In a regulatory framework for new genomic techniques that is still open, the regulation of intellectual property between exclusive rights for new plant varieties, process patents and access rights to technologies is one of the key issues. Our Giulia Tatangelo and Valentina Predazzi, with Federico Caruso of SIB LEX, delve into the complexities of this topic in an article that sums up the main insights that emerged from the “Agrobio Next Gen and Protection – Tribute to Stefano Borrini” conference we organised in Rome in November 2025, but also considers a subsequent important development in EU legislation.

The current European regulatory framework relating to new genomic techniques (NGTs) is undergoing a thorough review. The ruling of the Court of Justice of the European Union in “Confédération paysanne” (C-528/16), which made GMO legislation (and the stringent restrictions provided for by that legislation) applicable also to plants obtained through genome editing techniques, has clearly highlighted the inadequacy of the current regime.

This finding was formalised in the Commission’s 2019 Study, which highlighted that the current GMO legislation is not structured to operate adequately on new genomic techniques, paving the way for the need for an ad hoc legislative proposal, a true lex specialis dedicated to NGTs.

It was the start of an update process aimed at distinguishing between NGT1 organisms, obtained through specific genetic modifications and considered equivalent to those obtained using conventional techniques, and NGT2 organisms, which undergo more complex editing procedures and will continue to be classified as GMOs and to be subject to the relevant rules.

From the developments in 2019 (Council Decision 2019/1904 and related ‘Study on new genomic techniques’) to the proposed regulation of 2023, up to the most recent political developments, the picture remains unclear: the trilogue between Parliament, Council and Commission on 3 December ended positively with a provisional agreement on a regulation establishing a criterion of equivalence between NGTs and ‘conventional’ plants, reducing the labelling requirements originally envisaged and, above all, allowing patent protection on NGTs, in return for the introduction of mechanisms aiming to balance exclusive rights with the need for access to patented technologies and products.

However, the legislative process continues… Download the full article in English (free)

This article was originally published in Italian by Rivista di Frutticoltura, issue 8 of December 2025, in a special feature on Genetic Improvement which includes contributions by several prominent experts on plant variety protection and use of NGTs. The full special feature (in Italian only) can be purchased through the magazine’s website.

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