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- ACIP review of enforcement of Plant Breeder's Rights
- Company news
- BioTip: Unsolicited requests for payment of fees
- Events
ACIP review of enforcement of Plant Breeder's Rights
In brief: Partner Dr Trevor Davies (view CV) and Law Graduate Matt Vitins provide an outline of the recent Issues Paper released by the Advisory Council on Intellectual Property on its review of the enforcement of Plant Breeder's Rights in Australia.
Introduction
The rights of plant breeders have been specifically protected in Australia since the introduction of the Plant Variety Rights Act 1987 (Cth). This Act evolved to bring Australian law in line with international agreements and became the current Plant Breeder's Rights Act 1994 (Cth) (the PBR Act)
In 2002, the PBR Act was the subject of a series of amendments designed to clarify plant breeder's rights and to improve access to the PBR Scheme.1 However, concerns relating to enforcement of PBR persisted. In 2006, Parliamentary Secretary for the Minister for Industry, Tourism and Recourses, Bob Baldwin, requested The Advisory Council on Intellectual Property (ACIP) report to the Federal Government on:
...possible strategies to assist Australian plant breeder's rights holders effectively enforce valid rights...(and) whether any practices and procedures relating to the enforcement of Plant Breeder's Rights are appropriate to be referred to the Federal Magistrates Court2
In response to this request, ACIP has recently released an Issues Paper A Review of the Enforcement of Plant Breeder's Rights.3 The purpose of the paper is to elicit submissions that will form the basis of further consultations and an options paper. The options paper will be open to further comment before a final report is delivered to the Parliamentary Secretary in late 2007.
Background
Objectives
The primary objective of the PBR Act is to enable plant breeders to apply for and receive proprietary rights for new varieties of plants they develop. In short, it is 'fundamentally aimed at ensuring that plant breeders have an opportunity to gain reward for their innovation'.4
Protecting these rights in conformity with the International Convention for the Protection of New Varieties of Plants (the UPOV Convention) and the World Trade Organisation Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) allows for reciprocal rights recognition and thus international enforcement. In turn, this provides access to international markets and to overseas protected varieties.
The PBR Act is thus thought to generally underwrite innovation and the competitiveness of Australian agriculture.
Plant Breeder's Rights
Plant Breeder's Rights are granted upon application to the Plant Breeder's Rights Office through IP Australia following an examination process. For a plant variety to be registrable, section 43(1) of the PBR Act requires:
- that the variety has a breeder;
- that the plant variety be distinct, uniform and stable; and
- the variety has not been exploited, or has only recently been exploited.
The actual rights conferred by a successful PBR application are detailed in s11 of the PBR Act, which provides:
...PBR in a plant variety is the exclusive right, subject to this Act, to do, or to licence another person to do, the following acts in relation to propagating material of the variety:
- produce or reproduce the material;
- condition the material for the purpose of propagation;
- offer the material for sale;
- sell the material
- export the material
- stock the material for the purposes described (above)
PBR rights are granted for 20 years for plants, and 25 years for tree or vine varieties.5
Exceptions and limitations
ACIP identifies two exceptions under the PBR Act as particularly important.6 The first is the possible use of protected plant varieties for non-commercial purposes and for experimentation or use in breeding other varieties (s16).
The other is referred to as the 'farm-saved seed exemption', which exists under s17 and allows farmers to harvest propagating material derived from the crop grown from the original, legitimately obtained propagating material, and use it for subsequent cropping cycles on their own farm.
A further important limitation is found in s23 which states that PBR rights are exhausted after propagating material is sold by the grantee or with the grantee's consent.
Inter-generational PBR
Irrespective of the exceptions and limitations noted above, PBR can extend through subsequent generations of a protected plant variety. Where propagating material is reproduced without the authorisation of the grantee, and material is harvested from that propagating material, s14 extends PBR rights to the harvested material where the grantee has not had a 'reasonable opportunity' to exercise their rights in relation to the propagating material. Section 15 extends PBR to 'products obtained from harvested materials' on similar conditions.
The interaction between these provisions has been somewhat clarified by case law. ACIP cites Cultivaust Pty Ltd v Grain Pool7 as authority for the propositions that:
- the authorised sale of the initial seed does not exclude from the operation of PBR all subsequent generations of crop from seed originally purchased from the grantee; and
- exhaustion of PBR by the sale of initial seed applies to the first generation only.8
While acting as an exception to these principles, the effect of the farm-saved seed provisions are that PBR rights remain in tact. Royalties may be demanded where a farmer sells, exchanges, shares or barters harvested material to another grower without the further authorisation of the grantee.9
ACIP Issues Paper
The ACIP Issues Paper identifies a number of areas of concern related to the enforcement of PBR rights. The discussion in the Issues Paper can be organised according to suggestions that address the PBR rights as they are currently framed; procedural reforms; and cultural change.
ACIP seek views on the following issues.
Matters concerning the PBR Act
- The operation of the farm-saved seed provisions and 'reasonable opportunity' under s14 and s15;
- procedures relating to the declaration of Essentially Derived Varieties;
- process and mechanisms for protecting PBR; and
- lack of clarity in the language used in PBR Act;
Procedural
It is noted that the resources required to undertake legal action for infringement are often well beyond the means of most breeders.10 A possible solution raised in the Issues Paper is to direct PBR matters to the Federal Magistrates Court (FMC) in preference to the (more expensive) Federal Court. ACIP asserts that using the FMC to deal with less complex cases would mean a better use of judicial resources and reduced cost to litigants.11
Submissions are sought on preliminary suggestions either received or raised by ACIP, including:
- the FMC and PBR;
- provisions in the PBR Act to allow entry onto private property to gain evidence (and on evidence collection generally);
- mving the burden of proof in litigation from the plaintiff to the defendant;
- the inclusion of exemplary damages provisions in the PBR Act;
- criminal sanctions for PBR infringement as opposed to civil sanctions;
- provisions for either compulsory or voluntary alternative dispute resolution;
- a system of customs border seizure for goods that allegedly infringe PBR rights;
- random varietal determination testing to act as a deterrent to mis-declaration; and
- varietal identification and End Point Royalties.
Central information and a collective peak body
A factor inhibiting enforcement is that PBR rights are not well understood. ACIP writes:
The PBR Act is still relatively young in Australia and that there has been inadequate awareness by the community in general (and the farming community in particular) of the nature of the rights conferred, and the obligations that are a consequence of using PBR protected plant varieties.12
A further cultural issue identified by ACIP is that in small rural communities breeders are often reluctant to take infringement action when the infringer is also a customer of the breeder.13
For these reasons among others, ACIP canvasses the prospect of establishing a peak body to represent breeders' interests. The role of the peak body could potentially involve:
- increasing awareness through educating both breeders and users;
- undertaking enforcement activities on behalf of members; and
- collecting PBR royalties.
The second of these functions could be particularly useful in that a peak body responsible for enforcing PBR rights would spread the cost of enforcement across its members. It would also overcome the issue regarding the politics of enforcement in small rural communities.
Questions raised by ACIP as to the ultimate form of any such peak body include:
- whether the organisation should be statutory or independent;
- whether membership should be compulsory or voluntary;
- whether it should enforce grantees rights; and
- whether an educational role should be an integral function of the body.
Review Process
Written comments on the Issues Paper are sought by 27 April 2007 and can be sent to the ACIP Secretariat. Details of the review and Issues Paper can be found at http://www.acip.gov.au/
For further information please contact Dr Trevor Davies on 02 9230 4007
Footnotes
- Explanator y Memorandum to the Plant Breeder's Rights Amendment Act 2002 (Cth).
- Terms of Reference as cited in Advisory Council on Intellectual Property (ACIP), A Review of Enforcement of Plant Breeder's Rights (2007) at 1.
- Available at http://www.acip.gov.au/.
- Explanatory Memorandum to the Plant Breeder's Rights Amendment Act 2002 (Cth).
- PBR Act s22.
- ACIP above n2 at 8 (ACIP terms of reference).
- [2005] FCAFC 223.
- ACIP above n2 at 10.
- Ibid at 17.
- Ibid at 19.
- Ibid at 19.
- Ibid a t 13.
- Ibid at 29.
Company news
In brief: Regular news from the biotech industry.
- AstraZeneca announces Shanghai site as base for Chinese innovation centre
- Avexa reports HIV drug trial success
- Bayer and Novartis reach agreement over MS drug Betaseron
- Biota's HRV drug successfully completes Phase I clinical trial
- EvoGenix collaboration with GSK achieves milestone
- GSK's Altargo receives positive opinion for treatment of impetigo and other skin infections
- Permanent injunction granted prohibiting marketing of generic version of Topamax
- Pfizer wins Celebrex patent challenge
- Schering-Plough and Merck to develop new cholesterol lowering medicine
AstraZeneca announces Shanghai site as base for Chinese innovation centre
23 March - AstraZeneca has announced that Shanghai's Zhangjiang Hi-Tech Park will be the initial base for its new Innovation Centre in China. The centre, announced in May 2006 as part of a larger US$100 million investment package, will focus on the value of innovative medicines for Chinese patients. It will initially concentrate on cancer through the development of knowledge about Chinese patients, biomarkers and genetics. The facility is scheduled to open in mid-2007 and will provide a base to build capabilities and skills in China prior to the establishment of a permanent site. Recruitment for scientists and physicians is already underway.
[Source: Company announcement]
Avexa reports HIV drug trial success
19 March - Melbourne biotechnology company Avexa has announced successful results from its Phase IIb trial for its novel nucleoside reverse transciptase inhibitor (NRTI) apricitabine (ATC), being developed for the treatment of HIV infection in patients with drug-resistant HIV. The trial compared the effectiveness of ATC in reducing the viral load of patients with drug resistant HIV with the effectiveness of lamivudine (a leading NRTI in widespread use). Patients who received ATC exceeded the Phase IIb trial endpoint by a substantial margin. Remarkably, one patient achieved a decrease in the amount of virus after 21 days on ATC. CEO Dr Julian Chick said that the 'positive result allows us to continue to progress ATC into Phase III trials and towards commercialisation' and that 'overall the results of Avexa's Phase IIb clinical trial demonstrate that ATC is a clinically effective antiviral drug that can significantly reduce the replication of the virus in patients infected with drug resistant HIV.' NRTI's represent more than 50 per cent of the overall market for HIV therapies.
[Source: Company announcement]
Bayer and Novartis reach agreement over MS drug Betaseron
26 March Bayer AG and Novartis AG have settled a dispute over multiple sclerosis drug Betaseron. The deal gives Bayer full control of the product while letting Novartis launch a new version in 2009. As part of the arrangement, Bayer has purchased from Novartis a biologics manufacturing facility in California which is currently used to produce Bayer's Betaseron for patients in the US. Novartis will transfer manufacturing responsibility for Betaseron by selling related equipment and property to Bayer for a one-off payment of approximately US$110 million. Bayer will continue to pay Novartis royalties equivalent to those being paid currently on net sales of Betaseron manufactured at the California facility until expiration of the original agreement in October 2008. It is anticipated that Novartis will submit its own oral once-daily MS therapy FTY720 (Fingolimod) in 2009.
[Source: Company announcement]
Biota's HRV drug successfully completes Phase I clinical trial
26 March Biota Holdings Ltd has announced the successful completion of the second stage of its Phase I human safety and tolerability study of BTA798. This drug is a potent inhibitor of human rhinovirus (HRV), the major cause of the common cold, and is the product of original research at Biota. It is an orally available, small molecule drug that targets the capsid protein on the surface of the human rhinovirus to stop the spread of the virus infection. Biota intends to test the efficacy of the drug by advancing the development of the drug to Phase II trials. CEO Peter Cook said BTA798 'could be a world-first antiviral treatment for HRV in high risk patients. A safe and effective treatment for HRV would be a major breakthrough for high risk sufferers of asthma, chronic obstructive pulmonary disease, cystic fibrosis, and in patients with compromised immune systems for whom the common cold can trigger events leading to serious illness and hospitalisation.' The trial studied the effects of two dose levels, once or twice daily. The Phase I trial has established BTA798 to be safe and well tolerated in healthy volunteers.
[Source: Company announcement]
EvoGenix collaboration with GSK achieves milestone
26 March Australian biotech Evogenix Limited announced confirmation by collaboration partner GSK of successful completion of the first project between the two companies, triggering a milestone payment by GSK to Evogenix. Under the agreement, Evogenix utilised its protein optimisation technology, Evogene, to develop improved versions of a protein product from the GSK pharmaceutical pipeline. Improvements in affinity in the protein variants generated exceeded the 20-fold goal specified in the collaboration agreement. GSK will be responsible for further development of the product, with Evogenix eligible to receive additional milestone payments as the product progresses.
[Source: Company announcement]
GSK's Altargo receives positive opinion for treatment of impetigo and other skin infections
23 March GSK's announced that its new topical antibiotic Altargo (retapamulin ointment, 1 per cent) received a positive opinion from the European Committee for Human Medicinal Products for the treatment of impetigo (a superficial skin infection most commonly seen in children) and infected small lacerations, abrasions or sutured wounds. Altargo demonstrates no target-specific cross-resistance with other antimicrobial drugs and exhibits a low potential for the development of resistance in vitro.
[Source: Company announcement]
Permanent injunction granted prohibiting marketing of generic version of Topamax
22 March The validity and enforceability of the Ortho-McNeil Neurologics patent on epilepsy and migraine drug Topamax has been upheld by a US District Court Judge. Judge Stanley R Cheslar in New Jersey issued a permanent injunction against Mylan Laboratories Inc. The injunction prohibits Mylan from selling generic topiramate tablets and capsules in the US until the compound patent on Topamax expires in 2008. Cobalt pharmaceuticals, sued by Ortho-McNeil Neurologics in October 2005, agreed to be bound by the outcome of the Mylan case.
[Source: Company announcement]
Pfizer wins Celebrex patent challenge
20 March – Pfizer has announced that a federal court in the District of New Jersey has upheld the main US patents covering the company's selective non-steroidal anti-inflammatory (NSAID) medicine used to treat pain and inflammation. Judge John C. Lifland dismissed the challenge by generic manufacturer Teva Pharmaceuticals USA by ruling that the patents covering the active ingredient, pharmaceutical composition and method of use for Celebrex are valid, enforceable and infringed by the generic manufacturer's product. Teva is prohibited from launching a competitor drug in the US until December 2015. Celebrex's sales totalled US$1.57 billion in the U.S in 2006.
[Source: Company announcement]
Schering-Plough and Merck to develop new cholesterol lowering medicine
26 March Schering-Plough has entered into an agreement with Merck & Co to commence development of an ezetimibe and atorvastatin combination product. The development program is timed such that this combination product could be available at the time that patent exclusivity for atorvastatin expires in the US and internationally. It is anticipated that the combination will create yet another new option in the treatment of elevated LDL cholesterol
[Source: Company announcement]
BioTip: Unsolicited requests for payment of fees
There are private organisations in various countries which write directly to intellectual property rights owners with unsolicited requests for payments of 'official fees' or unsolicited offers to enter intellectual property rights details in private 'registers' or publications on payment of substantial fees. Such offers typically come in a form resembling an invoice and may even enclose a copy of the advertisement of acceptance or other similar official document prepared by the relevant patent office. Such 'requests' or 'offers' are not approved or endorsed by AAR and have no official standing. AAR recommends that all such correspondence be forwarded to your IP adviser for review before any action is taken to pay such fees.
Events
Information on the latest conferences
See conferences in: March | April | May
March
NEW AusBiotech Students Association Launch
Wednesday, 28 March
Edinburgh Hotel, Mitcham, SA
http://www.ausbiotech.org/
NEW The Australian Stem Cell Summit
Thursday 29 March - Friday, 30 March
Hilton on the Park, Melbourne, Vic
April
NEW BIO-BBQ
Wednesday, 4 April
i.lab bio.incubator, Brisbane Technology Park, Eight Mile Plains, QLD
NEW Life Science Alliances World 2007
Monday, 16 April Wednesday, 18 April
Victoria Park Plaza, London, UK
http://www.terrapinn.com/2007/alliance/
May
NEW BIO 2007
Sunday, 6 May 9 Wednesday, May
Boston Convention & Exhibition Centre, Boston, MA, USA
For further information, please contact:
- Dr Trevor DaviesPartner, Allens Arthur Robinson Patent & Trade Marks Attorneys,
Sydney
Ph: +61 2 9230 4007
Trevor.Davies@aar.com.au