Two vegetables have sparked conversation on one of the most controversial topics in the seed sector.

In March of 2015, the Enlarged Board of Appeal of the European Patent Office (EPO) made its decision — sparked by two high profile cases involving tomato and broccoli — that the patenting of products of essentially biological processes is allowed. The decisions were met with both support and criticism.

In the Netherlands especially, there were concerns over these decisions, and so during the Dutch presidency of the European Union between January and June 2016, a symposium was organized. Called “Finding the balance — Exploring solutions in the debate surrounding patents and plant breeders’ rights”, it took place in Brussels, Belgium, on May 18. To learn more about this controversial topic, European Seed visited the Symposium and spoke with representatives of several European organizations who all have a high stake in this discussion.

Judith de Roos of the Dutch Seed Association Plantum states that the Symposium was an event organized by the EU Commission, partly co-organized by the Dutch government, but mainly for the practical part. “The topic had already been flagged in the Council during the Luxemburg presidency, just before the Dutch presidency. The topic was first discussed in the Agriculture Council secondly in the Competitiveness Council, and since the topic is well understood in agricultural circles but less in those of the Ministers of Economics, the need was felt to bring all parties together to exchange information. As this subject was one of the priority topics for the Netherlands during the Dutch presidency, the Commission agreed to organize such a symposium. Not in the least because the European Parliament called upon the European Commission in their December 2015 resolution to take actions” she adds.

The May 18 symposium was well attended with over 200 participants showing up, a majority of them from the European Commission (mostly from the patent, competitiveness and agriculture sectors) and representatives from Member States, competent authorities and patent offices.

As far as interest groups go, four groups had received 10 invitations each: ESA, EuropaBio, No Patents on Seeds and COPA-COGECA. Unfortunately, the symposium was organized during the ISF World Seed Congress in Uruguay, which prevented several high-level seed representatives from attending.

Breeders Concerns

In the recent past, the Dutch government has been quite active in the field of IP for plant innovations, with discussions in Parliament and a report, which lead to a recommendation to the Dutch parliament indicating a need for a comprehensive (or full) breeder’s exemption in patent law, notes Szonja Csörgő, director of intellectual property and legal affairs of the European Seed Association (ESA).

“In the course of the past few years, the Dutch government has actively discussed the impact of patenting plant traits, with the concern that multinationals would decide what the variety assortment would look like,” says Chris van Winden of the International Licensing Platform Vegetable (ILP). One of the interim results of these discussions was the introduction of a limited breeder’s exemption into Dutch patent law. This process was driven by the state secretary on agriculture, Sharon Dijksma, who was recently replaced by Martijn van Dam.

“Because of the concerns, the Dutch government decided that during the Dutch Presidency of the EU, the perceived disturbed balance in IP on plant innovations should be placed on the agenda. The European Parliament was not in agreement with the EPO decision on the broccoli and tomato cases, so it was agreed with the Dutch government that this should become an important topic,” van Winden says.

“During this whole process, the Dutch government has realized that achieving a comprehensive breeder’s exemption in the EU Biotech Directive was going to be a very long and difficult process, as it would require opening the Biotech Directive. So it wishes also to limit the granting of patents in this field,” van Winden adds. He underlines that the ILP enables all members to get licenses for using patented germplasm under Fair, Reasonable and Non-Discriminatory (FRAND) conditions.

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Edgar Krieger, secretary-general of CIOPORA, feels this event was organized to limit the amount of patenting in plant innovation. “It is a well-known fact that the Dutch government wants to limit the amount of patents in the plant breeding sector,” he says. “However, after the symposium it is unlikely that the Dutch government will continue to steer towards opening the EU Biotech Directive. The EU Commission’s decision to develop guidance with an interpretation on patenting of plant innovations will now be used to influence EPO.”

Michael Kock, head of intellectual property at Syngenta, confirms that the Dutch government seems to be moving away from the comprehensive breeder’s exemption.

“The development process of a guidance document is not going to be an easy process and may not provide the legal certainty needed. Syngenta supports higher transparency, the ILP, the PINTO database, and we are aware that the EU Commission is also supportive of these measures,” says Kock. “The EU Commission’s ability to influence the patent granting practice at the EPO is limited. A pragmatic solution including industry-led elements might be more efficient, especially as there are bigger issues at hand that should deserve much more attention, such as the freedom to operate on new breeding methods and the implementation of the Nagoya protocol. Syngenta hopes that this symposium will close the subject.”

Disagreement

It might seem that the EU Commission and most organizations are convinced it would be a bad idea to open up the Biotech Directive. In fact, NPoS, which also took the stage during the symposium, disagrees. Christoph Then of NPoS mentioned that his organization is convinced that there can be no patenting of products produced via essentially biological processes. In case this goal cannot be achieved by clarifying the Directive, then it would be necessary to change the Biotech Directive, according to Then.

When asked, the EPO declined to comment on the event itself, other than to say that the situation is rather complicated since the conclusion of the event. One can imagine that EPO has been observing this event with special interest, as the underlying aim of many participants seems to be to overturn the EPO decision in the tomato and broccoli cases.

However, it should be noted that the EU Commission and the EPO are two separate organizations. The EPO in its capacity as patent-granting authority for European patents under the European Patent Convention (which has a broader geographical coverage than the EU) is not bound by a guiding document or clarifying notice issued by the EU Commission.

Clarifying Notice

At the end of the symposium, the EU Commission decided to work on a clarifying notice designed to examine relevant provisions in the Biotech Directive, and indicated that this notice is part of a package solution. Other elements of the package include endorsing practical solutions such as a higher transparency (e.g. the PINTO database), licensing possibilities (e.g. ILP), increased cooperation between the CPVO and the EPO, and raising the bar for ensuring high-quality patents.

Such a notice has no legally binding effect, and the EU Commission is aware of that. The head of the IP unit of the EU Commission, Jean Bergevin, said that “such a notice still offers a satisfactory solution in terms of interpreting the scope of the Biotech Directive.” However, several participants stated that a notice that is not legally binding opens the door for legal uncertainty. Bergevin also implied that only the EU Court of Justice can further clarify the scope and intent of the Biotech Directive.

After the symposium, Dominic Muyldermans, senior legal consultant at Croplife International, said, “It was disappointing to see that the EU farmer’s organization COPA-COGECA is so adamant in their anti-patent approach. This does not match their pro-innovation talking points and disregards the value of agricultural innovations for farmers”.

He further mentioned that all relevant stakeholders representing the plant industry would continue to engage with COPA-COGECA. “It should be noted that COPA-COGECA is a member of the EU Food and Feed Chain (FFC) and the Agri-Food Chain Coalition (AFCC) and lately, the AFCC has taken a strong pro-innovation stance. Innovation in agriculture is absolutely crucial for farmers and society alike. It is important that farmers understand that different types of intellectual property are crucial to their advancement.”

The current Dutch strategy with regards to the patenting of products of essentially biological processes is to aim for a legal interpretation that will provide a clarification of the position of the Biotech Directive, said de Roos. “As the intention of that Directive was to provide patent protection for biotechnological inventions, the scope was never meant to cover traditional crossing and selection or the plants resulting therefrom.”

“Once the Commission has provided guidance for the member states, then the EPO policy will need to follow. The question is whether all 28 member states are committed to taking this a step further within the Council of the EPO, where it will take 38 countries to decide,” she adds.

“Plantum realizes that the road towards and beyond a legal interpretative document is going to be a long one. However, this problem needs to be solved and if this is how it can be achieved without having to open the Directive, we should give it a fair try. But let’s be clear, if this doesn’t work, there is only one alternative for Plantum, and that is an amendment of the Directive.”

Szonja Csörgõ of the European Seed Association states that ESA’s position is that products obtained by essentially biological processes should not be patentable. “We are convinced that this was never the intention of the legislator and such a situation would also make the exclusion of essentially biological processes meaningless,” she says.

“At the same time, we hold that patent protection should remain available for technical inventions, such as plants obtained by a process not based on crossing and selection. ESA has argued for this position in the Commission Expert Group in the past two and a half years and hopes that the clarifying notice of the Commission will bring the necessary clarifications since an opening of Directive 98/44 would not be a desired way of action.”

Violeta Georgieva, legal and regulatory advisor for EuropaBio adds: “EuropaBio is of the strong opinion that the Biotech Directive should not be opened, because it defines a stable and efficient harmonized patent framework which promotes research and innovation and has greatly improved technology transfer in the European Union throughout the whole spectrum of biotechnology, including healthcare and industrial applications.”

Editor’s Note:

It seems that ensuring that only high quality patents are granted is paramount combined with a high level of transparency. The limited breeder’s exemption, licensing opportunities, the PINTO database and the efforts to raise the bar on patent quality are all solutions that take care of the different concerns. In previous articles in this magazine, I have argued that a strong and robust system of intellectual property rights remains crucial to deal with the huge challenges that we are faced with. With all the various solutions as mentioned above, it seems there is much less of a need to consider changes to the European patent system than a few years ago. It will now be necessary for the seed sector to follow the development process of this Clarifying Notice as good and as close as possible and continue to provide input into the drafting process. There is no guarantee that the EU Commission will take any of industry’s opinions into account, but not continuing to reach out to the Commission is in my view not an option. The efforts of various actors on the seed sector side over the past few months to align messages have led to speaking with one voice against opening the Biotech Directive. Let us hope progress towards reinforcing market-led solutions to alleviate the concerns of breeders continues.

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