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About
MIHR
PIPRA
Fiocruz, Brazil
bioDevelopments- Institute
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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 a scientist needs to be aware of his/her FTO or that of his/her commercial partners.
Key Implications and Best Practices: Setcion 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.
- Collaboration among scientists and the professionals who conduct freedom to operate (FTO) analyses is essential. The scientist is the most important person to explain the science behind technology, to help others understand the materials and the scientific approach, and sometimes to explain what specific patent claims mean. A scientist is the expert in his or her area of research and can provide important leads to other scientific groups, publications, and terms of art.
- Teams conducting FTO analyses will also need to understand precisely what the product is, how it was developed, what materials were used, and what reports were prepared. The purpose is not to check on the work, but to ascertain that all relevant information has been considered in the FTO analysis. It is important also to know what tangible property from a third party contributed to a product. A scientific member of an FTO team will need to provide this type of basic information for the FTO analysis. One of the best ways to manage that information is through careful record keeping, including rigorously kept laboratory notebooks.
- The results of an FTO analysis may allow you to make better use of technologies in the public domain and inform your choice of research tools or vector constructs. The analysis also may alert you to scientific discoveries and inventions related to your work.
- An FTO analysis is a foundation of IP management, but it is also something more. It is a way to demonstrate to your colleagues that you respect their property rights and understand that, when properly managed, intellectual property leads to the greater sharing of technology and related information. In a very real sense, it is a way of building relationships based on trust.
- Both patent search engines and scientific search engines are available at no cost on the Internet (such as the U.S. Patent and Trademark Web site and Google® Scholar).
- Knowledge of how to access, manipulate, and mine these tools for valuable information will serve you and your program well. Hence, you should encourage your staff to become well versed in Internet database search skills, and do not hesitate to ask your technology transfer office to organize short patent search workshops.
 Abstract
Freedom to Operate, Public Sector Research, and Product-Development Partnerships: Strategies and Risk-Management Options
by Anatole Krattiger
Abstract:
Freedom to operate (FTO) is—first and foremost—a strategic management tool. It is the synthesis of scientific, legal, and business expertise coupled with strategic planning. Strictly speaking, however, FTO is a legal concept. It is a legal opinion by patent counsel on whether the making, using, selling, or importing of a specified product, in a given geographic market, at a given time, is free from the potential infringement of third-party intellectual property (IP) or tangible property rights. As such, it is one type of input among many that managers use to make strategic risk-management decisions in relation to R&D and product launch. For academic and public research institutions, bringing products to market is often not a main goal. However, as a portion of their research moves downstream into product development, FTO becomes—or should become—an integral component of their endeavors. This is particularly relevant for product-development partnerships (PDPs) in health and for various public–private partnerships (PPPs) in agriculture, as well as for the Consultative Group on International Agricultural Research (CGIAR) and national agricultural research systems (NARS), all of which are concerned about global access.
Research exemptions exist in many jurisdictions, so most university research does not generally need to be concerned with FTO unless product development takes place. But PDPs, such as the Malaria Vaccine Initiative or the TB Alliance, are in a different category since their purpose is directly related to the distribution of products in the developing world. This chapter discusses three main categories of options that are available to reduce risk and obtain a manageable level of FTO. In practice, a combination of two or more options will often be pursued concurrently. These are:
- Legal/IP management strategies: license-in, cross-license, oppose third-party patents, seek nonassert covenant, seek compulsory license
- R&D strategies: modify product, or invent around
- Business strategies: merge and/or acquire, wait and see, abandon project
Each option presents its own risks and opportunities. Any action—including the decision not to take action—carries risk. Delaying the licensing of third-party intellectual property, for example, could lead eventually to expensive licensing terms, the inability to obtain a license, or the possibility of being sued for patent infringement. But for some organizations, such as those developing genetically modified crops, the reverse may be the case. For the public sector, the challenge will be to balance the various types of risks that each option presents.
The chapter concludes by urging the public sector to judiciously evaluate whether and when FTO concerns should be considered, and to build in-house capacity to conduct patent searches and cursory FTO analysis (as opposed to legal opinions). This will lead to benefits like better competitive intelligence and culture change in public sector organizations engaged in product development. An FTO strategy, therefore, is a plan that begins with research and evolves into an attitude throughout a product’s R&D and commercialization/distribution cycle.
Abstract
Freedom to Operate: The Preparations
by Stanley P. Kowalski
Abstract:
Freedom to Operate (FTO) is the ability to proceed with the research, development and/or commercial production of a new product or process with a minimal risk of infringing the unlicensed intellectual property (IP) rights or tangible property (TP) rights of third parties. The procedure for assessing whether the product or process possesses FTO is called the FTO analysis, performed by meticulously dissecting the product or process into its fundamental components and then scrutinizing each for any attached IP or TP rights. The early preparations for an FTO analysis are crucial, because they will influence all that follows and hence determine the quality of the work product. Thorough preparation will lay a solid foundation, supporting a credible and reliable FTO analysis. This chapter explains these preparations through an example.
Abstract
How and Where to Search for IP Information on the World Wide Web: The “Tricks of the Trade” and an Annotated Listing of Web Resources
by Harry Thangaraj, Robert H. Potter, Anatole Krattiger
Abstract:
Emphasizing patents and patent searching, this chapter will put readers on the initial path to understanding and protecting intellectual property (IP). By exploring patent information on the Web site of the European Patent Office and other Web sites listed in this chapter, the reader can begin to learn by doing and quickly gain experience that should improve his or her searching skills. Other resources dealing with IP in general are described. This collection is by no means exhaustive, given the vast amount of information on IP that is present on the Web, but the sites listed here should be valuable in accessing unbiased, useful information about the IP landscape, especially for key areas of technological interest. The value of IP searches for a typical technology transfer office is also discussed.
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