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Editor-in-Chief,   Anatole Krattiger

Editorial Board

Concept Foundation


Fiocruz, Brazil

bioDevelopments-   Institute

Freedom to Operate and Risk Management
Topic Guide for Policymakers

Why This Topic Is Important

Freedom to operate (FTO) is the absence of any third party IP claims against ones commercial operations. The more that public institutions use IP protection to transfer and develop new technology, the more likely it is that third parties will have competing IP. However, this section explains that the efforts to analyze and deal with competing IP should be commensurate with the amount of value put at risk. Therefore, the burden to analyze and manage FTO is usually on the licensee. However, there can be times when the public sector institution needs to be aware of its FTO or that of its partners.

Key Implications and Best Practices: Section 14

Given that IP management is heavily context specific, these Key Implications and Best Practices are intended as starting points to be adapted to specific needs and circumstances.

  • As intellectual property becomes more prevalent in health and agricultural research, public and not-for-profit institutions may increasingly need to consider the intellectual property of third parties. This may allow for efficient in-licensing of intellectual property and accelerate the development of products. For such purposes, a good knowledge of “who owns what” is needed. That is what a freedom to operate (FTO) analysis provides.
  • Translating an FTO analysis into an effective strategy requires some shifts in culture and thinking by those public sector institutions that are engaged in the development of products. Although a legal opinion by an attorney may be based on a solid FTO analysis, the use of such an analysis is strategic. National governments have a great responsibility to encourage the establishment of best practices in IP management, through sound national policies and funding allocations.
  • Taking FTO into consideration as one element of any product development strategy allows for a more judicious use of resources that can often lead to stronger and more effective partnerships, can increase opportunities for international collaboration, and may underpin effective public-private partnerships.
  • Governmental policies and programs that support capacity building in IP management should include the training of senior management in FTO strategies, including institutional boards. A dialogue between boards, which are responsible for policy, and senior managers that are more concerned with implementation is essential since an FTO analysis is a risk-management tool. This approach increases efficiency in the handling of products for further development and/or commercialization, even if the goal is to address the needs of the poor.
  • High speed Internet access and patent databases are valuable tools that can assist research-based institutions in the undertaking of meaningful patent and information searches that are necessary to conduct FTO analyses.

Recommended Chapters       Show All AbstractsShow All Abstracts

Show AbstractAbstract Freedom to Operate, Public Sector Research, and Product-Development Partnerships: Strategies and Risk-Management Options
by Anatole Krattiger

Show AbstractAbstract Managing Liability Associated with Genetically Modified Crops
by Richard Y. Boadi