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

• 1 The undersigned hereby applies for an authorization under section 21.04 of the Act.

• 2 The pharmaceutical product that the undersigned intends to manufacture and sell for export under the authorization is

  • (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act:

    (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

  • (b) if the pharmaceutical product is a medical device:

    (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of theMedical Devices Regulations).

• 3 The maximum quantity of the pharmaceutical product that the undersigned intends to manufacture and sell for export under the authorization is .

• 4 For each patented invention to which the application relates, the name(s) of the patentee(s) of the invention, the name(s) and postal address(es) of the representative(s) of the patentee(s) or, if no representative has been appointed, the postal address(es) of the patentee(s), and the patent number(s) issued in respect of the invention are as follows:

  	Name of Patentee	Name and Address of Patentee’s Representative or Address of Patentee	Patent Number
  (a)
  (b)
  (c)
  (d)

• 5 The name of the WTO Member or country that has notified, respectively, the TRIPS Council or the Government of Canada in writing of its requirement for the pharmaceutical product named in the application, and to which the pharmaceutical product is to be exported, is .

• 6 The name, postal address and telephone number of the person or entity referred to in paragraph 21.04(2)(f) of the Act, to which the pharmaceutical product is to be sold, are as follows:

  

  

  

  

• 7 For the purpose of subsection 21.06(1) of the Act, the website address of the undersigned is

• 8 The name, postal address and telephone number of the undersigned are as follows:

  

  

  

  

Dated at the day of ,

Signature of applicant

In the matter of an application by

(name of applicant) for export to

(name of country or WTO Member) of the following pharmaceutical product:

• (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act:

  

  (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

• (b) if the pharmaceutical product is a medical device:

  

  (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of theMedical Devices Regulations);

• 1 The undersigned (name of applicant) hereby declares, in accordance with paragraph 21.04(3)(c) of the Act, that on (date), being at least 30 days before the date of filing of the application for an authorization under section 21.04 of the Act, the undersigned

  • (a) sought from the patentee or, if there is more than one, from each of the patentees, namely,

    

    (name(s) of the patentee(s)), by certified or registered mail addressed to

    

    

    (name(s) and postal address(es) of the patentee(s) or the representative(s) of the patentee(s), if any), 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

  • (b) 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 required under paragraphs 21.04(2)(a) to (g) of the Act.

• 2 The name, postal address and telephone number of the undersigned are as follows:

  

  

  

  

Dated at the day of ,

Signature of applicant

In the matter of an application by

(name of applicant) for export to (name of WTO Member) of the following pharmaceutical product:

• (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act:

  

  (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

• (b) if the pharmaceutical product is a medical device:

  

  (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations);

• 1 The undersigned (name of applicant) hereby declares, in accordance with clause 21.04(3)(d)(i)(A) of the Act, that the pharmaceutical product to which the application relates

  • (a) is the pharmaceutical product specified in the notice in writing that the WTO Member has provided to the TRIPS Council; and

  • (b) is not patented in that WTO Member.

• 2 The name, postal address and telephone number of the undersigned are as follows:

  

  

  

  

Dated at the day of ,

Signature of applicant

In the matter of an application by

(name of applicant) for export to

(name of WTO Member) of the following pharmaceutical product:

• (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act:

  

  (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

• (b) if the pharmaceutical product is a medical device:

  

  (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations);

• 1 The undersigned (name of applicant) hereby declares, in accordance with clause 21.04(3)(d)(i)(B) of the Act, that the pharmaceutical product to which the application relates is the pharmaceutical product that is specified in the notice in writing that the WTO Member has provided to the TRIPS Council.

• 2 The name, postal address and telephone number of the undersigned are as follows:

  

  

  

  

Dated at the day of ,

Signature of applicant

In the matter of an application by

(name of applicant) for export to

(name of country) of the following pharmaceutical product:

• (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act:

  

  (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

• (b) if the pharmaceutical product is a medical device:

  

  (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations);

• 1 The undersigned (name of applicant) hereby declares, in accordance with clause 21.04(3)(d)(ii)(A) of the Act, that the pharmaceutical product to which the application relates

  • (a) is the pharmaceutical product specified in the notice in writing that the country has provided to the Government of Canada; and

  • (b) is not patented in that country.

• 2 The name, postal address and telephone number of the undersigned are as follows:

  

  

  

  

Dated at the day of ,

Signature of applicant

In the matter of an application by

(name of applicant) for export to

(name of country) of the following pharmaceutical product:

• (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act:

  

  (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

• (b) if the pharmaceutical product is a medical device:

  

  (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations);

• 1 The undersigned (name of applicant) declares, in accordance with clause 21.04(3)(d)(ii)(B) of the Act, that the pharmaceutical product to which the application relates is the pharmaceutical product that is specified in the notice in writing that the country has provided to the Government of Canada.

• 2 The name, postal address and telephone number of the undersigned are as follows:

  

  

  

  

Dated at the day of ,

Signature of applicant

In the matter of an application by

(name of applicant) for export to

(name of country or WTO Member) of the following pharmaceutical product:

• (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act:

  

  (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

• (b) if the pharmaceutical product is a medical device:

  

  (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations);

• 1 The undersigned (name of applicant) hereby declares, in accordance with clause 21.04(3)(d)(iii)(A), (iv)(A) or (v)(A) of the Act, as the case may be, that the pharmaceutical product to which the application relates is not patented in the country or WTO Member.

• 2 The name, postal address and telephone number of the undersigned are as follows:

  

  

  

  

Dated at the day of ,

Signature of applicant

In the matter of authorization number granted on (date) to (name of holder of authorization) for export to (name of country or WTO Member) of the following pharmaceutical product:

• (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act:

  

  (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

• (b) if the pharmaceutical product is a medical device:

  

  (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations);

• 1 The undersigned (name of holder of authorization) hereby declares, in accordance with paragraph 21.16(1)(b) of the Act, that

  • (a) the total monetary value of the agreement, expressed in Canadian currency, as it relates to the pharmaceutical product authorized to be manufactured and sold is $ ; and

  • (b) the number of units of the pharmaceutical product to be sold under the terms of the agreement is .

• 2 The name, postal address and telephone number of the undersigned are as follows:

  

  

  

  

Dated at the day of ,

Signature of holder of authorization

In the matter of application for authorization number by (name of applicant) for export to (name of country or WTO Member) of the following pharmaceutical product:

• (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act:

  

  (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

• (b) if the pharmaceutical product is a medical device:

  

  (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations);

• 1 I hereby authorize (name of applicant), whose postal address is , to make, construct and use, the patented invention(s) identified in patent number(s) solely for purposes directly related to the manufacture of the above-mentioned pharmaceutical product, and to sell it for export to the above-mentioned country or WTO Member.

• 2 The quantity of the pharmaceutical product authorized to be manufactured by this authorization is .

• 3 In accordance with section 21.09 of the Act, this authorization is valid for a period of two years beginning on the date shown below.

Granted at the day of ,

Signature of Commissioner of Patents

In the matter of an application for renewal of authorization by (name of applicant) for export to (name of country or WTO Member) of the following pharmaceutical product:

• (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act:

  (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

• (b) if the pharmaceutical product is a medical device:

  

  (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations);

• 1 The undersigned, whose postal address and telephone number are

  

  , hereby applies for a renewal of authorization number that was granted on (date) authorizing the making, construction and use of the patented invention(s) identified in the patent numbers below, solely for purposes directly related to the manufacture of (unexported quantity) of the above-mentioned pharmaceutical product and its sale for export to the above-mentioned country or WTO Member.

• 2 For each patented invention to which the application for renewal relates, the name(s) of the patentee(s) of the invention, the name(s) and postal address(es) of the representative(s) of the patentee(s) or, if no representative has been appointed, the postal address(es) of the patentee(s), and the patent number(s) issued in respect of the invention are as follows:

  	Name of Patentee	Name and Address of Patentee’s Representative or Address of Patentee	Patent Number
  (a)
  (b)
  (c)
  (d)

• 3 The undersigned hereby certifies that

  • (a) the quantities of the pharmaceutical product that were authorized under authorization number to be manufactured and sold for export under section 21.04 of the Act were not or will not have been exported before the authorization ceases to be valid; and

  • (b) the undersigned has complied with the terms of the authorization and the requirements of sections 21.06 to 21.08 of the Act.

Dated at the day of ,

Signature of applicant

Sworn before me this day of ,

Signature of Commissioner for Oaths

In the matter of an application for a renewal of an authorization by (name of applicant) for export to (name of country or WTO Member) of the following pharmaceutical product:

• (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act:

  

  (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

• (b) if the pharmaceutical product is a medical device:

  

  (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations);

And in the matter of authorization number that was granted in accordance with section 21.04 of the Act on (date) to make, construct and use the patented invention(s) identified in patent number(s) solely for purposes directly related to the manufacture of the quantity remaining to be shipped (quantity) of the above-mentioned pharmaceutical product, and to sell it for export to (name of country or WTO Member);

And whereas the applicant has not yet manufactured and exported the above-noted quantity of the pharmaceutical product on the date of its application for renewal;

I hereby renew the above-mentioned authorization in accordance with section 21.12 of the Act.

Dated at the day of ,

Signature of Commissioner of Patents