The Committee resumed consideration of the amendment of Joe Fontana, — That Bill C-9, in Clause 1, be amended by replacing line 19 on page 4 to line 23 on page 11 with the following:
“
21.04
(1) Subject to subsection (3), the Commissioner shall, on the application of any person and on the payment of the prescribed fee, authorize the person to make, construct and use a patented invention solely for purposes directly related to the manufacture of the pharmaceutical product named in the application and to sell it for export to a country or WTO Member that is listed in any of Schedules 2 to 4 and that is named in the application.
(2) The application must be in the prescribed form and set out
(
a
) the name of the pharmaceutical product to be manufactured and sold for export under the authorization;
(
b
) prescribed information in respect of the version of the pharmaceutical product to be manufactured and sold for export under the authorization;
(
c
) the maximum quantity of the pharmaceutical product to be manufactured and sold for export under the authorization;
(
d
) for each patented invention to which the application relates, 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;
(
e
) the name of the country or WTO Member to which the pharmaceutical product is to be exported;
(
f
) the name of the person or entity to which the product is to be sold, and prescribed information, if any, concerning that person or entity; and
(
g
) any other information that may be prescribed.
(3) The Commissioner shall authorize the use of the patented invention only if
(
a
) the applicant has complied with the prescribed requirements, if any;
(
b
) the Minister of Health has notified the Commissioner that the version of the pharmaceutical product that is named in the application 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
(i) in Canada as permitted by the General Council Decision, and
(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;
(
c
) the applicant provides the Commissioner with a solemn or statutory declaration in the prescribed form stating that the applicant had, within the prescribed time before filing the application,
(i) sought from the patentee or, if there is more than one, from each of the patentees a licence to manufacture and sell the pharmaceutical product for export to the country or WTO Member named in the application, and
(ii) provided the patentee, or each of the patentees, as the case may be, with information that is in all material respects identical to the information referred to in paragraphs (2)(
a
) to (
g
); and
(
d
) the applicant also provides the Commissioner with
(i) if the application 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
(A) a solemn or statutory declaration in the prescribed form by the person filing the application stating that the product to which the application relates is the product specified in the notice and that the product is not patented in that WTO Member, or
(B) a solemn or statutory declaration in the prescribed form by the person filing the application stating that the product to which the application relates is the product specified in the notice and 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,
(ii) if the application 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
(A) a solemn or statutory declaration in the prescribed form by the person filing the application stating that the product to which the application relates is the product specified in the notice and that the product is not patented in that country, or
(B) a solemn or statutory declaration in the prescribed form by the person filing the application stating that the product to which the application relates is the product specified in the notice and 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,
(iii) if the application 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 application relates, and
(A) a solemn or statutory declaration in the prescribed form by the person filing the application stating that the product to which the application relates is not patented in that WTO Member, or
(B) 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,
(iv) if the application 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 application relates, and
(A) a solemn or statutory declaration in the prescribed form by the person filing the application stating that the product to which the application relates is not patented in that WTO Member, or
(B) 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, or
(v) if the application relates to a country listed in Schedule 4 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 stating that it is faced with a national emergency or other circumstances of extreme urgency, that it has insufficient or no pharmaceutical manufacturing capacity for the production of the product to which the application relates, that it agrees that product will not be used for commercial purposes and that it undertakes to adopt the measures referred to in Article 4 of the General Council Decision, and
(A) a solemn or statutory declaration in the prescribed form by the person filing the application stating that the product to which the application relates is not patented in that country, or
(B) 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.
21.05
(1) The authorization must be in the prescribed form and, subject to subsection (2), contain the prescribed information.
(2) The quantity of the product authorized to be manufactured by an authorization may not be more than the lesser of
(
a
) the maximum quantity set out in the application for the authorization, and
(
b
) the quantity set out in the notice referred to in any of subparagraphs 21.04(3)(
d
)(i) to (v), whichever is applicable.
21.06
(1) 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 distinguishing features of the product, and of its label and packaging, as required by regulations made under the
Food and Drugs Act
.
(2) The holder must maintain the website during the entire period during which the authorization is valid.
21.07
Before exporting any quantity of a product manufactured under an authorization, the holder of the authorization must, at least fifteen days before the product is exported, provide to each of the following a notice specifying the quantity to be exported:
(
a
) the patentee or each of the patentees, as the case may be;
(
b
) the country or WTO Member named in the authorization; and
(
c
) the person or entity that purchased the product to which the authorization relates.
21.08
(1) Subject to subsections (3) and (4), on the occurrence of a prescribed event, the holder of an authorization is required to pay to the patentee or each patentee, as the case may be, a royalty determined in the prescribed manner.
(2) In making regulations for the purposes of subsection (1), the Governor in Council must consider the humanitarian and non-commercial reasons underlying the issuance of authorizations under subsection 21.04(1).
(3) The royalties payable under this section must be paid within the prescribed time.
(4) The Federal Court may, in relation to any authorization, make an order providing for the payment of a royalty that is greater than the royalty that would otherwise be required to be paid under subsection (1).
(5) An order may be made only on the application of the patentee, or one of the patentees, as the case may be, and on notice of the application being given by the applicant to the holder of the authorization.
(6) An order may provide for a royalty of a fixed amount or for a royalty to be determined as specified in the order, and the order may be subject to any terms that the Federal Court considers appropriate.
(7) The Federal Court may make an order only if it is satisfied that the royalty otherwise required to be paid is not adequate remuneration for the use of the invention or inventions to which the authorization relates, taking into account
(
a
) the economic value of the use of the invention or inventions to the country or WTO Member; and
(
b
) the humanitarian and non-commercial reasons underlying the issuance of the authorization.
21.09
An authorization granted under subsection 21.04(1) is valid for a period of two years beginning on the day on which the authorization is granted.
21.1
The use of a patented invention under an authorization is non-exclusive.
21.11
An authorization is non-transferable, other than where the authorization is an asset of a corporation or enterprise and the part of the corporation or enterprise that enjoys the use of the authorization is sold, assigned or otherwise transferred.
21.12
(1) The Commissioner shall, on the application of the person to whom an authorization was granted and on the payment of the prescribed fee, renew the authorization if the person certifies under oath in the renewal application that the quantities of the pharmaceutical product authorized to be exported were not exported before the authorization ceases to be valid and that the person has complied with the terms of the authorization and the requirements of sections 21.06 to 21.08.
(2) An authorization may be renewed only once.
(3) The application for renewal must be made within the 30 days immediately before the authorization ceases to be valid.
(4) An authorization that is renewed is valid for a period of two years beginning on the day immediately following the day of the expiry of the period referred to in section 21.09 in respect of the authorization.
(5) Applications for renewal and renewed authorizations issued under subsection (1) must be in the prescribed form.”
The debate continued.