By Rafael López. Head of Technology Transfer and Director of the PONS IP Office in Valencia
The fact that Dr Mojica had received numerous national honours since 2016 for his contributions to science in relation to CRISPR technology, a term he himself coined, had a huge impact. The fact that the 2020 Nobel Prize in Chemistry was awarded to Drs Carpentier and Doudna for their work, based on Dr Mojica’s findings, on the development of CRISPR-Cas9 technology for gene editing marked a turning point for the biological sciences. Although these developments foreshadowed a profound transformation across the biological sciences on a global scale, in both public and private research, the entry of the technology itself and the products derived from its application into the economic trade also raised an issue of unquestionable geostrategic significance.
Consequently, in order not to hinder the rapid progress driven by these technologies, a number of countries with significant influence in global trade began to adopt flexible regulatory frameworks for the marketing of products obtained through the application of new genomic techniques (NGTs): Argentina, the United States, Japan, Canada, the United Kingdom, Brazil, Chile, Australia… and, of course, China as well. Europe, however, has fallen behind, creating a gap that is beginning to show clearly in international indicators of innovation and plant variety protection.
In fact, according to data from the International Union for the Protection of New Varieties of Plants (UPOV), by 2023, China had already overtaken the EU in the number of applications for plant variety protection, with 16,184 applications compared to the EU’s 2,866. Similarly, the number of protected plant variety rights stood at 9,300 for China, while the EU had 2,718.
Furthermore, according to the excellent study published by the Swiss Federal Institute of Intellectual Property in August 2025, CRISPR Technology 2025: Patent & Licence landscape on Plants, of the 23,696 CRISPR-related patent families filed between 2001 and 2024, priority patent applications were filed mainly in the People’s Republic of China (11,965 – 50.50%) and in the United States (8,565 – 36.15%). The other countries appear to account for only small percentages, with European patents making up a negligible proportion (629 – 2.65%). Furthermore, another key point is that the majority of companies registering genome editing patents in Europe are not European, but from the United States.
Within China, leadership in patents almost entirely dominated by public and academic bodies, as only two private companies feature among the top 30 holders, and even then with much smaller portfolios. This predominance of public bodies in patent holdings shows that genome editing is a strategic priority for China and that its development is strongly backed by state investment. Outside China, however, large private agricultural multinationals predominate as patent holders.
If we focus on the development of plants produced using NGTs but not classified as transgenic, China once again leads the way, but by a landslide, accounting for almost 75% of all priority patent applications, while the United States comes a distant second, with Europe’s contribution being absolutely modest by comparison.
This pattern reveals a two-fold dependency: on the one hand, Europe is lagging behind in the development of patentable plant technology; on the other, its own market is becoming a venue for the commercialisation of plant innovations developed in third countries. The low level of intellectual property rights in Europe not only limits the ability to capture economic value, but also restricts the autonomy of its agri-food system, as it is subject to licences and business strategies determined outside its territory. In this context, the gap in intellectual property rights is not an isolated phenomenon, but rather a reflection of a less dynamic innovation ecosystem, where regulatory uncertainty and market fragmentation have acted as barriers to the development and protection of home-grown biotechnological advances.
These figures, which demonstrate the serious commitment of China and the United States to the protection of plants obtained through NGTs, demonstrates the flexibility these countries have shown in the commercialisation of such plants. Against this backdrop, it is entirely understandable that Europe has recently decided to relax the requirements for the commercialisation of plants produced using NGTs to enable plant breeders to produce and commercialise such material for the benefit of the agricultural sector and the general public. Essentially, it is a question of technological sovereignty.
The EU Council and Parliament reached a provisional agreement in December 2025 on a specific regulation for NGTs. In the EU’s proposed legislation, the concept of NGT primarily encompasses directed mutagenesis, as well as the insertion of genetic material derived from the same plant or from compatible plants (cisgenesis, including intragenesis), with classical transgenesis excluded from its scope, which would remain subject to the general regime applicable to genetically modified organisms (GMOs). On this basis, European lawmakers distinguish between NGT-1 plants, which are comparable to those that could be obtained naturally or through conventional plant breeding techniques, and NGT-2 plants, which are characterised by more complex genetic modifications and are therefore subject to a stricter legal regime, that of GMOs.
What is truly striking for the sector is the definition of NGT-1 plants, which Annex I of the Regulation defines—in the case of plants obtained through directed mutagenesis—essentially and clearly as those that may contain genetic modifications consisting of the substitution or insertion of up to twenty nucleotides or the deletion of any number of nucleotides.
There is a widespread view within the plant breeding sector, which relies on traditional methods of cross-breeding and selection, that patents on NGT-1 plants will restrict breeders’ access to developing new varieties. However, in this regard, the Agreement on the Unified Patent Court already established in 2013 that these rights did not extend to the use of biological material for the purposes of plant breeding, discovery or development (OJ C 175, 20.6.2013, p. 1, Article 27(c)).
NGT-1 plants meet the criteria set out in European patent law and are therefore not subject to the exclusions from patentability. Therefore, in Europe, patent protection for NGT-1 plants that meet the requirements for patentability seems inevitable, regardless of the nationality of the patent holder—whether China, the United States, or elsewhere.
To reassure those in the sector who are critical of patents, it should be noted that the final text of the aforementioned Regulation stipulates that the Commission must promote a code of conduct to ensure transparency in patent matters, fair licensing and the amicable resolution of disputes, particularly with SMEs and farmers. It is also provided that, in cases where patented plant material is present accidentally, the holders may choose not to exercise their rights. The aim is therefore to facilitate breeders’ access to patents on NGT-1 plants on fair and reasonable terms, while ensuring transparency regarding the granting of licences.
The Commission is also expected to set up an expert group on plant patents (NGT-1), which will be tasked with analysing the effects of the patent system on innovation, access to patented plant material and exploitation licences.
Furthermore, the claims of a patent for an NGT-1 must specify that they do not cover plants obtained by essentially biological processes, a point already clarified by the Commission several years ago (OJ C 411, 8 November 2016, p. 3, Communication from the European Commission on certain articles of Directive 98/44/EC on the legal protection of biotechnological inventions).
In view of all this, plant breeders—who provide society with plant material adapted to extreme environmental conditions and have access to a range of elite plant material—should urgently engage in dialogue with scientists who are knowledgeable about NGTs and plant genetics, of whom there are many excellent examples in Spain, in order to obtain NGT-1 plants swiftly without relinquishing intellectual property rights, which will give them a strong position in a situation such as this, which is unprecedented.
It is worth noting that a patent offers a form of protection that grants broader rights than a plant variety right, as a single patent covers the genetic modifications of a group of varieties—at least all those belonging to the same species.
There is a tendency to think that it is large companies that will secure this type of patent right and that they are the ones capable of hindering the development of other companies in the sector that are smaller and have fewer resources. However, the tools available to SMEs to address this possibility are precisely the same: the intellectual property rights they can themselves generate. This gives them access to an asset that may enable them to negotiate or obtain a compulsory licence. If a company does not hold a patent, it may find itself in a weaker negotiating position and be at the mercy of whether the requirements for proper and non-abusive exploitation set out in the aforementioned Regulation are met.
This is a crucial moment to prepare for the inevitable change that is already underway. A huge influx of projects is expected, the results of which will lead to the granting of patents and plant variety rights; the priority date of these will be crucial in securing an advantageous position in the event of a clash of interests with competitors. This is not a minor issue, but a strategic priority for the business’s long-term competitiveness. The race started a while ago. The geostrategic importance of intellectual property rights relating to the food provided by plants is enormous. In the current climate, China could well come to hold a position of significant influence within global agri-food supply chains, without even growing any crops in Europe. Therefore, Europe cannot afford to delay this new phase of plant innovation any longer. The ability to generate, protect and commercially exploit industrial property assets relating to NGT-1 plants will be a decisive factor in competitiveness, technological autonomy and agri-food resilience in the coming years.
