European Commission publishes study on IP and agricultural biotechnology
Jocelyn Bosse
European Commission publishes study on IP and agricultural biotechnology
Jocelyn Bosse Wednesday, December 03, 2025 - agriculture, Jocelyn Bosse, new genomic techniques, patents, plant varieties, trade secrets
To keep us entertained while we wait on an outcome from the EU trialogue negotiations on the proposed NGT regulation, the European Commission published its "NGT patent study" yesterday. In 2023, the Commission requested an evidence-based analysis of how patents related to new genomic techniques (NGTs) affect innovation in plant breeding, as well as breeders' access to genetic material and availability of seeds to farmers.
The report is 149 pages long, but as always, this Kat is happy to summarise the key points for readers. It provides a helpful overview of the legal situation and the perspectives from the industry.
The study tried to sniff out how IP for NGTs is affecting the breeders in Europe. Image by Scarlett1991 via Pixabay.
Background
The study was led by the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW), and was conducted by consultants, Technopolis Group. More information here.
The EU is the second-largest seed market in the world, and EU research represents about 12% of global activity on NGT traits. While much of the public criticism of plant IP rights tends to focus on the strategy of large, multinational seed conglomerates - especially agro-chemical companies like Monsanto - the report emphasises that many breeding companies in Europe are quite specialised and structurally diverse, with numerous small or medium-sized, independent, family-owned, or cooperative firms amongst the major IP holders.
The report also highlights that breeding is very research intensive, with R&D expenditure averaging 16% of turnover. The crux of the issue is that:
“Patents reward research and attract private investment; Plant Variety Rights (PVRs) safeguard accessibility and diversity. The real challenge lies in maintaining this equilibrium in a changing technological and economic landscape.”
Patents
The research environment has changed over time, with new breeding tools and techniques as well as new players: the emergence of NGTs has also led to more academic spin-offs and start-ups in the industry. For these companies especially, patents are important for reasons beyond enforcement; for instance, they are helpful for negotiating partnerships and attracting external funding (such as venture capital). When it comes to measuring the impact of patents on innovation, the report acknowledges that the empirical evidence in plant breeding is "thin," which makes it hard to evaluate the concerns about potential negative effects of patents.
The report considers the EPO statistics from 2024, which illustrate their strict examination standards: 51% of European patent applications in 1982-2024 for genetically modified plants (including patents on breeding tools) were withdrawn or refused, with 36.4% granted (some others are still pending). So far, there has been a much lower number of patent applications relating to "conventional" plants. The report also highlights that patent applications in the field of biotechnology - which includes plant breeding - have the lowest share of grants (21.8%) of any field of technology. Overall, there hasn't necessarily been a "surge" of patents for NGTs in Europe, although patenting is likely to increase if NGTs are deregulated.
However, many of the foundational technologies for NGTs are patented, such as the CRISPR/Cas patent complex. The landscape is dominated by patent holders from China and the US, who may not understand the European breeding model, which can make it a challenge for breeders to obtain licences. Companies from those jurisdictions rely on different IP strategies: for example, in the US, utility patents for plant varieties have overtaken use of PVRs (a massive shift from the 1990s) and there are more overlapping rights. As this Kat has discussed elsewhere, the overlapping rights in the US can have negative effects on innovation and competition. Plant IP litigation is also more common in the US than in the EU and UK (although the report notes there is an ongoing PVR case in the UK that went to trial last week and was previously discussed by this Kat here).
Plant Variety Rights
The study notes that "interviewees highlights the positive nature of the plant variety rights system," including the breeder's exemption (see this Kat's discussion of this topic here). They also note that PVRs are less costly than patents and they are well-understood by breeders. The statistics continue to show that Dutch, French, and German applicants dominate the Community PVR applications. The report notes that China now dominates the international PVR filings. China has also seen stronger PVR enforcement, with a number of high-profile infringement cases (the report cites this Kat's coverage of several recent cases here and here).
In the context of NGTs, some interviewees flagged concerns that certain NGT-derived traits may not be included on the defined lists of phenotypic characteristics for DUS testing - which is relevant for both PVRs and seed marketing approvals - so changes to the test guidelines might be needed.
Trade Secrets
The report notes that plant breeders may use trade secrets, although the trait might be disclosed once the variety is commercially released. Nevertheless, trade secrets may remain useful where the variety involves complex traits that would be more difficult to breed into new varieties without access to other information (i.e., markers). This can undermine follow-on innovation.
Trade Marks
Finally, the report acknowledges the role of trade marks in the plant breeding sector (for more detail, see this Kat's discussion of the topic here and here).
Bringing Balance to the IP System
In Europe, the efforts to ensure balanced protection for plant innovation has been fraught with controversy. The report acknowledges several existing measures in the Biotech Directive, EPO rules, and some national patent laws, such as the breeder's exemption or the exemptions in Austria and Germany for materials obtained "accidentally or in a technically unavoidable manner" - that is, from natural cross-pollination.
The complexity of the patent landscape was a key concern because it could hamper breeding programmes. Freedom-to-operate analysis can add to breeders' operational costs without a corresponding improvement in the breeding results - which has been helped, but not resolved, by the voluntary transparency databases that have cropped up over the years. Some expressed concerns that patents might facilitate higher concentration of the seed market to fewer dominant players, with knock-on effects for the diversity of available varieties. The report notes that "Even a moderate rise in NGT patents could shift the balance and increase the bargaining power of large companies," but most of the experts took the view that access to germplasm collections is bigger a driver of market concentration that patents.
The report considers the potential impacts on stakeholders if NGTs are allowed to be marketed in Europe, depending on whether the new regulation allows for patents or not:
Diagram by Technopolis Group
Without patents, it is expected that many breeding companies would move to other jurisdictions, while companies in Europe may rely more heavily on trade secrets. The report says that "Such developments could weaken Europe’s scientific base in knowledge-intensive key technologies and pose a serious threat to Europe’s long-term competitiveness in plant breeding."
By keeping patents, there would be more investment in developing new varieties, but it would increase the costs for FTO analysis considerably. The report continues that "the cost for breeders for stacking traits could get out of proportion. In the longer run, patent-free [plant reproductive material] may become scarce."
The report summarises the main opportunities to improve the system. These included options that could be pursued by private actors (such as better education about licensing platforms and the EPO’s disclaimer rule to assuage fears about infringement of patents covering native traits), while other may require legal interventions (such as mandatory transparency about patents, clarification of the conditions for a compulsory cross-licence, and adoption of the limited breeder's exemption in EU member states).
While these options are nothing new, the report does provide a useful reference point as we continue to discuss on how to promote innovation and competition in the European breeding sector. Now we wait to hear whether the trialogue negotiations decide on a new path forward for the marketing and patenting of NGT plants in the EU...
Further Reading
- The breeder's exemption as the route to agreement in the EU debate on NGT plants (November 2025)
- Expert report published on patent governance of agricultural gene editing (September 2025)
- EU moves one step closer to gene editing regulation (March 2025)
DO YOU WANT TO REUSE THE IPKAT CONTENT? PLEASE REFER TO OUR ‘POLICIES’ SECTION. IF YOU HAVE ANY QUERIES OR REQUESTS FOR PERMISSION, PLEASE GET IN TOUCH WITH THE IPKAT TEAM.
https://ipkitten.blogspot.com/2025/12/european-commission-publishes-study-on.html