novelty of any subsequent patent claims on the E8 promoter per se (e.g., applications filed
by Agritope and Epitope). Counsel concluded that the tomato E8 promoter constructs per se
can be reasonably considered to be in the public domain. However, some of the subsequent
patents claim chimeric constructs comprising the E8 promoter and heterologous genes and
use of the E8 promoter in conjunction with other promoter elements. Thus, certain specific
uses of the E8 promoter may infringe on these subsequent patents.
This example provides an overview of the data and information that should be con-
sidered in an FTO analysis. It is not difficult to imagine how the complexity of an FTO
analysis would grow dramatically with the inclusion of multiple enabling technologies,
one or more trait technologies, and proprietary germplasm. This is one of the challenges
in understanding IP constraints and developing FTO strategies in plant biotechnology
where multiple complementary technologies are necessarily integrated to develop new
crop varieties.
14.6 Strategies for Open Access
The complex IP environment surrounding agricultural biotechnology research and develop-
ment, exemplified by even a relatively simple FTO opinion, has spawned some new strat-
egies and new organizations committed to lower the IP barriers to new crop developments
and provide more open access to patented technologies. These issues are critical for small
private companies attempting to enter this sector but can also be important for public or not-
for-profit research institutions. For example, a Federal Circuit Court of Appeals ruling in the
Madey v. Dukecase emphasized that academic research is not protected by an “experimen-
tal use” exception from patent infringement, even when the research is purely fundamental
(Eisenberg 2003). Most plant biotechnology laboratories routinely use patented
Figure 14.4.Timeline of tomato E8-related scientific publications and patents. The timing of the
publication of scientific and patent literature illustrates the existing prior art at the time that related
patent applications were filed [from Fenton et al. (2007), used with permission].
336 INTELLECTUAL PROPERTY IN AGRICULTURAL BIOTECHNOLOGY