to a range of options: identifying in-licensing targets, considering the substitution of tech-
nologies, deciding to ignore the potential infringement, investing in workaround technol-
ogies, or perhaps deciding to abandon the project altogether. Although private firms are
more likely to engage in FTO analysis because any infringement risk may directly affect
their ability to develop new products and their ultimate profitability, public and not-for-
profit private institutions are becoming increasingly aware of the need for better freedom
to operate information. This is particularly true for research projects undertaken by univer-
sities or not-for-profit research centers for the specific purpose of developing new crops for
developing countries. In these cases, it is critical that IP considerations be taken into
account early in the research process.
While patents are the most common type of IP right encountered, a thorough FTO analy-
sis will assess all types of existing property rights for the likelihood of infringement by the
research project or the product being commercialized. Of particular concern are tangible
property rights, such as cell lines, transgenic plants, germplasm, and plasmids, because,
as described above, the transfer of tangible property often occurs under the terms of a
material transfer agreement that has no geographic or temporal limitation. These terms
can be particularly problematic and directly impact FTO.
Enabling technologies for plant transformation or transformation vectors combine
several components such as promoters, selectable markers, marker removal systems, and
more. Because of the fundamental role of these technologies, they have been extensively
patented. In addition, the FTO surrounding plant enabling technologies is further compli-
cated because these technologies are not used individually but are combined with a suite
of related enabling technologies and specific trait technologies and are deployed in many
different plant species. We can look at a relatively simple example of a single component
of a transformation vector to illustrate the elements of an FTO analysis.
The target technology for this case study was a fruit-specific promoter from the tomato
E8 gene. The E8 promoter has been used to improve fruit quality, extend fruit shelf life, and
express edible human vaccines specifically in ripening tomato fruit. The first step in an FTO
investigation is to clearly define the target technology. In this hypothetical case, the fruit-
specific promoter will be used exactly as described in the initial publications by Deikman
and Fischer (1988) and Giovannoni et al. (1989). The promoters in these publications are
virtually identical and consist of about 2100 nucleotides upstream of the E8 structural gene.
Further promoter characterization identifying the location and sequence of functional
elements within the promoter and upstream nucleotide sequence was reported by
Deikman et al. (1992). These publications draw the technical boundaries surrounding the
target promoter technology and provide important prior art to subsequently filed patents.
To establish the relationship of publications and patents that describe or claim the E8
promoter, a patent landscape must first be established. The patent landscape should
include patents and patent applications closely related to the technology. Keywords and
authors of key publications are used to search for patents or patent applications. A separate
search should then be conducted to identify patents or patent applications that referenced
the scientific publications describing the technology. Additionally, in the E8 case, patented
DNA and protein sequence databanks were searched using the promoter’s DNA sequence
as a query. The patent landscape will reveal “family” relationships among different patents
and published patent applications. Patent families include later patent applications that
claim the benefit of an earlier, related, application or later patent applications that arise
from foreign filings of the parent application. Figure 14.3 illustrates a patent family
334 INTELLECTUAL PROPERTY IN AGRICULTURAL BIOTECHNOLOGY