There was a wave of relief with the announcement that the EU had finally reached provisional agreement on a new regulation for New Genomic Techniques (NGTs) in plant breeding. The full text is still under negotiation, but the key features are clear. NGT plants in Category 1 will be considered equivalent to natural or conventionally bred plants and will not be subject to the more onerous requirement of the GMO regulation.
Patents Under the Microscope
The agreed has some key implications for intellectual property rights. To register an NGT1 plant, the breeder or company will be required to submit information on all existing or pending patents, which will be made available in a public database. This is designed to address the serious concerns about transparency and freedom to operate for competitors, but in practice, it could be very difficult to navigate this obligation. Experts have already voiced concerns that this requirement — especially the reference to pending patents — could cause confusion or even conflict with other measures. The regulation will also encourage voluntary disclosure of the patent holder’s intention to licence the use of a patented NGT1 plant or product, under equitable conditions.
Patents have been a key concern during the NGT debate. This was obvious when the European Parliament proposed a patent ban for NGTs, but that proposal was rejected. Even so, patents will remain in focus.
A patenting expert group will be established to review the effect of patents on NGT plants, with experts from all Member States, the European Patent Office, and the Community Plant Variety Office.
Finally, the Commission will publish another study on the impact of patenting on innovation, on the availability of seeds to farmers and on the competitiveness of the EU plant breeding sector within one year after the entry into force of the regulation.
If the study identifies any issues, the Commission will then indicate what follow-up measures are needed or publish a legislative proposal to address those issues.
The Need for Fairer comparisons with Plant Variety Rights
While the European Commission continues to scrutinise the role of patents in the plant breeding and seed sectors, it is important to tackle some misconceptions that have shaped the policy debate. The discussion about intellectual property has relied on a simplified comparison between patents as “strong” protection and plant variety rights (PVRs) as “weak” protection. Patents are seen to offer more exclusivity, but this has also generated controversy for hindering access to technology and increasing the concentration of corporate control. PVRs are seen to offer narrower protection because of their limited subject matter and generous exemptions for breeders and farmers.
The European Parliament latched onto these differences to justify its patent ban. Since PVRs offer a “full” breeder’s exemption — extending to both underlying breeding activities and the commercialisation of the new variety — the Parliament said that PVRs should be the only form of intellectual property available for NGT plants. This logic seems to ignore the legal developments in PVR and patent law over the last few decades.
In patent law, we have seen broad uptake of a limited breeder’s exemption in Europe. The exemption, which applies to the use of a patented invention during underlying breeding activities but not commercialisation, appears in the Agreement on a Unified Patent Court, as well as the national laws of many countries, including France, Germany, Switzerland, the Netherlands, Finland, Belgium, Italy, Poland, and Sweden.
Meanwhile, the “full” breeder’s exemption for PVRs is not as fulsome as it used to be, after UPOV 1991 introduced the concept of essentially derived varieties (EDVs). If a new variety is deemed to be an EDV, its commercialisation will require authorisation from the owner of the initial variety. The EDV definition contains many terms that are ambiguous and difficult to apply, so UPOV has sought to provide clarity through Explanatory Notes that were informed by the views of breeders. However, these Explanatory Notes are not binding. Therefore, it will be interesting to see how the EDV concept is interpreted by national courts, especially since we are seeing litigation on this topic, such as the ongoing case about the ‘Nadorcott’mandarin variety before the Patents Court of England and Wales.
Moving Forward
The final text of the NGT Regulation is yet to be published, but when it enters into force, the scrutiny of the patent system will continue. The work of the patenting expert group and the Commission’s study on the impact of patenting must be informed by a fair comparison between patents and PVRs, as well as the interplay between them. As we examine the role of the IP system in addressing important concerns like the biodiversity crisis and food security challenges, such issues must be approached with a fair and up-to-date understanding of the scope of protection and the role of the breeder’s exemption under both patent and PVR laws.
Editor’s Note: Jocelyn Bosse is Lecturer in Intellectual Property Law at the Queen’s University in Belfast, Northern Ireland.
