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

Regulations are current to 2013-04-29

Use of Patented Products for International Humanitarian Purposes Regulations

SOR/2005-143

PATENT ACT

Use of Patented Products for International Humanitarian Purposes Regulations

P.C. 2005-861 2005-05-10

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)Footnote a of that Act;

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

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. (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

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.