Last week, the proposed EU Regulation to ease the regulation of new genomic techniques (NGTs) for plants was approved by the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI). There are still more steps in the EU legislative process to come, but alongside the ENVI decision, the draft compromise text has now been published, which reflects the political agreement at the December trialogue meetings.
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| Photo by Mikhail Nilov via Pexels |
Patent Transparency
The transparency provisions have remained in draft Articles 6 & 7: companies or breeders who seek to register an NGT Category 1 plant will be required to submit information "on patents or published patent applications including one or more claims on the biological material of the NGT plant, or declare the absence of such patents or published patent applications." This language clearly excludes patent applications that are still in their confidential stage.
However, the language is not limited to patents (or applications) filed by the breeder/company themselves. Therefore, the declaration should also identify relevant third party rights - but the breeder/company need only do so "to the best of its knowledge." This information will not be verified by the competent authority. However, failure to provide any patent information (either identifying patents or declaring the absence thereof) would be grounds for the competent authority to declare the NGT1 verification request inadmissible.
The patent information will appear on the NGT1 database that will be established by the European Commission. Under draft Article 9, if there are any changes - to the best of their knowledge - the breeder/company shall without undue delay inform the Commission, and the Commission shall update the database accordingly.
Willing Licensors
Licensing has been a major point of concern throughout the NGT debate. The draft Article 6 & 7 seek to address these concerns by asking for declarations 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." This statement "shall only have declaratory value."
The declaration is optional if the patent is held by a third party. But if the breeder/company is the patent holder, then it is compulsory and must also be accompanied by "a written declaration stating whether they are, or intend to become, a member of relevant and appropriate licensing platforms." Here, the draft text is clearly alluding to existing platforms like Agricultural Crop Licensing Platform (ACLP).
These declarations will also appear on the NGT1 database and must be kept up to date.
The Breeder's Exemption
This Kat (and others) have argued that the breeder's exemption has an important role to play in addressing concerns about patents and NGT plants. While there were no changes to the main provisions, this Kat was very pleased to see some new text about the breeder's exemption in the draft recitals. Beyond the reference to the limited breeder's exemption under Article 27(c) of the Agreement on a Unified Patent Court, draft Recital 46b now adds that:
It is important that all Member States address the mentioned concerns and ensure legal certainty for plant breeders by taking appropriate steps to implement a corresponding limitation to patent rights in their national patent laws, to ensure its coherent application across the Union.
This shouldn't be a tall order: many EU member states (and other European countries) have already amended their national patent laws to include a limited breeder's exemption. Perhaps this language in the recitals will encourage the stragglers to hurry up and do the same.
The Future Focus on Patents
Even if the draft text is fully adopted, it will not be the end of the discussion about patents and NGTs. First, draft Article 29a says that the Commission, within 18 months of the entry into force of the Regulation:
"shall oversee the drawing up of a code of conduct at Union level to enhance the transparency of information relating to patents on plant biological material, to facilitate breeders’ access to such material and to enhance legal certainty for breeders and farmers."
Second, draft Article 30a requires the Commission to establish an "expert group" on the effect of patents on NGT plants. It will include two experts from each member state and may include one expert from each of the European Patent Office and the Community Plant Variety Office.
Third, within a year of the entry into force of the Regulation, the Commission will be required to conduct an assessment of the impact that the patenting of NGT plants, traits and techniques as well as related licensing and transparency practices. The assessment should take into account the findings of the expert group. 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."
This Kat is not alone in her doubts about whether a year would really be long enough to discern the impact of the new Regulation. However, if no follow-up measures are found to be necessary from that first assessment, the Commission will be required to do another assessment 4-6 years after its publication.
Final Thoughts
After years of angst about patents, many were relieved by the news of political agreement on draft provisions that are much less onerous than they might have been. The next hurdle for the draft NGT Regulation is a forthcoming vote on the text by the Council. But even if this text ultimately enters into force, it won't be the end of the story for patents.
Patents will be receiving close attention from the Commission's expert group and the impact assessment in the years to follow. In the mean time, draft Recital 46a acknowledges that the ongoing evaluation of the Community Plant Variety Rights system "will also consider the coherence between patents and plant variety rights, including any relevant provisions on the interface between them." [Merpel: public consultations for this evaluation are open until 20 April, by the way...].
More to come in due course!
Further reading
- EU moves one step closer to gene editing regulation (March 2025)
- European Commission publishes study on IP and agricultural biotechnology (December 2025)
- 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)
Reviewed by Jocelyn Bosse
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Thursday, February 05, 2026
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This is becoming very complicated. The Bolar exemption way of doing it would be better where certain products and activities were simply excluded from patent infringement. Now there is going to be a huge amount of uncertainty for plant breeders as to what position they are in if they don't identify all relevant patents that cover them. Mandatory licencing is also not a nice way of doing things. It means that in order to prevent oneself from being sued for patent infringement (for a plant variety) one must agree to licence one's own patent rights. Is that the correct balance?
ReplyDeleteIf you read the article 6 3b as well as the preamble, you will find that the license offer is not mandatory. What is mandatory is that the requester who is at the same time the patent holder needs to declare whether she is open to licensing or not (see preamble 17b, last sentence). So if you have a company that owns the patent and grants an exclusive license to a daughter company or affiliate being the requester for the NGT registration, then even this declaration is optional. So the IPkat wrote it a little bit misleadingly in leaving out what is mandatory (the declaration if patent holder = requester) and what not (a license offer, or even the declaration when requester != patent holder).
DeleteThank you BF for the reply. That is reassuring. For the record I am 'for' compulsory licencing in certain situations, but I am also very aware that lobbying power varies between larger corporations and the small players in the IP system. Where we are in the process of new IP systems being set up, it is important to be aware of how the power dynamics are playing out behind scenes, and which types of organisations are lobbying for what types of law. The EU has tried for a long time now for those creating new plant varieties through breeding to not be impacted by patents. I hope these efforts will not be undermined by the new laws which are being considered. Thank you again.
DeleteThank you very much for spotting that typo! Indeed, as commented above, the declaration is mandatory, but the licensing is not. I have corrected the typo from "that" to "whether" to accurately convey this.
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