Agriculture Reference
In-Depth Information
each of these requires specialized expertise and tends to be the purview of different
types of professionals. All four, however, interact extensively, thus requiring ulti-
mately a comprehensive management strategy by those ultimately responsible for
the R&D and commercialization of a new variety.
2.2.1 Technological Uncertainty
The first is technological uncertainty, not knowing whether the genetic innovation
would work under increasingly realistic conditions and achieve desired performance
parameters. Since this is the primary expertise of the molecular biologists, breed-
ers, and agronomists at the core of any agricultural research organization or seed
company, it is typically well addressed. Of course, until technical uncertainties are
overcome, the R&D process does not progress, but once targeted technical issues
are resolved, technological uncertainty can be greatly diminished in the later stages
of R&D, unless IP or regulatory issues arise that require changes in the technology.
New technological uncertainties can arise once a variety is commercialized and is
being grown under more diverse field conditions and farming practices.
2.2.2 Intellectual Property Uncertainty
The second form of uncertainty involves intellectual property (IP) rights. The most
fundamental concern whether a new variety—or a genetic component incorporated
into a variety—might infringe another's IP rights and the likelihood that the owner
would seek to enforce his IP rights against the infringing variety. If so, R&D or
commercial use of the variety may need to be terminated, resulting in a loss of in-
vestments and potential benefits. However, it may be possible to negotiate a license
to use the protected technology, but the outcomes of such negotiations, such as the
terms of license and the cost of royalties, can be uncertain (Cahoon
2007
; Nilsson
2007
; Satyanarayana
2007
). On the other hand, uncertainties also arise when seek-
ing to obtain one's own IP rights over new technologies invented or new varieties
developed or to enforce them. There are questions as to costs of pursuing IP rights,
when or whether an application will be granted, as well as questions about the
strength and enforceability of an IP right even if granted, as this can depend upon a
range of legal issues (Livne
2007
). Moreover, IP rights are country-or jurisdiction-
specific. (Some regions, such as Europe, have multi-country patent offices). IP is-
sues that arise in one market may not be relevant in another (Yin et al.
2007
). Yet,
such variations in IP coverage, can potentially affect international trade in agricul-
tural products resulting from protected varieties (Binenbaum et al.
2003
). Intellec-
tual property uncertainty is of little concern in the early stages of R&D, particularly
in the public sector, and, as such, many breeders and geneticists engaged in the
discovery and proof-of-concept stages, tend to give it little consideration; however,
IP becomes progressively more important as decisions are made to move a genetic
innovation closer to market, particularly when larger investments are required to
