Recent changes to EU law on GMOs and their potential influence on the patentability of GM plants. Some remarks on possible side effects of directive 2015/412/EU

Abstract

In this article I present recent changes in EU legislation on the cultivation of GM plants and I attempt to answer the question as to whether the new laws continue to follow the precautionary principle approach and the case by case approach that characterized the European Union’s GMO legislation until recently. Also, given the nature of the newly introduced grounds for restricting the cultivation of GMOs, I try to find out if the new legislation could influence the patentability of transgenic plants or methods of their production. While growing in popularity around the world, transgenic plants face strong opposition within the European Union. Recent changes to EU legislation governing the cultivation of GM plants are just another example of the said opposition. Directive (EU) 2015/412 of the European Parliament and of the Council amending Directive 2001/18/EC provided member states with means to restrict or effectively prohibit cultivation of genetically engineered plants in their territories, even if such plants have already been authorized for cultivation in the EU. The reasons countries can currently invoke in order to introduce limitations are no longer restricted to bio-safety, but rather encompass a set of political and social issues such as socioeconomic impacts, avoidance of GMO presence in other products, agricultural policy objectives, public policy etc. They are to a much lesser extent (than up till now) based on the precautionary principle, as possible restrictions will also concern already examined and authorized GMOs. Restrictions no longer need to target particular transformation events, they can now encompass certain traits or crops. When it comes to the patentability of GM plants or methods of their production, the recent changes seem to have limited influence, given the European Patent Office’s stance on the application of morality and “ordre public” exclusions and its relative independence from EU law. The possibility cannot be excluded that local laws adopted on the basis of the newly introduced changes could influence procedures before local patent office, should those offices decide to apply the morality or “ordre public” exception to patentability. The newly adopted laws have a rather different effect, though. The profitability of developing GM plants in the EU (and their patenting) may become questionable, should the exploitation of such inventions be prohibited in several EU member states.