06/11/2026
New genomic techniques (NGTs), including targeted mutagenesis and cisgenesis, are techniques that, compared to traditional genetic modification approaches, allow for targeted modifications at precise positions in the genome.
There is a need to ensure that plants produced by NGTs are appropriately regulated and protected by intellectual property (IP), in a way that does not stifle innovation.
Patentability of NGT plants at the European Patent Office (EPO) and the UK Intellectual Property Office (UKIPO)
The European Patent Convention (EPC) stipulates that plant varieties or essentially biological processes for the production of plants are excluded from patentability, but that the exclusion doesn’t encompass microbiological processes for the production of plants or the resultant products (Article 53(b) EPC).
Whilst plants bred by conventional breeding methods are not patentable, transgenic plants are patentable, as well as plants generated by targeted mutation (such as using CRIPSR technology), or random mutagenesis (EPO Guidelines for Examination, G-II, 5.4). It therefore follows that most NGT plants will be patentable.
The UKIPO adopts a similar approach to the EPO.
New legislation in the European Union (EU) for NGT plants
Regulation (EU) 2026/1388 entered into force on 16th July 2026 and establishes two types of NGT plants:
- Category 1 NGT plants – These are plants obtained by NGTs that comprise genetic modifications that could have occurred naturally or through conventional breeding methods. Category 1 NGT plants are associated with fewer safety concerns than traditional genetic modification approaches and are exempt from genetically modified organism (GMO) legislation.
- Category 2 NGT plants – These are plants obtained by NGTs that comprise more complex genetic modifications as well as plants that have been engineered to be herbicide resistant or produce insecticides. Category 2 NGT plants are subject to GMO legislation.
Earlier EU legislative proposals had suggested excluding NGT plants from patentability. However, the legislation that has entered into force is less restrictive and is largely focused on increasing transparency.
The first IP-related provision in Regulation (EU) 2026/1388 relates to category 1 NGT plants. In the verification procedure prior to placing category 1 NGT plants on the market or otherwise releasing the plants, the applicant needs to provide details of relevant patents or published patent applications. At the same time, the applicant can choose to indicate that they are willing to license the IP under fair and reasonable conditions (Articles 6 & 7, Regulation (EU) 2026/1388).
Secondly, the European Commission will draw up a code of conduct to “enhance the transparency of information relating to patents on plant biological material to facilitate breeders’ access to such material and to enhance legal certainty for breeders and farmers” (Article 30, Regulation (EU) 2026/1388).
Thirdly, an ‘expert group’ will be established that will look at the effect of patenting of NGT plants and the European Commission will regularly assess the impact of such patenting on innovation, breeders’ and farmers’ access to material, the risk of litigation, competition, transparency and legal certainty (Article 31, Regulation (EU) 2026/1388).
The situation in the UK
The corresponding UK legislation, the Genetic Technology (Precision Breeding) Act 2023 and The Genetic Technology (Precision Breeding) Regulations 2025 concern precision bred organisms. There is overlap between precision bred and NGT organisms: every genomic feature of a precision bred organism that results from the application of modern biotechnology “could have resulted from traditional processes, whether or not in conjunction with selection techniques, alone” (Section 1(2)(c), Genetic Technology (Precision Breeding) Act 2023). This legislation aims to streamline regulatory approval for precision bred plants, removing them from the regulatory system for GMOs. However, the legislation is silent on patentability.
Conclusions
Regulation (EU) 2026/1388 hasn’t disrupted the status quo with respect to the patentability of NGT plants, which will be a great relief to innovators. However, the EU clearly wants to ensure that the patent system does not have adverse effects on breeders and famers, and it is implementing systems to guarantee that this is not the case. Arguably, Regulation (EU) 2026/1388 hasn’t closed the case on the patentability of NGT plants but may pave the way for legislative changes in the future.
Whilst the EPO is not an EU institution (there are 40 EPC contracting states including 13 non-EU states, such as the UK), based on past experience with the EPO, any changes in EU law relating to patentability of NGT plants will likely be implemented into the EPC.
This content is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.
