b'before, either in a scientific publication, in a gene bank, another patent, or even in an existing plant in a collection. For example,EUROPEAN APPLICATIONS STATUSa 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.31% GrantedTake the example of a knockout muta- 46% Pendingtion, which deactivates a given gene that is already known to be involved in a spe- Refusedcific physiological pathway responsible for a desired trait. Subsequently, the deactivationDeemed Withdrawn of the same gene with a different mutation19% or Withdrawnwould make that invention possibly novel, but it would not make it inventive because4%it would already be known that deactivating that gene would lead to the expected trait.Lastly, to be granted a patent, inven-tions must also be Sufficiently Described inAverage fate of the European patent applications over the years which were the patent application to enable anyone elsepublished with claims relevant to NGT plants. Source: CLE Studyto reproduce it without excessive efforts. This means providing all the details about what the invention is, how it was obtained and,Strong IP protection also helps keep R&Din patent laws, but no breeders exemption. possibly, how to get the biological material.investment interest alive.Several EU Member States have remedied Only if all these criteria are complete canThinking more broadly, one may inthis in the last yearsamong them France, an invention be approved for patentability.fact consider an increase in the number ofGermany, the Netherlands and Poland, and The EPO reports on its website that itspatents to be a good sign for EU farmers,other Member States having ratified the grant rate across all sectors is around 60%,reflecting that R&D investments are madeUnified Patent Court Agreement (UCPA) meaning that 40% of the applications areto try addressing the problems they facein 2023. refused or abandoned during the exami- with the crops they grow. Enabling NGTThe breeders exemption in patent nation phase. The CLE study reveals that,plants for EU farmers requires not only alaws has the exact same effect as in the when it comes to plant-related inventionsscience-based regulation but also, separatePVP law, i.e. it enables any breeder to use obtained by NGTs, this grant rate reducesfrom any regulatory framework develop- a commercial variety containing a patented to 31%.ments, an effective IP framework that stim- trait of another breeder in its own breed-What may remain patentable are thoseulates R&D investments. ing program for the purpose of creating a NGT innovations involving more complexnew variety. If the new variety no longer traits, that may be controlled by more thanWOULD PATENTS ON PLANTcontains the patented trait, or if the patent one gene or that may not be achievable byTRAITS BLOCK SME BREEDERS? has expired or been abandoned at the time simply knocking out a gene, but by edit- PVP laws include one fundamental right,of its commercialization, it may be freely ing several target genes with very specificthe so-called breeders exemption. Thecommercialized. If however the breeder mutations at very specific gene locations.breeders exemption allows any breeder toof the new variety is interested to have the Typically, those will require much moreuse a commercial variety protected by ainnovative patented trait in its new variety R&D efforts to understand the implicationPVP of another breeder in its own breedingand the patent is still in force, the breeder and the functioning of genes involved in rel- program for the purpose of creating a newof the new variety would need to secure a evant traits. Companies investing in biotechvariety.license from the patent owner and pay royal-R&D can only rely on patents to obtain aHistorically, there has always been aties for the remaining lifetime of the patent, fair return on higher risk investments.similar exemption for research purposeswhich may be only a few years given the MAY 2025|SEEDWORLD.COM/EUROPEISEED WORLD EUROPE I 27'