The breeder's exemption as the route to agreement in the EU debate on NGT plants
Jocelyn Bosse
The breeder's exemption as the route to agreement in the EU debate on NGT plants
Jocelyn Bosse Tuesday, November 25, 2025 - Jocelyn Bosse, new genomic techniques, patents, plant varieties, TRIPS Agreement
There are hopes of a resolution to the negotiations on a proposed regulation for new genomic techniques (NGTs) for plants. Updates from Brussels have been rare, but some reports indicate that agreement might be reached during their fourth trialogue meeting planned for Wednesday 3 December. This Kat was particularly interested by the rumour that the Parliament may be prepared to abandon their demand for a "patent ban" and focus on licensing and the breeder's exemption.
This Kat has been working on an article about the debate over IP and NGTs for some time. A copy of the draft paper is now available here [Merpel: feedback on the full draft is welcome, but we know our readers are busy people who might appreciate this shorter summary].
A Kat hoping for a path to agreement. Image by Marsal1 from Pixabay.
Background
When the European Commission proposed a new NGT regulation in 2023, it was already aware that IP was a hot-button issue due to concerns that patents may hinder access to NGTs or NGT products, particularly for small/medium enterprises, and to genetic material for plant breeders.
The European Parliament's amendment to the proposal in 2024 to include a "patent ban" was one way to address these concerns, but it has received substantial pushback from experts (including our PatKat), not least because of the ambiguous and broad wording of the amendment.
Earlier this year, the trialogue began with a negotiating mandate that removed the patent ban and instead focused on patent transparency measures, although experts have concerns about these ideas too (see IPKat here and a more recent article here). Others have suggested that the EU should consider alternative options, like compulsory licensing or patent clearing houses. This Kat has focused on whether a breeder's exemption in patent law provides a way to resolve this debate.
Why focus on the breeder's exemption?
The breeder's exemption is the "cornerstone" of the plant variety rights (PVR) system, which ensures that other breeders can use a protected variety in their breeding programmes and commercialise a resulting variety, without the authorisation of the PVR holder. This is crucial because of the cumulative nature of innovation in plant breeding.
To the extent that EU members are concerned that patents may block access to genetic material for plant breeders, this Kat argues that strengthening the role of the breeder's exemption in patent law could be a suitable way to address these issues. This exemption is well understood and widely supported in the plant breeding sector. It allows for patents to be granted - with no change to the current patentability rules under the European Patent Convention or EU Biotech Directive - while ensuring a suitable balancing of the interests of other breeders.
In fact, a limited breeder's exemption is already feature of many European patent laws, from the UPC Agreement to the national patent laws of countries such as France, Germany, Switzerland, the Netherlands, Finland, Belgium, Italy, Poland, and Sweden. The limited breeder's exemption allows breeding activities with a patented invention to occur freely, but the commercialisation of a new variety would require a licence from the patent holder.
What about non-EU countries?
This Kat argues that the breeder's exemption could also be beneficial outside the EU. In England, the precision breeding framework came into force earlier this month, which makes no mention of patents. However, there are hints that the same concerns voiced by the European Parliament are being picked up in the UK (see IPKat here). The UK has already considered introducing the breeder's exemption on a number of occasions (following the Swiss model), but the most recent proposal was abandoned once the UK was no longer party to the UPC Agreement due to Brexit. To avoid the risk of becoming engulfed in similar debates to the EU, this Kat wonders whether the breeder's exemption for UK patents would head off these concerns.
The concerns are even more pressing in countries like Australia and the US, which allow double protection by both patents and PVRs over the same variety. The Australian Patents Act 1990 has already been amended to introduce a broader research exemption that extends to acts relating to the subject matter of the invention that were done for "improving or modifying the invention". While it does not explicitly mention breeding, this language would seem to equate to a limited breeder's exemption. The US has moved more slowly. During the Biden Administration, there were efforts to improve competition and innovation in the seed sector. This led the USPTO to seek feedback in 2024 on whether a breeder's exemption should be introduced for utility patents. Unsurprisingly, there has been little progress on this issue under the new administration.
What about a comprehensive breeder's exemption?
The limited breeder's exemption is a good step, but it seems unlikely that a breeder would use the exemption and invest substantial resources in breeding if they are completely uncertain about the prospects of a licence for commercial use. The uncertainties are even greater if the variety is covered by multiple patents with different owners, who may have complex and exclusive licensing policies including sub-licences. This has led to agitation for a "full" breeder's exemption that would allow breeders to freely commercialise their new variety without authorisation of the patent holder(s).
The European Parliament clearly took the view that the comprehensive breeder's exemption is necessary: alongside concerns about farmers’ access to seeds, the Parliament said that it "should be ensured that breeders have full access to the genetic material of NGT plants … [which] can best be secured when the right of patent holders is exhausted in the hand of the breeder (breeder’s exemption)." In the absence of a full breeder’s exemption under patent law, the Parliament concluded that PVRs - which do provide a full breeder’s exemption - should be the only available form of IP protection for NGT plants.
One problem is that this ignores how the law has changed in the last 40 years: the full breeder's exemption for PVRs is not as fulsome as it used to be. This is mainly because of the essentially derived variety (EDV) concept. In many cases, a variety developed using NGTs (amongst other techniques) will be deemed an EDV, which means that its commercialisation requires the authorisation of the PVR holder of the initial variety. The EDV concept is very controversial. But the point is, even PVR laws no longer allow for free commercialisation for all varieties, so the European Parliament's comparison to the limited breeder's exemption under patent law was a little bit unfair.
But more importantly, is a comprehensive breeder's exemption even allowed for patents? Some believe that the TRIPS Agreement would be a major barrier. But to cut a long story short (see the draft for the long version), the TRIPS Agreement is not really an obstacle, as long as the exemption is justified by clear and well-supported policy objectives. Some have suggested that a full breeder's exemption would be more justifiable if free commercialisation is restricted to particular species. The Humboldt White Paper suggested that this could be restricted to commercialisation of varieties "for any purpose in food and agriculture." In her major study on this topic, Viola Prifti suggested that this could be limited to the species listed in Annex I of the Plant Treaty.
Conclusions
In yesterday's co-signed letter from the majority of the European agri-food sector, they spoke clearly on their desire for a resolution of the NGT debate that would allow Europe to close the competitiveness gap with its global partners. To the extent that a new NGT regulation must address IP to achieve political agreement, with the global nature of plant breeding, this Kat takes the view that it would be better for the EU to focus on solutions that don't single out NGT plants and could achieve international buy-in. Many non-EU countries have already been willing to consider or adopt a breeder's exemption in their patent laws, albeit in the "limited" form.
There is increasing complexity of the patent landscape. Also, with the need for "stacking" of multiple traits in a single variety, this could mean that a breeder requires a licence from multiple different patent holders in order to commercialise one variety - which might deter them from breeding with the patented material at all. A comprehensive breeder's exemption would remove these concerns, but many patent holders would have objections to this broader exemption.
The rumours about the trialogue negotiations suggest that the EU representatives may be leaning towards an alternative approach [Merpel: here we are in the realm of wild speculation!]. Perhaps they are still focused on transparency measures. But perhaps they may combine the limited breeder's exemption with licensing obligations that would create more legal certainty for users of patented biological material. They might provide a way to guarantee breeders that they will be able to commercialise their variety without complex negotiations with multiple parties, while patent holders would still receive some royalties from the commercial use of their invention by breeders - which starts to sound more like a liability rule.
The Kat wouldn't dare to predict where the EU will land on this issue. We can only hope that it is on a solution that provides more legal certainty than earlier proposals and encourages, rather than hinders, breeding in Europe for the benefit of society.
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https://ipkitten.blogspot.com/2025/11/the-breeders-exemption-as-route-to.html