New update October 2025
In March 2025, the EU Council’s Committee of Permanent Representatives approved a proposal to begin negotiations on new rules for regulating plants produced using new genomic techniques (NGTs). Crucially, the latest Council proposal removes the earlier plan to ban patents for Class I NGT plants (those which could occur naturally or through conventional breeding methods).
This is of importance to plant breeders, seed companies, agriscience and biotech businesses, farmers, researchers, and IP owners across the EU.
What has changed?
As reported previously (original article dated February 2024 below), the EU had adopted a new legislative proposal relating to plant products obtained by new genomic techniques (NGTs) that do not contain any foreign DNA and which could also be obtained by conventional breeding techniques, including random mutagenesis (so-called Class I NGT products), which could be determined as not falling under the existing EU GMO legislation.
All other NGT products (Class II NGT products) would remain regulated as GMO’s as decided by the Court of Justice of the European Union, in its judgement C-528/16.
The new Regulation was intended to provide a framework for deliberate release and marketing of plants obtained by NGTs, such as gene editing, rather than conventional breeding techniques. The legislative proposal included a prohibition on patents for NGT plants and for any plants obtained by random mutagenesis, for methods of obtaining these plants, as well as genomic information and any products derived from such plants or genetic material.
In an update during the Belgian presidency of the Council of the EU, a compromise text was discussed which limited the ban on patenting of NGT plants to those plants falling under Class I NGT products (see update of June 2024 below). However, no agreement was reached at that stage.
Enter the Polish Presidency of the EU Council along with several suggestions for amendments and compromises to the text. In March 2025 the Committee of Permanent Representatives approved the latest proposal from the EU Council which now allows the start of negotiations between the Council of the EU, the European Commission and the European Parliament, with the goal to arrive at a final text for the Regulation.
New transparency obligations for Class I NGT plants
The newly agreed proposal has removed the proposed ban on patents covering Class I NGT products and states that the existence of one or more patents covering the plant will no longer affect Class I NGT status. Instead, it provides measures to increase transparency regarding patents relating to NGT plants, including:
- Public database disclosure: Information on all existing or pending patents relating to the NGT plant must be submitted (and kept up to date) to a public database of Class I NGT plants run by the Commission when applying to register a Class I NGT plant.
- Licensing indication: On a voluntary basis, the plant holder can indicate the patent holder’s willingness to issue licenses for the use of a patented Class I NGT plant or product.
- Expert group formation: The proposal provides for the creation of an expert group on the effect of patents on NGT plants, with experts from member states and the European Patent Office.
- Study commissioned: The Commission is mandated 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 is proposed to include a special focus on how breeders can access patented NGT plants.
Plant breeders and agriscience companies may be breathing a sigh of relief that there will be no ban on NGT plant patents. However, they will instead have to list plant patents when registering a Class I NGT plant. The promise of a study regarding breeder access to patented NGT plants could provide interest for stakeholders across the EU and the wider world where NGT plants are becoming more important, both economically and for food security, in the face of plant disease and a changing climate.
Article updated by Richard Maclennan.
June 2024 update – EU Plant Patents ban – compromise proposed but no agreement
We recently reported on a proposal by the EU Parliament for a blanket ban on patents for all plants obtained by new genomics techniques (NGTs). The proposal has proved highly controversial and prompted fears it could reduce innovation. The EU Parliament indicated that NGT plants should instead be subject to the Community Plant Variety Rights (CPVR) system but there are concerns that plant variety rights would not provide adequate protection for NGT plants.
Seeking to unlock the current stalemate the Belgian presidency of the EU council proposed a compromise text discussed on 22 and 23 May. The compromise concerned limiting the ban on patenting to plants falling under the NGT1 classification only or alternatively requiring the patent holder to “not exercise their rights”. NGT1 plants are considered “equivalent” to conventional plants and must differ from a recipient/parent plant by no more than 20 genetic modifications. The NGT plants with more genetic differences, so-called NGT2 plants, would theoretically still remain patentable under this proposal. Presumably this was considered a compromise between ensuring legal certainty and affordability for farmers and plant breeders whilst not deterring large multinationals investing in plant innovation in the EU.
However, agreement could not be reached on the compromise text and the current Belgian Presidency which lasts until 30th June 2024 has stated that they will continue to search for a solution which can be approved. We will continue to monitor the situation for a potential breakthrough.
Article updated by Alice Smart.
Original article
Can you get patent protection for a new engineered plant? As long as the plant is not produced by essentially biological processes then yes. However, change might be on the way. In this article we discuss the proposed EU regulation for the release of plants produced by new genomic technologies, and specifically how this regulation might affect the previously established Biotech Patent Directive and the protection available for new plants.
Prior to 01 July 2017 patents for products and plants formed by “essentially biological processes” were patentable, as confirmed by European Patent Office (EPO) appeal decisions G2/13 and G2/12 of March 2015 (commonly referred to as “Tomatoes II” and “Broccoli II”). However, the European Parliament then stated that this was not the intention of the Biotech Patent Directive 98/44/EC, and that the directive was intended to exclude from patentability those products and plants that are obtained by means of essentially biological processes. A subsequent EPO Board of Appeal decision (G3/19 “Pepper”) confirmed that products obtained by essentially biological processes are not patentable in Europe, a more detailed review can be found here.
Agritech and patent practitioners are used to taking these provisions into account when drafting patent specifications, and discussing IP strategy, over the last few years. Industry and patent practitioners reasoned that the debate had been settled for the time being, but the European Parliament has other ideas.
Recently, the European Parliament voted on the first reading of a new draft R regulation for plants produced by certain “New Genomic Technologies (NGT)”. The proposal by the European Commission aims to provide a framework for the deliberate release of NGT plants, and the marketing of products such as food and feed derived from NGT plants.
As part of the proposal, amendments to the Biotech Patent Directive have been suggested which include excluding from patentability all NGT plants (plants obtained by new genomics techniques such as targeted mutagenesis and cisgenesis) as well as plants obtained by random mutagenesis or cell fusion. The exclusion would extend to plant parts, and plant material thereof, as well as to genetic information and process features found in such plants. In addition, the exclusion would include biological material possessing the same characteristics as a patented plant but which is obtained independently of the patented plant and also to biological material obtained from such material through propagation or multiplication. This exclusion is in addition to the current exclusion of products and plants obtained by means of essentially biological processes.
The proposed exclusion to patentability as a consequence of amendments to the Biotech Patent Directive could affect European patents granted after the date of entry into force of the amendments. The European Patent Convention (EPC) specifically refers to the Biotech Patent Directive (Rule 26 EPC) and the amendments would presumably be adopted by the European Patent Office (EPO) which would cause the proposed exclusions to affect European patents.
According to the European Commission Committee on Environment, Public Health and Food Safety (ENVI), the amendments and exclusions to patentability have been proposed because “allowing for new genomic techniques and their results to be patented risks giving multinational seed companies even more power over farmers’ access to seeds” and that “in a context where large companies already have a monopoly on seeds and increasingly control natural resources, this would deprive farmers of all freedom of action by making them dependent on private companies“.
It should be recognised that current patent protection for plants is limited by a general research exemption and by plant breeders’ exemptions implemented by many EU Member States, EPC Contracting States and the new Unitary Patent system. For example, the UK Patents Act 1977 makes it clear that farmers are permitted to propagate and multiply seeds that result from their own harvest if the original seeds were obtained from the patent proprietor for the purposes of agriculture without the risk of infringing the proprietor’s patent. This exclusion to infringement is an attempt to balance the need for innovation in the field of agriculture often carried out using large investments in R&D expenditure with the needs of farmers and food security of the UK.
Since the proposed amendments are to the Biotech Patent Directive it is not expected that there would be any impact on Plant Variety Rights (PVRs) which are another form of intellectual property available in Europe and the UK. It is therefore possible that if the amendments to the Biotech Patent Directive are adopted PVRs may become an increasingly important way of protecting intellectual property relating to plants. Further information regarding the plant variety system can be found here, and in our recent podcast.
Whether or not the European Parliament incorporate the amendments to the Biotech Patent Directive, there is sure to be extensive lobbying both for and against these proposed amendments, we will be keeping an eye on any developments in the following months and years.
