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Use of Patents for International Humanitarian Purposes to
Address Public Health Problems (Jean Chrétien Pledge to Africa Regime)
Obtaining an Authorization in Canada
Communications with CIPO
The manner in which information is communicated to the Commissioner of
Patents is prescribed by the Regulations.
All correspondence and envelopes shall clearly indicate that they relate to
section 21.04 of the Patent Act, be written in English or French, and
addressed to the Commissioner.
Such correspondence must be delivered to CIPO either by hand or by mail.
Process and Forms
Responsibilities of the Canadian Pharmaceutical Manufacturer
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 all of the following:
Health Canada Requirements
In accordance with section 21.04(3)(b) of the Patent Act, the
Minister of Health is required to notify the Commissioner of Patents
that the pharmaceutical product to be exported meets the requirements
of the Food and Drugs Act and its Regulations. All pharmaceutical
products being exported under this regime must meet Canadian standards
prior to receiving an authorization from the Commissioner. This
requirement necessitates a review of the pharmaceutical product by
Health Canada to determine whether or not the product meets
Canadian standards of efficacy, safety, and quality. Manufacturers
must also meet additional regulatory requirements which aim to
distinguish the product being exported under this regime from the
innovative version of the same product sold in Canada.
For more information on the process for the evaluation of all
pharmaceutical products at Health Canada, please visit the Therapeutic
Products Directorate's website.
For particular information regarding Canada's implementation of the
World Trade Organization's Decision as it relates to Health Canada's
role, please send your inquiry to: C9@hc-sc.gc.ca
CIPO Requirements
- Form 1: Application for authorization under section 21.04 of
the Patent Act.
This form sets out the information which must appear in the application including:
- the pharmaceutical product for which an authorization is being sought;
- the quantity to be manufactured;
- the patent(s) which protect the pharmaceutical product;
- the country to which the pharmaceutical product is to be exported; and
- the identity of the purchaser.
- Form 2: Solemn or statutory declaration under paragraph
21.04(3)(c) of the Patent Act.
This form sets out the information which must appear in the applicant's
declaration including:
- that the applicant unsuccessfully sought a voluntary authorization from
the patentee(s) at least thirty (30) days prior to the date of the application; and
- that the applicant provided the patentee(s) with information that is substantially
the same as in its application.
- Submit one of the following solemn or statutory declarations. Choose the form
which corresponds to the schedule on which the importing country appears as well
as the patent status of the pharmaceutical product in that country.
Form 3: Solemn or statutory
declaration under clause 21.04(3)(d)(i)(A)
of the Patent Act
This form applies if the importing country:
- appears on Schedule 2;
- is a WTO member; and
- the pharmaceutical product is not patented in that country.
Form 4: Solemn or statutory
declaration under clause 21.04(3)(d)(i)(B)
of the Patent Act
This form applies if the importing country:
- appears on Schedule 2;
- is a WTO member; and
- the pharmaceutical product is patented in that country.
Form 5: Solemn or
statutory declaration under clause 21.04(3)(d)(ii)(A)
of the Patent Act
This form applies if the importing country:
- appears on Schedule 2;
- is not a WTO member; and
- the pharmaceutical product is not patented in that country.
Form 6: Solemn or
statutory declaration under clause 21.04(3)(d)(ii)(B)
of the Patent Act
This form applies if the importing country:
- appears on Schedule 2;
- is not a WTO member; and
- the pharmaceutical product is patented in that country.
Form 7: Solemn or
statutory declaration under clause 21.04(3)(d)(iii)(A),
(iv)(A) or (v)(A) of the Patent Act
This form applies if the importing country:
- appears on Schedule 3 or 4; and
- the pharmaceutical product is not patented in that country.
- Submit a certified copy of one of the following:
- If the importing country is a WTO member:
- submit a certified copy of the notification sent to the WTO of its
intention to import the pharmaceutical product and that the product is
not patented in the importing country; or
- if 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:
- submit a certified copy of the notice sent to the Government of
Canada of its intention to import the pharmaceutical product and that
the product is not patented in the importing country; or
- if 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.
- Submit Form 8: Solemn or statutory declaration under paragraph
21.16(1)(b) of the Patent Act within 15 days after the later of the
day on which the authorization was granted and the day on which the supply agreement to
which the authorization relates was entered into.
Form 8 sets out the information the holder of the authorization
must provide as to:
- the total monetary value; and
- the number of units of pharmaceutical product sold.
A copy of the holder of authorization's supply agreement with the importing country must
also be provided to the Commissioner and the patentee(s).
- Maintain a Web site
Before a pharmaceutical product subject to an authorization may be exported, the
holder of the authorization must establish a Web site pursuant to section
21.06 of the Patent Act.
The duty to maintain the Web site by disclosing the particulars remains
ongoing throughout the validity period of the authorization.
- 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 which 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 which 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 which 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 which is considered to be consistent with
the humanitarian and non-commercial considerations which gave rise to the
August 30, 2003 decision and the Jean Chrétien Pledge to Africa regime.
- Notice of Export
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.
- Submit Form 10: Application for renewal of authorization under section
21.12 of the Patent Act) if the holder of the authorization
wishes to renew the authorization.
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 Web site disclosing
the particulars of the authorized transaction and to pay the patentee(s)
the required royalty.
CIPO Responsibilities
The Commissioner of Patents has the following responsibilities under the regime:
- Post Applications on CIPO's Web site
Pursuant to section 21.06(4) of the Patent Act, the Commissioner must
post within seven (7) days of receipt a copy of each application for authorization
received on CIPO's Web site.
- Link to Web sites of Holders of Authorizations
Pursuant to section 21.06(3) of the Patent Act, the Commissioner must
post and maintain a link to each Web site required to be maintained by
the holder of the authorization.
- Form 9: Authorization under section 21.04 of the Patent Act
If the application meets all of the requirements and the Minister of
Health notifies the Commissioner that the pharmaceutical product is compliant
with the Food and Drugs Act as being safe, efficacious, of good quality
and distinctive from the innovator's version of the product sold in Canada,
the Commissioner will grant the applicant an authorization to manufacture
and export the pharmaceutical product. The Commissioner will also notify
the patentee(s), in writing, that an authorization has been granted.
- Form 11: Renewal of authorization under section 21.12 of the Patent Act
If the holder of the authorization complies with the requirements of
section 21.12 of the Patent Act including submitting Form 10 (Application
for Renewal of Authorization under section 21.12 of the Patent Act) within
thirty (30) days immediately before the authorization ceases to be valid, the Commissioner
will grant a renewal of the authorization and notify the patentee(s)
of the renewal.
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