European Council adopts negotiating mandate on patents for gene-edited plants

The EU is seeking to embrace more flexibility in the regulation of gene-edited plants but progress on the legislation has been slow due, in part, to a controversial proposal by the European Parliament to ban patent rights for gene-edited plants.

The European Commission proposed a new regulation for gene-edited plants back in 2023 and, in adopting its negotiating position at the start of last year, the European Parliament proposed an amendment to ban patents for plants produced by new genomic techniques (NGTs).

Most recently, the European Council has agreed its negotiating mandate on the proposed regulation, which notably moves away from the Parliament's proposed patent ban, instead favouring increased transparency in relation to intellectual property (IP) rights concerning NGT plants.

The presidency of the Council can now start negotiations with the Parliament to agree the final text of the regulation. However, there may be a lot of road to travel before agreement is reached given the divergence of approaches to this issue.

Gene editing

NGTs refer to a wide range of techniques that alter the genetic material of a plant but which, crucially, do not involve the insertion of genetic material from another species. In the EU, at present, all plants obtained through NGTs are subject to the same rules as genetically modified organisms (GMOs).

The Commission proposed a less stringent approach to the regulation of plants produced by NGTs and products, food and feed containing or consisting of NGT plants. This proposal seeks to introduce two categories of NGT plants:

• Category 1 NGT plants (NGT1): plants that would be considered "equivalent" to conventional plants that could occur naturally or through conventional breeding methods. NGT1 plants would be subject to a simplified regulatory regime and approval process.
• Category 2 NGT plants (NGT2): all other NGT plants would fall into this category. NGT2 plants would be subject to the majority of GMO legislation, including an environmental risk assessment and authorisation procedure.

Proposed patent ban

In February 2024, the European Parliament introduced amendments to the Commission's proposal to exclude all NGT plants, parts thereof, genetic information and process features from patentability.

This proposal faced substantial resistance, particularly due to concerns that the "patent ban" could be interpreted broadly and extend to the genetic tools used for targeted mutagenesis.

While some argued that plant variety rights are more suitable for NGT plants and patents should not hinder breeders' access to varieties, banning patents for the gene editing techniques themselves was seen as highly controversial.

The Council's approach

The European Council has proposed several changes to address concerns about patenting and move away from the European Parliament's suggested "patent ban". This revised text received a qualifying majority vote and forms the Council's negotiating mandate, which allows the Council's presidency to proceed to negotiations with the Parliament. To assist discussions, a comparison of the Commission, Parliament and Council's proposals has been published.

The Council's new text emphasises transparency regarding IP rights and includes the following proposals:

• Patent information disclosure. Companies or breeders applying to register an NGT1 plant would be required to submit a declaration containing information on all existing or pending patents (to the best of their knowledge). This information would be included in a publicly available database set up by the Commission, listing all NGT1 plants to ensure transparency.
• Voluntary licensing indication. Companies or breeders would be able to voluntarily indicate the patent holder's willingness to license the use of a patented NGT1 plant or product.
• Expert group. The mandate provides for the creation of an expert group on the possible impact of patents on NGT plants, comprising experts from all EU Member States and the European Patent Office (EPO).
• Commission study. One year after the regulation's entry into force, the Commission would publish a study on the impact of patenting on innovation, seed availability for farmers, and the competitiveness of the EU plant breeding sector. The study would also focus on breeders' access to patented NGT plants.

These proposals seek to strike a more balanced approach. They aim to ensure that farmers and breeders have access to techniques and material to promote the diversity of plant reproductive material at affordable prices, while supporting innovation in plant breeding by preserving investment incentives.

The proposed amendments also refer to the EU Biotech Directive concerning the legal protection of biotechnological inventions and note that this sets out principles regarding the patentability of biological material including plants. The draft text also acknowledges that the Unified Patent Court Agreement provides that rights conferred by a patent shall not extend to the use of biological material for the purpose of breeding or discovering and developing other plant varieties.

These statements suggest that the Council's intention is to bring the EU's proposals in line with the usual EPO approach, which is also reflected in UK practice. Under this approach, plants and associated processes can be patented where they are not "exclusively obtained by means of an essentially biological process" and if the invention is not confined to a particular plant variety.

UK position

The UK has also been taking deregulatory steps with respect to gene-edited plants, but has been moving at a quicker pace than the EU. The Genetic Technology (Precision Breeding) Act 2023 has been enacted and regulations to bring into effect a new regulatory framework have been introduced to Parliament, although they will need to be approved by both the Commons and the Lords.

However, the Genetic Technology Act and the newly proposed regulations are silent on the IP position in the UK. Consequently, the current criteria for patentability is expected to continue to apply.

This assumption is consistent with the approach being taken to Plant Breeders’ Rights (PBRs) in the UK. These are distinct from patent rights and are a form of IP right over plant varieties in the UK that allow breeders to collect royalties from their protected varieties.

In a recently launched consultation by the Department for Environment, Food and Rural Affairs  entitled Plant Varieties and Seeds Framework for Precision Bred Plant Varieties, it confirmed that there are no proposed changes to the way in which PBRs are granted for precision bred varieties. Plant breeders will be able to apply for PBRs for precision bred plant varieties in the same way as for non-precision bred varieties.

Osborne Clarke comment

 The European Council's negotiating mandate represents a shift to a more balanced approach to patent rights for gene-edited plants, aiming to ensure transparency and to address concerns about the impact of patents on innovation and access.

As negotiations in the trialogue phase continue, stakeholders will be keenly watching the developments and their implications for the future of agri-tech in the EU. How quickly an agreed approach will be achieved remains to be seen.