Patents and Licences on Antiretrovirals - A Snapshot

The report provides an overview of the patent landscape with respect to a select number of antiretroviral (ARV) medicines in developing countries as of April 2014. The focus is primarily on those ARVs that are recommended by the World Health Organization (WHO) as well as new ARVs that have either recently obtained regulatory approval or are in phase III clinical trials.

Part 1 provides a brief introduction to patents and licences and their effect on the market for ARVs. It introduces key concepts that will facilitate an understanding of the report. It also explains which data sources were used for the report and notes a number of disclaimers with regard to the information contained in the report.

Part 2 is the core of the report. It outlines the patent status and licensing status of each ARV in the 81 developing countries for which data are available. For each ARV the report indicates whether that ARV is included in fixed-dose combinations for which there may be patents. General conclusions are drawn in light of the data. The key purpose is to provide an overview of the patent landscape for each ARV and, in particular, to show in which countries market competition for a given ARV is possible in view of existing patents and licences.