A plan to deregulate gene-edited crops in Europe has become entangled in a dispute over the technicalities of intellectual property.
In February, the European parliament agreed to loosen regulations by banning patents on crops produced by genetic editing. The move followed a proposal in 2023, by the European Commission, the EU’s politically-independent executive arm, to lift controls on some genetically modified crops in order to help farmers maintain yields in the face of climate change.
Genetically modified crops — in which genes from a different plant species are added to a plant’s DNA — can have various benefits, including making crops more nutritious, or more resistant to pests. These crops, among them soyabean, corn and cotton, are sold around the world, including in the US and India. But the technology remains contentious, with critics disputing its alleged benefits.
In the EU, prior to the deregulation plan, only one “genetically modified organism” had been authorised: an insect-resistant maize variety. In its February move, however, the European parliament decided to relax restrictions on a similar genome technology — that of “genetically edited” crops — which, under the proposed law, will be treated the same as crops grown in a conventional way.
Genetically edited crops do not involve “foreign” genetic material from other species being inserted into a plant. Instead, precise changes are made to a plant’s DNA, by editing it with the equivalent of molecular ‘scissors’.
The most common gene-editing technology is called Crispr: a laboratory biotechnology that uses elements naturally found in bacteria to modify the DNA of living organisms. Supporters of crop gene editing say it will strengthen Europe’s food system and make it greener, by developing plants that are more resilient to climate change and pests, have a higher yield, and require less fertiliser.
Gene-edited plants are “crucial to strengthen Europe’s food security and to green our agricultural production”, said Swedish lawmaker Jessica Polfjärd, the politician leading the genome deregulation plan in Europe’s parliament, earlier this year.
The European Commission proposal in 2023 said Europe was falling behind other parts of the world in gene editing and should relax restrictions on the technology to catch up, explains Andrea Williams, a partner and European patent attorney at law firm Marks & Clerk. “The European parliament was like, ‘we agree’,” she says. But there was a catch. The parliament said that cutting back restrictions and regulations would have to include banning patents on genetically edited crops.
Among critics of the proposal to ban the patents are green activists, farmers, biotech start-ups, and multibillion-dollar agriculture technology companies. A key concern is that banning patents will stifle innovation because companies will no longer be able to prevent their inventions from being copied.
“Farmers and biotech companies are investing in technical innovations they may not be able to protect through patents,” points out Camilla Kiørboe, a partner and Danish patent agent at law firm Potter Clarkson. “This causes legal uncertainty for companies investing in R&D in this sector as well for investors.”
Kiørboe — an expert in food and agricultural technology intellectual property — acknowledges the arguments for lightening the “regulatory framework” for gene-edited crops. Current patent rules for plant breeders can be “difficult to navigate”, she admits. However, uncertainty over if, or how, the proposed patent ban will be implemented makes it “super difficult” to know how to advise clients, she says.
UK biotech start-up, Resurrect Bio is already using gene editing to develop crops resistant to disease. Its co-founder, Cian Duggan, says patents are essential to protect biotech intellectual property and breakthroughs.
It can take up to 10 years of research, including up to four years of field trials, to develop crops with new disease-resistant traits and bring them to market, he notes. “We develop new technologies [and] new solutions for farmers, and we license that intellectual property to the seed industry,” Duggan says. “Without a patent, we have no product.”
He adds that a patent ban would also make it harder for small companies to compete against the half a dozen or so large biotech companies that dominate the industry. If the European proposal becomes law “it would encourage our board to want to move to the US”, Duggan says.
Yet, even if the EU pushes ahead with its patent proposal, other small businesses in agriculture doubt whether it would achieve its intended objectives — for example, avoiding legal uncertainties.
According to one such small crop business, Nordic Maize Breeding (NMb) of the Netherlands, a patent ban on gene edited crops could still leave them subject to legal action for infringements, making it “irrelevant”.
Grietje Raaphorst-Travaille, co-founder of NMb, which breeds maize through conventional and organic methods, suggests that, if farmers think a patent ban on gene edited crops will give them the peace of mind, they may be disappointed. “Farmers run the risk of violating patent rights without knowing it,” she warns — and they may be sued as a result.
Gene editing in agriculture will drive small businesses “even more into the trap of dependence on large companies”, Raaphorst-Travaille believes.
Large biotech companies, however, are also worried. Matthias Berninger, head of public affairs, science and sustainability at Germany’s multinational pharmaceutical and biotechnology company Bayer, which supports patentable gene edited crops, says gene editing is a “very important” innovation at the “intersection of biology, chemistry and artificial intelligence”.
One alternative to the European patent proposal, favoured by some patent lawyers — and Bayer — would be to allow patents for gene-edited crops but insert a clause into the law that allows small plant breeders and farmers to use materials and techniques covered by patent, without having to pay a licence fee to the patent holder. Bayer uses this principle for small vegetable breeding companies in the EU.
Critics of the proposal appear less flexible, though, and say it should either be scrapped or modified to reward companies for technical breakthroughs. One source familiar with EU legislative procedures says the “best-case scenario” is for the plan to become law in the first half of 2025.