martedì, Maggio 28, 2024
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Plant variety protection: an introduction

a cura di Giulio Serafino

1. A peculiar IP right

Plant Variety Protection (PVP), also called a Plant breeder’s right (PBR) is a specific form of Intellectual Property that grants the breeder an exclusive right over a newly bred Plant Variety, preventing any third party from commercially exploiting it without his previous authorisation.[1]  Such right, similarly to other intellectual property forms of protection,  is granted for a specific territorial area, lasts for a limited time and can be subject to limitations under the fulfilment of certain conditions established by law.  In particular, the right expires after a certain amount of time to allow the free exploitation of the variety by the society, and it is subject to exceptions and limitations in its scope to render it compliant with other conflicting rights and interests.

The main peculiarity of PVP is that an exclusive right lies in a living being. This aspect has been the source of a persistent and continuous debate. Regulators, jurists and law experts lengthily questioned the opportunity to introduce a form of intellectual property protection over living matter, claiming that it would have been immoral and unethical to recognise a monopoly in the exploitation of natural resources. Moreover, it was believed that patents were unfeasible to protect plant varieties on the ground that living matter does not fulfil the requirement of industrial application, a concept that, according to them, would be intelligible only if referred to inert matter.[2]

Nowadays, outdated the “industrial-application” debate also thanks to the disruptive discoveries in the field of molecular biotechnology, and recognised that an  industrial property title over plant varieties can be  an essential tool for assuring the continuous circle of innovation to the benefits of our  society, the debate shifted on assessing which is the most suitable intellectual property regime deemed to guarantee a reasonable balance between the interests of the rightsholders and those of the several stakeholders, in particular those present in the agricultural sector. In this regard, the advancements in genetics and biotechnologies are calling for a reform of the current legal regimes of protection with regard to plant varieties and derived foods and feeds in order to avoid undermining the weakest and most vulnerable actors. For instance, a major concern is that, due to the massive use of genetic engineering techniques, newly bred plants and crops will be in the hands of only few big companies, to the detriment of small farmers and SMEs.[3]

Anyway, the need to provide regulations in face of technological innovation is not the only challenge with which the system of Plant Variety protection is dealing with. Indeed, the possibility to implement proportionate rules is furtherly complicated by the lack of legislative harmonisation of Plant Variety protection at international level. Agriculture is closely related to “superior” factors, like climate conditions, availability of natural resources, but also well-established commercial prassi and structure. Therefore, what is considered a balanced regulation for Country A, where intensive farming methods are in place, could create major disproportionate effects for country B, whose agricultural production is based on small family-business practices.

As a consequence, Countries tend to adopt the policy that is better suited for their production model. Despite the differences that emerge in the different regulations of plant varieties, a minimum common basis can be detected. As a standard feature, right is granted to the creator (also called breeder, that can be a physical person or a legal entity) who discover and develops a new plant variety that meets the requirements fixed by the law to be considered eligible for protection. The breeder has an exclusive right, a monopoly over the plant variety and anyone who wants to commercially exploit the protected variety must require his authorisation (usually in the form of a license agreement). However, beyond this basic conceptual understanding, countries enjoy great flexibility in setting up the preferred intellectual property regulation for plant varieties, as we will see below.   For now, let us focus on the fact that as a general rule, countries decided to grant protection, in the form of an exclusive right given to the legitimate holder, to new plant varieties.

2. The need for PVP

It falls outside the scope of this article to provide a detailed report on the intertwinings among IP law and competition law. However, it is enough to say that , since the granting of a monopoly is itself a limitation to the principle of free competition in the market, the exclusive right  shall not only be subject to limitations and conditions but also needs to be grounded in a valid and overwhelming justification in order to be held as legitimate.

The basic justification for granting such limited monopoly in the form of an exclusive right of exploitation relies on the essential role that plant breeding has played for the development of our society from immemorial time. Indeed, either by means of primitive conventional breeding methods (cross and selection) or by applying modern biotechnology techniques(genetic engineering, genome editing) the tremendous progress in the agricultural productivity in various parts of the world has been largely based on the possibility to cultivate and commercialise new and improved plant varieties which provide all sort of traits, from higher quality and taste to better appearance, resistance to pests and improved yields.

Today, breeding new varieties is extremely important to face major issues, such as environmental pollution, limited farmland resources, food deficiencies in developing countries. In addition, the exploitation of improved, commercially attractive varieties is a decisive factor in fostering the economic development and income increase in poor rural areas of the world.[4]

However, since the breeding process is a  costly and time-consuming one, to be able to enjoy the above-mentioned benefits the society needs to reward the breeders to allow them to economically exploit their variety, recoup the investment, and continue to breed new varieties. This reward is issued in the form of an exclusive right, limited in time and subject to exceptions. The temporary character means that the variety enters in the public domain once the time of protection expires, being from this moment freely exploitable by anyone.  The other exceptions and limitations render the right compatible with other rights and principles constitutionally granted. In particular, such limitations are drafted in order to make possible that the circle of innovation is not hampered by the granting of an exclusive right. Indeed, the most common, and generally foreseen exception within Plant Variety legal regimes is the breeder’s exemption which allows other breeders to use the protected variety to create a new one without the authorisation of the right-holder.

It is thus evident, that the justification for recognising PBRs is not different from that of other IP rights since, as the social-contract theory foresees, they result from a bargain between the inventor and the society. The inventor or breeder invests time and money in developing improved varieties, and the state rewards him with an exclusive right on his creation. A right that can be considered as a monopoly whose scope it is limited in order to guarantee a balanced relation with other valuable principles and ultimately allow the free enjoyment of innovation to the benefits of the society as a whole. [5]

The trait that renders Plant Variety protection particularly challenging and diverse from other IP systems is that the right is granted over a living being. This aspect generates legal issues and requires the enactment of specific rules that would not have been foreseen in case of the inert subject matter of protection. For instance, a variety can be easily reproduced by means of multiplication of plant material, hence can be particularly burdensome for the right-holder to identify infringements and enforce his rights without the provision of a detailed and specific set of rules.

3. Legal framework

The leading international systems that provide rules for the protection of plant varieties are the International Union for the Protection of New Varieties of Plants (UPOV, under which the UPOV Convention was enacted) and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS agreement) adopted under WTO law. [6]

The UPOV treaties regulate plant varieties using a sui generis system of protection, specially drafted to meet the needs of plant breeders. However, in its last 1991 version, the treaty has been amended and now it allows member states to protect the same Plant Variety with both a breeder’s right and a patent. The TRIPS agreement, adopted in 1994 as a treaty administered by the WTO, is the first and only IP treaty that seeks to establish universal, minimum standards of protection across the major fields of intellectual property, including patents, copyrights, trademarks, industrial designs, integrated circuits and trade secrets. Despite having only one article dedicated to Plant Variety protection (Art.27.3b) the TRIPS agreement, given its widespread adherence by states, has been of striking importance for fostering the adoption of Plant Variety regulations worldwide. [7]

In addition, while the provisions of the TRIPS  agreement with regard to other IP rights generally foresee as a mandatory requirement in order to join the Treaty that the member States comply with the main legal instruments already in force in the respective fields(for instance, in the case of copyright, member states can ratify the Trips agreement only where they have already joined the Berne Convention on the protection of intellectual and artistic creations), this is not the case of Plant varieties. Indeed, mandatory compliance with the UPOV system is not required to join the Treaty, meaning that member states enjoy great flexibility in choosing the intellectual property regime applicable to plant varieties and in shaping their own rules. In particular, they can opt for the UPOV system, the patent rights, implement their own sui generis system and further, regulate plant varieties by both patents and sui generis right.

The result is a fragmented legal framework. For instance, US regulate plant varieties using both patent and plant breeder rights, other countries adopted legislation mirroring the UPOV system, developing countries, like India, arranged their own sui generis regulation in order to strengthen the rights of farmers. Most European states and the EU itself have joined the UPOV convention, and their system of protection follows the sui generis UPOV scheme.   In Europe national legislations granting national PBRs are coupled with a centralised system managed by a specific body, the Community Plant Variety Office(CPVO), the agency of the European Union responsible for the management of the Community Plant Variety rights, which grants one title valid and enforceable in all EU member states.

4. Conclusions

The details of the Plant Variety protection will be provided in the forthcoming articles, the purpose of this article consisting in providing an introduction to a system of protection whose role and importance is not always perceived at full extent by the general public.  For this reason, assessing some basic questions and concepts can favour the reader in his approach to this complex yet fascinating matter.

First, the fundamental question, having come to the last part of this article, is “what is a Plant Variety?”. According to Art.5(2) of the Council Regulation 2100/94 on Community Plant Variety rights “variety shall be taken to mean a plant grouping within a single botanical taxon of the lowest known rank, which grouping, irrespective of whether the conditions for the grant of a Plant Variety right are fully met, can be:

– defined by the expression of the characteristics that results from a given genotype or combination of genotypes,

– distinguished from any other plant grouping by the expression of at least one of the said characteristics, and

– considered as a unit with regard to its suitability for being propagated unchanged.”[8]

In order to clarify such a technical and complex definition, we can use the concept of natural Kingdoms. Indeed, all living organisms can be grouped into 6 different biological Kingdoms. We as humans belong to the Animal Kingdom, the varieties belong to the Plant Kingdom. The variety is nothing but the most specific description of an organism which belongs to the Plant Kingdom. For instance, Granny Smith, Gala, Golden Delicious are all different Varieties of the Specie Apple (Malus Domestica is the scientific name) that, in turn, belongs to the Genus Malus of the Family of Rosaceae, of the Kingdom of Plants. Varieties are distinguished among each other on the basis of their external characteristics (colour, shape, dimensions). A second doubt that could lie in the mind of the reader is wheatear there is a real necessity to protect plant varieties. Indeed, the fact that a monopoly is granted on an inert invention is widely perceived as more acceptable and justifiable than a monopoly over something that we eat and is considered as essential for our sustainment, thus should be freely available to anyone.

To understand why the granting of such monopoly is justified is necessary to have a clear picture of the role that varieties and plant breeding played in the historical development of our societies. The argument will be the subject of further and more in-depth analysis. Here it is sufficient to point out that almost all the fruits and crops that form part of our diet are improved varieties obtained using plant breeding techniques over the centuries. For instance, the maize that we know today is a plant that has experienced so many modifications throughout history that its ancestor, called teosinte, looks barely like the contemporary. Indeed, the teosinte is a grass and its fruits are nothing like the big, fleshy, yellow kernels we all recognise. They have a completely different appearance. Teosinte was discovered by the indigenous people of Mesopotamia who worked together to produce improved varieties choosing the best traits and selected plants. With time and patience, they obtained the modern corn, giving us a delicious crop and all the food derived from it.[9]

However, plant breeding benefits are not limited to improved food quality and taste. Varieties resistant to pests and diseases can reduce the amount of pesticide used by farmers, crops that are less dependent on water supply for their survival can be used to foster agriculture production in less developed countries. In addition, with the advent of modern biotechnology, the breeding process has been industrialised and works on a large scale. Breeding programs are complex and can easily lead to unthinkable developments which are of striking importance to face significant issues, such as health and environmental crisis. It is likely that the continuous progress in genetic engineering will lead to the possibility to breed varieties of plants able to contain all the nutrients that a human being needs to include in its diet, thus helping to solve the food crisis in the least developing countries. In conclusion, the benefits for the whole society justify the recognition of an exclusive right to incentivise the breeding companies setting up of ambitious breeding programs to develop and create better varieties.

Currently, Plant Variety protection system is facing major challenges. The discovery of new genetic engineering techniques is leading to an overlapping among patents and PBR protection, the lack of international harmonisation hampers the chance to face large scale issues such as environmental sustainability and food crises in an effective manner, the weakest economies and agricultural actors are under serious threat, and free trade and competition among countries are under serious harm

[1] Article 14.1(a) of the UPOV Convention defines the scope of the Breeder’s Right stating that the following activities with regard to the propagating material of a protected variety shall require the authorisation of the breeder: (i) production or reproduction (multiplication), (ii) conditioning for the purpose of propagation, (iii) offering for sale, (iv) selling or other marketing, (v) exporting, (vi)importing, (vii)stocking.

[2] L.C. Ubertazzi, “Commentario breve alle leggi su proprietà intellettuale e concorrenza”, Cedam, 2017.

[3] See UPOV, “Getting the Most out of your New Plant Variety” , Available at www.wipo.int/sme/en/documents/upov_plant_variety_fulltext.html. Accessed on 24 September 2019.

[4] WIPO, “Benefits of Plant Variety Protection” , in WIPO Magazine Issue 3, 2010, available at www.wipo.int/wipo_magazine/en/2010/03/article_0007.html. Accessed on 24 September 2019.

[5] See Shubha Ghosht, “Patents and the regulatory state: rethinking the patent bargain metaphor after eldred” in 19 Berkeley Tech. L.J. 1315, 2004, pp.1316-1387.

[6] The International Union for the Protection of New Varieties of Plants (UPOV) was established by the International Convention for the Protection of New Varieties of Plants (“UPOV Convention”). The UPOV Convention was adopted on December 2, 1961, by a Diplomatic Conference held in Paris, entered into force in 1968, and has been revised on November 10 1972, on October 23, 1978, and on March 19, 1991, in order to reflect technological developments in plant breeding and experience acquired with the application of the UPOV Convention; the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is an international legal agreement between all the member nations of the World Trade Organization (WTO). It sets down minimum standards for the regulation by national governments of many forms of intellectual property as applied to nationals of other WTO member nations. TRIPS was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) between 1989 and 1990, entered into force on 1 January 1995 and is administered by the WTO.

[7] Art.27 Trips: “Members may also exclude from patentability: (….) (b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof (….).”

[8] Council Regulation (EC) No 2100/94 of 27 July 1994 on Community Plant Variety rights, OJ L 227, 1.9.1994.

[9] Estibaliz Urarte and Ernesto Llamas, “The great-grandparents of our fruits and vegetables”, in Journal of Sketching Science, available at  www.authorea.com. Accessed on 24 September 2019.

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