While breeders are constantly looking for new plant varieties, such as pesticide-resistant plants, the legal protection of those new varieties is a regular topic of debate. These debates are at the core of patent protection: supporting innovation but at the same time limiting access to the patented subject matter.
What does the legal framework say?
Under the EU Biotech Directive and the European Patent Convention (EPC), plant varieties and essentially biological processes for the production of plants are not patentable. Plant varieties can be protected by “plant variety rights”, which grant exclusivity to the right holder while leaving room for others to use the protected material as a starting point for further breeding (the breeders’ exemption).
The EPC is a non-EU convention and the Biotech Directive was implemented in the EPC by the EPC Implementing Regulations. Those Regulations also provide that the examining and opposition divisions of the European Patent Organisation (EPO) use the Directive as a supplementary means of interpretation when examining European patents and patent applications for EPC compliance. In addition, the EPO Guidelines provide that judgments of the Court of Justice of the European Union on the interpretation of the Directive may be “considered as being persuasive”.
In its Broccoli I and Tomato I and Broccoli II and Tomato II decisions about breeding methods, the EPO’s Enlarged Board of Appeal gave its interpretation of the relevant provisions on exclusion of patentability and left the door open for certain plant-related patents: patents on breeding processes which include an additional step of a technical nature, and patents on products derived from using essentially biological processes (product-by-process). The decisions led to much commotion and speculation, as they favoured large agrochemical companies, but put the smaller breeding industry and consumers at a disadvantage.
Commission and Council view
In December 2015, the European Parliament adopted a resolution calling on the European Commission to clarify the scope and interpretation of the Biotech Directive, as the Broccoli and Tomato decisions could lead to more plant-related patents. Following the May 2016 EU Symposium in the Netherlands, the Commission issued a Notice on certain articles of the Biotech Directive in November 2016. In this Notice, the Commission indicated that the EU legislators’ intention was to exclude from patentability products (plants/animals and plant/animal parts) that are obtained by means of essentially biological processes.
More recently, in February 2017, the European Council decided to publish the Notice, as well as its own Conclusions that the Enlarged Board of Appeal’s decisions are in conflict with the legal provisions of certain EU Member States. The Council urged EU member states, in their capacity as EPO members, to advocate for the EPO’s practice to be aligned with these conclusions.
The clarification at the EU level is welcome news for plant breeders: the end of patent protection for plant varieties seems near. This means that they will have access to plant materials to breed new plant varieties. Supporters of this new direction refer to its positive effect on food diversity and global food security. Meanwhile, companies owning plant-related patents, mainly large agrochemical companies, will probably not be cheering, as the development of plant varieties is a time consuming and difficult process. According to an expert group report referred to in the Council’s Conclusions, the development of one single new variety is a complicated process and can easily take 12 to 15 years.
As to actual impact, the Commission’s Notice and the Council’s Conclusions are not legally binding on the Court of Justice of the EU and the EPO. Ultimately, it is up to the Court of Justice to interpret the Biotech Directive and up to the EPO and national courts to decide on patentability matters. At the same time, there are already calls for the text of the Biotech Directive to be amended to incorporate the interpretative guidelines given by the Commission and the Council.
Still, the EPO has already responded to the signals coming out of the EU by deciding that, in view of the potential impact of the Commission’s Notice, all proceedings that entirely revolve around the patentability of a plant (or animal) obtained by an essentially biological process will be automatically suspended. In December 2016, the EPO indicated that it would follow its member states’ interpretation on this matter of patentability. It is unclear for how long pending proceedings will be suspended. As the majority of EPO member states are also EU members, this new EU direction is very likely to be implemented in the EPO practice and, as a consequence, existing plant patents will not survive. New patents of this type will no longer be granted either.
In addition to EPO practice, national courts will also have to decide how to deal with national proceedings and existing patents. For some countries (including the Netherlands, Germany and France) the new signals do not affect national patent laws, as these laws already explicitly exclude patents on plants or parts of plants that are derived from essentially biological processes. For those countries, the question of how to interpret their national laws remains, as these should be in line with EU law, including the Biotech Directive and its interpretation.
In the end, the Court of Justice of the EU will need to answer these questions in order to end the existing legal uncertainty on plant-related patents.