A Canadian pharmaceutical manufacturer that wishes to supply a low-cost version of a patented pharmaceutical product to an eligible importing country must comply with Health Canada requirements and follow the application procedures below.
Please contact our Client Service Centre to obtain more information.
Initial application
1. Submit an Application for authorization under Section 21.04 of the Patent Act. (Form 1)
Application for a compulsory licence to manufacture and export a generic version of a patented pharmaceutical product or medical device.
2. Submit a Solemn or statutory declaration under paragraph 21.04(3)(c) of the Patent Act. (Form 2)
Declaration that the applicant sought a voluntary licence from the patent holder or holders.
3. Submit a Solemn or statutory declaration under clause 21.04(3)(d) (Form 3, Form 4, Form 5, Form 6, or Form 7)
Choose the form that corresponds to the schedule on which the importing country appears as well as the patent status of the pharmaceutical product or medical device in that country.
- Solemn or statutory declaration under clause 21.04(3)(d)(i)(A) of the Patent Act (Form 3)
Schedule 2, WTO member, product not patented - Solemn or statutory declaration under clause 21.04(3)(d)(i)(B) of the Patent Act (Form 4)
Schedule 2, WTO member, product is patented - Solemn or statutory declaration under clause 21.04(3)(d)(ii)(A) of the Patent Act (Form 5)
Schedule 2, not WTO member, product not patented - Solemn or statutory declaration under clause 21.04(3)(d)(ii)(B) of the Patent Act (Form 6)
Schedule 2, not WTO member, product is patented - Solemn or statutory declaration under clause 21.04(3)(d)(iii)(A), (iv)(A) or (v)(A) of the Patent Act (Form 7)
Schedule 3 or 4, product not patented
4. Submit a certified copy of the appropriate notification, based on WTO and patented status. (if required)
Note: certified copies of the appropriate notification are not required if the importing country is:
- a Schedule 2 country and Form 3 or Form 5 are submitted.
- a Schedule 3 or 4 country and Form 7 is submitted.
If the importing country is a WTO member, and:
- The product is not patented in the importing country:
submit a certified copy of the notification sent to the WTO of its intention to import the pharmaceutical product and confirmation that the product is not patented in the importing country; or - The product is patented in the importing country:
submit a certified copy of the notification sent to the WTO of its intention to import the pharmaceutical product and that it has granted or intends to grant authorization to use the invention pertaining to the product.
If the importing country is not a WTO member, and:
- The product is not patented in the importing country:
submit a certified copy of the notice sent to the Government of Canada of its intention to import the pharmaceutical product and confirmation that the product is not patented in the importing country; or - The product is patented in the importing country:
submit a certified copy of the notice sent to the Government of Canada of its intention to import the pharmaceutical product and that it has granted or intends to grant authorization to use the invention pertaining to the product.
Before exporting
1. Submit a Solemn or statutory declaration (Form 8)
Pursuant to paragraph 21.16(1)(b) of the Patent Act, within 15 days after the day on which the authorization was granted OR the day on which the supply agreement to which the authorization relates was entered into, whichever is later.
2. Provide a copy of the supply agreement with the importing country to the Commissioner and the patentee(s).
Pursuant to paragraph 21.16(1)(a) of the Patent Act, within 15 days after the day on which the authorization was granted OR the day on which the supply agreement to which the authorization relates was entered into, whichever is later.
3. Maintain a website
Before a pharmaceutical product subject to an authorization may be exported, the holder of the authorization must establish a website pursuant to Section 21.06 of the Patent Act.
The duty to maintain the website by disclosing the particulars remains ongoing throughout the validity period of the authorization.
4. Pay royalties
The Regulations provide that a holder of an authorization is required to pay royalties within a prescribed time, and in accordance with a prescribed regulatory formula that takes into account the humanitarian and non-commercial reasons underlying the issuance of an authorization.
The formula calculates the royalty by multiplying the monetary value of the supply agreement between the holder of the authorization and the importing country by an amount that fluctuates on the basis of that country's standing on the United Nations Human Development Index (UNHDI).
The formula to determine the royalty rate is 1, plus the number of countries on the UNHDI, minus the importing country's rank on the UNHDI, divided by the number of countries on the UNHDI, multiplied by 0.04.
According to this formula, the royalty payable in respect of the lowest eligible country that currently appears on the UNHDI would be 0.02 percent, and the highest, 3.5 percent.
Mathematically, the regulatory formula cannot result in a royalty rate in excess of 4 percent, a ceiling that is considered to be consistent with the humanitarian and non-commercial considerations that gave rise to the August 30, 2003 decision and the Jean Chrétien Pledge to Africa regime.
5. Provide a notice of export
Pursuant to Section 21.07 of the Patent Act, within fifteen (15) days prior to the export of each shipment, the holder of the authorization must provide an export notice, by certified or registered mail, to the patentee(s), the importing country or WTO Member, and the person or entity that purchased the product.
Renewing an application
1. Submit an Application for renewal of authorization under Section 21.12 of the Patent Act (Form 10)
An authorization is valid for a period of two years and can be renewed only once for an equal period, on application by the holder of the authorization and within thirty (30) days immediately before the authorization ceases to be valid.
An applicant seeking renewal of an authorization must certify that the quantity of the pharmaceutical product that had been authorized to be made and exported had not been fully exported within the initial two-year term and that the applicant has otherwise complied with the terms of the authorization and its statutory obligations to establish a website disclosing the particulars of the authorized transaction, to provide a notice of export for each shipment, and to pay the patentee(s) the required royalty.