- with readers working within the Insurance and Construction & Engineering industries
The European Union’s new regulatory framework for plants obtained through certain New Genomic Techniques (NGTs) enters into force today, 16 July 2026.
Regulation (EU) 2026/1388 was published in the Official Journal on 26 June 2026. Most of its provisions will apply from 17 July 2028, giving regulators and businesses two years to prepare for the new regime.
As discussed in our previous news item on the European Parliament’s approval of the Regulation, the framework divides NGT plants into two categories.
NGT1 plants are those meeting defined criteria intended to identify genetic changes that could have arisen naturally or through conventional breeding. Once verified, they will generally be treated in the same way as conventionally bred plants and will fall outside the EU genetically modified organism (GMO) regime. Plants with herbicide-tolerance traits or traits supporting the production of a known insecticidal substance cannot qualify as NGT1 plants.
NGT2 plants will remain subject to GMO-style risk assessment and authorisation requirements.
Patent protection remains available
The Regulation does not exclude NGT plants from patent protection. Patentability will continue to be determined under the European Patent Convention. However, the Regulation introduces greater transparency around patents and licensing. Applicants seeking verification of an NGT1 plant must, to the best of their knowledge, identify relevant patents and published patent applications. This information will be included in a public database.
The Regulation also provides for monitoring of the effects of patents and licensing practices on innovation, access to plant genetic material and competitiveness within the plant-breeding sector.
Preparing for implementation
Plant breeders and agricultural biotechnology businesses should use the implementation period to assess how their products are likely to be classified, identify relevant patent rights and prepare for the new verification, disclosure and labelling requirements.
Regulatory and patent strategies should be considered together. An NGT plant’s regulatory classification affects its route to market but does not determine whether it is patentable.
To mark the Regulation’s entry into force, we have published a new briefing, Patenting plants in Europe and the UK. The briefing examines which plant-related inventions remain patentable, effective claim-drafting strategies, the relationship between patents and Plant Variety Rights, and the regulatory frameworks for gene-edited plants in the EU and the UK.
J A Kemp LLP acts for clients in the USA, Europe and globally, advising on UK and European patent practice and representing them before the European Patent Office, UKIPO and Unified Patent Court. We have in-depth expertise in a wide range of technologies, including Biotech and Life Sciences, Pharmaceuticals, Software and IT, Chemistry, Electronics and Engineering and many others. See our website to find out more.
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