The European Union is in the process of drawing up a regulation on plants and foods obtained through the so-called new genome techniques (NGT). According to the proposed new regulation, NGT plants are those obtained through specific genetic modifications: guided mutagenesis, cisgenesis or a combination thereof.

NGT plants are to fall into two categories: NGT-1 (biologically equivalent to conventionally derived plants) and NGT-2 (other genetically modified plants). The regulatory provisions currently in force for GMOs will generally not apply to NGT-1 plants. An exception is to be made for the exclusion of NGT-1 plants from organic production and the associated obligation to label the seed of such plants. NGT-2 plants are, in principle, to be treated like “classic” GMOs, i.e. they are to be subject to the rules on their experimental release or marketing.

On 7 February, the European Parliament accepted most of the principles of the new system, but with some modifications. For Category 2 NGT plants, the MEPs decided to maintain most of the regulatory requirements specific to GMOs, including the approval procedure and mandatory labelling of products. The European Parliament’s most important demand, however, is for a total ban on the patenting of all NGT plants, plant material or parts thereof and the genetic information contained therein in order to avoid legal uncertainty and increased costs and new dependencies on the part of farmers and breeders. The Council of the EU has not yet reached a position on this issue.

What IP protection options for genetically modified plants?

While the draft regulation provides for a period of exclusivity for reference data, it does not assume the possibility of obtaining marketing exclusivity for NGT products on the basis of such data. However, such exclusivity could be obtained if the plant is authorised as a novel food. In any case, breeders will also be able to rely on the exclusivity arising from the plant variety right. The relationship between a product’s regulatory status and the IP protection available thereto will be crucial if a ban on patenting NGT plants in Europe is enacted. Traders and growers must take this possibility into account.