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Amendment to Motion No. 1 — January 31, 2011 — , seconded by , — That the motion proposing to restore Clause 2 of Bill C-393 be amended by replacing the definition “pharmaceutical product” with the following: |
““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 and any other patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address public health problems, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics, and includes active ingredients necessary for its manufacture and diagnostic kits needed for its use.”. |
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Motion No. 2 — January 31, 2011 — , seconded by , — That Bill be amended by restoring Clause 4 as follows: |
“4. (1) Subsection 21.04(1) of the Act is replaced by the following: |
21.04 (1) Subject to subsections (3) and (4), the Commissioner shall, on the application of any person and on the payment of the prescribed fee, authorize the person to |
(a) manufacture the pharmaceutical product or products named in the application; |
(b) make, construct and use any patented invention solely for the purpose of manufacturing the product or products; and |
(c) sell the product or products for export to a country that is listed in the Schedule. |
(1.1) In addition to what is authorized under subsection (1), an authorization under that subsection authorizes the person to |
(a) manufacture any active ingredient used in the manufacture of a finished product; and |
(b) make, construct and use any patented invention solely for the purpose of manufacturing any active pharmaceutical ingredient used in the manufacture of a finished product. |
(1.2) If a country is removed from the Schedule an authorization continues to apply with respect to that country for 30 days as though that country had not been removed from the Schedule. |
(2) Subsection 21.04(2) of the Act is amended by adding “and” at the end of paragraph (a) and by repealing paragraphs (b) to (f). |
(3) Subsection 21.04(3) of the Act is replaced by the following: |
(3) The Commissioner shall grant an authorization only if the applicant has complied with the prescribed requirements.” |
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Amendment to Motion No. 2 — January 31, 2011 — , seconded by , — That the Motion proposing to restore Clause 4 of Bill C-393 be amended by deleting all the words after the words “4. (1)Subsection 21.04(1) of the Act is replaced by the following:” and substituting 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 any country listed in Schedule 2. |
(2) Paragraph 21.04(2)(c) of the Act is repealed. |
(3) Paragraphs 21.04(2)(e) and (f) of the Act are repealed. |
(4) Subparagraphs 21.04(3)(c)(i) and (ii) of the Act are replaced by the following: |
(i) sought from the patentee or, if there is more than one, from each of the patentees, by certified or registered mail, a licence to manufacture and sell the pharmaceutical product for export to one or more of the countries listed in Schedule 2 on reasonable terms and conditions and that such efforts have not been successful; and |
(ii) provided the patentee, or each of the patentees, as the case may be, by certified or registered mail, in the written request for a licence, with the information that is in all material respects identical to the information referred to in subsection (2). |
(5) Paragraph 21.04(3)(d) of the Act is repealed. |
(6) Section 21.04 is amended by adding the following after subsection (3): |
“(4) The solemn or statutory declaration referred to in paragraph (3)(c) is not required in the case of an application to the Commissioner for an authorization to supply the product named in the application to an eligible importing country for purposes of addressing a national emergency or other circumstances of extreme urgency in that country or for purposes of public non-commercial use, but in such cases, the Commissioner shall notify the patentee or patentees of the issuance of the compulsory licence as soon as reasonably practicable after it has been issued.””. |
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Motion No. 3 — January 31, 2011 — , seconded by , — That Bill be amended by adding after line 22 on page 3 the following new clause: |
“18. (1) The provisions of this Act that amend the Patent Act shall cease to apply on the day that is the fourth anniversary of the day on which this Act comes into force unless, before that day, the application of those provisions is extended by a resolution — the text of which is established under subsection (2) — passed by both Houses of Parliament in accordance with the rules set out in subsection (3). |
(2) The Governor in Council may, by order, establish the text of a resolution providing for the extension of the application of the provisions that amend the Patent Act referred to in subsection (1) and specifying the period of the extension, which may not exceed five years from the first day on which the resolution has been passed by both Houses of Parliament. |
(3) A motion for the adoption of the resolution may be debated in both Houses of Parliament but may not be amended. At the conclusion of the debate, the Speaker of each House of Parliament shall immediately put every question necessary to determine whether or not the motion is concurred in. |
(4) The application of the provisions that amend the Patent Act referred to in subsection (1) may be further extended in accordance with the procedure set out in this section. |
(5) In the event that the provisions that amend the Patent Act referred to in subsection (1) cease to apply, applications that have been granted an authorization under section 21.04 of that Act shall be concluded if they were submitted before the day on which those provisions cease to apply.” |
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