On 17 June 2026, after nearly two and a half years of debates, compromises and back-and-forth discussions between the European institutions, the European Parliament finally adopted the regulation on plants obtained through “new genomic techniques”, known as “NGTs”. NGTs make it possible to modify the genome of plants in a targeted manner, without necessarily introducing foreign DNA.
Although, ultimately, plants obtained through NGTs may sometimes be impossible to distinguish from conventional plants, their placing on the market was governed by the very burdensome framework of Directive 2001/18 on GMOs, involving a lengthy and demanding process of risk assessment, traceability and labelling. These constraints were hardly compatible with the rapid dissemination of varietal innovations, thereby limiting the use of genome-editing techniques in this field.
The newly adopted regulation creates a category of NGT plants known as category 1 (“NGT1”), which will no longer be subject to this GMO regime. These plants will benefit from faster market access, provided that they contain a limited number of genetic modifications[1] — no more than 20.
The expected impact is far from marginal. According to the study by Bohle et al.[2], 94% of NGT applications in agriculture would have fallen, in 2024, within the NGT1 category. In other words, the regulation would facilitate access to the European market for the vast majority of edited plants.
Another important point: the European Parliament ultimately refused to give in to supporters of a “patent ban”. The regulation as finally adopted therefore maintains the possibility of protecting all NGT plants by patent, even where they will now be treated, from a regulatory standpoint, as conventional plants.
Patentability of Plants Obtained by Targeted Editing
Under European patent law, plants and plant material obtained exclusively by “conventional” essentially biological processes are excluded from patentability (Article 53(b) EPC, Rule 28(2) EPC).
This conventional approach to plant breeding typically includes crossing, hybridisation, backcrossing, introgression through successive crossings, self-fertilisation followed by selection, mass selection, pedigree selection, recurrent selection, or marker-assisted selection where this is used solely to identify the desired progeny without directly modifying their genome (Guidelines for Examination in the EPO, G-II, 5.4.2.).
New genome-editing techniques shift this practical boundary, since modifications that could be obtained by conventional selection can now be introduced in a targeted manner through genetic engineering. The techniques concerned include, in particular, programmable nucleases such as CRISPR/Cas, TALENs or zinc-finger nucleases, oligonucleotide-directed mutagenesis, base editing, prime editing, as well as certain forms of cisgenesis or intragenesis depending on the nature of the modification introduced.
It is precisely this technical step that matters under patent law: where the genomic characteristic present in the plant results from such targeted technical intervention, the plant escapes the exclusion covering products obtained exclusively by essentially biological processes. However, if the claimed mutation may also result from an essentially biological process, the claim will have to be drafted so as to explicitly exclude plants obtained exclusively by such a process.
The European Choice: Transparency Rather Than Exclusion from Patentability
In early 2024, the European Parliament had proposed prohibiting the patentability of NGT1 plants, in order to avoid plants comparable to natural or conventional plants being subject to exclusive rights.
The risks put forward included market concentration, legal uncertainty and increased dependence of breeders on patent portfolios. The plant variety rights system, which is less restrictive for breeders, was presented as sufficient to protect plants developed by breeders.
The Council of the European Union adopted a different approach. Rather than a general prohibition on patentability, it proposed the introduction of transparency principles (see section III below).
On 17 June 2026, the European Parliament finally approved this compromise. Last-minute amendments seeking to reopen the debate on an exclusion from patentability were rejected.
New Transparency Obligations
The maintenance of patentability for NGT1 plants is accompanied by specific transparency obligations.
When a company applies for recognition of “NGT1” status, it will have to provide information on published patents or patent applications containing claims directed to the biological material of the plant concerned and of which it is aware, or declare the absence of any such known rights.
If patents or patent applications exist, the company will also have to indicate whether the holder is willing to grant licences on fair and reasonable terms, and whether it is, or intends to become, a member of relevant licensing platforms. However, this information will have declaratory value only and will not be a condition for classification in the “NGT1” category.
This information will be integrated into a public database.
The Commission will also have to publish guidance on intellectual property rights applicable to plants, including licensing platforms, bodies assisting breeders, databases enabling applicable rights to be identified, as well as the basic principles of patent law and compulsory cross-licensing.
The text also provides for a European code of conduct on patents relating to plant biological material, as well as an expert group responsible for assessing the impact of patenting NGT plants on innovation, breeders’ access to plant material, farmers’ access to seeds, litigation risks, competition and transparency.
Finally, the Commission will have to assess the impact of maintaining patentability for NGT1 plants within one year of the regulation’s entry into force. If this assessment reveals significant obstacles to access to patented plant material, or negative effects on innovation, competition or farmers, it may propose additional measures, including legislative measures. Failing this, a further assessment will take place subsequently, within a period of 4 to 6 years.
What About NGT2?
In parallel with NGT1, the regulation creates a second category of plants: category 2 NGT plants (“NGT2”).
The NGT2 category will cover plants with more complex modifications, exceeding the regulatory threshold applicable to NGT1, but also certain plants bearing traits expressly excluded from the NGT1 category, including herbicide tolerance or the production of known insecticidal substances.
NGT2 plants will remain subject to the European legislation applicable to GMOs: prior authorisation, risk assessment, traceability and mandatory labelling. Member States will also retain some discretion to restrict or prohibit their cultivation on their territory, as well as to adopt coexistence measures intended to avoid their accidental presence in other productions.
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After several years during which regulatory risk had slowed the development of edited plants for the European market, the NGT regulation could therefore restore commercial interest in genome-editing programmes in agriculture.
Thanks to the maintenance of patentability for plants resulting from targeted genomic intervention, the economic impact of this new regulation should be considerable for breeders, seed companies and players in plant biotechnology.
The timetable must nevertheless be kept in mind. The newly adopted regulation will enter into force twenty days after its publication in the Official Journal of the European Union, but most of its provisions will apply in the EU Member States only after a transitional period of 24 months, i.e. in practice during 2028.
[1] The regulation also provides for qualitative exclusions: a herbicide-tolerant plant or a plant producing a known insecticidal substance will fall within the NGT2 category, even if it otherwise complies with the quantitative threshold applicable to NGT1.
[2] BohleF,SchneiderR,MundorfJ,ZühlL,SimonS and Engelhard M (2024), Where does the EU path on new genomic techniques lead us? Front. Genome Ed. 6:1377117. doi: 10.3389/fgeed.2024.1377117
June 2026
Contributing author
