PBR HOME > Background / Clarification of Breeding Issues

Clarification of Plant Breeding Issues under the
Plant Breeder's Rights Act 1994
December 2002

• Background
• Clarification of Breeding Issues
  • Breeding - A Mandatory Requirement for a Grant of PBR
  • Definition of Breeding
  • Precedents
  • Proof of Breeding
  • Principles of Breeding and Administration of PBR Based on the PBRA

BACKGROUND

In July 1998, the then Standing Committee on Agriculture and Resource Management (SCARM) considered a report on Western Australian experience with the Plant Breeder's Rights Act 1994 (PBRA) focussing on the relationship between the PBRA and End Point Royalties on grain. Subsequently, SCARM initiated research into more general experiences with the PBRA through a survey of government and private stakeholders. Twenty-seven organisations responded, including seven SCARM agencies, four Universities/Co-operative Research Centres, three Research and Development Corporations, three grain/seed industry organisations, three horticultural plant nurseries and two seed companies. Respondents were consistent in their support of the PBRA, recognising it as the most appropriate scheme for the granting of intellectual property rights on new plant varieties.

Nevertheless, a majority of respondents (i) felt that applicants and objectors generally had a poor understanding of the threshold of eligible breeding required by the PBRA and, (ii) questioned the balance between first and subsequent breeder rights in relation to 'essentially derived varieties'. Accordingly, SCARM recommended that the Registrar of the PBR Office establish an Expert Panel (the Panel) to clarify and explain what constitutes eligible breeding, and issues relating to EDV. The Plant Breeder's Rights Advisory Committee (PBRAC) considered the possible composition of such a panel and the Expert Panel on Breeding was formed, convening for the first time on 3 February 2001.

While the Panel acknowledges the PBRA has the potential to apply to all new varieties, it understands that about 1% of all applications are opposed on the basis that they have 'not been bred'. Considerable controversy often ensues with some opponents claiming, inter alia, that the threshold of eligible breeding is set too low.

Despite the small number of such disputes, decisions are not arrived at easily, involving delays and uncertainties, and consuming a disproportionate amount of resources.

The Panel aims, through this report, to provide guidance to minimise future dispute and conflicts and to assist in the understanding of the principles of 'patent-type' legislation, UPOV 1991 and of the PBRA.

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CLARIFICATION OF BREEDING ISSUES

Breeding - A Mandatory Requirement for a Grant of PBR

To be a registrable plant variety, the variety must have a breeder, be distinct, uniform, and stable (see PBRA sections 34 and 43), and not have been exploited, or if so, only recently (see PBRA section 43(1)(5) and (6)).

The same requirement is reflected in UPOV 1991[1] Article 1 viz: 'breeder's right means the right of the breeder provided for in this Convention'.

To be a breeder of a new variety, a person (or persons) must have bred that variety (see PBRA section 3(1) and UPOV 1991 Article 1).

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Definition of Breeding

Section 5 of the PBRA broadly defines breeding as including 'discovery' and 'selective propagation'. Neither 'discovery' nor 'selective propagation' is defined.

The Panel's view, based on the advice of the Australian Government Solicitor[2], regarding 'discovery' is that:

1. it has its normal meaning (as there is no relevant jurisprudence in the PBRA context);
2. it can occur on more than one occasion;
3. it does not occur if the variety is commonly known;
4. in the absence of information to the contrary, the 'discoverer' is the first to file for PBR protection; and
5. a person cannot normally be considered the 'discoverer' of a plant if someone else provides the particulars of its existence to that person.

The Panel's view regarding 'selective propagation' is that:

1. 'selective propagation' has its normal biological meaning; and
2. the scientific basis for assessing whether 'selective propagation' has occurred is a comparison, between the candidate plant variety[3] and the population/parents[4] from which it was developed, that demonstrates a clear difference in at least one characteristic[5].

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Precedents

The Panel notes that the Plant Variety Rights Act 1987 (PVRA) did not include a definition of breeding. 'Originator' was used as a threshold for eligibility to apply for protection. The Panel therefore concludes that references to the PVRA, or the precedents set during its operation, are not appropriate for deciding whether breeding has been satisfied for the purposes of the PBRA.

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Proof of Breeding

The Panel acknowledges the wide range of methodologies used by breeders and notes that the level of complexity is usually directly related to the level of domestication of the species.

For example, the level of complexity is usually lower in the case of species that have not undergone extensive domestication, such as Australian wild flowers. Conversely, the level of complexity of breeding is usually far higher in respect of wheat, barley, and maize. Very sophisticated techniques may be applied to either highly domesticated or to undomesticated species.

The Panel's view of breeding is that, for the purposes of the PBRA, eligible breeding methodologies include the same three fundamental steps[6]:

1. Amassing, or locating, plant material with sufficient variation (herein after referred to as the 'source population') to enable genetic variation to be identified. This variation could be: 'natural' variation (i.e. created without human interference such as spontaneous mutation); or could be 'man-made' variation (e.g. through genetic transformation, cross-pollination, induced mutations, etc).
2. Selection of a particular plant[7], or group of plants, having a set of 'desirable' characteristics from within the source population.
3. Propagation of the particular plant form (in preference to other plant forms in the source population) must occur, resulting in a change in the expression[8] of one or more characteristics between the source population and the new variety. For a registrable new variety to be produced, this propagation would have to result in a variety that also met the criteria of distinctness, uniformity and stability, and of non-exploitation.

The Panel specifically notes that the finding/importation of a variety, by itself, does not meet the above criteria of breeding. Consequently, the test for eligibility for PBR protection is not satisfied.

The Panel also notes that the PBRA does not discriminate between varieties and, therefore, all varieties are assessed against the same criteria, regardless of the method of their origination. The Panel acknowledges that, because some applicants will not be able to meet all of the criteria under the PBRA, not all new varieties will be eligible for PBR protection.

The Panel has endeavoured to give greater clarity to eligible breeding methodologies through the illustrative examples (see case scenarios) provided in this report.

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Principles of Breeding and Administration of PBR Based on the PBRA

While the PBRA does not provide a comprehensive list of acceptable breeding methodologies, the aide-memoire to the UPOV Convention (on which the PBRA is based) lists, as methodologies usually accepted as breeding:

1. bulk or pedigree selection within an existing population;
2. discovery of a natural mutation;
3. the inducing of an artificial mutation;
4. chance cross-pollination;
5. deliberate cross-pollination;
6. any combination of the above.

Over time, a number of other more sophisticated methods have also come into common practice, including double haploids, somaclonal variation, etc.

The Panel believes that most of the misunderstandings related to breeding arise in the context of (a) and (b) above[9] and often focus on matters connected with the source population.

The Panel acknowledges that breeding methodologies continue to evolve and, therefore, it would be inappropriate to limit eligibility for PBR to varieties developed by the application of existing methods.

The Panel notes, and agrees with, the following administrative practice, which is consistent with UPOV 1991. It further notes that no new, higher, or lower requirements for breeding are imposed.

1. Development of new varieties by way of selection from within existing variation is a practice that has been used commonly for generations and constitutes breeding, which may lead to registrable varieties under the PBRA (see PBRA section 43).
2. Where a new variety has been developed by selective propagation from within an existing population:
   1. the applicant's claim that they discovered the plant from which the new variety was developed is accepted by the PBR Office on provision of a declaration to that effect in the Part 1 Application Form (see PBRA section 26);
   2. selective propagation is established where the population of the new variety is different from the population from which the discovered plant originated;
   3. the applicant must supply either:
      1. evidence that the new variety has been selectively propagated by a direct comparison with the source population, or
      2. a declaration specifying how the expression of a characteristic or characteristics in the new variety clearly differs from the expression of the same characteristic or characteristics in the source population.
   4. a new variety must also meet the criteria demonstrating distinctness, uniformity and stability, (the so-called DUS criteria, see PBRA sections 34 and 43);
   5. where apparently conclusive evidence is produced challenging an applicant's claims of discovery and/or selective propagation, the applicant has the opportunity to address that evidence before PBR protection is withdrawn/revoked (see PBRA sections 35 and 50). The penalties for false statements are significant, including imprisonment (see PBRA sections 75 and 76);
   6. the legal test of whether an application for rights in a new variety must be granted, is that the Secretary of the Department is satisfied that requirements have been met (see PBRA section 30, 31, 32 and 44).
3. Proof of breeding, and of distinctness, are separate issues and can be tested and satisfied independently. Breeding relates to comparisons with the source population/parents, while distinctness relates to comparisons with all varieties of common knowledge.[10]

In situations where the source population/parent is also the most similar variety of common knowledge, breeding and distinctiveness can be tested and satisfied simultaneously.

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[1] The Panel notes that Australia is a member of UPOV and is obliged to administer the PBRA in accordance with the Convention (see Articles 1 and 5).

[2] See Appendix 1.

[3] A plant variety is contained within a single botanical taxon of the lowest known rank (see PBRA section 3 (1) 'plant variety'). As a corollary PBR protection is not available to a species per se.

[4] A candidate variety can be compared to, and differentiated from: (i) its parents or, (ii) the original population/source material or any other generation between it and the original population/source.

[5] 'Characteristics' means traits that result from the expression of a genotype or combination of genotypes.

[6] Varieties maintained as hybrids, synthetics etc may not include the selective propagation component of step 3.

[7] 'A plant' hereafter includes 'a group of plants' sharing the same characteristic(s).

[8] Also includes a change in the frequency of expression.

[9] These misconceptions often stem from (i) philosophical positions opposed to the granting of Intellectual Property (IP) rights in living materials, or (ii) expectations about the PBRA that bear little resemblance to the legislative requirements.

[10] See Appendix 2 on 'Variety of Common Knowledge.'

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