Billed as a lifeline out of the COVID-19 pandemic with the goal of making Europe the world’s first climate-neutral continent by 2050, the European Commission’s Green Deal was introduced in December 2019.

It encompasses a wide range of policies and measures across various sectors including energy, transport, industry, agriculture, and buildings. Key objectives include climate neutrality, clean energy transition, sustainable industry, sustainable mobility, protecting biodiversity, reducing pollution, and ensuring an environmentally friendly food system.

Gene-editing of crops in Europe

In recent years, the emergence of techniques of gene editing has allowed specific edits to DNA to be made in a highly targeted way.  This has allowed the rapid development of plants with improved characteristics, which in the past may have taken many years to achieve through traditional breeding techniques such as crossing and selection.

On 5 July 2023, the European Commission published a collection of food and biodiversity rules as part of the Green Deal agenda. These include proposals which aim to  boost innovation and sustainability by enabling new genomic techniques (NGT) such as gene-editing.  Specifically, the European Commission proposal will:

• establish two categories of plants obtained by NGTs: NGT plants comparable to naturally occurring or conventional plants, and NGT plants with more complex modifications;
• both categories will be subject to different requirements to reach the market taking into account their different characteristics and risk profiles. The plants from the first category will need to be notified. The plants from the second category will go through the more extensive process of the GMO directive;
• give incentives to steer the development of plants towards more sustainability;
• ensure transparency about all NGT plants on the EU market (for e.g., through labelling of seeds);
• offer robust monitoring of economic, environmental, and social impacts of NGT products.

Whilst the Court of Justice of the EU has previously ruled that gene editing falls under laws covering transgenic plants, the proposal of the European Commission may help ease the strict controls on gene-edited plants, so long as they have traits which could have instead been achieved through conventional breeding techniques.  Specifically, plants may be exempt from GMO regulations if no more than 20 nucleotides are added or replaced during the gene-editing.  The draft also allows researchers to add or move genes if the gene already exist within the gene pool of the plant species. This should make it easier to develop and commercialise gene-edited plants in Europe, as they may no longer need to go through the EU’s laborious and expensive GMO regime. However, the draft law still requires gene-edited seeds to be labelled and registered in a public database. Notably, introduction of any herbicide resistant traits is also excluded from the proposals. Moreover, it could take several years for the proposals to be approved by the European Parliament and Council. 

Gene-editing of crops in the UK

The proposals of the European Commission appear to be broadly in line with the recent approach proposed by the UK Government.  After leaving the EU, the UK this year passed into law the Genetic Technology (Precision Breeding) Act.  This Act creates a simpler regulatory and approval process for “precision bred crops”.  This applies to crops which are created through gene-editing, so long as they could have resulted from traditional processes of plant breeding.  Thus, the UK law also seeks to draw a distinction in regulatory requirements between gene-edited crops (produced in a targeted way) vs. transgenic plants (which may include genes from different species).

Patentability of plants in Europe

Following the landmark decision of the EPO’s Enlarged Board of Appeal G3/19, plants obtained (after 1 July 2017) exclusively by means of an “essentially biological process”, such as traditional breeding techniques, are excluded from patentability under Article 53(b) of the European Patent Convention (EPC).  Instead, plant variety rights (PVRs) are available to the plant breeding and seed industries to protect new, distinct, uniform and stable plant varieties.

In principle, however, patent claims may be awarded to plants obtained by technical interventions such as gene-editing, so long as these plants fulfil other requirements of patentability such as novelty, inventive step and sufficiency.  In assessing whether any gene-edited crops are novel and inventive, the European Patent Office (EPO) takes all relevant prior art into consideration when examining a patent application, including exchange of data with the Community Plant Variety Office (CPVO). Thus, it may be necessary to establish that plants obtained by gene-edited crops can be distinguished (and are non-obvious) from plants obtained by more conventional breeding techniques.

The European Patent System provides an incentive for research organisations and companies to innovate in new genomic techniques such as gene-editing.  However, to ensure that patents on plants obtained by technical methods such as gene-edited cannot be extended to plants that have been produced by biological processes and carry the same characteristics, it may be necessary to “disclaim” from the patent claims any plants produced by standard techniques of crossing and selection and having the same characteristic or trait. 

Continuous innovation in areas such as precision agriculture is key to more resilient food systems, and it’s fantastic to be involved in protecting some of the technologies that are leading the way in creating a sustainable future. 

If you would like further information regarding the IP protection for plants (either through patents or plant variety rights), please contact Huw Jenkins at docketing@secerna.co.uk.