NGTs Shake Up Intellectual Property

Even when protected by a Plant Variety Certificate, breeders can legally access the source material or the plant material, solely to create a new variety. This fosters innovation. The upcoming arrival of New Genomic Techniques (NGTs), if an agreement is reached within the European Union, could lead to more patents. However, farmers would have access to better seeds, more suited to their needs and climate change.

© DR

Patenting Life? Some multinational companies have tried it, and many NGOs have decried it as an illegitimate appropriation of nature, which should belong to everyone. Nevertheless, protections do exist, much like those for artists, writers, inventors, and journalists, to recognize the intellectual work and investment of seed professionals, who also create. In this case, a new variety. To protect this varietal creation, most countries have opted for the Plant Variety Certificate (PVC).

Others, including the United States, have preferred patents, although Europe also has such a system. However, there is a fundamental difference: the European patent only applies to a specific trait of a plant, provided it meets precise criteria of inventiveness and novelty, while the American patent protects the variety as a whole.

Thus, while native traits of a plant cannot be patented in Europe, a specific trait within a plant, developed through research, can be patented. If creators do not want to pay royalties on a patent held by another seed company, for example, they will need to eliminate that trait from the new variety created. However, beyond the work during the patent’s duration, the decision mostly depends on the advantage that trait, whether desired or not, could offer to the new variety. If it provides real added value, it is better to keep it—and pay the royalty.

Over 30,000 PVCs in force in Europe

The PVC, resulting from evolving intellectual property philosophy, was internationally formalized in 1961 and is currently governed by a European regulation (EC No. 2100/94), establishing a community protection system for plant varieties. Consequently, and across the plant kingdom, the PVC grants, from its issuance, exclusivity for 25 years, or 30 years for fruit trees and vines, to its holder. PVC holders have the right to produce, reproduce, process, market, export, and import their variety, as well as the right to prohibit any third party from using their protected variety without authorization. The PVC allows control over conditions of use of the breeders’ variety and compensating their work. Anyone using their reproductive material for production must pay a royalty, included in the sale price.

The International Union for the Protection of New Varieties of Plants (UPOV), established by the International Convention for the Protection of New Varieties of Plants in 1961, manages the PVC. “The UPOV system encourages the development of new varieties, offering new opportunities for farmers. It is important that they are informed of the benefits and conditions applicable to producing protected varieties,” emphasizes Yolanda Huerta, UPOV’s Deputy Secretary-General. Today, UPOV has 79 members: 77 states from Europe, America, Africa, and Asia, and two regional organizations (the European Union and the African Intellectual Property Organization, covering the territory of its 17 member states). This means that 98 states have a legal framework for plant variety protection, in line with the UPOV Convention. In 2023, 30,939 PVCs were in force in the EU.

Breeder’s exemption, a key provision

Given that it takes a good ten years of effort and investment to develop a new cereal variety, for example, and that seed companies typically invest 11% of their revenue in research and development, the PVC, like any other intellectual property system, allows not only recognition of the work done but also “protection against plagiarism or counterfeiting,” notes Olivier Lucas, Director of Valorization for RAGT Semences, who also participates in the work of the seed industry association on intellectual property.

However, he quickly adds, “the breeder’s exemption is very important to maintain the virtuous circle of innovation”. In fact, explains Yolanda Huerta, “under the ‘breeder’s exemption’ provided for in the UPOV Convention, the use of protected varieties to create other varieties does not require the breeder’s authorization.” This is the breeder’s exemption. “New breeding methods and techniques have been developed and will continue to emerge, likely leading to the creation of essentially derived varieties. The UPOV Convention has therefore included provisions on these issues,” she adds.

Protected varieties by a PVC can be freely used, but only for research and breeding purposes, without compensation. In other words, anyone, but generally a seed professional, can use a new variety to create another, as long as the latter is distinct from the first, without the need of the owner’s consent. As pointed out by the interprofessional seed and plant organization (Semae), this “ensures the continuity of genetic improvement for each plant species.”

However, notes Yolanda Huerta, “nowadays, thanks to recent technological advances, the growing number of patents in the genetic field, and rapid progress in genetic engineering, the links between patents and breeders’ rights are tightening.”

The Deputy Secretary-General of UPOV is referring to new techniques, the NGTs (New Genomic Techniques). Unlike genetically modified organisms (GMOs) that introduce foreign DNA, NGTs involve precise gene corrections using specific molecular scissors, based on CRISPR-Cas9.

Patentability in debate for NGTs

But this is where things get complicated... After nearly four years in the making, NGTs still lack consensus among European Union member states. Indeed, on February 7, 2024, the European Parliament adopted, in plenary session, its position on the proposed regulation to frame the use of these new plant breeding techniques. With a differentiated approach: on the one hand, NGT 1, in other words, genetically modified plants indistinguishable from those obtained by conventional breeding, which would therefore be exempt from GMO legislation requirements; and on the other hand, NGT 2, with more complex modifications, which would be subject to stricter rules.

Despite this anticipated relaxation for NGT 1, patentability remains a topic of debate. On February 7, the members of Parliament amended the proposal to entirely ban patents on all NGT plants, plant material, parts thereof, genetic information, and process characteristics they contain, aiming to avoid legal uncertainties, cost increases, and new dependencies for farmers and breeders. However, though the text excluded NGT products from patentability, the techniques used to obtain these products could still be patented. These are “process patents.”

Nevertheless, after the European Parliament adopted its position last February, member states were expected to reach an agreement during negotiations at the Council of the European Union. They failed, however. On June 28, 2024, member states could not reach a consensus on the NGT regulation project. In fact, due to a lack of consensus among member states, the topic was removed from the agenda and was not discussed in session. Consequently, no vote was held.

The main reason for this situation was patentability. Indeed, several countries - Austria, Croatia, Slovakia, and especially Poland - demand that plants cultivated through NGTs be entirely exempt from patents. Poland believes that “patents should not restrict the use of [NGT-derived] plants in the creative work of breeders and growers - in particular, our concerns relate to NGT 1,” according to a Council document consulted by the press. Still, some observers actually consider this position more political than based on regulatory issues.

For the moment, market players still do not know what a new project might contain. Seed companies are nevertheless eagerly awaiting the adoption of a final text. “Through the use of NGTs, operators will be able to create characteristics, unique elements that can meet the novelty and inventiveness criteria of the patent system,” notes Olivier Lucas of RAGT Semences. “Moreover, these new techniques allow for more precise and efficient work. NGTs thus open up a new field of innovation, while accelerating R&D.” This saves valuable time, especially in the face of the climate emergency.

Will this new patent opportunity offered by NGTs have consequences for seed companies, and ultimately for farmers? European parliamentarians have requested a report by June 2025 on the impact of patents on farmers’ access to various plant reproduction materials. This could “objectify the debate,” emphasizes Sébastien Paque, head of the plant breeding department at the French Union of Seed Companies (UFS), a professional organization distinct from the interprofessional seed and plant organization, Semae. “We will remain pragmatic,” says Olivier Lucas of RAGT Semences. “If a new patented characteristic offers a real advantage and real market value, and if we can share it with farmers, it is better to pay the license fees associated with the patent and benefit the agricultural sector,” he explains.

In short, seed companies will do their calculations and include strategic and competitive reflections, just as farmers will. If certain plant characteristics – resistance to diseases, tolerance to drought, etc. – provide additional value to the product, it is worth it for seed companies to pay the patent royalty and for farmers to benefit, perhaps by paying a little more, from these advantages while simultaneously reducing their input costs or enjoying better harvest guarantees.

Towards Mandatory Access to Licenses?

This philosophy is shared by UFS, which believes it is necessary to promote effective protection of innovations without blocking access to progress. “This implies the harmonious coexistence of PVCs and patents: the PVC to protect a variety and the patent to protect traits obtained through biotechnological processes like NGTs that meet patentability criteria,” says Sébastien Paque. But under several conditions. The first is that the patent system includes an exemption, like the PVCs, for breeders, allowing them to use a variety containing a patented trait for research and breeding without restrictions. True, this is a limited exemption, but it is necessary to avoid legal risks in the face of increasing NGT applications. The second condition is to make access to licenses for these patents mandatory.

In concrete terms, this means, at the EU level, prohibiting plant patents from blocking any access to licenses. If no agreement is reached with the patent owner, there should be a transparent and non-discriminatory system that sets the price of the license. The goal is to ensure that patent holders cannot block the use of a trait or variety by demanding prohibitive fees. This system, which already exists in the United States, is supported by a coalition of seed companies and organizations, including UFS. Mandatory access to licenses is necessary to create a level playing field among seed companies, regardless of size. Small structures need to have access to certain patented traits, at a reasonable price, to offer high-performance varieties to farmers. Conversely, a large group should not be able to monopolize a new trait, which would cause a loss of access for competitors and stifle innovation. This would be contrary to the objectives of patent law.

Farmers’ Rights, another Key Issue

However, there remains the third challenge: preserving farmers’ rights. Article 27 of the International Treaty on Plant Genetic Resources for Food and Agriculture, signed in 2004, recognizes the right of farmers to save, use, exchange, and sell farm-saved seeds. In the context of patents, this is often complicated. The situation is clearer for varieties protected by PVC, as the EU recognizes the farmer’s privilege, allowing them to sow seeds of varieties obtained on their farm, but with royalties.

As a result, each year, tens of thousands of farmers in France pay these royalties on their farm-saved seeds. “The adoption of NGTs, and thus patents, must not hinder farm-saved seeds,” insists UFS, which has proposed that farmers be allowed to use farm-saved seeds of NGT-derived varieties, paying royalties at the same level as for PVC-protected varieties. The French Ministry of Agriculture has already announced that it is open to this discussion with agricultural organizations.

It remains to be seen what the final outcome will be at the EU level. This approach has already been adopted in the Netherlands and Germany. “We must avoid a step backward on these rights,” concludes Sébastien Paque. The end result could be a reform that tries to harmonize the coexistence of PVCs and patents with NGTs, balancing innovation and accessibility. This reform could lead to increased investment in research and more innovation, but it could also create new challenges regarding the accessibility and cost of seeds for farmers. The debate is far from over, but the ongoing discussions will shape the future of agricultural innovation in the EU.

© dr