Agritech Thymes: A review of protection for gene edited plants

As we head into a new season, it’s a good time to revisit the current status of protection for Essentially Derived Varieties (EDVs) and plants derived from New Genomic Techniques (NGTs).

The “Breeders Exemption” allows the development of new varieties from a protected variety without having to wait for the initial PVR to expire. If the new variety falls within the definition of an EDV, as set out below, its owner will need permission from the initial PVR holder in order to commercialise it, so providing some economic recompense to the PVR owner.  If a third party, for example another breeder, wants to use that EDV, they would need permission from both the PVR owner and the new EDV owner. Any new EDV may itself be protected by a PVR, provided it meets the requirements of stability, uniformity and distinctiveness.

As a reminder, an EDV is a plant which is “predominantly derived” from the initial variety – meaning that it has more of the genome of the original variety from which it is derived than would be expected from a normal cross. It must also retain the expression of “essential characteristics” of the initial variety, and be “distinguishable” from the initial variety by one or more characteristics which are capable of a precise description.

Of course, an EDV may be used to generate further EDVs. But when considering protection, it is important to remember that the PVR only extends to the first “generation” of EDVs.  So, if a party is planning to use an EDV generated from an earlier EDV, they would need permission from the initial PVR holder (until the PVR ceases) and from the owner of the last EDV from which it is derived if this is protected by a PVR, but not from the owners of any intermediate EDVs. This becomes interesting when we look at how New Genomic Techniques are being used to generate new plant varieties.

It has been acknowledged by Defra and UPOV that an EDV may be produced from the initial variety by methods including genetic engineering, including precision breeding techniques. However, in 2023 UPOV issued non-binding Explanatory notes which suggested that an EDV does not need to completely share the essential characteristics of the initial variety, as long as the missing essential characteristics are missing as a result of the act of derivation. These Explanatory notes have been interpreted as broadening the definition of an EDV to encompass offspring plants which do not share all essential characteristics with the initial variety. Because the initial PVR provides protection for the first generation EDV but not for intermediate EDVs, if all NGT plants fall within the definition of an EDV then the effective scope of protection of the PBR would be reduced because a greater number of gene edited plants may fall within an intermediate EDV category.

Over a year since the Explanatory Notes have been issued, there remains uncertainty in the field regarding the scope of PBR protection for precision bred EDVs.

In addition, further talks on how to simplify and accelerate the approval process for NGT plants have recently been halted, as the parties have been unable to agree on several issues including labelling of NGT plants. It is hoped that agreement will be reached and the proposed regulation finalised during the Danish presidency in the second half of 2025.

For the time being, HGF’s advice remains to continue with existing patent and PVR filing strategies.

This article was prepared by Partner & Patent Attorney Punita Shah.