The Genetic Technology (Precision Breeding) Bill, announced in the Queen's Speech in May, aims to take advantage of the UK's post-Brexit position to make the UK a beacon for agri-food research and innovation by providing a more relaxed set of regulations around the release and marketing of gene edited plants and animals.
The implications of this for the Life Science IP sector was considered in an article for Life Sciences Intellectual Property Review. Dehns' Senior Associate (Life Sciences), Dan Rowe, provided his expert insights into the matter.
In Dan's view, the proposed legislation represents a welcome attempt to reduce the regulatory burden on organisations looking to invent and develop gene edited organisms that could also be created by traditional breeding techniques, albeit much more laboriously. The risks associated with such organisms are significantly less than classical genetically modified organism and so research into such organisms should not be stifled by the strict regulation quite rightly currently in place for conventional GMOs. Dan believes that the proposed legislation requires more work to ensure only the safest gene edited organisms are encompassed, but he believes this should be within the capabilities of attentive legislators.
If all goes to plan, the UK should see an explosion of investment into the research and development of gene edited organisms. This should see a commensurate rise in associated IP, and an impetus to protect that IP will follow. The Genetic Technology (Precision Breeding) Bill does not currently address this situation and, unless this changes, stakeholders in this potentially burgeoning UK industry will have to rely on existing legal frameworks to protect their new IP.
Today, gene edited plants and animals, and the processes which create them are, at least in principle, capable of patent protection and such plants may be the subject of Plant Breeders Rights (also known as Plant Variety Rights). As such, the types of organisms to which the present Bill relates should enjoy IP protection of some form in the UK. That being the general case, Dan went on to make the point that obtaining patent protection for gene edited plants and animals is however not always straightforward and he foresees enforceability issues for the types of organisms envisaged by the Bill, i.e. those that are meant to obtainable by traditional processes and/or which could potentially arise naturally. In addition, it might often be the case that such gene editing processes will give rise to new varieties rather than have cross-species applicability. As a result, Plant Breeders Rights may come to the fore as the protection of choice in the plant specific side of the industry. There is however no equivalent rights for animal varieties and so in the future the UK government might be lobbied by industry to introduce such a system. This would be the first of its kind in the world.
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