Patents vs Plant Variety Rights

There are two distinct types of intellectual property when it comes to plants: plant variety rights and patent protection.

In Europe, Plant Variety Rights (PVRs) are a form of intellectual property that protect new plant varieties based on their distinctness, uniformity, and stability, giving breeders exclusive rights to commercialise the variety while generally allowing further breeding and research use. Plant varieties are not patentable under the European Patent Convention (EPC) and most national patent laws in Europe; and furthermore, essentially biological processes such as traditional breeding methods, even if assisted by technical means, are also excluded from patentability in Europe.

Patents can protect plant-related inventions such as plants with engineered traits, genetic constructs, biotechnological processes, methods of genetic engineering or genetically modified plants where permitted, and patents can provide broader exclusive rights that can restrict use of the protected invention, including for further breeding.

Plant biotechnology patents have been dominated by Genetically Modified Organism (GMO) technologies in recent history, and this is now transitioning to New Genomic Techniques (NGTs).

Background: Genetically Modified Organisms and New Genomic Techniques

Genetically Modified Organisms (GMOs) are organisms with altered DNA using transgenic techniques, often the insertion of foreign DNA into a plant’s DNA.

New Genomic Techniques (NGTs), such as CRISPR-based gene editing, enable precise modifications of a plant’s genome and can often do so without introducing foreign DNA. NGTs are generally regarded as distinct from transgenic GMOs because the resulting genetic changes may also be achievable through conventional breeding or natural mutation.

GMO-related patent applications have historically faced challenges at the EPO. Commercial exploitation has also been limited because GMOs are subject to extensive regulation under Directive 2001/18/EC which treats GMOs as high-risk biotech due to the use of foreign DNA. Until now, NGTs have been regulated by the same GMO directive which has created a barrier to commercialisation of NGTs in the EU, even though NGTs do not carry the same risks as GMOs due to the absence of the introduction of foreign DNA.

The EU parliament has recently approved a new regulation which distinguishes between certain New Genomic Techniques and Genetically Modified Organisms.

New regulations for NGTs

In 2019 the EU Council requested a study into whether the current GMO law is fit for purpose for NGTs and after a detailed review, new regulations for NGTs were proposed in 2023. The new regulations define two different types of NGTs to legally distinguish NGTs from GMOs.

NGT Category 1 (NGT1): plants that satisfy the equivalence criteria set out in the Regulation, including a limit of up to 20 qualifying genetic modifications relative to the parent plant. These are subject to a simplified verification procedure and are largely exempt from GMO requirements.

NGT Category 2 (NGT2): all other NGT plants that do not meet the Category 1 criteria. These remain subject to GMO-style risk assessment, authorisation and regulatory requirements, albeit with some tailored provisions

In 2024 the European Parliament adopted amendments proposing the exclusion of certain gene-edited plants from patentability. Although these amendments would not have directly amended the European Patent Convention, they created uncertainty and challenges when patenting New Genomic Techniques. On the other hand, many farmers’ groups, breeders and some Member States were concerned that patents on NGT plants could make it difficult for smaller breeders to identify relevant patent rights and obtain access to genetic material without being accused of infringement, leading to increased market concentration and reduced freedom to operate in the plant breeding sector.

In 2025 the amendment to exclude gene edited plants from patentability was removed and as a compromise, it was replaced with the following IP transparency terms:

• Mandatory disclosure of patents and patent applications: applicants seeking registration of an NGT1 plant must disclose any relevant existing patents and pending patent applications. This disclosure obligation extends beyond patents owned by the applicant and requires identification of relevant third-party patents and patent applications. This information is entered into a public database.
• Voluntary licensing statements: patent holders may indicate whether they are willing to license the patented technology on fair and reasonable terms, helping breeders assess freedom to operate.

• The Regulation requires the Commission to establish an expert group to monitor patent-related issues and the effects of patents on NGT plants and to publish, within one year of the Regulation’s entry into force, a study on the impact of patenting on innovation, access to seeds and sector competitiveness.

On 17 June 2026 the European parliament voted and approved the new NGT regulations with the IP transparency terms and without any patentability exclusion terms. It is expected that the regulations will take around 2 years to be fully implemented.

Whilst GMO and NGT regulations continue to be complex, this is a step towards providing much needed regulatory distinction between the two technologies to help future research and development in plant technology.

If you have any questions, please contact one of our attorneys for advice.