Legal confusion on essentially derived varieties must be cleared up for the sake of innovation – Green light to gene-editing plants risks uncertainty…

The UK Government announced on 10 May in the Queens Speech that it intends to pass the Genetic Technology (Precision Breeding) Billto permit the use of gene-editing technologies in the commercialisation of plants and animals to improve agricultural efficiency and food production in the UK. This comes on top of a recent change in legislationback in Aprilto permit research and development using gene-editing techniques.

Both changes come in a post-Brexit change to the regulatory landscape, bringing the contentious issue of GMOs and intellectual property to the fore once again. The ground-breaking news follows a decade of a largely EU-wide moratorium on the approval and commercialisation of gene-edited crops.

With the fast pace of change brought by genome editing as part of new breeding techniques (NBTs) to develop plant varieties, there is a real concern that breeders may seek to launch new crops with a biotech trait, by using existing plant material without authorisation or any compensation to the holder of plant breeders rights in that existing variety.

Meanwhile, some biotech companies argue that the uncertainty of the legal concept of essentially derived varieties (EDVs) is stifling innovation. Others cite the difficulty of policing use of material of their protected initial variety, bringing a claim for infringement and the risk of damage to their business from competition from a derived variety.

We expect to see increased regulatory challenges and disputes in this area and businesses must monitor the latest developments to ensure they are prepared. A revolution in genetic engineering has transformed plant breeding. Development of all new plant varieties typically involves access to, and use of, plant material of existing plant varieties. The traditional process of crossing and selection relies largely on unintended recombination of genes and random mutants occurring naturally, which are selected and developed further over many years. Using multiplication techniques, a new variety can take over ten years to get to market. However, new breeding techniques can reduce the development time for a new variety to only two to four years.

One of the most controversial legal areas of plant breeding is the concept of essentially derived varieties (EDVs). The concept first set out in the 1991 UPOV Convention 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 breeders exception (Art 15(1)(iii)).

Recognising the advent of biotechnology, UPOV introduced a compulsory limitation upon the breeders exception in respect of EDVs under Art 14(5)(b). 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 DUS (distinct, uniform and stability) requirements for protecting a new variety.

The complex EDV concept was intended to prevent the commercialisation of a bred derived variety, without the consent of the owner of the plant breeders rights in the protected 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 rights in the initial variety should be entitled to licence the material embodied in the derived variety and obtain a financial benefit. It would prevent the developer from 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. It is not intended to prevent the developer of a derived variety from obtaining protection for that variety.

The complex definition of EDV raises many legal issues and uncertainties, including what amounts to predominantly derived, and whether it is relevant to the expression of the essential characteristics that the EDV has strong phenotypical similarity to, as well as genetic identity. The concept has polarised views and been applied differently around the world, making this an even more complex issue to grasp.

The lack of clarity on EDVs has already led to significant controversies and litigation, notably in the case of Danziger'Dan' Flower Farmv.AsteFlowers B.V. where the Dutch Court of Appeal, The Hague, held that the Gypsophila variety, Blancanieves, was not an EDV of Million Stars Dangypmini.

There is also a long-running dispute over the mandarin varieties Nadorcott and Tango, over whether Tango is an EDV of Nadorcott. The latest spin-off in 2021 pitted the King of Morocco (owner of Nadorcott) against a Spanish farming business over alleged unlicensed production of the variety, with the Advocate General giving his Opinion upon a preliminary reference to the CJEU on 14 October 2021 from a reference from the Supreme Court in Spain. Cases have been heard over whether Tango is an EDV in the US, Australia and South Africa and before the Community Plant Variety Office as to whether Tango is a distinct variety capable of protection.

So, what is the way forward? The debate continues but there have been some recent developments which businesses should be aware of. For example, a Working Group on EDVs was set by UPOV for the revision of the Guidance on EDVs. In addition, a draft text was last discussed on 19 October 2021, with a view to being adopted by the UPOV Council.

Some experts are keen that the new Guidance provides a more practical framework to distinguish between the cases which are clearer instances of EDV or non-EDV and how borderline cases may be determined. They argue that the inventive contribution of both the initial variety and the derived variety should be reviewed, in terms of the expression of their essential characteristics.

The legal presumption may be upon the owner of the protected initial variety to prove essential derivation and then claim dependency. However, some argue that the burden of proof should be reversed as the developer of the derived variety may have better data about the gene edit.

There is a role for the use of biochemical and molecular markers, though they need to be used cautiously, if used to determine whether a variety is an EDV.

There may also be a role for plant variety or patent offices to be able to provide an early declaratory decision, based upon receiving technical evidence. Alternative dispute resolution, such as expert determination or mediation facilitated by an industry expert, may also become more commonplace.

In addition, there may be value in developing industry-standard approaches to licensing and model form contractual clauses, perhaps drawing upon other licensing regimes (such as SEPs) or perhaps even under the Nagoya Protocol for plant genetic resources.

Biotech companies and plant breeders alike should closely monitor these developments and weigh up the risks of dispute, to avoid disruption to a smooth launch of a new crop into the desired market.

The UPOV Council needs to take a clear position soon on how to determine easily an EDV to give certainty to industry when using gene editing to develop new varieties, on situations when a licence may be required and royalties payable before launching commercially.

This article was first published in May 2022, on IAM media.com here.

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Legal confusion on essentially derived varieties must be cleared up for the sake of innovation - Green light to gene-editing plants risks uncertainty...