Use of Patented Products for International Humanitarian Purposes Regulations (SOR/2005-143)

Interpretation

1 In these Regulations, Act means the Patent Act.

Communications

• 2 (1) Any correspondence and envelope that relate to an application under section 21.04 of the Act shall clearly indicate this fact. The correspondence shall be written in English or French and shall be addressed, together with the envelope, in English or French to the Commissioner.

• (2) Correspondence shall be delivered to the Patent Office by hand or by mail and

  • (a) if it is delivered during the ordinary business hours of the Patent Office, it is considered to be received by the Commissioner on the day of the delivery; and

  • (b) if it is delivered outside the ordinary business hours of the Patent Office, it is considered to be received on the next business day.

3 [Repealed, SOR/2018-141, s. 1]

Application for Authorization

4 For the purpose of subsection 21.04(2) of the Act, an application for authorization shall be in the form set out in Form 1 of the schedule and shall be signed by the applicant.

Solemn or Statutory Declarations

• 5 (1) The solemn or statutory declaration referred to in paragraph 21.04(3)(c) of the Act shall be in the form set out in Form 2 of the schedule and shall be signed by the applicant.

• (2) The solemn or statutory declarations referred to in clauses 21.04(3)(d)(i)(A) and (B) and (ii)(A) and (B) of the Act shall be in the form set out in Forms 3, 4, 5 and 6, respectively, of the schedule and shall be signed by the applicant.

• (3) The solemn or statutory declarations referred to in clauses 21.04(3)(d)(iii)(A), (iv)(A) and (v)(A) of the Act shall be in the form set out in Form 7 of the schedule and shall be signed by the applicant.

• (4) The solemn or statutory declaration referred to in paragraph 21.16(1)(b) of the Act shall be in the form set out in Form 8 of the schedule and shall be signed by the holder of the authorization.

Authorization

6 For the purpose of subsection 21.05(1) of the Act, the authorization shall be in the form set out in Form 9 of the schedule.

Website

7 For the purpose of section 21.06 of the Act, the website of the holder of an authorization shall disclose the following information:

• (a) if the pharmaceutical product named in the application is a drug as defined in section 2 of the Food and Drugs Act, the name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product, or if the pharmaceutical product is a medical device, the name of the medical device;

• (b) the name of the country or WTO Member named in the application to which the pharmaceutical product is to be exported;

• (c) if the country or WTO Member referred to in paragraph (b) is not itself the purchaser of the pharmaceutical product, the name of the person or entity — other than a governmental person or entity — referred to in paragraph 21.04(2)(f) of the Act, to which the product is to be sold, together with their postal address;

• (d) the quantity of the pharmaceutical product that, under section 21.04 of the Act, has been authorized to be manufactured for export to the country or WTO Member referred to in paragraph (b);

• (e) the distinguishing features of the pharmaceutical product — including its colour if applicable — and of its label and packaging, as required by regulations made under the Food and Drugs Act;

• (f) the name and postal address of the shipping agent and any other party that, to the knowledge of the holder of the authorization, will be handling the pharmaceutical product while it is in transit from Canada to the country or WTO Member referred to in paragraph (b);

• (g) if the consignee in the importing country or WTO Member is a person or entity other than the country or WTO Member referred to in paragraph (b), or the person or entity referred to in paragraph (c), as the case may be, the name and postal address of the consignee;

• (h) the quantity of the pharmaceutical product contained in each shipment;

• (i) the export tracking number issued by the Minister of Health in respect of each shipment; and

• (j) the number of the bill of lading for each shipment.

Royalties

• 8 (1) In this section, Index means the Human Development Index developed and maintained by the United Nations Development Programme.

• (2) For the purpose of subsection 21.08(1) of the Act, the events on the occurrence of which a royalty is required to be paid, and the manner of determining the royalty, are as follows:

  • (a) if the total quantity of the pharmaceutical product that is authorized to be manufactured and exported is exported in a single shipment, the amount of the royalty determined in accordance with subsection (4) or (6), as the circumstances require, shall be paid in full within 45 days after the date of the export notice provided under section 21.07 of the Act; and

  • (b) if the quantity of the pharmaceutical product that is authorized to be manufactured and exported is exported in a series of shipments, a royalty shall be paid within 45 days after the date of the export notice provided under section 21.07 of the Act in an amount for a shipment that is the same proportion of the full amount of the royalty determined in accordance with subsection (4) or (6), as the circumstances require, as the quantity of the pharmaceutical product exported in the shipment is of the quantity of the pharmaceutical product that has been authorized to be manufactured and exported.

• (3) If the name of the country or WTO Member to which an authorization relates appears on the Index, the rate for calculating the royalty that is required to be paid to the patentee or to each of the patentees, as the case may be, in respect of the authorization shall be determined by

  • (a) adding 1 to the total number of countries listed on the Index;

  • (b) subtracting from the sum determined under paragraph (a) the numerical rank on the Index of the country or WTO Member to which the pharmaceutical product is to be exported;

  • (c) dividing the difference determined under paragraph (b) by the total number of countries listed on the Index; and

  • (d) multiplying the quotient determined under paragraph (c) by 0.04.

• (4) If the name of the country or WTO Member to which an authorization relates appears on the Index, the amount of royalty payable to the patentee or to each of the patentees, as the case may be, shall be determined

  • (a) when there is only one patentee, by multiplying the total monetary value, expressed in Canadian currency, of the agreement pertaining to the pharmaceutical product to be manufactured, sold and exported under the authorization by the royalty rate determined in accordance with subsection (3); and

  • (b) when there is more than one patentee, by dividing the amount determined under paragraph (a) by the number of patentees.

• (5) If the name of the country or WTO Member to which an authorization relates does not appear on the Index, the rate for calculating the royalty that is required to be paid to the patentee or to each of the patentees, as the case may be, in respect of the applicable authorization shall be determined by

  • (a) adding 1 to the total number of countries listed on the Index;

  • (b) subtracting from the sum determined under paragraph (a) the average

    • (i) in the case of a country or WTO Member to which the pharmaceutical product is to be exported and whose name appears in Schedule 2 or 3 to the Act, of the numerical ranks on the Index of all of the countries and WTO Members whose names appear both on the Index and in the same Schedule to the Act as the country or WTO Member to which the pharmaceutical product is to be exported,

    • (ii) in the case of a country — other than a WTO Member — to which the pharmaceutical product is to be exported and whose name appears in Schedule 4 to the Act, of the numerical ranks on the Index of all of the WTO Members whose names appear both on the Index and in Schedule 3 to the Act, and

    • (iii) in the case of a WTO Member to which the pharmaceutical product is to be exported and whose name appears in Schedule 4 to the Act, of the numerical ranks on the Index of all of the WTO Members whose names appear both on the Index and in Schedule 4 to the Act;

  • (c) dividing the difference determined under paragraph (b) by the total number of countries listed on the Index; and

  • (d) multiplying the quotient determined under paragraph (c) by 0.04.

• (6) If the name of the country or WTO Member to which an authorization relates does not appear on the Index, the amount of royalty payable to the patentee or to each of the patentees, as the case may be, shall be determined

  • (a) when there is only one patentee, by multiplying the total monetary value, expressed in Canadian currency, of the agreement pertaining to the pharmaceutical product to be manufactured, sold and exported under the authorization by the royalty rate determined in accordance with subsection (5); and

  • (b) when there is more than one patentee, by dividing the amount determined under paragraph (a) by the number of patentees.

Renewal Application

9 For the purpose of section 21.12 of the Act, an application for the renewal of an authorization shall be in the form set out in Form 10 of the schedule and shall be signed by the holder of the authorization.

Renewal of Authorization

10 The renewal of an authorization by the Commissioner under section 21.12 of the Act shall be in the form set out in Form 11 of the schedule.

Product Price Publications

11 For the purpose of paragraph (b) of the definition average price in subsection 21.17(6) of the Act, the publications reporting the prices in Canada of pharmaceutical products sold by or with the consent of the patentee that are equivalent to the pharmaceutical product to which an authorization under section 21.04 of the Act relates are the following:

• (a) the Ontario Drug Benefit Formulary/Comparative Drug Index published by the Ministry of Health and Long-Term Care of Ontario;

• (b) the list of insured medications set out in Schedule 1 to the Regulation respecting the List of medications covered by the basic prescription drug insurance plan, CQLR, c. A-29.01, r. 3, as is published under the title “List of Medications” on the website of the Régie de l’assurance maladie du Québec; and

• (c) the PPS Buyers Guide published by ProActive Pharma Solutions (PPS) or the parts of its website known as PPS Centrus where those prices are set out.

Coming into Force

Footnote ^*12 These Regulations come into force on the day on which An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa), being chapter 23 of the Statutes of Canada, 2004, comes into force.

• Return to footnote ^*[Note: Regulations in force May 14, 2005, see SI/2005-46.]