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Bill C-56

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2nd Session, 37th Parliament,
51-52 Elizabeth II, 2002-2003

House of Commons of Canada

BILL C-56

An Act to amend the Patent Act and the Food and Drugs Act

      Her Majesty, by and with the advice and consent of the Senate and House of Commons of Canada, enacts as follows:

R.S., c. P-4

PATENT ACT

1. The Patent Act is amended by adding the following after section 21:

USE OF PATENTS FOR INTERNATIONAL HUMANITARIAN PURPOSES TO ADDRESS PUBLIC HEALTH PROBLEMS

Purpose

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.

Definitions

21.02 The definitions in this section apply in this section and in sections 21.03 to 21.17.

``authorizatio n''
« autorisation »

``authorization'' means an authorization granted under subsection 21.05(1), and includes an authorization renewed under section 21.12.

``General Council ''
« Conseil général »

``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.

``General Council Decision''
« décision du Conseil général »

``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.

``patented product''
« produit breveté »

``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.

``pharmaceuti cal product''
« produit pharmaceutiq ue »

``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.

``TRIPS Agreement''
« Accord sur les ADPIC »

``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.

``TRIPS Council''
« Conseil des ADPIC »

``TRIPS Council'' means the council referred to in the TRIPS Agreement.

``WTO''
« OMC »

``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.

Amending Schedules

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

    (a) Schedule 1

      (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

      (ii) by removing any entry listed in it;

    (b) 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, in accordance with the General Council Decision, pharmaceutical products, as defined in paragraph 1(a) of that decision;

    (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

    (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.

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.

Removal from Schedules 2 to 4

(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

    (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;

    (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

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

      (i) notified the TRIPS Council that it will not import pharmaceutical products, as defined in paragraph 1(a) of the General Council Decision, or

      (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.

Notice of intent to apply

21.04 (1) A person who intends to apply for an authorization under subsection 21.05(1) must first file with the Commissioner

    (a) a notice of intent to apply containing the information referred to in subsection (2); and

    (b) every applicable document referred to in subsection (3).

Content of notice of intent

(2) The notice of intent must set out

    (a) the name of the pharmaceutical product the person intends to manufacture and sell for export under the authorization;

    (b) information that may be prescribed in respect of the version of the pharmaceutical product intended to be manufactured;

    (c) the quantity intended to be manufactured of the pharmaceutical product referred to in paragraph (b);

    (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;

    (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

    (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.

Documents

(3) The documents that must accompany the notice of intent are

    (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

      (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

      (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;

    (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

      (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

      (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;

    (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

      (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

      (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

    (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

      (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

      (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.

Prescribed fee

(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.

Copy of notice to patentee with statement

(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.

Content of statement - single patentee

(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,

    (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

    (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.

Content of statement - more than one patentee

(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

    (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

    (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.

Authorization

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.

Contents of application

(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.

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; and

    (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

      (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.

Restriction

(4) The Commissioner may not grant the authorization if the person making the application has not complied with subsections 21.04(1) and (4).

Restriction

(5) In the case where subsections 21.04(1) and (4) have been complied with, the Commissioner may not grant the authorization if

    (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

    (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.

Form and content of authorization

21.06 (1) The authorization must be in the prescribed form and, subject to subsection (2), contain the prescribed information.

Quantity

(2) The quantity of the product authorized to be manufactured by an authorization may not be more than the lesser of

    (a) the quantity set out in the notice of intent related to the application for the authorization, and

    (b) the quantity set out in the notice referred to in paragraphs 21.04(3)(a) to (d), whichever is applicable.

Disclosure of information on website

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.

Royalty

21.08 (1) The holder of an authorization must pay