A Practical Guide to FtO Analysis for Drug Repurposing Ventures

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A recent whitepaper by Hermann Mucke summarizes the steps to performing an FTO for drug repurposing:

Overview

An FtO analysis determines if a new product or process can proceed without infringing third-party intellectual property (IP) rights, especially patents. It is crucial for drug repurposing projects involving known compounds that may still be patent-protected.

Basic Principles

  • Perform FtO analysis early once the compound, new indication, dose, and formulation are defined.
  • Focus on specific objectives like developing a certain formulation or geographic markets.
  • Only patent claims matter for FtO, not other statements in patents.
  • FtO analysis can never be 100% complete due to broad patent claims.
  • It provides a snapshot valid only at the time of the search.
  • It does not evaluate patentability or provide risk mitigation strategies.

Methodology

  1. Compound and Disease Searches
    • Use PubChem to find the compound’s IUPAC name, synonyms, and InChIKey.
    • In WIPO PatentScope, use the InChIKey for a structure search filtered by patent offices, IPC codes, and years.
    • Download relevant patent claims mentioning the compound into text files organized by year.
    • Search the claims files for the compound name and target disease/indication.
    • Download full patent documents for relevant hits.
  2. Supplier Searches
    • Search FDA Orange Book and other databases for approved drugs containing the compound.
    • Identify potential API suppliers by searching for drug master files and CEP/ASMF certificates.
    • Evaluate if suppliers can provide the API in required quality (e.g. cGMP).

The results form the basis for further analysis involving patent attorneys and business decisions on proceeding with the repurposing project.

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