The EU Commission strikes again – New patent ban?
In times of the pandemic it was called to ban patents that are related to Covid-19 vaccines, medicaments, and diagnostics and the European Parliament was in favour of it. Now there is a call from the European Parliament to ban all patents on new genomics techniques (NTG) and plants. Quo vadis?
On February 7, 2024, the Members of the European Parliament (MEPs) adopted, by way of plenary vote, a position supporting a proposal of the Committee on Environment, Public Health and Food Safety (ENVI) to ban patents for all plants obtained by New Genome Techniques (NGT plants), plant material, parts thereof, genetic information and process features they contain. What does this mean?
New Genomic Techniques (NGTs), such as genome editing using CRISPR-Cas, can significantly improve the speed and precision with which new plant varieties are created. In Europe, intellectual property (IP) protection of biotechnological inventions, including NGTs, is regulated through the European Union (EU) Biotechnology Directive 98/44/EC. In addition, breeders can obtain single IP rights on both propagating and harvested materials (i.e., Plant Breeders Rights), but especially the patenting of harvested materials is heavily debated and controversial.
Back to the future
But – before jumping into the details of the heated discussion let us take a step back to have a look at the full picture. The world is full of legitimate interests that needs to be balanced. There are different stakeholders in a certain ecosystem that have different legitimate positions. There is the legitimate interest of patients to have access to affordable medicines. There is on the other hand the legitimate interest of those who invest into the development of medicines to get some return on their investment once the medicament is marketed. Patents are one tool of those who invest into innovations to secure some return on investment. These different interests need to be balanced.
Populistic voices who pretend to represent the interests of the patients called for a ban of patents to certain medicines, e.g. Covid-19 vaccines or drugs. Their populistic logic consists of the assumption that the ban of patents on medicines would free those medicines and hence, everybody has affordable access thereto. Like most populistic ideas, this falls short. Like most populistic ideas, they are nevertheless liked by people and disturbingly also by politicians. The real world is, however, a bit more complex: No patents on drugs means no investment into new drugs, no new drugs, no access to new drugs for patients as there are none. For those who work in this business this is an easy-to-understand reality. Unfortunately, this reality is mostly unknown to the public as the populistic voices are more popular and politicians tend to follow the easy and populistic route it seems. Furthermore, pharma and patent bashing seems woke, isnt it?
Breeders and inventors
Now, there is a legitimate interest of the breeders and farmers who do not employ NGT not to be unnecessarily bothered by patents. New Genomic Techniques (NGT) can improve the speed and precision with which new plant varieties are created. For breeders not using such techniques, developing new plant varieties is generally an expensive and time-consuming endeavour. The patentability of NGTs raises concerns among breeders and farmers, e.g. regarding the possible monopolisation of traits via the patent system and the possible accidental infringement of patents. Also, many small- and medium-sized breeders fear that it may become impossible to have access to the protected genetic material for breeding on reasonable terms.
On the other hand, companies investing into NGTs have a legitimate interest to protect their innovation and get some return on their investments. Mankind may have a legitimate interest in sustainable crop development, environmental safety, and food security through the development of more drought- and/or salt-resilient, disease-resistant, and higher-yielding varieties.
Banning NGT patents?
Will the proposal to ban patents for all plants obtained by NGT provide a balance of all legitimate interests? Certainly not! Instead of balancing these legitimate interests it seems the baby shall be thrown out with the bathwater. The populistic approach to ban patents will not lead to new sustainable crop development, environmental safety, and food security that may be provided by NGT. It will also not lead to investments into NGTs, at least not in Europe. The proposed plant patent ban would put the future of innovation in this area in Europe at risk, and compromise Europes long-term competitiveness. The proposed ban, therefore, undermines the aims of the original Commission proposal, which was expressly intended to create an enabling environment for research and innovation in the NGT plant sector. Breeders fear that they do not have access to all genetic material for further breeding due to the protection of these materials by patents. Breeders are concerned to infringe an existing NGT-plant-related patent in case they develop plants with the same features as the patented ones without using the patented NGT. There are concerns whether breeders may obtain affordable licenses if needed. Quite often the risk of unintentional patent infringement is debated that may occur due to naturally occurring cross-pollination between fields. For breeders it is often nontransparent what patents exist at all.
Risk of patent infringement
The legitimate interests of the farmers and breeders can and shall be addressed without compromising Europes competitiveness. Research exemptions, limited breeders exemption, patent pools, in certain cases compulsory licenses may all be tools to address the interests of farmers and breeders. Certainly, there are open issues that need to be addressed. This should, however, be done by involving all stake holders in this area. And it should be done by keeping all interests in mind: the interests of the farmers and breeders, the interests of the many European-based start-ups, SMEs, and research organisations active in the plant- and agricultural-biotechnology fields, the interests of Europe and the European community to have a competitive Europe that is not compromised by populistic politics and a Europe that can compete with China and the USA.
Thus, the impact study as requested by MEPs should also engage with representatives from the full breadth of (industry) stakeholders, including the many European-based start-ups, SMEs, and research organisations in the fields.
New monopolies?
It is an unfortunate misconception that patents are merely used by large multinationals to create monopolies to the detriment of SMEs and the public. This is untrue. In particular SMEs and research organiszations must rely on patent protection to compete with the established players. And it is in the interest of the public that new technologies come to the market. Moreover, it is in the interest of the European community that Europe is strong and competitive – which would be put at risk by any new patent ban.
This article was orginally published in European Biotechnology Magazine Spring 2024.
