27 June 2016
By Penny Maplestone FRSB, Chief Executive of the British Society of Plant Breeders
Say the words broccoli and tomato to a group of European plant breeders and the chances are you will spark an excited and at times furious debate about the best way to protect Intellectual Property (IP) in plants. Key decisions taken last year by the European Patent Office may have changed the plant IP landscape in Europe for ever.
What is the issue?
The world wants plant science to deliver more yield, better nutrition, stronger pest and disease resistance, and greater resilience in the face of climate change and extreme weather events. One route to deliver these benefits is through the crop varieties developed by the commercial plant breeding industry. Plant breeding is a research intensive, expensive and highly competitive business which relies on IP as the mechanism to protect its innovation and generate a financial return for reinvestment in more breeding. Globally, the industry has had a range of options for protecting its IP. Some multinational companies that invest heavily in biotech and trait development have favoured patenting, which brings strong protection and opportunity for income through licensing. In Europe, the tradition is that breeders use Plant Variety Rights (PVR) , the bespoke global system for protecting plant varieties, to protect their IP and guard jealously the open source approach that the ‘breeders’ exemption’ offers as a cornerstone of that system. The breeders’ exemption means that any commercial PVR protected variety is available to all other breeders for unfettered further breeding and commercialisation. It has long been regarded as vital to ensure free access to germplasm, thereby promoting innovation. Proponents of patents may argue to the contrary that the stronger protection they offer safeguards their investment, allowing them to return more income to their breeding programmes and in that way speed innovation. In Europe a plant variety is not patentable, but a trait or a breeding technology may be, provided that it meets the normal requirements for patentability, effectively bestowing patent protection on relevant plant material, the subject of the patent claims. All well and good, and until now the PVR and patent systems have rubbed along just fine with most European varieties protected by PVR and some patents awarded for specific developments.
What changed was that the European Patent Office (EPO) granted the broccoli patent (broccoli with high levels of glucosinolates with antioxoidant properties) and the tomato patent (tomatoes with low water content). These were challenged on the grounds that the methodology involved crossing and selecting –traditional plant breeding which was deemed to be an ‘essentially biological process’ and therefore not patentable under European patent law. That was a welcome point of clarification and dealt with the patentability of the process. But what about the products? If an essentially biological process is not patentable then surely, logically, any products derived from such process should also not be patentable? Well no, came back the somewhat surprise answer from the EPO, according to our interpretation of the law, the products can be patentable if they meet the standard criteria. This judgement rather set the cat amongst the breeding pigeons, raising concerns across the industry that the ability to patent the products of plant breeding could seriously damage the freedom that plant breeders currently have to access genetic material in the form of protected varieties. What might this mean for freedom to operate and ability to innovate? It has also sparked a debate about what is best for plant breeding innovation – is it PVR, is it patents or is it some form of harmonious co-existence.
What happens now?
There is no doubt that the world needs innovation in plant breeding and it needs that innovation to be delivered faster than plant breeders can currently manage. For that the industry, wherever in the world it operates, needs to have access to the full range of breeding technologies, practical and workable access and benefit sharing mechanisms for genetic resources, and effective and enforceable IP protection. Breeders also need to have some legal certainty about the world that they are operating in, and the decisions in the broccoli and tomato cases have not helped. The EU Commission announced recently that later this year it will produce a ‘clarifying notice’ based on the original legislator’s intent in drafting the EU patent legislation in relation to this question of the patentability of the products of essentially biological processes. Whatever this says, it will be welcomed as it will define some boundaries and go some way towards the desired legal certainty. We can then begin a measured discussion about how PVR and patents can co-exist in the plant breeding world, balancing the central tenets of access to germplasm and freedom to operate with robust and enforceable IP protection with positive consequences for plant breeding innovation to the benefit of society.