Delivery Pathways and Processes

MAS has enhanced conventional breeding methods by providing greater flexibility and new selection strategies than were previously possible. The delivery pathway for biotechnology has been facilitated by training of a new generation of plant breeders who have a thorough knowledge of molecular biology, genetics and heritability. Some of the key factors influencing marker application are listed in Table 12.6.

From 1995 a new industry rapidly developed to generate GM plants, but there have only been a small number of successful exploitations. Large firms have commercialized

Table 12.5. Material Transfer Agreements (MTAs), licences, documents and agreements required for 'Golden Riceā„¢' (modified from Kryder et al., 2000).

Component

Source

Germplasm

Rice lines used for transformation

Taipei 309 from IRRI

Vector

pGEM4

Promega

pBluescriptKS

Stratagene

pCIB900

Ciba-Geigy (now Syngenta)

pKSP-1

Tom Okita, Washington State University

pUCET4

N. Misawa, Kirin Brewery Co.

pYPIET4

Clontech (now marketed through Life

Sciences)

Promoters

CaMV 35S promoter

Monsanto

GT-1 promoter

Tom Okita, Washington State University

Terminators

CaMV 35S terminator

Monsanto

Selectable marker

AphIV gene, hygromycin

Ciba-Geigy (now Syngenta)

phosphotransferase

Expression enhancement

Pea Rubisco transit peptide

N. Misawa, Kirin Brewery Co.

pPZP100

Pal Malinga, Rutgers University

Transformation process

Electroporation apparatus

Bio-Rad

Microprojectile bombardment

Bio-Rad

apparatus

Biolistic transformation

DuPont

Trait gene

Crt1 gene, phytoene desaturase

N. Misawa, Kirin Brewery Co.

Obtain licence or

Work around solutions

Infringe deliberately (or unknowingly)

Avoid using technologies

Fig. 12.4. Intellectual property (IP) options for scientists.

Some countries have therefore legislated research exemptions so that scientists may access and use patented technologies for research. In 2005, the Australian Advisory Council on Intellectual Property recommended that the Australia Patent Act be modified to allow restricted experimental use (ACIP, 2005). This recommendation

Table 12.6. Factors related to effective delivery of marker technologies.

Factor

Comments

Direct involvement of breeders in defining targets and germplasm Use cultivated germplasm pool first

Access suitable staff

'Outsource' marker work

Use 'technology champions'

Establish new generation of breeders

Molecular groups should act in a support capacity, challenging breeders by questioning their methods and breeding strategies

For many crop species the level of understanding of variation and the germplasm base is still poor and introgression of useful alleles from landraces and wild relatives remains slow It remains difficult to attract high-quality students and staff to breeding-related programmes and to attract staff trained in molecular techniques to breeding stations that are often in remote locations

High quality and cost-effective service labs are available but many still believe that marker development and application is still a research activity and is best carried out in-house Success in marker application in the public sector is often driven by a few individuals who had the energy to drive aggressive, and often risky, new breeding strategies Major advances in marker application are often driven by more recently trained breeders

GM technologies mainly focusing on single gene events conferring either herbicide or pesticide resistance, selected because they are of high commercial value, quick to market and synergistic with chemical businesses often owned by the same companies. Many outcomes of more difficult projects, such as conferring drought tolerance, more efficient use of fertilizer, resistance to salinity and so on, have yet to be commercialized. Much of the gene discovery work in these areas is occurring in the public sector where public funding is able to overcome the market failure issues that arise from the extended time needed to solve these difficult problems.

The delivery pathway for GM technologies is somewhat more complex than delivering technologies via conventional breeding.

Identifying genes responsible for traits of interest is in itself a long and costly process. Many years of expensive research can elapse before a trait-gene relationship is discovered and the gene is isolated. In the case of the boron tolerance gene, Bot1, at least 4 years of work was required before the gene was discovered and patented (Sutton et al., 2007).

After gene discovery, suitable plants must be transformed with the gene of interest. The complex IP landscape in agricultural biotechnology means that access must be sought for the enabling technologies that are used to create transgenic plants because, as already mentioned, many of the enabling technologies are patented. Generating GM events means that vectors must be constructed, often also using elements such as promoters that are also patented (Fig. 12.5).

Transgenic plants are then subjected to years of testing in glasshouses under controlled and contained environments. Monsanto's 'product pipeline' (see Table 12.7) describes just a 25% chance of successfully delivering a technology once that initial discovery work has been done.

Plants are then tested under field conditions at many sites, and usually over several years, so that the full extent of the plant improvements are understood and validated. While initial work often occurs in 'model' plants that are easily transformable, adapted germplasm must be selected that is suitable for the target environment and which must also be suitable for transformation or, if not, then capable of being 'backcrossed' with material that has been transformed.

Large multinational firms have resources and expertise, access to complex patent thickets, extensive access to germplasm and

Gene discovery Access to IP

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