Clarification of Plant Breeding Issues under the
Plant Breeder's Rights Act 1994
Incremental Breeding, Benefit Sharing, Gene Patenting
The following observations are extrinsic to the focus of this report.
The view of the Panel is that the attitudes of 'traditional' breeders towards the alleged threat posed by 'biotech' breeders are in a state of flux. Some take the view that by working co-operatively there are mutual benefits to be gained by all parties and that failure to work together will see many opportunities slip irretrievably away. Others have difficulty with this concept.
There is a view that favours extending the rights of the first breeder to cover the development and commercialisation of all incrementally bred varieties (as opposed to essentially derived varieties as defined under the Act), whether or not those varieties exhibit important differences. The Panel notes that this view, while bringing PBR more into line with patents, is fundamentally inconsistent with UPOV principles.
The Panel understands that this push for benefit sharing across varieties derives from the perceived threat that 'biotech' breeding springs easily off 'traditional breeding' without recognising the true contribution of 'traditional', or first, breeders. It is also held that bio-technicians gain an unfair advantage when they insert patented genes into 'traditional' varieties. This is because the new gene inserted PBR registered variety may not be accessible for further research/development/commercialisation (because of patent considerations) while all other registered varieties without patent complications are available for further research/development/commercialisation. This situation is said to highlight the 'imbalance' of rights between PBR and patents. The real effects of this imbalance need to be verified before changes to the 'core' of the PBR system could be considered.
The view of the Panel is that changes to EDV cannot resolve the fundamental differences between patent and PBR principles. Patents give the capacity for almost total lockup of the invention while PBR gives free access. The wisdom of recreating those elements of the patent system that PBR was specifically designed to address, is questionable.
While broad empowerment of the individual breeder, in terms of exclusive right over incrementally bred varieties, has the potential to bring patents and PBR more into line, it would not resolve the underlying fundamental differences, and
- such a move would be a major shift negating the checks and balances envisaged by Parliament in introducing the PBR system by moving the balance of power more in favour of the individual, and away from public-good interests,
- such a proposition would require extensive consultation that this Panel is not in a position to conduct.
Patented Genes in PBR Varieties
UPOV envisages the registration of new varieties arising from all potential breeding methodologies, including genetic engineering, as does the Australian PBR system. The insertion of a patented gene into a PBR variety to create a new variety could prevent automatic access to that variety, while automatic access for further breeding is, in normal circumstances, guaranteed under PBR.
The new 'patented gene inserted variety' would not have to be PBR-protected because it would already have a deal of protection arising from the patent, would not be automatically accessible, would probably fall inside the set of varieties susceptible for a declaration of EDV (other countries) but outside the set of varieties than can be declared EDV in Australia.
Moreover, the patentee can choose whether to use a PBR/non-PBR variety as a 'host variety', and whether or not to apply for PBR in the second variety in order to avoid any possibility of EDV challenge.
Biotech Gene Insertion - The "First Breeder's Nightmare"
In dealing with the notion that it is simple to insert a gene to create a new market-ready variety, the Panel has posed the following ad hoc propositions for discussion.
The first breeder is at the mercy of those with a gene gun.
Putting a gene into a variety to create a new variety is a disincentive for the first breeder to maintain/increase baseline varieties.
Those who seek to insert genes in baseline varieties have no interest in the maintenance of such varieties, or in benefit sharing.
Putting a gene into a variety is not creating a new variety. It is plagiarism.
Putting a gene into a variety to create a new, market ready variety is quick and getting easy.
Once these gene-inserted varieties are created they can be locked up by patent from further incremental breeding.
Once a breakthrough transformative technology has been achieved, its application over a range of adapted varieties is straightforward.
Better protection for the first breeder will promote plant innovation and benefit Australia.
Mixing and recombining genes to form new varieties is the essence of plant breeding and has been carried on for generations. There is nothing new in this concept. Plagiarism (copying), in plant breeding terms, only occurs when the new variety is virtually identical to the parent variety. Plagiarism can be dealt with under the current definition of EDV in the PBRA.
There are some common misconceptions about gene technology. It is not simply a matter of choosing a gene and putting it into a plant. Considerable effort and resources and risk are involved. Firstly, the relevant gene needs to be identified, isolated and the process for insertion established. Secondly, it may take many, perhaps hundreds of attempts to insert a gene successfully without deleterious side effects. A screening process is required to identify which plant(s) have been transformed in the desired manner. Thirdly, a transformed plant is often less than adequate and needs to be backcrossed with a well-adapted variety (although, this is less the case in relation to a number of field crops). Fourthly, rigorous testing and scrutiny by the Office of the Gene Technology Regulator is required to ensure that the transformed variety has no detrimental consequences to environment or public health.
Gene technologists rely on well-adapted varieties into which to insert their genetic sequences. Where do they get these well-adapted varieties from? They either use public varieties (which will presumably either run out or become outdated) or they use PBR varieties. It may be possible for them to use PBR varieties without recognising the efforts of the first breeder but they run the risk of EDV claims and/or ultimately a decline in baseline varieties. If the first breeder does not get their financial return there will be no funding for the breeding of future varieties. The logical process is for gene technologists to negotiate with 'conventional' breeders to produce the base material (i.e. well adapted varieties) into which genes can be inserted. Moreover, conventional breeders are usually required to make the transformed variety market ready.
Experience in the US to date, admittedly a relatively short timeline, shows that there has been no demonstrated decrease in the breeding of baseline varieties as a result of gene technology. Gene technologists generally recognise that they share a mutual interest in having a wide choice of baseline varieties on which to work and there are numerous alliances with conventional breeders that demonstrate this. Further, organisations are competing to gain access to baseline varieties (provided legal title is clear) creating the circumstances for parties to negotiate mutually beneficial arrangements. The development of co-operative arrangements is recommended.
More than ninety per cent of biotechnological and genetic resources for food and agriculture arise overseas. Creating barriers to the introduction of such technology into Australia can only lead to Australia becoming a less desirable investment destination and, ultimately, will ensure its decline as a vanguard plant breeding nation. Biotech companies may simply remove Australia from their investment maps if 'freedom to operate/access to varieties' is harder here than elsewhere. This would mean that investment and technology imports into Australia would decrease and that breeding would go offshore.
Problems perceived in the patents system (e.g. the potential power of patents to 'lock up' material for future breeding through broad patent claims) are matters of current debate. Plant Breeder's Rights' regimes have been developed specifically to meet the particular needs of intellectual property in plants. Accordingly there are some differences between the two systems. Consequently, it is not possible to apply all of the concepts associated with industrial patents to plants. Moreover, since the PBRA policy intent is to promote the development of new varieties of plants, any proposals that may hinder that intent would need to be examined carefully.
Plant breeding has become a technically sophisticated science. It is no longer necessary to utilise the descendants of a long breeding line to achieve a new variety that is all but identical to current varieties, save for one or more distinct characteristics. For example, this can be done in the major field crops by accessing and crossing unprotected germplasm before applying the appropriate selection methods to isolate the desired individuals. This would avoid the necessity to recognise/work with the 'traditional' or first breeder (and all but circumvents EDV issues). The effect of the PBRA should be to encourage breeders and biotechnologists to work cooperatively to mutual benefit, and should not alienate the parties by polarising their efforts.
Level of Understanding of PBR
The Panel notes that there is considerable scope for improvement in the general level of understanding of the PBR scheme and that the PBR Office should continue to make efforts to improve such understanding.
Intellectual Property Rights
Ownership of intellectual property in plants is a long established, legitimate system. Such rights form the basis of an international multilateral agreement (the International Convention for the Protection of New Varieties of Plants 1991 (UPOV)) supported by 51 member countries under the aegis of the United Nations. Participation in this international system, on which the PBRA is based, enhances Australia's competitiveness in agriculture and benefits our overall economy due to the pervasive usage of plants in industry. The PBRA includes specific provisions to protect the public interest, while the rights accorded are of limited scope and duration.
A 'Perfect' System
Perfect regulatory systems are a rarity. Most systems are in a continual state of adjustment to reflect all kinds of changes, technological, market, ethical, etc.
The Panel believes that PBR is a good system and, like most systems, is a work in progress. Indeed, the Panel's current consideration of how 'breeding' might be clarified has itself been stimulated by an overwhelmingly positive response to a review of the worth of the PBR scheme through the SCARM process.
Variety of Common Knowledge
The Panel acknowledges the absence of a comprehensive definition of 'variety of common knowledge' (VCK).
Historically, UPOV has approached the issue by way of an inclusive list of activities that may bring a variety into common knowledge. The Panel notes recent discussions in UPOV have been unable to develop a definition of VCK that is acceptable to all and supports continuing discussions on this matter in the UPOV forum.
The Panel notes that the test for VCK is not limited only to Australia,
but is addressed in a worldwide context. Accessing the requisite information
may be problematic. However, section
50 of the PBRA provides a means to revoke a grant of rights if new
information comes to light.
PBR and Other Legislation
There is a general lack of understanding that the PBR system (like others) co-exists with other legally enforceable rights, and of the various possible implications of this reality.
For example, dispute over the physical ownership of plants is an issue for common law proceedings in the courts. Intellectual property ownership is the basis of the UPOV and the derived PBR system. Physical ownership is not an issue under UPOV, or under the PBRA. Some parties are not familiar with this reality, or choose not to accept it. There is scope for commercial agreement in relation to such matters outside the PBR.
It is feasible for a new variety to be registered under the PBRA but for the exercise of the breeder's right to be restricted by other legislation, for example, prohibition against the use of a variety in food, or against the growing of a variety as a noxious weed.
Opposition to Grant of Rights
The Panel is critical of uninformed/unsupported opposition to applications for protection, emphasizing that clear and convincing evidence is the only foundation of valid objection. Assertions, or unsubstantiated claims, are invalid and unacceptable. The Panel also recognizes that it is not the responsibility of the PBR Office to provide legal advice to an objector, or to act on behalf of any party.
The Panel further recognises that:
- UPOV (and the derived PBR system) operates on the presumption that, if nothing is proved to the contrary, a breeder's prima facie claim to have produced a new variety is valid;
- UPOV's premise is that the benefit of doubt lies with the breeder;
- the legal test of eligibility for protection under the PBRA is when the Secretary (or delegate) of the Department of Agriculture, Fisheries and Forestry is satisfied that the relevant criteria have been, and continue to be, met;
- lack of comprehensive supporting information or the presence of inconclusive contradictory information is not a bar to the Secretary being satisfied that a grant of rights should be made, while conclusive proof would be;
- if all requirements of the PBRA are met, and the truthfulness, accuracy and correctness of the breeder's claims are not disproved, a grant of rights must be made; and
- the penalties for false statements in relation to PBR are significant, including imprisonment.
PBR and the Convention on Biodiversity (CBD)
The Panel perceives a lack of understanding of the interaction between PBR and the Convention of Biodiversity (CBD). While acknowledging that the linkages between PBR and the CBD are not seamless, scope for conflict is more imagined than real. The two are not so much in conflict as having different emphases.
 UPOV 1991Article 15 (1) (iii) - the 'breeder's exemption'.
 Subject to the normal assumptions regarding claims made in patent applications.