Open Government Portal
Found 10 records similar to Submit an application under Canada's Access to Medicines Regime
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.
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.
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.
The pharmaceutical company must complete and submit to the Commissioner of Patents one of the forms listed below. The company should choose the form that corresponds to the schedule on which the importing country appears, as well as the patent status of the pharmaceutical product in that country.
In August 2003, negotiations among World Trade Organization (WTO) members resulted in a landmark decision to waive two licensing provisions of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) that appeared to prevent the export of generic drugs and medical devices to developing countries faced with public health problems.
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.
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
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".
The legislation establishing Canada's Access to Medicines Regime contains a "Good Faith Clause" that provides patent holders with the right to challenge a compulsory licence in the Federal Court of Canada. A challenge can be mounted if the patent holder believes the licence is being used for predominantly commercial rather than humanitarian purposes.
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.