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Found 10 records similar to Capacity to manufacture under Canada's Access to Medicines Regime
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.
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.
Below are some of the unique features of Canada's Access to Medicines Regime, many of which resulted from negotiations between the Government of Canada, the private sector and various non-governmental organizations.
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.
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.
The electricity capacity and generation data to accompany the report Canada’s Renewable Power Landscape – Energy Market Analysis 2017. The data includes provincial and Canadian electricity capacities and generation from all sources. Annual data from 2005-2016.
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 company must submit the application package to the Commissioner of Patents at the Canadian Intellectual Property Office (CIPO).
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
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.