Plant variety rights and patent: which way to go?
Innovation is stimulated by a well designed regulatory framework as well as a balanced and effective Intellectual Property (IP) protection. IP protection gives the innovator an exclusive right on his innovation and allows a fair sustained return for his investment. In agricultural industry, plant variety rights system is one of the most important mechanisms.
During the 19th EIPIN congress in Maastricht, Intellectual Property and Legal Affairs Director Szonja Csörgö from European Seed Association (ESA) gave a speech on the EU regulatory framework for legally protecting innovations for plants and seeds on 27th January 2018.
A plant variety is protected if it is new, distinct, uniform and stable. Another mechanism is patent protection. Article 27(3)(b) of TRIPS provides for a choice for protection of plant varieties either by patents or by sui generis protection system, or a combination thereof.
PVR and patent protection in plant breeding sector
The plant variety rights (PVR) legislation in European Union is based on the 1991 version of the UPOV Convention and has created a level playing field for European farmers and breeders.
Under this system, there is a compulsory exception to breeder’s right – “breeder’s exemption”. This feature is similar to an “open source” model by safeguarding free access to biological material for further breeding. According to Szonja’s speech, by allowing for using protected varieties for further breeding and marketing of those new varieties without any obligations towards the right holder, it has greatly enhanced the innovation of the plant breeding industry in Europe and has proved to be a cornerstone of the system. The breeders have always relied on this exemption for further improvement on each other’s varieties.
As for plant varieties as such, they are excluded from patent protection according to Article 53(b) EPC and are protected by plant breeder’s rights. However, the techniques used when obtaining the biological material or developing new varieties could seek for patent protection. Indeed, there is no such concept of breeder’s exemption in patent system under EPC but still breeders also take into account patent protection because of the innovations involving technical solution to develop new varieties. Under the current European patent protection, which is a stronger and more absolute protection than PVR in respect of the strict substantial requirements examination and its scope of exclusive rights, any use of the patented products (e.g. genetic material) and processes covered by the patent must obtain permission from the patent owner. This blocks access to biological materials for further breeding.
Significance of breeders’ exemption and potential concerns
To guarantee plants that can endure natural changes (for example diseases, climate, etc) and to ensure production yields, varieties have to be continuously improved and therefore access to all these materials is required. Furthermore, the PVR system is subject to a considerable number of very time consuming field trials, de facto giving the right holder a lead time advantage, as a third party breeder would have to go through a similar time consuming exercise before he could ever bring his new variety on the market. To acquire the interesting traits of genetics to achieve breeding goals, access to all possible biological materials is key element for plant breeders for a successful breeding program as it allows for speedy innovation. If lack of such a basic principle for free access, it puts too much strain on plant breeders since it is not affordable for them not to have access to various biological materials for further breeding.
However, the enforcement of PVR may not be so satisfactory and could become an obstacle to plant breeding, which is a weak point of the system. The potential problem is that it is possible to make small changes to the genetic structure of an existing variety and then get a new variety to be granted since it demonstrates distinctive feature. It seems be easy to circumvent previous protection as the fellow plant breeders may obtain new protection by the benefit of breeder’s exemption.
The PVR system and the patent system interact and overlap in the protection of plant breeding. Breeder’s exemption is a special feature in PVR system while protection is stronger by patents. To protect plant breeders’ interest for certain important subject matters by patent, it is possible to discuss whether a limited breeder’s exemption can be provided in the European patent system under EPC, in order to guarantee access to genetic material. However this would raise another issue that is it justified introducing the special exemption only in plant breeding sector, and if so, whether the door to similar exceptions would open in other sectors. Too many exceptions would undermine patent protection and limit innovation as well. The approaches should be designed to achieve a balance solution among the competing interests and sustainable development to ensure continuous innovation. There are still lots of discussions and rooms to find a better solution.