European Parliament wants to ban patents for NGT plants

EU Parliament to vote on a new patentability exclusion thereby re-opening the Biotech Patent Directive

Biotechnology has been identified as one of the key technologies with a significant potential to boost Europe’s competitiveness whilst providing solutions that contribute to reaching the EU’s sustainability ambitions. A new Regulation for plants produced by certain New Genomic Techniques (NGT), such as targeted gene editing, would represent an important milestone in fostering the biotechnology sector in Europe, although it has been contentious to what extent such genetically modified organisms should be permitted to be released into nature.

Therefore, the EU-Commission (EC) made a proposal for a new regulatory framework to regulate the release and use of such NGT plants in agriculture (Document COM/2023/411 final). The new legislation is currently pending with the European Parliament and on 24.01.2024, its Committee on Environment, Public Health and Food Safety (ENVI) expressed its consent with the EC proposal for a new Regulation on NGT plants.

At the same time, Members of the EU-Parliament (MEPs) amended the EU Commission’s proposal to introduce a new full exclusion from patentability for all NGT plants (plants obtained by new genomics techniques such as targeted mutagenesis and cisgenesis) and further even for plants obtained by random mutagenesis techniques or cell fusion. It was said that the exclusion from patentability may help to avoid legal uncertainties, increased costs and new dependencies of farmers and breeders from patent holding companies. The ban on patents would also extend to plant parts, and plant material thereof, as well as to genetic information and process features found in such plants. MEPs also request a report on the impact of patents on breeders’ and farmers’ access to varied plant reproductive material by June 2025.

The proposed patentability exclusion would be achieved by including in the proposed Regulation two Articles (Article 4a and Art 33a) amending Art. 4 of Biotech Patent Directive 98/44/EC. The patentability exclusion in these articles would apply from the date of entry into force of the proposed NGT Plant Regulation. Since the Biopatent Directive is explicitly referred to in the European Patent Convention, European Patents issued by the EPO could also well be affected, if the new patent exclusion would be adopted by the EU legislator as proposed.

Following the proposal from the ENVI Committee the European Parliament is scheduled to vote on the draft legislation during the upcoming 5-8 February 2024 plenary session, after which it is ready to start the trilogue negotiations with EU Commission and EU member states in the Council before the Regulation could be finally adopted.

epi, together with other associations and companies has called upon MEPs to reconsider the proposed amendment to ban patents on NGT plants, because without adequate protection, companies in Europe will not be able to invest in NGTs, the pace of innovation will slow down and the EU’s goal of fostering competitiveness with stronger biotechnology contributions will be put at risk.

New technologies such as gene editing (e.g. CRIPR-Cas9) and NGTs offer new opportunities. However, they require significant investments. The ability to protect newly created traits with patents is therefore an essential component to secure sustainable investments in the creation of innovative crops that help farmers to keep up productivity in times of climate change and help to introduce more sustainable cropping systems.

The MEPs seem to be motivated by concerns that patents may limit breeder´s and farmer´s access to these novel plant materials. It is important to note in this connection that already today, the scope of the patent protection is limited by the general research exemption in European patent law and by the breeders’ exemptions implemented also by many EU Member States as well as in the recently implemented EU unitary patent system.

Moreover, the Biotech Patent Directive, the EU Plant Variety Regulation as well as the Unified Patent Court Agreement all contain provisions allowing farmers to save protected seeds for using it in a next cultivation cycle on their own farm. Small farmers do not have to pay anything.

Finally, over the last years, the Administrative Council of the European Patent Organisation has introduced provisions into the European Patent Convention to exclude from patentability plants or plant material, if the claimed product is exclusively obtained by means of an essentially biological process or if the claimed process features define an essentially biological process.

A solution should be reached that acknowledges the importance to gain access on fair licensing terms to genetic material especially for small market players whilst respecting the importance of patent protection for trait innovators.