| Intellectual Property Rights
Intellectual property rights are statutory rights exclusively granted for certain products of the intellectual effort and ingenuity. For holders of a particular intellectual property ("IP"), IPRs serve to protect their inventions, innovations, creativity and inventiveness from someone copying them without permission.
But what is IP? Intellectualproperty can be considered tangible proof of the creativity of the human intellect. Once an idea or creative process has been described and obtains an IPR it can be treated as property for which a value can be assigned. This potential value is what makes IP tradable and is the principle driver behind several mergers and acquisitions, not only in the agricultural sector, but also in all sectors of the economy.
Intellectual
Property Rights and Genetically Modified Organism
Public research institutes play an important role in developing science
and technology and disseminating information and knowledge to the
private sector. Over the past two decades, public research institutes
have been forced to face the challenge of systematically forming
alliances with the private sector. Several factors have acted as drivers
to these public-private sector collaborations. These factors include for
example:
-
the
increased innovations in science in particular pharmaceuticals,
agriculture, biotechnology (genetic engineering)
-
globalisation
and the resulting trade liberalization
-
emphasis
on product differentiation
-
global
competitiveness
-
reduced
availability of research funds
Also
of significance was the passing of the Bayh-Dole Act in the USA in 1980.
This Act set the precedent that allowed universities to have title to
publicly funded research and innovations. They could file for patent
protection and negotiate royalty-bearing licenses with private sector
entities.
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This
meant that profitable public-private sector alliances could be formed
allowing universities to reap some financial gains from their research
inventions developed. While the potential exists for universities and
private companies to benefit financially from IPRs and their marketable
value, their ability to do so depends on whether they have strategically
developed the "Freedom To Operate ("FTO"), based on legal
access to all enabling technologies.
Gene
Manipulation
To fully understand the IP concerns of genetically modified organisms (GMOs)
and the implications for trade and movement of GMOs, one must first
understand what is involved in producing a GMO. Gene manipulation
generally involves the following steps:
-
Identification
of gene with desirable trait
-
Identification
of donor organism into which the gene will be transferred
-
Collecting,
purifying or sequencing gene sequences of interest
-
Preparation
of the gene sequence of interest (promoters, upstream and down
stream regulatory sequences, selectable markers etc.)
-
Making
copies of the required gene
-
Transfer
of gene sequence into a vector for transport into recipient organism
(other direct gene transfer techniques can be used)
-
Growth
and selection of transgenic organism
-
Mass
production of the GM material by for example tissue culture methods
-
Risk
assessment analysis in growth chambers, greenhouse and field
The
ability of a company to commercialise a genetically modified product is
limited by several factors including:
-
A
large number of technologies used to develop a single product
-
Technologies
subject to proprietary IPRs, which will most likely be patented
-
Ownership
of many technologies is uncertain because of several pending patent
applications, interference claims on granted patents and litigation.
- Patented
technologies may or may not be available on a licensing basis, based
on
different degree of exclusivity.
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The
application of biotechnology to plants for example represents a wide
range of technologies. It is therefore clear that the ability to produce
genetically engineered product with a specific trait (agronomic or
quality) and the freedom to operate from a commercial viewpoint,
requires legal access to a number of lPs such as:
- Enabling technologies - transformation, promoters, selectable markers etc.
- Trait specific genes - herbicide tolerance, ripening etc.
- Methodology - transformation
- Product patents - proprietary germplasm, hybrids etc.
Each
of the steps in the process to develop a GMO is highly technical and
subject to IPRS. Patents have been awarded for the products and
materials used in genetic engineering and also for the processes
developed to facilitate gene transformation. For example, recently in
the USA patents were awarded on fragments of genes. The result being
that several companies now hold IPRs over different parts of one gene
and some form of agreement, and possibly royalty payments, will be
required from each of these companies to use these genes in a research
project. In the case of patents granted on a process, the patentee can
prevent, not only the use of the process but also the commercialisation
of products derived directly from the process.
IPRs, Biotechnology and Food Security
Biotechnology has the potential to contribute to future food security, but only if it benefits small farmers in developing countries. The concern with biotechnology is that it has not lived up to its promise to the world's poor. Protection of IPRs encourages private sector investment in agricultural research, but in developing countries the needs of resource poor farmers and protection of the environment are not likely to attract private funds for research. The presence of few 'mega giants' i.e. Multinational corporations within agricultural biotechnology has raised fears that the food security needs of developing countries will be overlooked.
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