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UK - change in gene editing regulations

UK - change in gene editing regulations

Industry news 01/10/2021

Gene editing is a type of genetic engineering in which DNA is either inserted, deleted, modified or replaced within the genome of a living organism. This ground-breaking tool is highly precise and makes the process of plant breeding significantly more efficient, enabling the production of resistant, nutritious and productive crops that have a reduced impact on the environment. Specifically, the use of gene editing technologies could facilitate the production of sugar beet varieties that are resistant to viruses which cause major yield losses unless pesticides are used, reducing the need for chemical pesticides.

In contrast to genetic modification, gene editing utilises the genetic resources that nature has provided and is able to create new varieties similar to those that would occur by natural breeding processes in the future. However, they are currently placed under the same regulatory guidelines as genetically modified organisms. The UK government plans to ease the burden for research and development of plants using gene editing technologies, through excluding organisms produced by gene editing from the definition of a genetically modified organism.

This response puts the UK on course to diverge from the EU, who regulate genetically edited organisms in the same way as genetically modified organism. Since leaving the EU, the UK is now free to set its own rules and foster innovation through taking a more scientific approach to the regulation of genetic technologies.

IP implications

Consistent with Article 53(b) EPC, the Patents Act 1977 states “any variety of animal or plant or any essentially biological process for the production of animals or plants, not being a micro-biological or other technical process or the product of such a process” are not patentable. However, as the gene editing of plants comprises technical steps outside of an essentially biological process, inventions within this area do not fall into this exception. Therefore, the patent system currently provides an incentive to develop technologies in this area by granting monopolies, however commercially developing these inventions was a challenge under the strict and lengthy EU regulatory processes.

The proposed regulatory changes from the UK government will create a more favourable environment for businesses to exploit their innovations within this technical field. This incentivises the filing of direct UK patent applications to inventions in this area, which is a relatively inexpensive process (usually less than £1000).If you would like any further information, please do not hesitate to contact Charlotte Watkins or Huw Jenkins at