European Parliament votes for a Regulation on NGT plants supporting the ban on plant patents.

On February 7, 2024, the European Parliament voted in first reading on the draft Regulation for plants produced by certain New Genomic Techniques (NGT) and their food and feed.

While the proposal by the Commission is aimed at providing a new regulatory framework for the deliberate release of NGT plants and the placing on the market of related products including food and feed, suggested amendments to the Regulation by the Committee on Environment, Public Health and Food Safety (ENVI) included a new full exclusion from patentability for all NGT plants, as well as for plants obtained by random mutagenesis techniques or cell fusion.

The text adopted by the European Parliament includes, in addition to the already proposed amendment to Articles 4 of Biotech Patent Directive 98/44/EC, further proposed amendments to Articles 8 and 9 of the Biotech Patent Directive.

By these new amendments, the protection conferred by a patent on biological material including plant product, would not extend to all biological material possessing the same characteristics that is obtained independently of the patented biological material nor to biological material obtained from such material through propagation or multiplication (proposed amendment to Article 8).

The proposed amendment to Article 9 of the Biotech Patent Directive would limit the protection currently afforded by a patent on a product containing or consisting of genetic information as extending to material in which the product is incorporated and in which the genetic information is contained and performs its function, by excluding such protection for plant material which is not distinguishable from plant material obtained or which can be obtained by an essentially biological process, as well as for such plant material obtained by a technical process that enables the production of a product containing or consisting of genetic material.

As a reason for this ban on patenting and restricted scope of protection for plant patents, newly proposed recital 1a states in an unfounded allegation that “[a]llowing for new genomic techniques and their results to be patented risks giving multinational seed companies even more power over farmers’ access to seeds“ and that “[i]n a context where large companies already have a monopoly on seeds and increasingly control natural resources, this would deprive farmers of all freedom of action by making them dependent on private companies“.

New recital 45a asserts that “[f]or patents already granted or pending patent applications covering plant material, the effects of patents should be further limited“.

In a previous publication, epi has already warned 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.

The matter is expected to enter trilogue. However, a compromise text for the NGT proposal in the Council discussions was apparently not supported by a qualified majority of Member States, and as a consequence, the interinstitutional negotiations cannot yet begin.

epi will prepare a position paper on this topic and keep its members informed.