Use of Patented Products for International Humanitarian Purposes Regulations

SOR/2005-143

Whereas, pursuant to subsection 21.08(2)Footnote a of the Patent Act, the Governor in Council has considered the humanitarian and non-commercial reasons underlying the issuance of authorizations under subsection 21.04(1) of that Act;

Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of Industry, pursuant to section 12 of the Patent Act, hereby makes the annexed Use of Patented Products for International Humanitarian Purposes Regulations.

INTERPRETATION

Section 1.  

In these Regulations, Act means the Patent Act.

COMMUNICATIONS

Section 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

Section 3.  

(1) For the purposes of sections 21.01 to 21.2 of the Act, any correspondence to be sent to a patentee shall be sent to its representative in Canada, as shown in the records of the Patent Office or, if no representative has been appointed, to the patentee.

(2) Any correspondence sent to the patentee's representative in Canada is deemed to have been received by the patentee.

APPLICATION FOR AUTHORIZATION

Section 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

Section 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

Section 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

Section 7.  

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

ROYALTIES

Section 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:

(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

(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

(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

(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

RENEWAL APPLICATION

Section 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

Section 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

Section 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:

COMING INTO FORCE

Section 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.

SCHEDULE

FORM 1 (Section 4)

APPLICATION FOR AUTHORIZATION UNDER SECTION 21.04 OF THE PATENT ACT

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

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 PatenteeName and Address of Patentee's Representative or Address of PatenteePatent 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

FORM 2 (Subsection 5(1))

SOLEMN OR STATUTORY DECLARATION UNDER PARAGRAPH 21.04(3)(c) OF THE PATENT ACT

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

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

Dated at _____________ the _____________ day of _____________, _____________

_____________

Signature of applicant

FORM 3 (Subsection 5(2))

SOLEMN OR STATUTORY DECLARATION UNDER CLAUSE 21.04(3)(d)(i)(A) OF THE PATENT ACT

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:
_______________________________________

(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 clause 21.04(3)(d)(i)(A) of the Act, that the pharmaceutical product to which the application relates

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

Dated at _____________ the _____________ day of _____________, _____________

_____________

Signature of applicant

FORM 4 (Subsection 5(2))

SOLEMN OR STATUTORY DECLARATION UNDER CLAUSE 21.04(3)(d)(i)(B) OF THE PATENT ACT

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:
_______________________________________

(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 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

FORM 5 (Subsection 5(2))

SOLEMN OR STATUTORY DECLARATION UNDER CLAUSE 21.04(3)(d)(ii)(A) OF THE PATENT ACT

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:
_______________________________________

(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 clause 21.04(3)(d)(ii)(A) of the Act, that the pharmaceutical product to which the application relates

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

Dated at _____________ the _____________ day of _____________, _____________

_____________

Signature of applicant

FORM 6 (Subsection 5(2))

SOLEMN OR STATUTORY DECLARATION UNDER CLAUSE 21.04(3)(d)(ii)(B) OF THE PATENT ACT

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:
_______________________________________

(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) 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

FORM 7 (Subsection 5(3))

SOLEMN OR STATUTORY DECLARATION UNDER CLAUSE 21.04(3)(d)(iii)(A), (iv)(A) AND (v)(A) OF THE PATENT ACT

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:
_______________________________________

(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 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

FORM 8 (Subsection 5(4))

SOLEMN OR STATUTORY DECLARATION UNDER PARAGRAPH 21.16(1)(b) OF THE PATENT ACT

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:
_______________________________________

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

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

Dated at _____________ the _____________ day of _____________, _____________

_____________

Signature of holder of authorization

FORM 9 (Section 6)

AUTHORIZATION UNDER SECTION 21.04 OF THE PATENT ACT

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:
_______________________________________

(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); or

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

FORM 10 (Section 9)

APPLICATION FOR RENEWAL OF AUTHORIZATION UNDER SECTION 21.12 OF THE PATENT ACT

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:
_______________________________________

(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, 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 PatenteeName and Address of Patentee's Representative or Address of PatenteePatent Number
(a)
(b)
(c)
(d)

3. The undersigned hereby certifies that

Dated at _____________ the _____________ day of _____________, _____________

_____________

Signature of applicant

Sworn before me this _____________ day of _____________, _____________

_____________

Signature of Commissioner for Oaths

FORM 11 (Section 10)

RENEWAL OF AUTHORIZATION UNDER SECTION 21.12 OF THE PATENT ACT

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:
_______________________________________

(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);

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


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