Allens Biotech News is a fortnightly news service to keep you on top of developments in this fast-moving industry.
Bio-prospecting in Australia
In brief:
Partner Dr Trevor Davies
Bio-prospecting is the search of natural resources, such as native flora and fauna, and subsequent screening and extraction to obtain potentially useful compounds and genetic material. Bio-prospecting may require gaining access to controlled and protected geographical areas to obtain the natural resources. Australia, estimated to contain about 10 per cent of the world's biodiversity, is an extremely valuable resource for bio-prospecting and provides an immense bank of natural compounds and genetic data.
Access and benefit-sharing issues over genetic resources, particularly involving ownership and intellectual property rights, have been of widespread international interest over the past 15 years. Concern over these issues has risen in recent years in connection with the vast growth in commercial activity and research in the biotechnological and biological fields. The following discussion provides a brief overview, including a review of Australia's new regulatory regime for controlling access to its natural resources.
The founding international agreement in this area was the 1992 Convention on Biological Diversity (CBD), which has been ratified by about 180 nations including Australia and New Zealand. The CBD recognizes state sovereignty over genetic resources but extends obligations to ensure that local activities do not damage the environment or territory of other states. The CBD is focused on access to biological resources and the benefit sharing from commercial exploitation of such resources.
Concern has been raised that traditional knowledge of beneficial uses of flora and fauna, typically held by indigenous groups, is being exploited for commercial gain via the grant of intellectual property rights without appropriate compensation to the original holders of the traditional knowledge. Consequently, a further objective of the CBD was to protect indigenous people's access to, and traditional knowledge of, their native flora and fauna.
The World Intellectual Property Organisation (WIPO) also targeted similar objectives to that of the CBD when it established an Intergovernmental Committee on Intellectual Property and Genetic Resources Traditional Knowledge and Folklore (IGC) in April 2000. The IGC focus was directed to the effect of intellectual property rights on the access to genetic resources and benefit sharing, together with protection of traditional knowledge and expressions of folklore. Recommendations arising from subsequent discussions have included requirements to disclose in patent applications the origin of genetic resources and traditional knowledge, and the development of benefit sharing clauses for use in negotiated agreements. Many countries are also investigating establishing governmental bodies to regulate and control access to their genetic resources.
In Australia, an inquiry was undertaken in October 2000 by the House of Representatives Standing Committee on Primary Industries and Regional Services to review the impact and benefits of bio-prospecting and to provide recommendations on how Australia can better position itself to take advantage of the growth in this industry, while maintaining its national and international obligations. The Federal Government's response was tabled in September 2002 and supported, in principle, most of the recommendations put forward by the Standing Committee. The Government agreed that the regulations being created to control access to biological resources, which were to be made under section 301 of the Environment Protection and Biodiversity Conservation Act 1999 (the EPBC Act), would not establish any new property rights.
The EPBC Act is directed to a very broad range of human activities that impact on the environment. Section 301 covers the control of access to biological resources, the setting of terms for granting such access, and the promotion of equitable sharing of subsequent benefits arising from such access. Part 8A of the EPBC Regulations 2000, which was finalised in 2005, fleshes out the regulatory framework for controlling access to biological resources under s301 of the EPBC Act and came into force on 1 December 2005.
The purpose of the national administrative regime created under Part 8A for controlling access to biological resources is to provide certainty, promote conservation, protect biodiversity, ensure equitable sharing of benefits arising from such access, and to protect indigenous people's access and traditional knowledge. The regime, administered by the Department of the Environment and Water Resources (formerly the Department of the Environment and Heritage), controls access to biological resources in 'Commonwealth areas', which includes land owned or leased by the Commonwealth, the coastal sea and continental shelf of Australia, and any area in a Commonwealth reserve or national park. The regulations specifically relate to obtaining biological resources from native species for the purpose of genetic research and development, and do not include other activities such as taking animals, plants or marine life for food.
A permit must be obtained to gain access to biological resources in a Commonwealth area. If the access is for a commercial purpose, a benefit-sharing agreement must be provided to the Department, together with the application for the permit. A more flexible system is provided for non-commercial scientific research.
The benefit-sharing agreement must include full details of the proposed activity and address benefit-sharing arrangements, including the recognition, and valuing, of any indigenous knowledge being used. The terms of such an agreement are not prescribed and can be freely determined by the parties. However, the agreement must also address other aspects, including:
- the quantity of the resources that can be removed;
- purpose of the access;
- details of the labelling of samples;
- ownership in samples and details of any proposed transmission of samples to third parties;
- a statement regarding the use of indigenous people's knowledge (if relevant), including details of the source of the knowledge, benefits to be provided for such use and copies of any relevant agreements; and
- details and proposals of any benefits accruing to the biodiversity conservation in the area and to the access provider of the area, if access is granted.
If the area of access to biological resources is on indigenous land, informed consent must also be obtained from the indigenous people of that area. If a benefit-sharing agreement impacts on native title rights, then indigenous land use agreements under the Native Title Act 1993 (Cth) should also be considered.
If an environmental assessment is required, the Department of the Environment and Water Resources will conduct a review of the assessment and determine if the proposed access is ecologically sustainable and consistent with the conservation of Australia's biodiversity. Submissions from interested parties will also be taken into account, if considered relevant.
The administrative fees for permits have been set relatively low with a maximum fee of $50 for a commercial permit. Permits can also be applied for online. In addition, a register of permits is maintained and can be publicly accessed at this Federal Government site.
Disclosure of a permit can be withheld from the register if it could damage a person's commercial interests. Full records of biological samples obtained must also be kept and provided to the Department. The penalties for breaching the permit system have been set at a modest level of $5500.
Conclusion
Australia's new regulatory regime addresses the transparency of bio-prospecting and benefit-sharing issues. It will be interesting to see whether the regime is supported and adopted by the relevant industries and organisations. Most other countries in the region, including New Zealand, have yet to implement regulatory regimes to control the access to its biological resources. Australia is leading the way and has provided a model system for other countries in the region to assess and adopt in order to fulfil its own international obligations.
Company news
In brief: Regular news from the biotech industry.
- Top scientists appointed as CSIRO Fellows
- Acux and Organon to develop contraceptive sprays
- New studies indicate GSK's pre-pandemic influenza vaccine can protect against different strains of H5N1
- Biotech signs Australian-first agreement
- New JACC analysis details cardiovascular protective benefits of Carvedilol in heart failure patients
- Results of Australian pilot skin cancer clinical trial: PEP005-008
- Schering-Plough to buy Organon BioSciences
- Brisbane biotech company at the forefront of bird flu fight
Top scientists appointed as CSIRO Fellows
27 February - Seven of CSIRO's outstanding scientists have been appointed as CSIRO Fellows. CSIRO Fellowship is a merit-based award given to scientists who have demonstrated eminence in their field. The seven new fellows join the three current fellows - Chief Scientist Jim Peacock and Liz Dennis, both renowned plant scientists from CSIRO Plant Industry, and Ezio Rizzardo from CSIRO Molecular & Health Technologies. The new CSIRO fellows are: Dr Trevor Bird (CSIRO Information and Communication Technologies Centre); Dr Greg Constable (CSIRO Plant Industry); Dr Ron Ekers (Australian Telescope National Facility); Dr Dick Manchester (Australian Telescope National Facility); Dr Trevor McDougall (CSIRO Marine and Atmospheric Research); Dr Steve Rintoul (CSIRO Marine and Atmospheric Research); and Dr David Trimm (CSIRO Petroleum Resources). The Fellows will be involved in a number of CSIRO initiatives planned to enhance the organisation's science and attract more young scientists.
[Source: Company announcement]
Acux and Organon to develop contraceptive sprays
1 March – Drug delivery company Acrux announced that it has signed an agreement with Organon, the human healthcare business unit of Akzo Nobel. Organon and Acrux will develop and commercialise contraceptives, delivered through the skin using Acrux's unique spray technology. Under the agreement, Organon has licensed Acrux's technology for use with selected contraceptive compounds. Acrux will be responsible for developing formulations of such contraceptive compounds and, upon successful completion of this program, Organon will undertake and fund all clinical trials, regulatory submissions, manufacturing and marketing. For each contraceptive compound that Organon selects to develop, Acrux may receive payments totalling between US$12 million and US$16 million as development and regulatory milestones are achieved. Acrux will also earn royalties on worldwide sales of each product. Acrux is free to develop and commercialise sprays containing other contraceptive compounds, including Nestorone®, which it is currently advancing through clinical trials. Worldwide sales of hormonal contraceptive products in 2006 were approximately US$6.7 billion.
[Source: Company announcement]
New studies indicate GSK's pre-pandemic influenza vaccine can protect against different strains of H5N1
5 March - GlaxoSmithKline (GSK) announced clinical trial data from two new studies which show for the first time that GSK's candidate pre-pandemic split antigen H5N1 vaccine, formulated with GSK's proprietary adjuvant system, provides a substantial level of cross-immunity against a 'drifted' (diverse) strain of H5N1. It is hoped that the immune response elicited with this vaccine could help prepare or 'prime' the immune system to rapidly respond against variants of the H5N1 strain and, therefore, protect the vaccinated population in the event of an H5N1 human pandemic.
[Source: Company announcement]
Biotech signs Australian-first agreement
6 March - BioChip Innovations, based at the i.lab bio.incubator at the Brisbane Technology Park, has become the first Australian company to sign a Research Collaboration Agreement with Singapore's Institute of Microelectronics (IME). i.lab Incubator CEO Anne-Marie Birkill said the deal would provide BioChip Innovations access to the world's most advanced silicon chip sensor technology that was developed by IME. 'The new agreement is between IME, a division of Singapore's Agency for Science, Technology and Research, and SiMEMS Pte Ltd – BioChip Innovation's strategic partner in Singapore and will be extremely beneficial to all parties,' Ms Birkill said. CEO Dr Graeme Barnett said BioChip Innovations was now aiming to develop the first-of-its-kind silicon nanowire biochip commercially for use in a wide range of RNA and DNA testing. He said the detection of specific DNA was central to many areas of healthcare and the life sciences, ranging from uncovering and diagnosing disease to the discovery and screening of new drug molecules.
[Source: Company announcement]
New JACC analysis details cardiovascular protective benefits of Carvedilol in heart failure patients
8 March - Patients with heart failure who received the heart medication Carvedilol suffered fewer heart attacks and strokes and were less likely to die of these and other vascular events than patients prescribed another beta blocker, metoprolol tartrate, according to a retrospective analysis of COMET (the Carvedilol or Metoprolol European Trial) published in the 6 March issue of The Journal of the American College of Cardiology . Study investigators looked at whether the effects on vascular events contributed to the beneficial effect of Carvedilol in the COMET trial, the longest and largest mortality trial comparing beta-blockers in heart failure patients. Among its key findings, the analysis documented that Carvedilol reduced the risk of heart attacks, unstable angina, or stroke by 19 per cent (p = 0.017). During the study, 106 of the 160 patients on metoprolol tartrate who had a non-fatal heart attack or stroke later died, while 61 of 124 patients on Carvedilol who had a nonfatal heart attack or stroke later died. The study included more than 3000 patients with heart failure primarily due to ischemic or dilated cardiomyopathy. Study participants were followed for an average of 58 months. According to COMET investigators, the study results suggested that the use of Carvedilol in patients with heart failure extended median survival by 1.4 years.
[Source: Company announcement]
Results of Australian pilot skin cancer clinical trial: PEP005-008
9 March - Peplin Limited recently announced results from its Australian pilot clinical trial (PEP005-008) of its proprietary drug PEP005. Topical in squamous cell carcinoma in situ (SCCIS), a non-invasive form of squamous cell carcinoma, a form of skin cancer. The goals of this clinical trial were to evaluate the safety and efficacy of PEP005. Topical (at a concentration of 0.05 per cent) when applied once a day on two consecutive days in the treatment of SCCIS. In this trial, PEP005 Topical demonstrated a favourable safety profile and was well tolerated. There were no drug related serious adverse events. The majority of local skin responses were graded mild and resolved spontaneously, typically within one month of treatment. These results are consistent with the safety profile previously reported in clinical trials of PEP005 Topical to treat superficial and nodular forms of basal cell carcinoma. The observed favourable safety profile of two days treatment at 0.05 per cent, the concentration used in this study and the highest concentration used in earlier studies, gives Peplin confidence that it could explore the activity of PEP005 Topical in the treatment of non-melanoma skin cancer at a higher concentration.
[Source: Company announcement]
Schering-Plough to buy Organon BioSciences
13 March - Pharmaceutical giant Schering-Plough has announced it will acquire Dutch human and animal healthcare business Organon BioSciences, a subsidiary of Akzo Nobel, for approximately 11 billion euros (A$19.25 billion). Organon BioSciences develops, manufactures and markets products targeting selected therapeutic areas in human pharmaceuticals and a wide range of species in animal health. It has particular interest in gynaecology, infertility, selected areas of anaesthesia and animal health. It consists of two operating units: Organon is the human pharmaceuticals business and Intervet is the world's third largest animal health company. Organon had sales of A$4.4 billion in 2006 and owns leading products such as Follistim/Puregon, a follicle-stimulating hormone for infertility; Esmeron/Zemuron, a muscle relaxant; and NuvaRing and Implanon for contraception.
[Source: Company announcement]
Brisbane biotech company at the forefront of bird flu fight
14 March - A Brisbane biotech company is close to releasing a new product it says will identify different strains of influenza, including avian flu, quicker and cheaper than any other product currently on the market. Minister for State Development John Mickel said BioChip Innovations expects to release its Influenza PrimRset product by the end of this year and will market it to the hundreds of medical and veterinary research and reference laboratories worldwide that are actively investigating influenza viruses. 'The current genetic tests being used to detect and subtype influenza viruses have a number of deficiencies,' Mr Mickel said. 'The recent transference of the H5N1 subtype from wild birds to poultry to humans demonstrates a desperate need for a simple, accurate and affordable test that can detect and identify any influenza strain.' Mr Mickel further said that Influenza PrimRset will be capable of testing for different strains of influenza in humans, eggs, birds, tissue culture, respiratory samples and blood. The Minister said BioChip Innovations, which is based at the Queensland Government's $1.25million i.lab bio-incubator at Brisbane Technology Park at Eight Mile Plains, has developed a diagnostic testing system that can run a battery of tests on a virus within just three days rather than the three weeks it takes at present. 'Within two years we anticipate using this technology to develop a fully automated hand-held device to genetically detect and identify any influenza virus within 30 minutes,' he said.
[Source: Company announcement]
BioTip: Contributions to technology development
Collaborative efforts between individuals and/or companies may result in the development of new technologies. To prevent potential difficulties (and disputes) arising between the parties involved, the duties and obligations of each contributor should be clearly established from the outset. It is good practice for entities seeking to develop new technologies to carefully plan out such a collaborative framework, making it transparent to all those concerned. Preferably, each party should execute appropriate agreements/undertakings, giving effect to the framework, prior to commencement of any collaboration.
Events
Information on the latest conferences
See conferences in: March
Excellence in Biotechnology and Investment Conference
Monday, 19 March –
Tuesday, 20 March
Sofitel Wentworth Hotel, Sydney, NSW
http://www.biotechnologynews.net/eventdetail.asp?eventid=2146
NEW – Women in Biotech Dinner
Tuesday, 20
March
Blackbird Café, Cockle Bay
+61 2 9325 3261; Corinne.Turner@csiro.au
NEW – Hong Kong – Medical and Bio Tech Gateway to
China
Wednesday, 21 March
Level 47, MLC Centre, 19 Martin Place,
Sydney, NSW
Tel: +61 2 9338-6622
CEO Forum: The Business of Biotech
Wednesday, 21March – Friday, 23
March
Hyatt Regency, Sanctuary Cove, QLD
http://www.ausbiotech.org
NEW – Hong Kong – Medical and Bio Tech Gateway to China
Wednesday, 21 March 2007
MLC Centre, Sydney
roseline.yardin@business.nsw.gov.au
NEW – Using Patented Inventions for Research
Monday, 26
March
Sofitel Melbourne, Carillon Room, VIC
Tel: +61 3 9523 7207 or
email information@techip.com.au
Pharmaceutical and Biotech Patent Litigation Strategies
Tuesday, 27 March – Wednesday, 28 March
London, United Kingdom
http://www.iqpc.com/uk/ppl
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
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