Expert report published on patent governance of agricultural gene editing
Jocelyn Bosse
Expert report published on patent governance of agricultural gene editing
Jocelyn Bosse Monday, September 08, 2025 - agriculture, european union, GMO directive, Jocelyn Bosse, new genomic techniques, plant patents, plant varieties, Ukraine, United Kingdom
Following a workshop in London back in June, a report has now been published on patent governance of gene editing in agriculture. The participants included legal experts, policy advisors, IP practitioners, plant scientists, and regulatory officials (and also this Kat), who were brought together to discuss how patent policy could ensure that the use of gene editing techniques in agriculture contributes positively to global food security and environmental sustainability, with a focus on the UK, European Union, and Ukraine.
Photo by Andrea Mosti via Pexels.
The event was organised by Duncan Matthews and Hanna Ostapenko at Queen Mary University of London, with funding from the British Academy/Cara/Leverhulme Researchers at Risk Research Support Grants Scheme. The full report of the discussion has now been published here, thanks to the efforts of several PhD students who acted as rapporteurs at the meeting: Özlem Çorapçıoğlu, Luisa Herra, Gertrud Metsa, and Maciej Padamczyk.
This Kat thought readers might appreciate a short overview to highlight some of our key discussion points and conclusions from the report. The workshop was conducted under the Chatham House Rule and the full list of participants appears at the end of the report. The discussion was divided into three topics:
Recent developments in the EU and lessons for third countries
The regulatory approach to new genomic techniques (NGTs) varies across Europe. Following the CJEU decision that NGTs should be treated as genetically modified organisms (see IPKat here), there has been ongoing debate about a proposal for an EU Regulation on plants obtained by certain new genomic techniques (NGTs) and their food and feed. Patents have received considerable attention, leading to proposals ranging from the EU Parliament's patent ban (see IPKat here), to the Polish Presidency's revised approach of patent transparency measures (see IPKat here).
Meanwhile, the UK government pushed forward with England-only legislation to deregulate NGT plants (so-called "precision-bred organisms"), with no impact on the Patents Act. By contrast, Ukraine has pursued its policy of alignment with EU standards by amending its laws to mirror the current EU approach: treating NGTs as genetically modified organisms.
Reflecting on the proposed EU provisions, workshop participants recognised that transparency is an important goal, but it is not easy to achieve. There are ongoing discussions about the methodology for undertaking patent landscaping studies, which means that statistics may not be reliable; for example, there needs to be clarity about whether pending applications, or only granted patents, should be counted. Participants noted that this might have knock-on effects for Category 1 NGT plants and lead to unintended confusion, since marketing authorities may lack awareness of a patent's status while making critical regulatory decisions.
Participants also expressed concerns that the mere declaratory character of the transparency provisions carries a risk of undermining existing measures against patent mismarking (in the case of a false declaration) and forfeiture (in the case of a missing declaration).
A recurring point during the workshop was that the US and China are also significant countries in terms of patent ownership for NGTs, and patent policy should not encourage the NGT sector to shift outside Europe (as occurred with GMOs). Workshop participants noted that those countries that lead in innovation will also hold greater leverage in shaping market regulations globally. Therefore, the EU would not be the only influence on Ukraine.
However, what works for the EU, China, or the US may not align with the interests or needs in other national contexts, so Ukraine and other countries would need to pursue balanced regulatory approaches that consider the interests of all stakeholders, including smaller scale actors in the agricultural sector.
Patents, innovation and the precautionary principle
The precautionary principle is of particular importance for EU law. Participants considered that EPC art 53(a), i.e. the ‘ordre public’ or morality exception, is broad enough to incorporate the precautionary principle. However, it is an ambiguous and broadly stated legal concept, and participants noted that it might be understood as shifting the burden of proof from the EPO Examining Division to the inventor to prove that their invention is safe.
As a practical matter, participants also noted that patent applications are often filed at such an early stage of the innovation life cycle - without a commercialised product on the market to evaluate - that it would be incredibly difficult to predict the full spectrum of a technology's risks and benefits anyway.
The role of licensing and patent pools
Workshop participants highlighted that, while licensing can in principle facilitate access to innovation, the actual application of this policy mechanism often remains hampered by bureaucratic hurdles, a general lack of awareness among stakeholders, and the practical difficulty of reconciling divergent interests.
A recurring concern was the lack of transparency in licensing arrangements. Some participants highlighted the need to maintain confidentiality on the grounds that licences are commercial agreements. Other workshop participants suggested increased government intervention to declare certain technologies as essential and to require open or public interest licensing, and also potentially using compulsory licensing.
There are also compulsory cross-licensing measures for patents and plant variety rights in Article 12 of the Biotech Directive, but participants could not identify any real-life instances of these provisions being used in practice. Therefore, participants had serious doubts that this would be an effective policy tool for improving access to NGTs.
Participants also discussed the topic of the breeder's exemption under patent law. A limited version already appears in the UPC Agreement and the national patent laws of Germany, France, the Netherlands, and Switzerland (which only covers breeding activities, and not commercialisation of a new variety). Some participants suggested that a full exemption (i.e. to include commercialisation of the variety) could be adopted to support innovation, while others were concerned that this might undermine the integrity of the patent system.
Final Thoughts
A few weeks after this workshop, the NGT trialogue talks arrived at the topic of patents, only for the Parliament to halt the talks altogether, as they refused to make concessions on labelling and excluding NGT plants from patentability. Denmark has now assumed the Presidency, and one of its goals is to bring the trilogue negotiations to a close. The matter remains politically fraught and, as this workshop highlighted, deeply complicated. We will see whether the Danish presidency is able to thread the needle and finalise the negotiations.
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