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Found 10 records similar to Process map of terms and conditions of a compulsory licence under Canada's Access to Medicines Regime

Federal

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.

Last Updated: Sep. 17, 2020
Date Published: Apr. 28, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Process map, application under Canada's Access to Medicines Regime, application for a compulsory licence.
Federal

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.

Last Updated: Sep. 17, 2020
Date Published: Mar. 29, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Canada's Access to Medicines Regime, compulsory licences, override patent rights, authorizes a third party, patented invention, patent holder's permission.
Federal

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.

Last Updated: Sep. 17, 2020
Date Published: Mar. 29, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Canada's Access to Medicines Regime, renewal of licence, original compulsory licence, pharmaceutical company.
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

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

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

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.

Last Updated: Sep. 17, 2020
Date Published: Mar. 29, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Country access, Canada's Access to Medicines Regime, insufficient or no manufacturing capacity in the pharmaceutical sector, import a lower cost drug and medical devices.
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 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.
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