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Found 10 records similar to Declaring an attempt at negotiating a voluntary licence under Canada's Access to Medicines Regime
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 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.
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).
To participate in the Regime, an eligible importing country must declare that it has insufficient or no pharmaceutical manufacturing capacity in relation to the specific product it is requesting. It is up to each country to determine for itself the level of its manufacturing capacity.
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 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
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 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.
This dataset contains a list of Significant or Commercial Discovery Declarations (SDD and CDD), on Frontier Lands under the CPRA, that the CER regulates. This list includes the declaration date, company, the field name and/or well name, CER area and sections identified.