Facts on how patents and Plant Variety Protection can co-exist in a functional system.
Since the publication by the European Commission of the Proposal for a Regulation on plants obtained by certain New Genomic Techniques (NGTs) in July 2023 (the “Proposal”), the EU institutions have engaged in democratic political debate, involving both the European Parliament and the Council of the EU. Even though the intention of the Commission’s Proposal was to address the regulatory status determination of plants obtained by NGTs, the topic of intellectual property (IP) entered the scene through the backdoor and has dominated almost all debates. The Parliament has voted to exclude NGT plants from patentability, while a Council majority was blocked for more than a year with member states exploring various paths to address the topic and to finally agree on a text in March 2025 obliging disclosure of NGT-related patents by applicants. Political debates on IP are also echoed in the seeds industry where some, mostly SME breeding companies, advocate against patents on NGTs while others, mostly the largest breeding companies and the biotech startups, defend that patents are needed to protect NGT plant innovations. Seed World Europe reported several times on the diversity of positions reflected in the seed industry.
In an attempt to shed light on the various claims made about IP and NGTs, CropLife Europe (CLE) contracted independent experts to compile factual data from publicly available sources helping understand what patents actually are and do, and whether the concerns expressed by the various actors are justified. This article summarizes the results of their findings (CLE Study)1.
Could Plant Variety Protection be Sufficient to Protect NGT Traits ?
Many conventional plant breeders claim that Plant Variety Protection (PVP, or PBR for Plant Breeder’s Rights) should be sufficient to protect all innovations in plant varieties, therefore patents should not be necessary.
The CLE study reveals that PVP rights in the frame of the UPOV Convention are effectively the tool adapted to protect plant varieties. Less than a handful of countries, including the USA, offer patents to also protect new plant varieties. However, in the vast majority of countries worldwide, including Europe, the only legal means to protect plant varieties is PVP.
This does not mean that all plant breeding innovations can be protected by PVP. For example, a plant trait developed through NGT is not protected under Plant Variety Protection (PVP), which only covers the variety as a whole, not individual traits.
Once the PVP protected variety is commercialised, every breeder can use it in their breeding programs to integrate certain traits of that variety into their own ones and create new varieties containing the NGT trait. Those derived new varieties would not be protected by the PVP on the initial variety.
The only IP tool available to protect a technically created element of a plant, like an NGT trait, is the patent. In Europe, the EU Directive 98/44/EC is tailor-made for the legal protection of all such biotechnological inventions. PVP and patents are therefore complementary — not mutually exclusive — because they have a different scope and protect different types of innovation, and plant breeders will either use one or the other, or both, depending on the type and nature of R&D they invest in.
Only with a patent can the NGT trait be protected when used by other breeders to create new varieties.
Europe’s Diverse Plant Breeding Sector has Different IP Needs
The breeding sector in Europe is historically composed of a diversity of small, medium and large companies, who develop new varieties by conventional breeding methods of crossing and selection, including with the assistance of genetic markers or even NGT to introduce well-known mutations in developed varieties at faster pace. Developers of such new varieties must rely on PVP for protecting their research efforts.
Other companies, mostly startup companies, explore the potential of all biotechnological techniques now available to create new traits, including NGT. Those companies do not create new varieties themselves and do not need PVP. They develop new traits for breeding companies and must rely on patents to secure protection of their trait innovations.
There are also some breeding companies that both develop traits using biotechnologies and new varieties in which they introduce those traits. These companies need both PVP and patents to protect all their innovations.
Both PVP and patents enable companies to protect their research endeavours and avoid being copied for a limited period.
Would the Number of Patents Increase Dramatically with NGT?
Some stakeholders are worried that there will be a huge wave of patents rolling over the European market with NGTs. The assumption that every patent applied for will become a granted patent is, however, far from true. As reported in the CLE study, not everything is patentable, and there are exceptions to patentability.
In the field of plants, one exception which has always existed is the exclusion of essentially biological processes to produce plants (or animals). This exclusion is enshrined in the World Trade Organization (WTO) agreement on Trade related aspects of IP rights, TRIPS. The European Patent Office (EPO) includes it in its Article 53(b). This exclusion is expressly directed towards avoiding that conventional breeding methods, consisting essentially in crossing of plants and selecting the ones bearing useful characteristics, be protected by patents, because these methods are deemed not technical and the traits selected would be “native”. The EPO’s Enlarged Board of Appeal has even clarified that the use of genetic markers in the selection process does not make an essentially biological process patentable. More recently, in July 2017, the EPO has also excluded the plants obtained by such essentially biological processes, i.e. plants that would essentially contain native traits.
The main criterion for an invention being considered patentable subject-matter is that it has been obtained by technical means. Plant traits obtained by technical means such as random or targeted mutagenesis techniques (e.g. NGT) can be considered patentable and enter the field of inventions for which a patent may possibly be granted.
It is, however, not because a patent application can be filed for a technical invention that this invention will satisfy the criteria for obtaining a granted patent.
The first criterion is that of Novelty. Nothing that was already known or existing can be patented. Regarding plant traits, a specific mutation in a gene responsible for a certain trait may not satisfy the Novelty criterion if that mutation was already known before, either in a scientific publication, in a gene bank, another patent, or even in an existing plant in a collection. For example, a known mutation in a gene cannot become novel simply by having it created again by a technical means.
Assuming a given NGT trait would be novel, it would further have to satisfy the patentability criterion of Inventiveness before possibly being protectable by a patent. Take the example of a “knockout” mutation, which deactivates a given gene that is already known to be involved in a specific physiological pathway responsible for a desired trait. Subsequently, the deactivation of the same gene with a different mutation would make that invention possibly novel, but it would not make it inventive because it would already be known that deactivating that gene would lead to the expected trait.
Lastly, to be granted a patent, inventions must also be Sufficiently Described in the patent application to enable anyone else to reproduce it without excessive efforts. This means providing all the details about what the invention is, how it was obtained and, possibly, how to get the biological material. Only if all these criteria are complete can an invention be approved for patentability.
The EPO reports on its website that its grant rate across all sectors is around 60%, meaning that 40% of the applications are refused or abandoned during the examination phase. The CLE study reveals that, when it comes to plant-related inventions, this grant rate reduces to 31%.
One likely reason for the low grant rate is that a lot is already known about genes involved in plant traits, especially the simple plant traits that are governed by only one or a few genes. There are many scientific articles about the role of certain genes in the expression of a given trait being constantly published worldwide (e.g. see the database of EU-SAGE)2 which decreases the scope of what may satisfy the novelty and inventiveness criteria of patents.
The CLE study has also revealed that the current portion of commercial varieties in Europe that are covered by a patent is between 3 and 4% in terms of number, and between 1.6 and 2.1 % in terms of market shares.
What may remain patentable are those NGT innovations involving more complex traits, that may be controlled by more than one gene or that may not be achievable by simply knocking out a gene, but by editing several target genes with very specific mutations at very specific gene locations. Typically, those will require much more R&D efforts to understand the implication and the functioning of genes involved in relevant traits. Companies investing in biotech R&D can only rely on patents to obtain a fair return on higher risk investments. Strong IP protection also helps keep R&D investment interest alive.
Thinking more broadly, one may in fact consider an increase in the number of patents to be a good sign for EU farmers, reflecting that R&D investments are made to try addressing the problems they face with the crops they grow. Enabling NGT plants for EU farmers requires not only a science-based regulation but also, separate from any regulatory framework developments, an effective IP framework that stimulates R&D investments.
Would Patents on Plant Traits Block SME Breeders?
PVP laws include one fundamental right, the so-called breeder’s exemption. The breeder’s exemption allows any breeder to use a commercial variety protected by a PVP of another breeder in its own breeding program for the purpose of creating a new variety. Under EU PVP Regulation (2100/94), if such a new variety were an essentially derived variety, it would still be dependent on the PVP of the initial variety, i.e. only if sufficiently different could the new variety be freely commercialized.
Historically, there has always been a similar exemption for research purposes in patent laws, but no breeder’s exemption. Several EU member states have remedied this in the last years – among them France, Germany, the Netherlands and Poland, and other member states having ratified the Unified Patent Court Agreement (UCPA) in 2023. Today, 19 member states include a breeder’s exemption in their patent laws.
The breeder’s exemption in patent laws has the exact same effect as in the PVP law, i.e. it enables any breeder to use a commercial variety containing a patented trait of another breeder in its own breeding program for the purpose of creating a new variety. If the new variety no longer contains the patented trait, or if the patent has expired or been abandoned at the time of its commercialization, it may be freely commercialized. If however the breeder of the new variety is interested to have the innovative patented trait in its new variety and the patent is still in force, the breeder of the new variety would need to secure a license from the patent owner and pay royalties for the remaining lifetime of the patent, which may be only a few years given the time necessary to develop a new variety. CLE supports the implementation of such a breeder’s exemption by all EU member states in their patent laws, regardless of whether they ratified the UPCA or not.
As highlighted in the CLE study, it is worth mentioning that a new variety would also not be covered by the patent if it would contain a conventional-like version of the patented trait. Indeed, only the technically obtained trait, e.g. from NGT, would be protected by a patent. Its conventional or native equivalent would be expressly carved out from the patent claims as imposed by the EPO under the so-called “disclaimer” solution3.
Would Breeders Not Know if a Commercial Variety is Protected by a Patent?
It is in fact easy for a breeder to verify if a commercial variety is protected by a PVP title because both have in common the denomination of the variety, i.e. its name. The interested breeder can simply enter the variety’s denomination in the CPVO database and will immediately find out.
This is admittedly not as straightforward for patents. A patent on a NGT trait would use language to describe the trait and might refer to some gene sequences and some specific mutations which would not tell without a thorough expert analysis if it covers a given variety or not. However, most recently, to enable breeders to make informed decisions whether to use a given commercial variety under the breeder’s exemption, the European seed industry association, Euroseeds, has developed a database named PINTO4 in which companies list their commercial varieties covered by patents. The database can be searched by the variety denomination, and it indicates immediately if a patent covers a trait in that variety, also indicating the patent number and the name of its holder.
CLE has noted that certain provisions on transparency similar to PINTO have been proposed to be made mandatory for NGT plant requesters in both the EU Parliament and the EU Council proposals. CLE supports transparency measures like PINTO that enable plant breeders to readily identify varieties containing patented traits and make informed decisions to use them or not.
Would Breeders be Unable to Commercialise their New Varieties Because of Patents?
Should they be granted, patents, like PVP, are IP titles that avoid copying by others for a certain period in compensation for the creative efforts of their holder. If, by using a commercial variety containing a patented trait identified with PINTO, a breeder creates a new variety under the breeder’s exemption containing the patented trait, he may need to obtain a license from the patent holder to commercialize it. This has worried some breeders about how to commercialize their new varieties and that the cost for a license might supposedly be exorbitant.
To address these concerns, the majority of seed companies in Europe have committed to license their patented traits to any breeder asking for it, through licensing platforms. Notably there are two licensing platforms covering the EU, the ILP for vegetables5, created in 2014, and the ACLP, for agricultural crops6, created in 2023. Both oblige their members holding patents on traits to commit granting a license on their patent on fair conditions to any other member requesting it for a new variety created under the breeder’s exemption. The grant of such a license cannot be refused by a member and uses a standard license agreement that is publicly available on the platforms’ websites. Only the royalty rate remains to be agreed between the parties. To avoid excessive royalty rates, either high or low, both licensing platforms have established an arbitral mechanism to be activated in case the parties find themselves unable to reach agreement. This arbitral mechanism operates under the principles of “baseball” arbitration. Under such a mechanism, each party makes a royalty rate offer to three independent arbitrators, who then decide which of the proposed rates is the closest to the market value of the trait in the crop considered. Importantly, the arbitrators will not make an intermediate proposal between the two, they will pick the one closest to the market value. Parties are thereby incentivized to make realistic proposals, as theirs would otherwise likely be rejected. In over 10 years of existence in the ILP Vegetables, the baseball arbitration has never been activated despite many license agreements having been executed between its members.
It is worth noting that, as of today, 95% of the patented traits that are in commercial varieties are available via one or the other licensing platform.
Would Farmers be Prevented to Save Seeds with Patents?
The CLE study clearly highlighted that the right for farmers to save seed exists in both PVP and patent laws in Europe. This is the farmers right to reuse some of the seeds of their harvest of a PVP or patent protected variety to replant on their own holding. This right is well established under the EU PVP Regulation 2100/94, where farmers making use of it must pay moderate compensation to the PVP holder, except for small farmers for whom this right can be exercised freely. It is also present under the patent rules of the Directive 98/44/EC, which expressly refers to the legal provisions of the EU PVP Regulation 2100/94 for its implementation. The conditions of application of this right by farmers are therefore the same under European PVP and patent laws.
Farmers therefore not only have the right to save seeds of a variety containing a patented trait, but this right is also applicable under the exact same conditions as under PVP law.
The CLE study shows that the current IP framework in Europe is already well adapted to the development of NGT plants.
CLE considers that for NGT plants to reach European farmers in the coming years, there needs to be both an appropriate regulatory framework, which the current NGT proposal is trying to achieve, and separately there needs to be an appropriate IP framework enabling all actors to protect the results of their R&D efforts.
The CLE members active in seeds are mostly companies that are both breeding companies developing new varieties and biotech companies developing new traits for their varieties. As a result, they rely on both PVP and patents to protect the results of their research activities. They are also mindful of the negative perception that patents may carry to those not familiar with them. CLE therefore requested this study about the factual nature and effects of patents in the plant breeding sector, as summarized in this article.
Not only do patents not hinder breeding, but they also generate much value to farmers and society. Some years ago, an economic study was published about the patented Ogura trait developed by the French research institute INRAE7and licensed to the seed sector developing oilseed rape varieties. This study demonstrated that 80% of the economic value generated with a patented trait has gone to the farmers and to the downstream users in the value chain up to consumers.
The CLE member companies believe that with strong PVP and patents, companies will be incentivised to develop NGT plants. Together with the transparency and licensing tools that have been developed, NGT plants will be accessible to all breeding companies whatever their size, thereby enabling European farmers to be competitive and have access to such plants in a large offering of varieties from the whole European breeding sector.
[1] Data on file from a study performed by Altius law firm, De Clercq & Partners IP law firm and Acutifolius Consultancy Firm are available upon request to CLE (croplife@croplifeeurope.eu)
[2] https://www.eu-sage.eu/genome-search
[3] https://www.epo.org/en/news-events/press-centre/fact-sheet/447625#q3
[4] https://euroseeds.eu/pinto-patent-information-and-transparency-on-line/
[5] https://www.ilp-vegetable.org/
[6] https://aclp.eu/
[7] https://croplife.org/wp-content/uploads/2014/11/Ogura-Final-report.pdf
See more articles abut this topic here:
