Clarification of Plant Breeding Issues under the
Plant Breeder's Rights Act 1994
The Panel wishes to thank all those who have provided comments that have assisted in development of this report, which seeks to clarify issues relating to eligible breeding methodologies and essential derivation under the Plant Breeder's Rights Act 1994 (PBRA). This report is not a legal document. It is intended to reflect the views and opinions of the Panel for generic problem areas. Consequently it may not be applicable for every situation or particular purpose.
The Panel agreed that the draft report should be the subject of an extensive consultation process before finalisation. Comment has been invited from independent experts, a reference group with interests in 'traditional' and 'biotech' breeding, the Plant Breeder's Rights Advisory Committee (PBRAC) and, finally, publication seeking the views of the general community.
The consultation process encourages various and sometimes conflicting views that, in the final analysis, cannot always be reconciled. Such a process is, nevertheless, invaluable in assisting those responsible for the task at hand. The Panel acknowledges that its conclusions will not meet with unconditional approval from all sides. However, it is hopeful that its endeavours will promote greater clarity and understanding.
The Panel wishes to express its appreciation to a number of experts who offered comment on the report. These include Mr D Boreham, Dr P Brennan, Mr G Constable, Dr L Cook, Dr I Edwards, Dr M Ewing, Dr B Hare, Dr D Loch, Mr P Neilson, Ms C McCaffery, Mr D Moore, Mr H Roberts, Prof M Sedgley, and Ms A Sharpe.
The Panel would also like to thank the staff of the Plant Breeder's Rights Office (PBR Office) for providing the secretariat support for this report, in particular, the Deputy Registrar, Mr N Hulse, and Mr B Blazey.
TERMS OF REFERENCE
Following the 1999 review of Plant Breeder's Rights (PBR), the then Standing Committee on Agriculture and Resource Management (SCARM) recommended that:
- the Registrar of Plant Breeder's Rights consult and communicate widely with the breeding community with the objective of providing a clearer explanation of breeding;
- the Registrar of Plant Breeder's Rights convene a panel of experts to provide examples of breeding methodologies that conform with the Plant Breeder's Rights Act 1994 and internationally accepted practice in accordance with the UPOV Convention;
- the Plant Breeder's Rights Office publish, through the Plant Varieties Journal and web page, a clearer explanation of breeding to respond to current uncertainties and guide applicants;
- the Plant Breeder's Rights Office work with the plant breeding and biotechnology industries to clarify essential derivation, develop practical solutions to intellectual property management of essentially derived varieties and, through this process, examine ways in which changes might be made to the Plant Breeder's Rights Act 1994 to better protect the interests of the first breeder.
MEMBERS OF THE EXPERT PANEL ON BREEDING
Mr Iain Dawson is Registrar of the Australian Cultivar Registration Authority, the internationally recognised registration authority for cultivars derived from Australian plant genera. He has over 20 years experience of horticultural and agricultural research specialising in the development of industries based on the exploitation of the native flora and is a regular contributor to cut flower and nursery industry conferences and forums. Mr Dawson is a manager at the Australian National Botanic Gardens in Canberra and an Accredited Consultant Qualified Person for Plant Breeder's Rights.
Professor Don Marshall has over 35 years experience in research and research management in the areas of plant genetics and breeding. He is currently Professor of Plant Breeding and Director of the Plant Breeding Institute at The University of Sydney.
Professor Marshall completed his studies in Agriculture at The University of Sydney in 1962 graduating with first class honours and The University Medal, and his Ph.D. studies in Genetics at The University of California, Davis in 1968. He subsequently worked at the Division of Plant Industry, CSIRO; the Grains Research Centre, Narrabri; and The University of Adelaide, principally in the areas of crop improvement and genetic resource conservation.
Dr Peter Stearne is an intellectual property lawyer and leads the chemical/biotechnology patent practice group in Davies Collison Cave. His practice includes pharmaceutical chemistry, polymer chemistry, protein and nucleic acid chemistry, general chemistry, molecular biology, immunology and plant innovations. He prepares patent applications, advice in relation to patent validity, patent strategy, patent opposition and patent litigation. He is an Accredited Consultant Qualified Person for Plant Breeder's Rights.
Mr Doug Waterhouse is a quantitative geneticist and has worked for over 20 years as a researcher and plant breeder. He is currently Registrar of the Plant Breeder's Rights scheme in the Commonwealth Department of Agriculture, Fisheries and Forestry. He has led the Australian delegation at meetings of the International Convention for the Protection of New Varieties of Plants 1991 (UPOV) since 1996 and is Vice Chairman of its Legal and Administrative Committee.
This report focuses on clarifying issues relating to 'breeding' and 'essential derivation' in the Plant Breeder's Rights Act 1994 (PBRA), as proposed by the Standing Committee on Agriculture and Resource Management (SCARM).
The catalyst for the report was a perception that (i) applicants and objectors generally had a poor understanding of the threshold of eligible breeding required by the PBRA and (ii) the balance between first and subsequent breeder rights in relation to 'essentially derived varieties' (EDV) should be reviewed.
The report is set against the requirements of the PBRA and Australia's commitments under the Convention of the International Union for the Protection of New Varieties of Plants 1991 (UPOV).
The Panel believes that, generally, breeders will welcome the report because it provides guidance, albeit at a general level, on how to satisfy the criteria for breeding required by the PBRA. The report concentrates on those situations where the eligibility of the breeding methodologies is most often questioned (for example bulk/pedigree selection within an existing population or the discovery of a natural variation/mutation).
The report provides guidance and clarification on 'breeding' by defining 'discovery', 'selective propagation', and 'eligible breeding' methodologies, as well as question and answer resolutions to common 'difficult' situations.
The Panel confirms that all varieties must meet the same minimum criteria regardless of the method of their origination. The Panel also notes that there are a number of misconceptions about what may automatically qualify or disqualify a variety from PBR registration.
The Panel acknowledges that in some exceptional cases the clarifications proposed might prove disadvantageous to the eligibility for protection of some varieties (for example, those varieties without information on their parents/origin).
The Panel confirms that Australia's current interpretation of breeding is consistent with international best practice and that no new, higher, or lower requirements for breeding are imposed.
EDV refers to the situation where the breeder of one variety (the 'first variety') claims that another breeder has developed another variety (the 'second variety') that is directly related to, and essentially the same, as the first variety.
The Panel agrees that breeding is an incremental process and the intent of the PBRA is to encourage the introduction of new varieties based on research and development.
The PBRA is not intended to facilitate or encourage 'copies'. In Australia, the second breeder's major defence against vexatious claims of EDV is to demonstrate 'important' difference otherwise the challenger's case will succeed, all else being equal. This is consistent with the intent of the PBRA, which is to produce new varieties and not copies. Therefore, in the opinion of the Panel, the current legislation encourages innovation, while providing protection for all breeders against plagiarism and vexatious challenge.
On a separate issue, occasionally seen as related, some see the development of new plant varieties through gene insertion as a 'quick and easy' process. The Panel believes that successful gene insertion is generally not quick and easy. Moreover, recognition is growing that 'traditional' and 'biotech' breeders share a mutual interest in working together. The Panel encourages the development of such mutually advantageous relationships.
The principal outcomes of this report are to:
- promote greater clarity as to what constitutes eligible 'breeding' for the purposes of the PBRA; and
- explain why, in respect of 'essentially derived varieties', the current balance between the first breeder and subsequent breeders is generally appropriate.
The Panel concludes that the provisions of the PBRA, and administrative approaches regarding breeding issues are soundly based. Accordingly, the only changes that the Panel recommends are in respect of EDV. Those changes are that PBR owner's ability to exercise their rights in respect of EDV should be extended to non-PBR varieties and that the responsibility to determine EDV is more appropriately a matter for the courts.
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 also concludes that many of the criticisms relating to breeding arise through misunderstanding of the scope of the legislation. Accordingly the Panel also recommends that the PBR Office should make further efforts to improve overall understanding of the PBRA and of administration of the PBR scheme.
 Essentially derived variety (EDV) refers to the situation where the breeder of one variety (the 'first variety') claims that another breeder has developed another new variety (the 'second variety') that is distinct from, but closely resembles and is directly related to, the first variety in all important respects.
 Essentially derived variety refers to the situation where the breeder of one variety (the 'first variety') claims that another breeder has developed another new variety (the 'second variety') that is distinct from, but closely resembles and is directly related to, the first variety in all important respects.
 Acknowledging that advanced technologies are being developed and refined to speed the process of gene insertion.