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2nd Session, 37th Parliament,
51-52 Elizabeth II, 2002-2003
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House of Commons of Canada
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BILL C-56
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An Act to amend the Patent Act and the Food
and Drugs Act
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Her Majesty, by and with the advice and
consent of the Senate and House of Commons
of Canada, enacts as follows:
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| R.S., c. P-4
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1. The Patent Act is amended by adding
the following after section 21:
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| Purpose
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21.01 The purpose of sections 21.02 to
21.17 is to facilitate access to pharmaceutical
products to address public health problems
afflicting many developing and
least-developed countries, especially those
resulting from HIV/AIDS, tuberculosis,
malaria and other epidemics.
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| Definitions
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21.02 The definitions in this section apply
in this section and in sections 21.03 to 21.17.
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``authorizatio
n''
« autorisation
»
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``authorization'' means an authorization
granted under subsection 21.05(1), and
includes an authorization renewed under
section 21.12.
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``General
Council ''
« Conseil
général »
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``General Council'' means the General
Council of the WTO established by
paragraph 2 of Article IV of the Agreement
Establishing the World Trade Organization,
signed at Marrakesh on April 15, 1994.
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``General
Council
Decision''
« décision du
Conseil
général »
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``General Council Decision'' means the
decision of the General Council of August
30, 2003 respecting Article 31 of the TRIPS
Agreement, including the interpretation of
that decision in the General Council
Chairperson's statement of that date.
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``patented
product''
« produit
breveté »
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``patented product'' means a product the
making, constructing, using or selling of
which in Canada would infringe a patent in
the absence of the consent of the patentee.
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``pharmaceuti
cal product''
« produit
pharmaceutiq
ue »
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``pharmaceutical product'' means any
patented product listed in Schedule 1 in, if
applicable, the dosage form, the strength
and the route of administration specified in
that Schedule in relation to the product.
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``TRIPS
Agreement''
« Accord sur
les ADPIC »
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``TRIPS Agreement'' means the Agreement
on Trade-Related Aspects of Intellectual
Property Rights, being Annex 1C of the
Agreement Establishing the World Trade
Organization, signed at Marrakesh on April
15, 1994.
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``TRIPS
Council''
« Conseil des
ADPIC »
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``TRIPS Council'' means the council referred
to in the TRIPS Agreement.
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``WTO''
« OMC »
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``WTO'' means the World Trade Organization
established by Article I of the Agreement
Establishing the World Trade Organization,
signed at Marrakesh on April 15, 1994.
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| Amending
Schedules
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21.03 (1) The Governor in Council may, by
order, amend
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(i) by adding the name of any patented
product that may be used to address
public health problems, especially those
resulting from HIV/AIDS, tuberculosis,
malaria and other epidemics and, if the
Governor in Council considers it
appropriate to do so, by adding one or
more of the following in respect of the
patented product, namely, a dosage form,
a strength and a route of administration,
and
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(ii) by removing any entry listed in it;
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(b) Schedule 2, by adding the name of any
country recognized by the United Nations
as being a least-developed country that has,
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(i) if it is a WTO Member, provided the
TRIPS Council with a notice in writing
stating that the country intends to import,
in accordance with the General Council
Decision, pharmaceutical products, as
defined in paragraph 1(a) of that
decision, and
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(ii) if it is not a WTO Member, provided
the Government of Canada with a notice
in writing through diplomatic channels
stating that the country intends to import,
in accordance with the General Council
Decision, pharmaceutical products, as
defined in paragraph 1(a) of that
decision;
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(c) Schedule 3, by adding the name of any
WTO Member not listed in Schedule 2 that
has provided the TRIPS Council with a
notice in writing stating that the WTO
Member intends to import, in accordance
with the General Council Decision,
pharmaceutical products, as defined in
paragraph 1(a) of that decision; and
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(d) Schedule 4, by adding the name of any
WTO Member not listed in Schedule 2 or 3
that has provided the TRIPS Council with a
notice in writing stating that the WTO
Member intends to import, in accordance
with the General Council Decision,
pharmaceutical products, as defined in
paragraph 1(a) of that decision.
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| Restriction -
Schedule 3
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(2) The Governor in Council may not add to
Schedule 3 the name of any WTO Member
that has notified the TRIPS Council that it will
import, in accordance with the General
Council Decision, pharmaceutical products,
as defined in paragraph 1(a) of that decision,
only if faced with a national emergency or
other circumstances of extreme urgency.
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| Removal from
Schedules 2 to
4
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(3) The Governor in Council may, by order,
amend any of Schedules 2 to 4 to remove the
name of any country or WTO Member if
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(a) in the case of a country or WTO Member
listed in Schedule 2, the country or WTO
Member has ceased to be recognized by the
United Nations as being a least-developed
country;
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(b) in the case of a WTO Member listed in
Schedule 3, the WTO Member has notified
the TRIPS Council that it will import, in
accordance with the General Council
Decision, pharmaceutical products, as
defined in paragraph 1(a) of that decision,
only if faced with a national emergency or
other circumstances of extreme urgency;
and
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(c) in the case of a WTO Member listed in
Schedule 4, the WTO Member has
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(i) notified the TRIPS Council that it will
not import pharmaceutical products, as
defined in paragraph 1(a) of the General
Council Decision, or
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(ii) revoked any notification it has given
to the TRIPS Council that it will import
pharmaceutical products, as defined in
paragraph 1(a) of the General Council
Decision, only if faced with a national
emergency or other circumstances of
extreme urgency.
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| Notice of
intent to apply
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21.04 (1) A person who intends to apply for
an authorization under subsection 21.05(1)
must first file with the Commissioner
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(a) a notice of intent to apply containing the
information referred to in subsection (2);
and
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(b) every applicable document referred to in
subsection (3).
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| Content of
notice of
intent
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(2) The notice of intent must set out
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(a) the name of the pharmaceutical product
the person intends to manufacture and sell
for export under the authorization;
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(b) information that may be prescribed in
respect of the version of the pharmaceutical
product intended to be manufactured;
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(c) the quantity intended to be
manufactured of the pharmaceutical
product referred to in paragraph (b);
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(d) for each patented invention to which the
application is to relate, the name of the
patentee of the invention and the number, as
recorded in the Patent Office, of the patent
issued in respect of that invention;
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(e) the name of the country or WTO
Member to which the pharmaceutical
product referred to in paragraph (b) is
intended to be exported; and
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(f) the contractual terms and conditions of
the agreement between the person and the
government of the country or WTO
Member, or the agent of that government,
under which the pharmaceutical product
referred to in paragraph (b) is to be
manufactured and sold for export.
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| Documents
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(3) The documents that must accompany
the notice of intent are
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(a) if the notice of intent relates to a WTO
Member listed in Schedule 2, a certified
copy of the notice in writing that the WTO
Member has provided to the TRIPS Council
specifying the name of the pharmaceutical
product, as defined in paragraph 1(a) of the
General Council Decision, and the quantity
of that product, needed by the WTO
Member, and
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(i) a solemn or statutory declaration by
the person filing the notice of intent
stating that the product to which the
notice relates is not patented in that WTO
Member, or
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(ii) a certified copy of the notice in
writing that the WTO Member has
provided to the TRIPS Council
confirming that the WTO Member has, in
accordance with Article 31 of the TRIPS
Agreement and the provisions of the
General Council Decision, granted or
intends to grant a compulsory licence to
use the invention pertaining to the
product;
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(b) if the notice of intent relates to a country
listed in Schedule 2 that is not a WTO
Member, a certified copy of the notice in
writing that the country has provided to the
Government of Canada through diplomatic
channels specifying the name of the
pharmaceutical product, as defined in
paragraph 1(a) of the General Council
Decision, and the quantity of that product,
needed by the country, and
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(i) a solemn or statutory declaration by
the person filing the notice of intent
stating that the product to which the
notice relates is not patented in that
country, or
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(ii) a certified copy of the notice in
writing that the country has provided to
the Government of Canada through
diplomatic channels confirming that the
country has granted or intends to grant a
compulsory licence to use the invention
pertaining to the product;
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(c) if the notice of intent relates to a WTO
Member listed in Schedule 3, a certified
copy of the notice in writing that the WTO
Member has provided to the TRIPS Council
specifying the name of the pharmaceutical
product, as defined in paragraph 1(a) of the
General Council Decision, and the quantity
of that product, needed by the WTO
Member, and stating that the WTO Member
has insufficient or no pharmaceutical
manufacturing capacity for the production
of the product to which the notice relates,
and
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(i) a solemn or statutory declaration by
the person filing the notice of intent
stating that the product to which the
notice relates is not patented in that WTO
Member, or
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(ii) if the product is patented in that WTO
Member, a certified copy of the notice in
writing that the WTO Member has
provided to the TRIPS Council
confirming that the WTO Member has, in
accordance with Article 31 of the TRIPS
Agreement and the provisions of the
General Council Decision, granted or
intends to grant a compulsory licence to
use the invention pertaining to the
product; and
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(d) if the notice of intent relates to a WTO
Member listed in Schedule 4, a certified
copy of the notice in writing that the WTO
Member has provided to the TRIPS Council
specifying the name of the pharmaceutical
product, as defined in paragraph 1(a) of the
General Council Decision, and the quantity
of that product, needed by the WTO
Member, and stating that the WTO Member
is faced with a national emergency or other
circumstances of extreme urgency and that
it has insufficient or no pharmaceutical
manufacturing capacity for the production
of the product to which the notice relates,
and
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(i) a solemn or statutory declaration by
the person filing the notice of intent
stating that the product to which the
notice relates is not patented in that WTO
Member, or
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(ii) a certified copy of the notice in
writing that the WTO Member has
provided to the TRIPS Council
confirming that the WTO Member has, in
accordance with Article 31 of the TRIPS
Agreement and the provisions of the
General Council Decision, granted or
intends to grant a compulsory licence to
use the invention pertaining to the
product.
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| Prescribed fee
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(4) The person filing the notice of intent
must, at the time of filing it, or within the
prescribed time, if any, pay the prescribed fee.
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| Copy of
notice to
patentee with
statement
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(5) If the country or WTO Member named
in the notice is listed in any of Schedules 2 to
4, the Commissioner shall, without delay,
send to each patentee named in the notice, by
registered mail, a copy of the notice of intent
and the statement referred to in subsection (6)
or (7), as the case may be.
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| Content of
statement -
single
patentee
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(6) If only one patentee is named in the
notice of intent, the statement must inform the
patentee that an authorization may be granted
in relation to the pharmaceutical product
named in the notice unless the patentee
provides the Commissioner, within thirty days
after the statement is sent, with a solemn or
statutory declaration in the prescribed form
stating that the patentee, or an agent of the
patentee,
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(a) will supply the pharmaceutical product
to the country or WTO Member named in
the notice on terms and conditions that are
no less favourable than those referred to in
paragraph (2)(f); or
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(b) has agreed, on the payment of a royalty
equal to the royalty referred to in paragraph
21.08(a), to grant to the person who filed
the notice a right to use the patented
invention pertaining to the pharmaceutical
product so that it can be manufactured and
sold for export as set out in that notice.
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| Content of
statement -
more than one
patentee
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(7) If more than one patentee is named in the
notice of intent, the statement sent to each of
them must inform that patentee that an
authorization may be granted in relation to the
pharmaceutical product named in the notice
unless
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(a) one or more of the patentees provide the
Commissioner, within thirty days after the
statement is sent, with a solemn or statutory
declaration in the prescribed form stating
that the patentee, or an agent of the
patentee, will supply the pharmaceutical
product to the country or WTO Member
named in the notice on terms and conditions
that are no less favourable than those
referred to in paragraph (2)(f); or
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(b) each of the patentees provides the
Commissioner, within thirty days after the
statement is sent, with a solemn or statutory
declaration in the prescribed form stating
that the patentee, or an agent of the
patentee, has agreed, on the payment of a
royalty equal to the royalty referred to in
paragraph 21.08(b), to grant to the person
who filed the notice a right to use the
patented invention pertaining to the
pharmaceutical product so that it can be
manufactured and sold for export as set out
in that notice.
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| Authorization
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21.05 (1) Subject to subsections (3) to (5),
the Commissioner shall, on the application of
any person and on the payment of the
prescribed fee, authorize the use of a patented
invention by that person solely for the
purposes of manufacturing the
pharmaceutical product named in the
application and selling it for export to the
country or WTO Member named in the
application.
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| Contents of
application
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(2) The application must be in the
prescribed form, if any, and contain the
information referred to in paragraphs
21.04(2)(a) to (f) and any other information
that may be prescribed.
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| Conditions for
granting of
authorization
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(3) The Commissioner shall authorize the
use of the patented invention only if
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(a) the applicant has complied with the
prescribed requirements, if any; and
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(b) the Minister of Health has notified the
Commissioner that the version of the
pharmaceutical product that is named in the
application that the applicant intends to
manufacture meets the requirements of the
Food and Drugs Act and its regulations,
including the requirements under those
regulations relating to the marking,
embossing, labelling and packaging that
identify that version of the product as
having been manufactured
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(i) in Canada as permitted by the General
Council Decision, and
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(ii) in a manner that distinguishes it from
the version of the pharmaceutical
product sold in Canada by, or with the
consent of, the patentee or patentees, as
the case may be.
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| Restriction
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(4) The Commissioner may not grant the
authorization if the person making the
application has not complied with subsections
21.04(1) and (4).
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| Restriction
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(5) In the case where subsections 21.04(1)
and (4) have been complied with, the
Commissioner may not grant the
authorization if
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(a) in the case where only one patentee was
named in the notice of intent, the patentee
has provided the Commissioner with the
solemn or statutory declaration referred to
in paragraph 21.04(6)(a) or (b) within the
time provided in that subsection; or
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(b) in the case where more than one patentee
was named in the notice of intent, one or
more of the patentees have provided the
Commissioner with the solemn or statutory
declaration referred to in paragraph
21.04(7)(a), or all of the patentees have
provided the Commissioner with the
solemn or statutory declaration referred to
in paragraph 21.04(7)(b), within the time
provided in that subsection.
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| Form and
content of
authorization
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21.06 (1) The authorization must be in the
prescribed form and, subject to subsection (2),
contain the prescribed information.
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| Quantity
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(2) The quantity of the product authorized
to be manufactured by an authorization may
not be more than the lesser of
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(a) the quantity set out in the notice of intent
related to the application for the
authorization, and
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(b) the quantity set out in the notice referred
to in paragraphs 21.04(3)(a) to (d),
whichever is applicable.
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| Disclosure of
information
on website
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21.07 Before exporting a product
manufactured under an authorization, the
holder of the authorization must establish a
website on which is disclosed the prescribed
information respecting the name of the
product, the name of the country or WTO
Member to which it is to be exported, the
quantity that is authorized to be manufactured
and sold for export and the product's
distinguishing features as required by the
Food and Drug Regulations.
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| Royalty
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21.08 (1) The holder of an authorization
must pay
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