a promoter database that includes information on expression characteristics as well as their
IP status (the database will be hosted at PIPRA: http://www.pipra.org)..)
14.4.5 Subcellular Localization
In addition to specificity in tissue-level transgene expression, it is also often important to
direct the targeting of the new protein to a specific subcellular location. For example,
becauseb-carotene is produced in the plastids, the development ofb-carotene-enriched
rice utilized a transit peptide derived from the small subunit of Rubisco to target proteins
to this subcellular compartment (Ye et al. 2000). This and other transit peptides have
been the topic of intense study, and several companies have patented their use to direct pro-
teins into plastids (Herrera-Estrella et al. 2000; Dehesh 2002). However, several early pub-
lications from public-sector research organizations described alternative transit peptides that
were not subsequently patented and thus should be accessible in the public domain
(Smeekens et al. 1986). Because transit peptides do not have a high degree of sequence
similarity, it is likely that additional transit peptides will not be dominated by existing
patent claims and alternative sources of functional transit peptides could be developed
from public-domain information or from public-sector laboratories. Targeting to other sub-
cellular locations has been the topic of intense research in both the public and private
sectors, and there are many examples of public-sector research describing unpatented
sequences targeting proteins to a variety of subcellular sites, including the cell wall,
vacuole, plastids, and peroxisomes (Komarnytsky et al. 2000; Bednarek et al. 1989;
Tague et al. 1989; Kato et al. 1996; Volokita, 1991; Hayashi et al. 1996).
Developing a new genetically engineered crop requires the assemblage of a number of
patented technologies throughin-licensingor, potentially, by a series of strategic mergers
and acquisitions. Several companies have effectively done this and have used platforms
of proprietary technologies to develop new varieties of major crops. However, work on
crops of less commercial interest has progressed slowly, with few of the benefits of biotech-
nology having been realized in specialty crops (Clark et al. 2004). With the requirement for
assembling a large number of patented technologies to produce genetically engineered crop
and the fragmentation of IP ownership, it appears that the preconditions for the development
of an anticommons exist in this technology sector. In addition, the observed slowdown in
the development of new agricultural biotechnology products may be, at least in part, an
effect of such an IP anticommons (Graff et al. in press).
14.5 Freedom to Operate (FTO)
Navigating the complex IP landscape of a research project in agricultural biotechnology
requires some analytical tools and specialized analytical capabilities (Fenton et al. 2007).
The analysis requires both legal and scientific knowledge as well as access to both patent
and literature databases and typically takes the form of what is known as a “freedom to
operate” (FTO) opinion. The FTO opinion is a legal assessment of whether a research
project or the development of a new product can proceed with a low, or tolerable, likelihood
that it will not infringe on existing patents or other types of IP rights. It is important to note
that the FTO determination is not absolute but reflects an evaluation of risk since there is
typically some uncertainty around the interpretation of patent claims as well as uncertainty
as to whether new IP may issue or be discovered at a later date. The FTO opinion may lead
14.5. FREEDOM TO OPERATE (FTO) 333