D6.5 Generic guideline for conducting an extended FtO analysis and FtO analyses for all intended clinical trials

This document provides the generic methodology and specific resource access points to conduct a freedom-to-operate (FtO) analysis tailored to the needs of a drug repurposing project. It has been compiled based on the extensive experience the author has accumulated with many projects of this type. Its most valuable feature is that it can be executed with minimal technical resources (only web access is required) and can be conducted internally up to the point where potentially critical findings (if any) are discussed with a patent attorney. When conducted properly this method actually improves the relevance of the analysis because no patent attorney can be expected to be fully familiar with all scientific aspects of a repurposing project. Despite its simplicity it integrates easily into the REPO4EU drug repurposing platform as a module that draws mostly on internal resources, and involves minimal expenses. While patent searches form the dominant motive, we also discuss how suitable suppliers can be recruited, an issue that is particularly important when the active ingredient is reformulated (as mostly will be the case).