32, as amended by
1992, c. 1, s. 145(F) (Sch. VIII, item 22):

Payments to provinces

"31. (1) The Minister of Consumer and Corporate Affairs shall pay to each
province for each of the fiscal years commencing in the period April 1, 1987 to
March 31, 1991, for the purpose of research and development relating to
medicine, an amount equal to the product obtained by multiplying

(a) the quotient obtained by dividing

(i) twenty-five million dollars

by

(ii) the total population of all provinces for the fiscal year in respect of
which the payment is made,

by

(b) the population of the province for the fiscal year in respect of which the
payment is made.

Time and manner of payment

(2) Payment of any amount under this section shall be made out of the
Consolidated Revenue Fund at such times and in such manner as the Governor in
Council may, by regulation, prescribe.

Determination of population

(3) For the purposes of this section, the population of a province for a fiscal
year shall be the population of that province on June 1 of that year as
determined and published by the Chief Statistician of Canada.

Prohibition

32. (1) Notwithstanding anything in section 39 of the Patent Act or in any
licence granted under that section, no person shall, under a licence granted
prior to March 28, 1989 under that section in respect of a patent pertaining to
the medicine Diltiazem hydrochloride, have or exercise any right to

(a) import Diltiazem hydrochloride, if it is to be sold for consumption in
Canada; or

(b) make Diltiazem hydrochloride for sale for consumption in Canada.

Duration of prohibition

(2) The prohibition under subsection (1) expires on March 28, 1989.

Actions and proceedings barred

(3) No action or proceedings for any compensation or damages lie against Her
Majesty in right of Canada as a result of the application of subsection (1) to a
licence referred to in that subsection."

-                 1993, c. 2, ss. 9 to 14:

Definitions

9. In this section and sections 10 to 13,

"commencement day" � date d'entr�e en vigueur �

"commencement day" means the day on which section 3 of this Act comes into
force;

"former Act" � loi ant�rieure �

"former Act" means the Patent Act, as it read immediately before the
commencement day.

Pending proceedings

10. Any proceeding pending before the Patented Medicine Prices Review Board
immediately before the commencement day shall be taken up and continued under
and in accordance with sections 79 to 101 of the Patent Act, as enacted by
section 7 of this Act, as if the proceeding had been commenced on or after that
day.

Licences continued

11. (1) A licence that has been granted under section 39 of the former Act
before December 20, 1991 and that has not been terminated before the
commencement day shall continue in effect according to its terms and, subject to
subsection (2), sections 39 to 39.14 of the former Act shall continue to apply
in respect of that licence as if they had not been repealed by section 3 of this
Act.

Exception

(2) For the purposes of applying sections 39 to 39.14 of the former Act in
respect of a licence continued by subsection (1), the prohibitions set out in
subsections 39.11(1) and 39.14(1) of the former Act do not apply in respect of
any medicine or medicines in respect of which an order has been made under
paragraph 39.15(3)(d) of the former Act, if that order is in force immediately
before the commencement day.

Licences ceasing to have effect

12. (1) Every licence granted under section 39 of the former Act on or after
December 20, 1991 shall cease to have effect on the expiration of the day
preceding the commencement day, and all rights or privileges acquired or accrued
under that licence or under the former Act in relation to that licence shall
thereupon be extinguished.

Actions for infringement barred

(2) For greater certainty, no action for infringement of a patent lies under the
Patent Act in respect of any act that is done before the commencement day under
a licence referred to in subsection (1) in accordance with the terms of that
licence and sections 39 to 39.17 of the former Act.

Actions and proceedings barred

13. 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 section 11 or 12 or the repeal of sections 39
to 39.17 of the former Act.

Review of certain sections

14. (1) On the expiration of four years after this Act is assented to, the
provisions of the Patent Act enacted by this Act shall be referred to such
committee of the House of Commons, of the Senate or of both Houses of Parliament
as may be designated or established for the purpose of the review referred to in
subsection (2).

Idem

(2) The committee shall undertake a comprehensive review of the provisions of
the Patent Act enacted by this Act and shall, within one year after the review
is undertaken or within such further time as the House or Houses that designated
or established the committee may authorize, submit a report thereon, including
such recommendations as the committee may wish to make pertaining to those
provisions.

-                 1993, c. 44, s. 191(2):

No liability

(2) Her Majesty in right of Canada or a province is not, by reason only of the
enactment of subsection (1), liable for any use of a patented invention before
the day on which subsection (1) comes into force.

AMENDMENT NOT IN FORCE

-                 1997, c. 9, s. 111:

R.S., c. 33 (3rd Supp.), s. 5

111. Section 22 of the Patent Act and the heading before it are replaced by the
following:

PATENTS RELATING TO NUCLEAR ENERGY

Communication to Canadian Nuclear Safety Commission

22. Any application for a patent for an invention that, in the opinion of the
Commissioner, relates to the production, application or use of nuclear energy
shall, before it is dealt with by an examiner appointed pursuant to section 6 or
is open to inspection by the public under section 10, be communicated by the
Commissioner to the Canadian Nuclear Safety Commission.

Payment Clearing and Settlement Act

See Schedule of Financial Institutions