Patent Act (R.S.C., 1985, c. P-4)

Marginal note:Agreement between Canada and other government

21 Where by any agreement between the Government of Canada and any other government it is provided that the Government of Canada will apply section 20 to inventions disclosed in any application for a patent assigned or agreed to be assigned by the inventor to that other government, and the Commissioner is notified by any minister of the Crown that the agreement extends to an invention in a specified application, the application and all the documents relating thereto shall be dealt with as provided in section 20, except subsections (3) and (4), as if the invention had been assigned or agreed to be assigned to the Minister of National Defence.

Use of Patents for International Humanitarian Purposes to Address Public Health Problems

Marginal note:Purpose

21.01 The purpose of sections 21.02 to 21.2 is to give effect to Canada’s and Jean Chrétien’s pledge to Africa by facilitating 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.

Marginal note:Definitions

21.02 The definitions in this section apply in this section and in sections 21.03 to 21.19.

authorization

authorization means an authorization granted under subsection 21.04(1), and includes an authorization renewed under subsection 21.12(1). (autorisation)

General Council

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. (Conseil général)

General Council Decision

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. (décision du Conseil général)

patented product

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. (produit breveté)

pharmaceutical product

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. (produit pharmaceutique)

TRIPS Agreement

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. (Accord sur les ADPIC)

TRIPS Council

TRIPS Council means the council referred to in the TRIPS Agreement. (Conseil des ADPIC)

WTO

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. (OMC)

Marginal note:Amending Schedules

• 21.03 (1) The Governor in Council may, by order,

  • (a) on the recommendation of the Minister and the Minister of Health, amend Schedule 1

    • (i) by adding the name of any patented product that may be used to address public health problems afflicting many developing and least-developed countries, 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

    • (ii) by removing any entry listed in it;

  • (b) on the recommendation of the Minister of Foreign Affairs, the Minister for International Trade and the Minister for International Development, amend Schedule 2 by adding the name of any country recognized by the United Nations as being a least-developed country that has,

    • (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

    • (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 pharmaceutical products, as defined in paragraph 1(a) of the General Council Decision, that it agrees that those products will not be used for commercial purposes and that it undertakes to adopt the measures referred to in Article 4 of that decision;

  • (c) on the recommendation of the Minister of Foreign Affairs, the Minister for International Trade and the Minister for International Development, amend 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

  • (d) on the recommendation of the Minister of Foreign Affairs, the Minister for International Trade and the Minister for International Development, amend Schedule 4 by adding the name of

    • (i) 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, or

    • (ii) any country that is not a WTO Member and that is named on the Organization for Economic Co-operation and Development’s list of countries that are eligible for official development assistance and that has provided the Government of Canada with a notice in writing through diplomatic channels

      • (A) stating that it is faced with a national emergency or other circumstances of extreme urgency,

      • (B) 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 to deal with the emergency or other urgency,

      • (C) stating that it has no, or insufficient, pharmaceutical capacity to manufacture that product, and

      • (D) stating that it agrees that 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.

• Marginal note:Restriction - Schedule 3

  (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.

• Marginal note:Removal from Schedules 2 to 4

  (3) The Governor in Council may, by order, on the recommendation of the Minister of Foreign Affairs, the Minister for International Trade and the Minister for International Development, amend any of Schedules 2 to 4 to remove the name of any country or WTO Member if

  • (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 or, in the case of a country that is not a WTO Member, the country has permitted any product imported into that country under an authorization to be used for commercial purposes or has failed to adopt the measures referred to in Article 4 of the General Council Decision;

  • (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;

  • (c) in the case of a WTO Member listed in Schedule 4, the WTO Member has 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;

  • (d) in the case of a country listed in Schedule 4 that is not a WTO Member,

    • (i) the name of the country is no longer on the Organization for Economic Co-operation and Development’s list of countries that are eligible for official development assistance,

    • (ii) the country no longer faces a national emergency or other circumstances of extreme urgency,

    • (iii) the country has permitted any product imported into that country under an authorization to be used for commercial purposes, or

    • (iv) the country has failed to adopt the measures referred to in Article 4 of the General Council Decision;

  • (e) in the case of any country or WTO Member listed in Schedule 3 or 4, the country or WTO Member has become recognized by the United Nations as a least-developed country; and

  • (f) in the case of any country or WTO Member listed in any of Schedules 2 to 4, the country has notified the Government of Canada, or the WTO Member has notified the TRIPS Council, that it will not import pharmaceutical products, as defined in paragraph 1(a) of the General Council Decision.

• Marginal note:Timeliness of orders

  (4) An order under this section shall be made in a timely manner.

Marginal note:Authorization

• 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.

• Marginal note:Contents of 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 governmental person or entity, or the person or entity permitted by the government of the importing country, 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.

• Marginal note:Conditions for granting of authorization

  (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, at least thirty days before filing the application,

    • (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 the country or WTO Member named in the application 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 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.