PBRs are a hot mess---only compiling into one patent system including a breeder’s exemption solves. It’s not unprecedented---they did it in Europe!

314 Research handbook on intellectual property rights and inclusivity applicable are limited to the ones listed in Art. 14 Regulation 2100/94.50 In general, it concerns those species where traditionally the harvested material is used as propagating material (for instance fodder plants such as field peas and field beans, cereals such as oats, barley and rice, potatoes and oil and fibre plants), and hence not for plant species where this is not the case.

3.3 Breeders’ Exemption in the Patent System

Amongst the traditional exemption from patent infringement, we have the research exemption and the private use exemption, amongst other ones. Until recently we did not have a spe- cific exemption for breeding. Some national jurisdictions had already introduced a limited breeders’ exemption,51 and the advent of the unitary patent in Europe52 has now harmonised the exemption (at least amongst all countries who have ratified the Unified Patent Court Agreement (AUPC). 53

The concept of a breeders’ exemption is not new, as it is derived from the already longstand- ing concept under the PBR system. But its presence in the patent system is, as said, a more recent phenomenon. The principle of a breeders’ exemption is straightforward and entails that a breeder is allowed to use protected biological material, or propagating material, for breeding purposes, without thereby committing an infringement. Such an exemption could arguably not fall within the traditional research exemption in patent law, as the latter exempts research on the subject matter for research purposes from patent infringement. Using protected biological material for breeding purposes is 1) not research on, but mostly with the protected subject matter, and 2) it has very likely a commer- cial affinity, i.e., to bring a new plant or plant variety to market.

There is a major distinction to be made between the breeders’ exemption under patent law, also dubbed a limited breeders’ exemption, and the one under the PBR system, also labelled as a full breeders’ exemption. The limited breeders’ exemption requires no consent for the use of the protected material for breeding purposes, but if the breeder wants to commercialise the ensuing new plant (variety), a licence from the patent holder will be required. Under the full breeders’ exemption as we know it in PBR systems, no such consent or licence will be required, hence the term ‘full’ breeders’ exemption.54 What does the AUPC say about the exclusive rights and the breeders’ exemption? Art. 25(a)–(c) Unified Patent Court Agreement (AUPC) states: 50 Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights, OJ L 227, 1.9.1994, p. 1–30.

51 Amongst which The Netherlands, Germany and France. 52 EU Regulation on implementing enhanced cooperation in the area of the creation of unitary patent protection (Regulation No 1257/2012) and the EU Regulation on implementing enhanced cooperation in the area of the creation of unitary patent protection with regard to the applicable translation arrangements (Regulation No 1260/2012). 53 Agreement on a Unified Patent Court, OJ C 175, 20.6.2013, p. 1–40. 54 I hasten to add that the scope of the full breeders’ exemption under the PBR system has in practical effect been limited since the introduction of the concept of essentially derived variety, to which we revert later in this chapter (see section 4.3). Patenting plants, plant variety protection and inclusion of plant breeders 315 A patent shall confer on its proprietor the right to prevent any third party not having the proprietor's consent from the following: (a) making, offering, placing on the market or using a product which is the subject-matter of the patent, or importing or storing the product for those purposes; (b) using a process which is the subject-matter of the patent or, where the third party knows, or should have known, that the use of the process is prohibited without the consent of the patent proprietor, offering the process for use within the territory of the Contracting Member States in which that patent has effect; (c) offering, placing on the market, using, or importing or storing for those purposes a product obtained directly by a process which is the subject-matter of the patent. Art. 27(c) Unified Patent Court Agreement (AUPC) then defines the breeders’ exemption: [The rights conferred by a patent shall not extend to any of the following:] […] (c) the use of biological material for the purpose of breeding, or discovering and developing other plant varieties

[…]. The breeders’ exemption under the patent system refers to the use of biological material for the purposes of breeding. Absent a definition in the AUPC of what biological material is and taken that the Unified Patent Court is bound by EU law,55 we can look for a definition of bio- logical material in other EU patent law legislation. The only relevant source is then the Biotech Directive, which defines biological material as ‘any material containing genetic information and capable of reproducing itself or being reproduced in a biological system’.56 That would imply that a DNA construct, molecular markers, and arguably also a CRISPR-Cas system could be defined as biological material.

However, method patent claims, defining methods of carrying out genome editing, are argu- ably not covered by the breeders’ exemption in patent law, as they do not constitute biological material. Two types of method patents can be distinguished. These could be first methods relating to how to carry out genome editing, and second methods of producing a genome editing system, etc. Whether the first type of methods would be covered by the breeders’ exemption can be argued. Methods for breeding also fall within this first category, and are also, perhaps more straightforwardly, excluded from the breeders’ exemption. The second type of methods will likely fall within the scope of the breeders’ exemption, as at least in the member states of the EPC, those methods also protect the product directly obtained by the patented process, as per Art. 64(2) EPC. As the breeders’ exemption in patent law, despite its prior existence in the patent acts of several EU countries, has not yet been tested in court, we will have to wait to see what the exact scope of the exemption is. 55 See Art. 24 AUPC. 56 Art. 2(1)(a) Directive 98/44/EC (Biotech Directive). 316 Research handbook on intellectual property rights and inclusivity 4. PLANT VARIETY PROTECTION

4.1 The Basics of PBR Protection

Plant related technologies are special in that they can use (take advantage of) more than one form of intellectual property protection for technical innovations. Even though we have seen that there is a ban on double protection for plant varieties, there is no ban on double protection for plant related technologies in general. That means that plants can be protected by patents (under the conditions and caveats discussed in the previous section), whilst plant varieties, which may very well encompass patent protected technologies, can be protected under the PBR system. A patent for a herbicide resistant plant will include within its scope of protection any plant variety developed which has the patent protected herbicide resistant gene construct embedded in its genetic make-up and where that construct is also capable of carrying out its function in that plant variety.57 We will discuss this interdependency of rights later in this chapter, but for now it suffices to flag it up. PBR protection is a form of IPR protection which aims to provide protection for the devel- opment of new plant varieties.58 One of its main features is the protection and stimulation of innovation, something it shares with many other intellectual property rights, amongst which the patent system. The PBR system is in many respects quite different, though, from the patent system. Some of these features will transpire in what follows in this chapter, even though it does not aim at an exhaustive discussion of the same. At the international level, it is governed by the UPOV Convention, and in Europe a community plant variety right system59 has been created based on the UPOV Convention.60 The PBR system and the UPOV Convention take a special place in the IPR system. It is one of the older IP rights in modern times, and its foundational rationale, apart from providing some form of exclusive right to PBR holders, has also more equitable society features than some of the other traditional IPRs, such as for instance patent rights. The first sentence of the preamble to the International Convention for the Protection of New Varieties of Plants, signed in Paris on December 2, 1961, reads: ‘Convinced of the importance attaching to the protection 57 This is by virtue of both Art. 8 and 9 of the Biotech Directive, which are also not very clear, and will cause problems of interpretation in the future. For more details, See, BOSTYN, A decade after the birth of the biotech directive: Was it worth the trouble?, in, AREZZO, GHIDINI (eds.), Biotechnology and Software Patent Law: A Comparative Review on New Developments, Edward Elgar Publishing, 2011, p. 221–259, at 243–256. 58 I have taken the liberty to inspire this section on parts of an earlier publication on plant variety rights and the concept of essentially derived varieties, a topic on which we will come to speak about later in this chapter. See, BOSTYN, Towards a Fair Scope of Protection for Plant Breeders’ Rights in an Era of New Breeding Techniques: Proposals for a Modernization of the Essentially Derived Variety Concept, in Agronomy 2021, 11, 1511. https://doi .org/10 .3390/ agronomy11081511. 59 Council Regulation (EC) No. 2100/94 of 27 July 1994 on Community Plant Variety Rights, OJ L 227, 1 September 1994, pp. 1–30. 60 UPOV 1991 Convention International Convention for the Protection of New Varieties of Plants of December 2, 1961, as Revised at Geneva on November 10, 1972, on 23 October 1978, and on 19 March 1991. Patenting plants, plant variety protection and inclusion of plant breeders 317 of new varieties of plants, not only for the development of agriculture in their territory, but also for safeguarding the interests of breeders […].’

According to some commentators, ‘in recognition of the fact that new varieties of plants are a powerful tool to enhance agricultural and overall economic development, the States party to the UPOV Convention wished to provide incentives for sustainable plant breeding. Their aim was to guarantee the moral and material rights of breeders in respect of their varieties, in accordance with clearly defined and internationally harmonized principles.’61 There was an additional 1972 Act, introducing a new financial contribution system, and a Revision in 1978, solidifying the position of UPOV as an international organization, endowing it with legal personality. The 1978 Revision also allowed the United States of America to maintain their dual right system, i.e., both PBR and patent protection for new plant varieties (which Europe does not allow by virtue of Art. 53(a) EPC, as seen in the previous section of this chapter). The 1991 Revision introduced the still quite controversial essentially derived variety (EDV) concept, to which we will revert later. It was also the revision that introduced the most impor- tant substantive law changes, considering lessons learned from using the UPOV system since the 1960s, whilst also recognising important scientific developments, such as a more common use of DNA based techniques.62 What is a plant variety has been defined in Article 1(vi) of the UPOV Convention: ‘variety’ means 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 breeder’s right are fully met, can be, • – defined by the expression of the characteristics resulting from a given genotype or combination of genotypes, • – distinguished from any other plant grouping by the expression of at least one of the said char- acteristics and • – considered as a unit regarding its suitability for being propagated unchanged.

A basic example can illustrate the definition. A ‘Golden Delicious’ apple is 1) a plant grouping within a single botanical taxon of the lowest known rank, being a grouping of apples. 2) It is defined by the expression of the characteristics resulting from a given genotype or combi- nation of genotypes, which means that it has certain phenotypical characteristics, which can relate to both morphological and physiological traits of the variety. 3) It is distinguished from any other plant grouping by the expression of at least one of the said characteristics, which are the specific characteristics of ‘Golden Delicious’ apples, i.e., golden colour and a mild sweet flavour, amongst other things. 4) The variety must also be capable of being propagated unchanged, which means that the specific characteristics of the variety must remain present after propagation (be it that slight variations will be inevitable when propagating plants). For instance, if a certain white rose would after propagation turn red, it would not fulfil this requirement, and could not be labelled a plant variety. 61 JÖRDENS, Progress of plant variety protection based on the International Convention for the Protection of New Varieties of Plants (UPOV Convention), in World Pat. Inf. 2005, 27, 232–243, at 233. 62 Ibid.

318 Research handbook on intellectual property rights and inclusivity To obtain PBR protection, a variety must fulfil the following requirements, also called the DUS criteria.63 According to Article 5(1) UPOV Convention, the plant variety for which protection is sought must be: (i) new, (ii) distinct, (iii) uniform and (iv) stable.

The PBR system suits the needs and demands of breeders. The most important of those are the need to obtain some form of exclusive rights for innovation in the breeding and development of new plant varieties. Second, and quite importantly, it also guarantees access to third parties to use protected varieties with a view to developing new varieties. This guaranteed access, in the form of a full breeders’ exemption (about which more in section 4.3 of this chapter), is unique to the PBR system, and does not exist to the same extent in any other IPR system. The system is also relatively low-cost, at least when compared to the rather expensive patent system, which is another point of attraction for a business where margins can be quite small. The scope of protection is relatively narrow, i.e., protection is limited to the specific variety which will be commercialised. In that sense it is rather different from patent protection, which commonly has a wider scope of protection.

4.2 Farmers’ Privilege in the PBR System Under the international PBR system, the farmers’ privilege is an optional exception. It is laid down in Art. 15(2) UPOV 1991, 64 and the principles have already been set out when we discussed the same privilege in the patent system (see section 3.2 above). 65 Within the EU, the privilege is a mandatory exception under Art. 14 Regulation 2100/94. 63 For a more detailed appraisal of the DUS criteria, which is by no means an easy exercise, see, General Introduction to the Examination of Distinctness, Uniformity and Stability and the Development of Harmonized Descriptions of new Varieties of Plants. UPOV, TG/1/3, 19 April 2002. Available online: https:// www .upov .int/ resource/ en/ introduction _dus .html (accessed 30 August 2023).

64 Art. 15(2) UPOV 1991 states: ‘[Optional exception] Notwithstanding Article 142, each Contracting Party may, within reasonable limits and subject to the safeguarding of the legitimate interests of the breeder, restrict the breeder’s right in relation to any variety in order to permit farmers to use for propagating purposes, on their own holdings, the product of the harvest which they have obtained by planting, on their own holdings, the protected variety or a variety covered by Article 14(5)(a)(i) or (ii).’ 65 For more details on the scope of the privilege under the UPOV system, see EXPLANATORY NOTES ON EXCEPTIONS TO THE BREEDER’S RIGHT UNDER THE 1991 ACT OF THE UPOV CONVENTION, UPOV/EXN/EXC/1, https://www.upov.int/edocs/expndocs/en/upov_exn _exc.pdf (accessed 30 August 2023).

Patenting plants, plant variety protection and inclusion of plant breeders 319 4.3 The Full Breeders’ Exemption in the PBR System As said, the PBR system contains an exemption unique in IP systems, and that is the full breeders’ exemption. Under this exemption, third party breeders are allowed to use the PBR protected variety or variety constituents for purposes of breeding a new variety and can com- mercialise the latter without the need to obtain a licence from the PBR holder whose protection plant variety has been used. The full breeders’ exemption has no counterpart in the other IP right that protects technical innovation, i.e., the patent system. As seen, there is now a limited breeders’ exemption avail- able in the patent system in Europe.

The exemption under the PBR system hence lays down a very important principle, which is that the PBR system, unlike the patent system, guarantees access to germplasm for pur- poses of further breeding.66 This allows for continuous innovation, by using the fruits of the previous plant innovation. But it does not stop there. The breeders’ exemption under the PBR system also allows commercialisation of the newly developed variety without the need to pay a licence to the PBR holder whose variety has been used. In the context of inclusion, the main theme of this book, the breeders’ exemption will facilitate that small or financially less powerful communities can gain access to the fruits of plant innovation for purposes of further breeding, and even commercialise the new varieties developed therewith. For example, the full breeders’ exemption would in principle allow small communities in Africa to use a PBR protected maize variety which has the specific feature of drought resistance for developing a new maize variety, and commercialise the latter, all without the need to pay a licence fee. This principle facilitates access by poorer communities to potentially expensive technology (all provided there is no patent protection). The principle reads as very promising, but there are caveats, however.

66 Art 15(1) UPOV 1991 states: (1) [Compulsory exceptions] The breeder’s right shall not extend to (i) acts done privately and for non-commercial purposes, (ii) acts done for experimental purposes and (iii) acts done for the purpose of breeding other varieties, and, except where the provisions of Article 14(5) apply, acts referred to in Article 14(1) to (4) in respect of such other varieties. The acts referred to Art. 14(1) to (4) refer to, amongst others:

(1) [Acts in respect of the propagating material] (a) Subject to Articles 15 and 16, the following acts in respect of the propagating material of the protected variety shall require the authorization 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 for any of the purposes mentioned in (i) to (vi), (b) The breeder may make his authorization subject to conditions and limitations. (2) [Acts in respect of the harvested material] Subject to Articles 15 and 16, the acts referred to in items (i) to (vii) of paragraph (1)(a) in respect of harvested material, including entire plants and parts of plants, obtained through the unauthorized use of propagating material of the protected variety shall require the authorization of the breeder, unless the breeder has had reasonable oppor- tunity to exercise his right in relation to the said propagating material.

320 Research handbook on intellectual property rights and inclusivity The latter part of the full breeders’ exemption (i.e., the fact that third parties can also commercialise the newly developed variety by using a PBR protected one without the need to take a license) has come under considerable pressure, especially since the introduction of the concept of essentially derived varieties, about which more in the subsequent section of this chapter.

4.4 Essentially Derived Varieties (EDVs)

The full breeders’ exemption, and especially its effects on the non-enforceability of PBR rights on breeders using protected material, has to some extent been limited by the introduction in the 1991 UPOV Convention of the concept of essentially derived varieties (hereinafter EDVs). Under the EDV provision, if the normal protection requirements (novelty, distinctness, uni- formity and stability) are fulfilled, the breeder of an EDV is granted a PBR and may thus assert all rights resulting from variety protection against any third party. Use of the protected variety, called the initial variety (IV), for purposes of breeding an EDV, is also allowed without the consent of the PBR holder for the IV. However, the marketing of the EDV requires the author- isation of the breeder of the IV from which it was essentially derived. The result is that the breeder who desires to exploit commercially an EDV requires the permission of the owner of the IV such that this owner can reap some of the reward for his ‘efforts’ to create the IV, upon which the subsequent creation was dependent.

What is an EDV has been defined in Art. 14(5) UPOV 1991: Art. 14(5) [Essentially derived and certain other varieties] (a) The provisions of paragraphs (1) to (4) shall also apply in relation to (i) varieties which are essentially derived from the protected variety, where the protected variety is not itself an essentially derived variety, (ii) varieties which are not clearly distinguishable in accordance with Article 7 from the pro- tected variety and (iii) varieties whose production requires the repeated use of the protected variety. (b) For the purposes of subparagraph (a)(i), a variety shall be deemed to be essentially derived from another variety (‘the initial variety’) when (i) it is predominantly derived from the initial variety, or from a variety that is itself predomi- nantly derived from the initial variety, while retaining the expression of the essential char- acteristics that result from the genotype or combination of genotypes of the initial variety, (ii) it is clearly distinguishable from the initial variety and (iii) except for the differences which result from the act of derivation, it conforms to the initial variety in the expression of the essential characteristics that result from the genotype or combination of genotypes of the initial variety. (c) Essentially derived varieties may be obtained for example by the selection of a natural or induced mutant, or of a somaclonal variant, the selection of a variant individual from plants of the initial variety, backcrossing, or transformation by genetic engineering.

To provide some further context, it is useful to explain why the EDV concept has been introduced, as this is particularly relevant in relation to the foundational concept of the full breeders’ exemption under the PBR system. The concept of EDV has expanded the scope of protection of the PBR holder. As said, prior to the UPOV 1991 Convention, PBR holders could not enforce their PBRs against third parties who used the protected variety to develop a new variety, and market that new variety. That was because the full breeders’ exemption allows in principle for using the protected variety for further breeding and marketing that newly devel- Patenting plants, plant variety protection and inclusion of plant breeders 321 oped variety without the consent of the PBR holder of the variety that has been used to create the new variety. The rationale for the full breeders’ exemption is the fundamental principle of access. Plant breeding is an incremental and iterative process. Plant breeders use and build upon the work of previous plant breeders and rely on existing plant varieties for the initial source of genetic variation,67 which requires access. Absent an EDV concept, and considering the full breeders’ exemption, initial PBR holders would see competitors using their innovative effort and investment to develop and market varieties which largely use the genotype of the initial PBR. That implies that competitors developing and commercialising mutations based on the protected variety can do so without restrictions, effectively eating away at the profits of the plant variety right holder. That in turn may have rather negative consequences in terms of the preparedness of breeders to go through the laborious process of filing for PBR protection in the first place. That was seen as unfair, as it invites free-riding, and was deemed contrary to the innovation incentive idea underlying the PBR system. Indeed, most IP rights start from the underlying rationale that, in the absence of any kind of enforceable right, market players will have no incentive to invest in innovative activities.68 The full breeders’ exemption and its consequences is the conundrum with which breeders must live. Because access is a corner stone of the PBR system, doing away with the full breeders’ exemption was never deemed an option. However, not doing anything else was also deemed not an option, as it could have made the PBR system ineffective, and even worse, uninteresting for users. Something needed to be done to protect the legitimate expectations and rights of the plant variety right holders.

Now that we understand the rationale of introducing the EDV system, for better or for worse, we should now spend a little time on the conditions that need to be fulfilled. There are three fundamental conditions that must be fulfilled to qualify as an EDV. The first one is that the EDV is predominantly derived from the IV. Second, the EDV is clearly distinguishable from the IV. And third, the EDV conforms to the IV in the expression of the essential charac- teristics that result from the genotype or combination of genotypes of the initial variety. All these conditions must be cumulatively fulfilled. The UPOV 1991 Convention provides a couple of examples of breeding techniques that may result in EDV designation, in particular: the selection of a natural or induced mutant, or of a somaclonal variant, the selection of a variant individual from plants of the initial variety, backcrossing or transformation by genetic engineering.

An important question is how to determine whether a new plant variety is essentially derived or not. The problem is that no clear definitions have been provided for the abovementioned three criteria to qualify as an EDV. The UPOV Convention merely refers to the examples, but 67 SANDERSON, Plants, People and Practices. The Nature and History of the UPOV Convention, Cambridge University Press: Cambridge, 2017, at 205. 68 See supra note 2.

322 Research handbook on intellectual property rights and inclusivity further guidance is absent. There is a consensus, not only in the literature69 but also amongst users of the system, 70 that the provision is very complex. Fundamentally, essential derivation is determined by conformity (which is the same as ‘similarity’ in common parlance) to the initial variety and predominant derivation from the IV. It is of course given that the EDV is distinct from the IV.

The main issue is to distinguish between cases where a new variety is derived from the IV, but does not trigger the EDV concept, and cases where it is essentially derived from the initial variety, and which triggers the EDV rule. During the negotiations for the UPOV 1991 Convention, it was already made clear that this was always going to be a rather difficult task: ‘from a technical point of view it was rather difficult to decide what was an essentially derived variety and what was not.’ 71 Explanatory notes were eventually developed, 72 but they have become recently the subject of a rather heated discussion to amend them in the context of the emergence of NBTs. 73 It is beyond the scope of this chapter to deal with the intricacies of how essential derivation could be determined.