EU moves one step closer to gene editing regulation

In a vote earlier today, the EU reached an important milestone on the road to a new regulation for new genomic techniques (NGT) for plants. After some changes to the EU Parliament's proposed "patent ban", the member states' representatives endorsed the Council's negotiating mandate. The Polish Presidency can now start negotiations with the European Parliament on the final text of the regulation. 

Background

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New genomic techniques (NGTs) is a term used for gene editing tools (like CRISPR), by which the genome of a plant is modified at a selected targeted location (targeted mutagenesis) or a sequence from the same species or a closely related species is inserted (cisgenesis). 

The CJEU's ruling in Case C‑528/16 in 2018 found that NGTs were equally captured by the EU GMO Directive, even though the regulation was designed to regulate organisms produced by insertion of large sections of foreign DNA into an organism's genome (transgenics).

Since then, there has been pressure to change the rules for NGTs. The European Commission issued a proposal to relax the rules on gene-edited plants in 2023, which would treat plants produced by gene editing that do not contain genetic material from another plant species as equivalent to plants produced by traditional breeding methods. The proposal would create two categories of NGT plants which can be placed on the market:

• Category 1 NGT plants ("NGT1"): plants that could occur naturally or through conventional breeding methods. These would be exempted from the rules in the GMO legislation and would not be labelled, but seeds produced through those techniques would have to be labelled.
• Category 2 NGT plants ("NGT2"): all other NGT plants. The rules under GMO legislation would apply (including a risk assessment and authorisation before they are placed on the market). They would be labelled as such.

But in February 2024, the MEPs in the EU Parliament introduced amendments that would exclude from patentability all NGT plants, parts thereof, genetic information, and the process features they contain (see discussion in the IPKat here). This has been met with a lot of resistance, especially because the wording of the "patent ban" could have been interpreted as extending to the genetic tools used for targeted mutagenesis. It is one thing to argue that plant variety rights are the most suitable form of IP protection for NGT plants and that patents should not hinder breeders' access to varieties - it is another thing entirely to ban patents for the techniques themselves.

The New Text

The Polish Presidency suggested several changes that took account of the concerns about patenting, whilst moving away from the "patent ban" in the EU Parliament's proposed amendment. This text received a qualifying majority in a vote this morning, and can move forward to the negotiations with the EU Parliament ("trialogue").

The new text focuses on transparency of IP rights. Patents will no longer affect NGT1 status, but the relevant text on patenting includes the following conditions:

• If applying to register an NGT1 plant, companies or breeders must submit information on all existing or pending patents. The patent information must be included and kept up-to-date in a publicly available database set up by the Commission which lists all NGT1 plants, which aims to ensure transparency regarding NGT1 plants. 
• Companies or breeders can, on a voluntary basis, indicate the patent holder's willingness to licence the use of a patented NGT1 plant or product.
• The Council's mandate provides for the creation of an expert group on the effect of patents on NGT plants, with experts from all member states and the European Patent Office.
• One year after the entry into force of the regulation, the Commission will be required to publish a study on the impact of patenting on innovation, on the availability of seeds to farmers, and on the competitiveness of the EU plant breeding sector. The study will also have a special focus on how breeders can have access to patented NGT plants.

Many companies and breeders will see this relaxation of the exclusion from patentability as a welcome development. With examples of NGT plants developed in the UK like a non-browning banana and a blight-resistant variant of the 'Maris Piper' potato, there is a lot of hope that deregulation of NGTs would support the development of more sustainable varieties and promote food security. 

Hopefully the forthcoming EU negotiations will continue to take a balanced approach to address the complex needs of the plant breeding and agritech sectors.