Termination of authorization under Canada's Access to Medicines Regime

The patent holder may seek an order from the Federal Court of Canada to terminate a compulsory licence, if the patent holder can establish that any information in the application by the licence holder is inaccurate or that the licence holder has failed

• to establish and maintain an appropriate website;
• to provide for all shipments an export notice to the patent holder, the importing country and the purchaser;
• to pay the prescribed royalty to the patent holder; or
• to provide the patent holder and the Commissioner of Patents with a copy of any supply agreement related to the licence.

The patent holder may also seek an order to terminate a compulsory licence, if it can be proven that the drug or medical device exported

• has been re-exported in a manner contrary to the August 2003 World Trade Organization Decision with the knowledge of the licence holder;
• was exported to a country other than the country named in the licence;
• was exported in an amount greater than the quantity authorized by the compulsory licence; or
• was used by a non-WTO member country for commercial purposes or the country failed to adopt anti-diversion measures as specified by Article 4 of the Decision.

For more information on the termination of an authorization by the Federal Court of Canada, refer to Section 21.14 of the Patent Act.