Diplomatic Notices re: Applications for Compulsory License under Bill C-9 (Jean Chrétien Pledge to Africa)

On May 14, 2005, Bill C-9, An Act to Amend the Patent Act and the Food and Drugs Act (the Jean Chrétien Pledge to Africa) and its accompanying regulations came into force. The legislation amends the Patent Act and the Food and Drugs Act in order to implement an August 30, 2003, decision of the World Trade Organization (WTO) that waives certain obligations set out in the World Trade Organisation Agreement on Trade-Related Aspects of Intellectual Property Rights. That decision allows developed countries, such as Canada, to authorize someone other than the patent holder to manufacture a lower-cost version of a patented pharmaceutical product in order to export it to a developing country with insufficient or no pharmaceutical manufacturing capacity.

Pursuant to Section 21.19 of the Patent Act, the Minister of Foreign Affairs must maintain a Web site on which is set out a copy of every notice (referred to in subparagraphs 21.04(3)(d)(ii) and (v) of the Act) that is provided to the Government of Canada through diplomatic channels by a country that is not a Member of the World Trade Organization (WTO). In providing the notice of its intention to import licensed versions of patented pharmaceutical products, the country agrees not to use those products for commercial purposes and undertakes to adopt the measures referred to in Article 4 of the WTO General Council Decision. The Minister must add a copy of the notice to the Web site as soon as possible after it has been provided to the Government of Canada. Failure to comply with the conditions set out above may result in the termination of the authorization of the use of the patented pharmaceutical product, as set out in Section 21.14.

For greater certainty, subparagraphs 21.04(3)(d)(ii) and (v) provide:

• (d) the Commissioner of Patents shall authorize the use of the patented invention only if: the applicant provides the Commissioner with ...

  • (ii) if the applicant relates to a country listed in Schedule 2 that is not a WTO member, a certified copy of the notice in writing that the country has provided to the Government of Canada through diplomatic channels specifying the name of the pharmaceutical product, as defined in paragraph 1(a) of the WTO General Council Decision, the quantity of that product needed by the country, and

    • (A) a solemn or statutory declaration in the prescribed form by the person filing the application stating that the product to which the application relates is the product specified in the notice and that the product is not patented in that country, or

    • (B) a solemn or statutory declaration in the prescribed form by the person filing the application stating that the product to which the application relates is the product specified in the notice and a certified copy of the notice in writing that the country has provided to the Government of Canada through diplomatic channels confirming that the country has granted or intends to grant a compulsory licence to use the invention pertaining to the product ...

  • (v) if the application relates to a country listed in Schedule 4 that is not a WTO Member, a certified copy of the notice, stating in writing that the country has provided to the Government of Canada through diplomatic channels specifying the name of the pharmaceutical product, as defined in paragraph 1(a) of the WTO General Council Decision, and the quantity of that product needed by the country, and stating that it is faced with a national emergency or other circumstances of extreme urgency, that it has insufficient or no pharmaceutical manufacturing capacity for the production of the product to which the application relates, that it agrees that product will not be used for commercial purposes and that it undertakes to adopt the measures referred to in Article 4 of the WTO General Council Decision, and

    • (A) a solemn or statutory declaration in the prescribed form by the person filing the application stating that the product to which the application relates is not patented in that country, or

    • (B) a certified copy of the notice in writing that the country has provided to the Government of Canada through diplomatic channels confirming that the country has granted or intends to grant a compulsory licence to use the invention pertaining to the product.

[Copy of Notices (referred to in subparagraphs 21.04(3)(d)(ii) and (v) of the Act)]