Open Government Portal

The pharmaceutical company must complete and submit to the Commissioner of Patents a Solemn or Statutory Declaration Under Paragraph 21.04(3)(c) of the Patent Act. The form sets out the information that must appear in the declaration.

Within 15 days of the day on which the compulsory licence was granted or the supply agreement was signed, whichever is later, the pharmaceutical company must complete and submit to the patent holder and the Commissioner of Patents a "Solemn or Statutory Declaration Under Paragraph 21.16(1)(b) of the Patent Act".

To participate in the Regime, a pharmaceutical company must enter into a sales agreement with an eligible importing country for the purchase of a specified amount of an eligible product listed on Schedule 1. A pharmaceutical company must also submit an application for authorization to Canada's Commissioner of Patents. Once the authorization or compulsory licence is issued, there are additional terms and conditions that the company must meet and maintain.

A pharmaceutical company that holds a compulsory licence under Canada's Access to Medicines Regime is required to pay royalties to the patent holder. The company must make payments within a prescribed amount of time and in accordance with a prescribed formula.

The company must submit the application package to the Commissioner of Patents at the Canadian Intellectual Property Office (CIPO).

It presents the Patent Act Schedules #1, #2, #3 and #4.

Governments can override patent rights when necessary. In such instances, the government authorizes a third party to use the patented invention without the patent holder's permission. This authorization comes in the form of a compulsory licence.

Countries with insufficient or no manufacturing capacity in the pharmaceutical sector can benefit from participating in Canada's Access to Medicines Regime. Under the Regime, eligible countries can import less expensive, generic versions of patented products manufactured in Canada.

Within 30 days of the end of the two-year period of the original compulsory licence, a pharmaceutical company may apply to have it renewed. A renewal will only be granted if the full shipment of the original authorization has not yet been shipped. Only one renewal is allowed for each original application for a total of four years for each compulsory licence.

This process map provides a visual overview of the steps that need to be followed by a pharmaceutical company that is preparing to submit an application for a compulsory licence under Canada's Access to Medicines Regime.