Gene editing and novel food technologies are creating new opportunities across the food and agribusiness sector. From precision-bred crops and cultivated products to fermentation-derived ingredients and alternative proteins, businesses developing these technologies face an evolving regulatory and intellectual property landscape.
In our recent food and agribusiness breakfast briefing, Jessica Burt was joined by Linus Pardoe from The Good Food Institute Europe and James Fry, partner and head of life sciences at Mills & Reeve, to discuss the latest developments and what they mean for businesses operating in this area.
The discussion covered the UK's developing approach to novel foods, the potential impact of future UK-EU alignment and the IP and commercial considerations around developing and bringing innovative food technologies to market.
A developing UK regulatory landscape
A key theme was the progress being made in developing the UK's regulatory framework for novel foods.
Linus Pardoe highlighted the importance of a modern, transparent and proportionate regulatory pathway for bringing innovative products to market. The Food Standards Agency has developed specialist expertise in areas including cell-cultivated products and precision fermentation, alongside opportunities for businesses to engage directly with the regulator around testing, data and application requirements.
This builds on developments explored in the recent Food Standards Agency update on the Cell-Cultivated Product Sandbox held at Mills & Reeve’s London office. The Sandbox was established to address scientific and regulatory questions associated with cultivated foods, improve understanding of how existing legislation applies and help businesses submit stronger applications.
What could UK-EU alignment mean for novel foods?
The future relationship between the UK and EU remains an important consideration.
The discussion considered the ongoing SPS negotiations and the potential implications of dynamic alignment with EU rules, including whether exceptions or carve-outs could allow the UK to retain flexibility in areas such as novel foods.
There is also a wider international picture, with different approaches emerging towards alternative proteins and other food technologies. A robust scientific risk assessment process and a clear regulatory pathway will therefore be important as businesses seek to bring new products to market.
Gene editing, freedom to operate and protecting innovation
For businesses working with technologies such as gene editing, regulation is only part of the picture. Protecting innovation and understanding the rights surrounding the underlying technology are also key.
James Fry highlighted the value of taking a strategic approach to IP from an early stage. Depending on the technology, businesses may need to consider a combination of patents, trade secrets and, where relevant, plant variety or plant breeders' rights.
Freedom to operate is particularly relevant where products rely on technologies developed by others. The discussion highlighted CRISPR gene-editing technology as an example of where businesses need to understand the underlying IP landscape and ensure appropriate rights or licences are in place.
Commercial arrangements matter too. Supply chain, manufacturing and joint development agreements can affect how technology and IP are developed and exploited, making appropriate contracts and internal governance an important part of the picture.
Data as a commercial asset
Data is another increasingly valuable asset for innovative businesses.
The protection of data can be an important part of regulatory submissions, investment, licensing and future IP protection. Where third-party data is being used, businesses should understand what rights they have and whether these cover the purposes for which the data may ultimately be needed.
Proprietary datasets may also need to be protected as trade secrets, particularly where they could support future IP. Appropriate control of data should therefore form part of the wider IP and governance strategy.
Looking ahead
Gene editing, novel foods and alternative proteins bring together questions of science, regulation, IP and commercial strategy.
Although the regulatory landscape continues to evolve, businesses can address many of these issues early. Understanding the relevant regulatory route, establishing rights to underlying technologies, protecting IP and proprietary data, and putting appropriate commercial arrangements in place can help support the path to commercialisation.
Our content explained
Every piece of content we create is correct on the date it’s published but please don’t rely on it as legal advice. If you’d like to speak to us about your own legal requirements, please contact one of our expert lawyers.