Freedom to operate (FTO) is the ability to proceed with research, development and commercialization of a crop science product, while fully accounting for any potential risks of infringing activity, that is, whether a product can be made, used, sold, offered for sale, or exported, with a minimal risk of infringing the unlicensed intellectual property rights (IPRs) or tangible property rights (TPRs) of another. An FTO analysis begins with the ‘FTO team’ systematically dissecting the crop science product into the components, combination of components, processes and germplasm that went into its research and development. This is followed by generating a series of FTO analytical questions, whereby each piece of the product is carefully scrutinized for the presence of potential IPRs, TPRs and germplasm property rights held by other parties. Finally, patent counsel may render an FTO opinion, indicating the likelihood of the risk of infringing the unlicensed IPRs or TPRs of another should research, development or commercialization proceed. FTO is not absolute. The proprietary landscape is in a continual state of flux, both in time and in space, as in the case where patents issue/expire in countries around the world. Therefore, an FTO analysis is a risk-management tool which is only applicable for a given product, at a given time, in a given jurisdiction, and, as such, must to periodically updated.
Digital Object Identifier (DOI)
Stanley P. Kowalski, “Freedom-to-Operate in the Crop Sciences: Procedure,” in “Encyclopedia of Plant and Crop Science,” 1-4 (Robert Goodman, ed., 2007).