Patents

Negotiations on the future European regulation on new genetic modification techniques have been focusing on two sensitive issues for several months: patentability and sustainability. Keen to conclude the dossier before the end of the year, the Danish Presidency is stepping up efforts to find a compromise, at the risk of neglecting issues that are of particular concern to small and medium-sized breeders and farmers. Denmark will seek an agreement this week, having already threatened to freeze discussions and refer the text back to the European Parliament for a second reading.

As the trilogue on the regulation of new genomic techniques (NGT) continues, civil society organisations are expressing their concerns about the outcome of the discussions, particularly on the issue of patents. This is evidenced by two recent position statements: those of the European Coordination Via Campesina (ECVC) and Arche Noah, which illustrate their mobilisation around this crucial debate at a key moment when European decisions are being made.

When reading legislation, one sometimes finds oneself thinking that it is a good thing that legislators are not responsible for editing the dictionaries in our libraries. The specific case of the term “microorganism” provides a striking example. Behind this term lie biological entities whose contours vary according to the regulatory texts. Bacteria, yeasts, algae, nematodes, even DNA or seeds: these are just some of the examples given by various regulatory texts, which show that the legislative definition of “microorganisms” has constantly varied according to economic interests. What do these texts have in common? They all can blur the traceability requirements imposed by GMO legislation.

“Artificial intelligence” (AI) is used to extract and restructure information from raw or unstructured data. Companies are using it to identify phenotypic traits associated with genetic sequences. Referring to a recent patent application by the company Inari, the German NGO Testbiotech points out the risks associated with the combination of new genomic modification techniques (NGT) and AI. It condemns the possible abuses of patentability and the need for robust GMO regulations. However, Inari has already filed other similar applications, which raises questions about the legal impact of such rights and their adaptation to AI-driven technologies.

The digitization of living organisms is the subject of a growing number of projects. Computer data, generated and stored in ever-larger “data centers”, are used by “artificial intelligence” matrices. These data are of all kinds: genetic sequences, proteins, etc. In these fields, which require increasing natural resources, investments are multiplying.

At the European Patent Office (EPO), one of the key principles for patentability of inventions is that the invention must be described in sufficient detail for any “person skilled in the art” to be able to reproduce it. In biotechnology, where living systems are manipulated, this requirement poses a particular challenge. The notion of “reproducibility” of the invention thus becomes an essential criterion, which can take on different meanings depending on the context. This article explores the subject of the reproducibility of biotechnological inventions according to the practice of the EPO, in particular the case law of its Boards of Appeal.

On 14 March 2025, the Member States of the European Union achieved a fragile qualified majority to launch a discussion with the European Commission and the European Parliament on the deregulation of GMOs. It took the member states almost two years to reach this majority, as there are still many disagreements. Negotiations between the three European decision-making bodies – known as a “trilogue” – could now get underway, subject to the vote of a final formal mandate by the European Parliament’s Environment Committee.

In September 2024, the European Patent Office (EPO) refused a patent for human-pig chimeras on the basis of the ethical rules governing patentability in biotechnology. By invoking the protection of “human dignity”, the EPO is drawing a sometimes fluctuating line between innovation and respect for fundamental values. This decision sets a – perhaps fragile – precedent for inventions affecting human identity, and highlights the complexity of an ethical framework in the era of unbridled biotechnology.

In July 2023, the European Commission’s proposal to deregulate GMOs was presented and understood as concerning only plants. Micro-organisms, animals and fungi would not be concerned. However, a careful reading will show that, contrary to what the European Parliament seems to have understood, some micro-organisms are indeed concerned… because they are considered to be plants!

Since July 2023, the issue of patents on living organisms has been at the heart of debates in the European Union. These debates were sparked by the European Commission’s proposal to stop assessing the risks associated with GMOs, to stop labelling them as such, and to put an end to their detection and identification. In December 2024, a conference allowed several stakeholders of the debate to express their opinion.

In March 2024, the European Commission announced measures aimed at driving what it called a “biotechnology revolution”, including a proposal for a “law” in 2025. This announcement came at a time when a number of legislative dossiers relating to biotechnology had already reached an impasse, such as the deregulation of plant GMOs. As Denmark, a fervent supporter of biotechnology, prepares to take over the Presidency of the Council of the EU from July 2025, is the Commission planning to bring everything together in a general “biotech law” to complicate political debates and force the issue through? The European Parliament has just taken up the issue on its own initiative.

In July 2023, the proposal to deregulate GMOs obtained using new genetic modification techniques (known as “new genomic techniques” – NGTs) highlighted a sensitive issue that is still under discussion: patents. Patents are fiercely criticised for their many negative effects on the rights of farmers and traditional seed producers, as well as on biodiversity. A report commissioned by the European Green Party addresses this issue and suggests ways out of the impasse.