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

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      REPO4EU
      Intellectual property, Patents, Good Manufacturing Practices
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            Abstract

            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).

            Content

            Author and article information

            Journal
            REPO4EU
            28 April 2023
            01 December 2022
            Affiliations
            [1 ] H.M. PHARMA CONSULTANCY e.U., Vienna, Austria
            Author information
            https://orcid.org/0000-0002-1491-6250
            Article
            10.58647/REPO4EU.202300D6.5
            4ac25d6e-bc5d-4b0e-9f80-6916c4d7e2b4

            All content is freely available without charge to users or their institutions. Users are allowed to read, download, copy, distribute, print, search, or link to the full texts of the articles in this journal without asking prior permission of the publisher or the author. Articles published in the journal are distributed under a http://creativecommons.org/licenses/by/4.0/.

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            Intellectual property,Good Manufacturing Practices,Patents

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