Guide for the Application and Granting of Compulsory Licences and Authorization of Government Use of Pharmaceutical Patents
(2009; 30 pages)


This paper is an attempt to foster a common approach in the use of TRIPS flexibilities in medicines procurement. Since the adoption of the Doha Declaration on the TRIPS Agreement and Public Health in 2001, it is acknowledged that countries are permitted to take measures, such as compulsory licensing and government use of patents, to ensure that patents do not constitute a barrier to access to affordable medicines. This paper aims to provide technical advice to governments, as well as procurement and nongovernmental organizations (NGOs), on the modalities for the application of compulsory licences and government use authorization. The paper focuses on the use of compulsory licences and government use authorization in the context of the purchase and import of patent-protected pharmaceutical products. It also addresses the special situation of least developed countries, as provided for in paragraph 7 of the Doha Declaration on the TRIPS Agreement and Public Health, which allows least developed countries a transition period until 2016, during which they need not provide for, nor enforce patents and exclusive marketing rights in relation to pharmaceutical products...

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