- What is “freedom to operate” (FTO) in the intellectual property context? What are the
main issues in considering FTO when developing an improved crop variety using
agricultural biotechnology? - In the E8 case study, how does prior art preclude patenting? Discuss ways research
scientist could use publications as a means to place inventions in the public domain. - While patent law has presented opportunities to protect intellectual property in the
field of biotechnology, it has also generated a struggle to reconcile public and
private interests. How are the emerging models represented by PIPRA and
CAMBIA trying to stimulate innovation and promote open access while avoiding
the tragedies of the anticommons?
14.1 Introduction
Scientific advances in many fields have been treated historically as public goods, and this
was particularly true in agriculture. Universities and other public-sector institutions were
the leaders in developing improved crop varieties that were transferred to farms through
cooperative extension services in the United States or equivalent organizations internation-
ally (Conway and Toenniessen 1998). This model, however, has changed rapidly in the last
few decades, primarily because of greater utilization of formalintellectual property(IP)
protection of agricultural technologies and plant varieties by the public sector, as well as
the development of a research-intensive private sector that now makes major contributions
in enhancing the productivity of US agriculture (Kowalski et al. 2002). In particular, the
expanded use of formal IP rights for agricultural biotechnology-based products can be
understood by considering the significant amount of time and financial resources needed
to develop a new transgenic crop and the high costs of obtaining regulatory approval to
market such a crop. In the face of these costs, the time-limited exclusivity provided by
patents allows the investor an opportunity to recoup the costs of research and development.
Indeed, it is very likely that the agricultural biotechnology industry would not have devel-
oped in the absence of a strong framework for IP protection.
The growth in patents related to agricultural biotechnology can be seen in Figure 14.1.
These data indicate a strong growth in the issuance of patents by the US Patent and
Trademark Office (USPTO), and similar trends are also apparent in patent applications
internationally, suggesting that this is a global trend. The scope of inventions represented
by the data in Figure 14.1 is quite broad but can be conceptually divided into two main cate-
gories: those that cover research tools orenabling technologiesthat are required to produce
transgenic plants or to discover new gene functions and those that covertrait technologies
that confer specific attributes to genetically modified plants. This distinction is important
because all researchers and research institutions need access to the fundamental tools of
agricultural biotechnology if the greatest benefits of the technologies are to be realized,
whereas exclusive access to specific trait technologies is an effective means of ensuring
that the new crop varieties expressing these attributes are developed. As a consequence,
there is a delicate balance in the overall innovation framework between exclusive access
to certain technologies while at the same time ensuring broad access to other technologies.
A very similar situation was addressed in the early 1980s when Stanford University and the
University of California, San Francisco patented the basic methods of recombinant DNA
manipulations (Cohen and Boyer 1980). This patent, covering the fundamental tool of
326 INTELLECTUAL PROPERTY IN AGRICULTURAL BIOTECHNOLOGY