Ten years ago gene editing plants was far from commonplace – indeed, the first CRISPR edited mammalian cells had only just been achieved. Fast-forward ten years and a search for gene edited crops lists numerous successful trials, from GABA-enriched tomatoes for better sleep to disease resistant risotto rice. The possibilities for gene editing to transform agriculture, initially at least, seemed limitless.

As a partner at a European intellectual property (IP) firm, and head of the Agritech Biotech practice, I’ve been closely following the ongoing developments regarding gene-edited plants and crops in the European Union. There’s been considerable confusion and misinformation circulating about the legal status of these innovations. In the following article I will clarify the current situation and discuss potential future changes.

Contrary to popular belief, gene-edited plants are not banned or illegal in the European Union. However, they are currently classified as Genetically Modified Organisms (GMOs) and subject to the same stringent regulatory framework. This classification stems from a 2018 European Court of Justice ruling, which determined that organisms obtained by new mutagenesis techniques should fall under the GMO Directive.

While this doesn’t constitute an outright ban, it can present significant hurdles for bringing gene-edited crops to market in the EU. The regulatory approval process for GMOs is exceptionally rigorous, involving extensive risk assessments and safety evaluations. As a result, only a handful of GMO crops have been approved for cultivation in the EU to date.

Regulatory hurdles aside, it is crucial to understand that – at the moment – companies can still obtain patent protection for their gene-editing innovations in Europe. Put simply, the issue lies not in intellectual property protection, but in the ability to commercialise these products due to the regulatory landscape.

Encouragingly, the European Commission has recently put forward a proposal to relax the regulatory approval process for certain gene-edited plants. This proposal aims to create a more favourable environment for innovation in agricultural biotechnology while maintaining safety standards.

However, and to the surprise of many of us in the intellectual property field, the European Parliament, while agreeing to relaxing the regulatory process, suggested that there should, in addition, be a ban on patenting gene-edited plants. Unsurprisingly, this potential ban has sparked considerable debate within the intellectual property and particularly agritech start-up communities.

As a patent attorney, I have serious concerns about the implications of such a ban. While the intention may be to promote access and prevent monopolisation, it seems difficult to conceive how a ban would not ultimately stifle innovation and investment in this critical field.

Patents in particular play a crucial role in incentivising research and development, particularly in fields like biotechnology that require a substantial upfront investment. In the context of gene-edited crops, a patent can protect groundbreaking innovations that have the potential to address global challenges such as food security, climate change adaptation, and sustainable agriculture. For example:

  1. Drought-resistant crops: Gene editing techniques could be used to develop plants with improved tolerance to water stress, helping farmers maintain yields in increasingly arid conditions.
  2. Pest-resistant varieties: By enhancing a plant’s natural immune responses, gene editing could reduce the need for chemical pesticides, benefiting both farmers and the environment.

Without patent protection, companies may be reluctant to invest in developing these crucial technologies, potentially slowing progress in addressing urgent agricultural challenges.

Rather than an outright ban on patents for gene-edited plants, a more nuanced approach could better serve the interests of innovation, farmers, and society at large. One potential solution is the expansion of the “breeder’s exemption” across all EU national patent laws.

The breeder’s exemption, which already exists in Plant Variety Rights (PVR) legislation, allows breeders to use protected varieties as starting material to develop new varieties without infringing on the rights of the PVR holder. Implementing a similar exemption in patent law could strike a balance between protecting innovators’ rights and ensuring access to genetic resources for further breeding and development.

As the debate over gene editing and patent protection continues in the EU, it’s essential to consider the long-term implications of any regulatory changes. While concerns about monopolisation and access are valid, we must be careful not to implement policies that could inadvertently hinder innovation in this critical field.

A thoughtful, balanced approach that protects intellectual property rights while promoting access and competition is crucial for fostering innovation in agricultural biotechnology. As patent attorneys, we have a responsibility to contribute our expertise to this ongoing dialogue and help shape policies that will drive progress in sustainable agriculture for years to come.

Originally published by Agri-TechE

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.