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Found 10 records similar to Compulsory licences under Canada's Access to Medicines Regime

Federal

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

Last Updated: Sep. 17, 2020
Date Published: Mar. 29, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Canada's Access to Medicines Regime, termination of authorization, terminate a compulsory licence, patent holder, Federal Court of Canada.
Federal

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.

Last Updated: Sep. 17, 2020
Date Published: Mar. 29, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Canada's Access to Medicines Regime, Good faith clause, patent holders, right to challenge, compulsory licence.
Federal

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.

Last Updated: Sep. 17, 2020
Date Published: Apr. 28, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Canada's Access to Medicines Regime, company that holds a compulsory licence, patent holder, Royalty payments.
Federal

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.

Last Updated: Sep. 17, 2020
Date Published: Apr. 28, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Canada's Access to Medicines Regime, declaring an attempt at negotiating a voluntary licence, pharmaceutical company, submit declaration, Commissioner of Patents
Federal

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".

Last Updated: Sep. 17, 2020
Date Published: Apr. 28, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Canada's Access to Medicines Regime, declaring monetary value and units sold, compulsory licence, supply agreement
Federal

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.

Last Updated: Sep. 17, 2020
Date Published: Apr. 28, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Canada's Access to Medicines Regime, declare identity and patent status of pharmaceutical product, pharmaceutical company, Commissioner of Patents.
Federal

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

Last Updated: Sep. 17, 2020
Date Published: Apr. 28, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Canada's Access to Medicines Regime, submit the application package, the Commissioner of Patents at the Canadian Intellectual Property Office.
Federal

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.

Last Updated: Sep. 17, 2020
Date Published: Mar. 29, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Company requirements under Canada's Access to Medicines Regime, sales agreement, compulsory licence, eligible importing country, eligible product, application for authorization to Canada's Commissioner of Patents.
Federal

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

Last Updated: Sep. 17, 2020
Date Published: Mar. 17, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Canada's Access to Medicines Regime, Patent Act Schedules.
Federal

Canada's Access to Medicines Regime provides a framework within which eligible countries can import less expensive generic versions of patented drugs and medical devices.

Last Updated: Sep. 17, 2020
Date Published: Mar. 23, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Canada's Access to Medicines Regime, developing and least-developed countries, import less expensive generic drugs, patented drugs and medical devices.
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