EU Parliament rejects last-minute patent amendments and passes NGT Regulation

A long saga is finally coming to a close in the EU. Earlier today, the European Parliament passed the text of the proposed regulation on new genomic techniques (NGTs) that would exempt certain plants obtained using NGTs from the obligations under the regulation on genetically modified organisms (GMOs). Notably, this meant that the Parliament rejected the last-minute proposed amendments that would have reignited the debate about patents.

The adopted text

Image by Sandra Kapella from Pixabay.

The negotiation of this proposed regulation began after a CJEU decision in 2018, which found that plants developed using genome editing tools were captured by the GMO Regulation and all the strict requirements that entails. The aim was to develop a regulation that would instead treat plants produced by gene editing that do not contain genetic material from another plant species as equivalent to plants produced by traditional breeding methods. These negotiations became especially interesting for IPKat readers when the EU Parliament voted in early 2024 to introduce amendments that would exclude gene edited plants from patentability (see PatKat here).

Over the last two years, the negotiations landed on a compromise text (see IPKat here) that removed the "patent ban" and instead adopted a suite of patent transparency requirements, a requirement to declare whether the holders of patents identified above are willing to "licence the protected subject matter under fair and reasonable conditions in all Member States where the patent holder is entitled to grant such a licence." 

The text also requires the Commission to:

• establish an "expert group" on the effect of patents on NGT plants;
• within a year of the entry into force of the Regulation, conduct an assessment of the impact that the patenting of NGT plants, traits and techniques as well as related licensing and transparency practices; and,
• if the assessment reveals significant barriers caused by patents, then the Commission shall, where appropriate, submit legislative proposals to set up mandatory conditions or safeguards. Otherwise, the Commission shall conduct another assessment after 4-6 years.

The proposed patent amendments

There were concerns that the NGT Regulation would not pass when MEPs from several parties tabled amendments that aimed to restrict the patentability of NGT plants (as well as to impose more labelling requirements). The amendments were tabled in the weeks leading up to the Parliament's vote and largely sought to reinstate the amendments that were first proposed in 2024 but subsequently rejected. However, they caused serious alarm because the amendments threatened to delay the adoption of the proposed regulation by sending them back to the negotiating table. 

The amendments needed an absolute majority to pass but failed to meet this threshold. The text adopted at the end of 2025 has now passed. Rapporteur Jessica Polfjärd (EPP, Sweden) said: "By approving the use of NGT, we have chosen innovation, competitiveness and food security. European farmers have long been calling for access to these modern breeding tools. ... By making these safe, science-based breeding technologies available, Parliament is benefiting European farmers, safeguarding our food security and building a more competitive and innovative Europe."

Where to from here?

It will be about two years before the new regulation is fully implemented, so the wait is not yet over. However, the news is still being well-received by the companies that plan to commercialise NGT plants in the European Union.

Meanwhile, the deregulation of NGTs in England (known as "precision breeding") has faced a major setback after the High Court granted leave to claim judicial review of the Genetic Technology (Precision Breeding) Regulations 2025 earlier this month in Beyond GM v Secretary of State for Environment, Food and Rural Affairs [2026] EWHC 1306 (Admin). Mr Justice Johnson rejected three of the grounds for review, but determined that the substantive claim for review could proceed on the ground of irrationality (including breach of duty to make adequate enquiries).

The Minister's decision to "press on" with the Regulation last year - even though it "put the regulatory regime in England out of kilter with the rest of the United Kingdom and the European Union" - was understandable because it gave England a "first mover competitive advantage" in plant genome editing. However, the irrationality of the Minister's decision not to introduce mandatory labelling arose because it was made under the misapprehension that his powers to mandate labelling arose only under the Plant Varieties and Seeds Act 1964 and extended only to seeds (for more on seed marketing, see IPKat here). He did not know (because he had been wrongly advised) that he had powers under the Genetic Technology (Precision Breeding) Act 2023 to mandate labelling for all precision-bred organisms that are placed on the market.

We will need to await the outcome of the judicial review. But this is not the only source of uncertainty for precision breeding the UK: with the ongoing negotiations of the UK-EU Sanitary and Phytosanitary (SPS) Agreement, there are questions about whether the deal might introduce "dynamic alignment" between the precision breeding and NGT regulatory regimes, including the EU's new rules on patent transparency. More to come...