Freedom-to-Operate in the Crop Sciences: Principles

Stanley P. Kowalski, University of New Hampshire School of Law

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Research and development in the crop sciences is increasingly impacted by the risk of infringing the intellectual property rights (IPRs; e.g., patents) and tangible property rights (TPRs; e.g., material transfer agreements) of others. Since crop science products now entail such a high degree of technical complexity, and the processes and components to make such products are so ubiquitously available, the potential for such infringement is simply omnipresent. A freedom to operate (FTO) analysis is a tool that provides the requisite information so as to systematically, and prophylactically, assess such legal risks, which can then be managed and significantly diminished. FTO, therefore, 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, i.e., whether a product can be made, used, sold, offered for sale, or exported, with a minimal risk of infringing the unlicensed IPRs or TPRs of another.