Growing pains
Genetic engineering is revolutionising our understanding of disease prevention in humans, including the use of gene therapy to prevent or cure genetic defects.
However, in plants, the use of genetic engineering to develop new varieties with desirable traits is long-established. Indeed, the first “genetically modified” (GM) plant, a tobacco plant engineered for antibiotic resistance, was reported in 1983. This was followed by the first commercial GM crop, the Flavr Savr tomato, which was introduced in the US in 1994.
However, with the advent of genome-editing techniques, led initially by ZFNs and TALENs, and now by CRISPR-Cas9, we now have the ability to add, remove or alter genetic material at targeted locations within the genome, with precision, relative ease, at scale and at low cost. This is transforming plant breeding.
The traditional process of crossing and selection relies largely on unintended recombination of genes and random mutations occurring naturally, which are selected and developed further over many years, using multiplication techniques, with a new variety taking often ten-plus years to get to market.
New plant breeding techniques (NBTs), which involve development of new plant varieties with desired traits by modifying their DNA, can reduce the development time for a new variety to only two to four years. Potential applications include traits for disease resistance, herbicide tolerance, drought or salt tolerance, low anti-nutritional compounds, improved nutritional value, improved yield and improved biomass conversion.
Development of all new plant varieties (traditional or using NBTs) involves access to (and use of) plant material of existing plant varieties.
The international regime for protection of plant varieties set out in the International Convention for the Protection of New Plant Varieties (1991) of the International Union for the Protection of New Varieties of Plants (UPOV) is predicated upon an open model of innovation, which allows breeders to use plant material for the purpose of breeding a new variety, the so-called “breeder’s exception” (article 15[1][iii] UPOV).
For instance, this compulsory exception was adopted in section 8(c) of the Plant Varieties Act 1997 in the UK and §10a(1) No. 3 of the German Plant Variety Protection Act (Sortenschutzgesetz).
What is an essentially derived variety?
Recognising the advent of biotechnology, UPOV introduced a further compulsory limitation upon the breeder’s exception in respect of essentially derived varieties (EDVs). The main driver for the limitation was to prevent plagiarism of traditionally-bred varieties using new technologies, but it was also in response to erosion of the minimum distance requirement in phenotypical characteristics as part of the distinct, uniform, and stability (DUS) requirements for a new variety.
The complex EDV concept was intended to prevent the commercialisation of a derived variety, without the consent of the owner of the plant breeder’s rights in the protected initial variety, where the derived variety fell within defined “scope” of the initial variety. The idea was that, given the significant contribution that the work in breeding the initial variety had made to the derived variety, the owner of the plant breeder’s rights in the initial variety should be entitled to license the material embodied in the derived variety and obtain a financial benefit.
It would stop the developer simply patenting the biotech trait and then commercialising the trait by inserting it into plant material already protected by plant breeders’ rights, to produce an improved variety.
The EDV concept is not intended to prevent the developer of a derived variety obtaining protection for the derived variety, if it otherwise satisfies the legislation as being DUS and new.
