In a vote held on February 7 2024, the European Parliament (EP) approved a proposal to:
Differentiate between two categories of plants obtained by gene editing or new genomic techniques (NGT), which include gene editing using CRISPR/Cas, with NGT 1 plants being exempted from the strict requirements of the genetically modified organism (GMO) legislation; and
Ban all patenting for NGT plants, plant material, parts thereof, genetic information, and the process features they contain, regardless of which of the two new categories they may belong to.
The proposal creates two distinct pathways for NGT plants to be placed on the market:
Category NGT 1 plants, defined as NGT plants that could also occur naturally or by conventional breeding, would, provided they meet certain criteria in a verification procedure, be treated like conventional plants and be exempt from the requirements of the GMO legislation. A public online list of all NGT 1 plants is intended.
Category NGT 2 plants, defined as all other NGT plants, would continue to be subject to the current GMO legislation. That is, they would be subject to risk assessment and authorisation prior to market approval, and would have to be traced and labelled as GMOs.
Intentions behind the proposal and its implications
According to the European Commission, the proposal, adopted on July 5 2023, not only aims to maintain a high level of protection of health and the environment but also to steer developments towards making a contribution to sustainability goals in a wide range of plant species, especially for the agrifood system, and create an enabling environment for research and innovation, especially for SMEs.
In stark contrast thereto, the proposal – via an amendment introduced during the parliamentary process by the Committee on the Environment, Public Health and Food Safety of the EP – would also establish a ban on all patenting for “NGT plants, plant material, parts thereof, genetic information and the process features they contain”, regardless of which of the two new categories the NGT plants in question may belong to.
The amendment also proposes that Biotech Directive 98/44/EC be amended accordingly, and the members of the EP have requested a report on the impact of patents on breeders' and farmers' access to plant reproductive material, as well as a legislative proposal to update the EU rules on intellectual property rights accordingly, which is due by June 2025. According to a press release from the EP, the intention behind the amendment is to “avoid legal uncertainties, increased costs and new dependencies for farmers and breeders”.
However, a complete lack of protection for NGT plants in the EU may prevent European companies from investing in the development of NGT plants, because they could not rely on a period of exclusivity in which to recoup their significant development investments. Such criticisms have been voiced by, among others, Garlich von Essen, the secretary general of the seed industry association Euroseeds, in Science Business, and by epi, the Institute of Professional Representatives before the European Patent Office.
Notably, a ban on all NGT plant patenting is also in direct conflict with the European Patent Convention (EPC) and the current practice and established case law of the EPO, both of which operate independently of the EU. In decision G 3/19 (Pepper), the Enlarged Board of Appeal of the EPO established that, while the patenting of plants “exclusively obtained by means of an essentially biological process” based on sexual crossing and selection is not permissible, plants produced by a technical process that modifies the genetic characteristics of the plant, which includes NGTs, are patentable in Europe (as reflected in the EPO Guidelines for Examination).
Next steps for the proposal
While the vote means that the EP is now ready to start negotiations with its member states on the final law, the Council of the EU must further approve the proposal for it to become law. A ban on all patents is not currently supported by all council members, so it remains to be seen how quickly the proposal will progress, if at all, in its current form.
