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Editorial and News,
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Editorial FROM THE PRESIDENT Conflicting signals from Government in 1996 - What now for 1997? If industry supports the Mortimer "Review of Business Programmes", there is a prospect that the arbitrary cost cutting of 1996 will be followed by a broader vision in 1997 Start-up companies that are innovative and knowledge-based, including most biotechnology companies, require a high degree of nurturing and patience on the part of financial supporters. Whether we like it or not, in Australia, given the absence of a viable venture capital market and the culturally engrained reluctance of business to invest in such companies, government policy is a vital ingredient in encouraging investment and in contributing to the nurture of new enterprises. There was therefore high expectation on the election of the Howard government, that, given the Liberal Party's traditional pro-industry stance, future government policy would at least maintain the advances made under the previous Labor governments, if not extend incentives for investment in research and development based companies. It was most disappointing, however, when the new government, despite pre-election commitments, took several steps that can only be interpreted as being hostile to the establishment and maintenance of innovative R & D enterprises. As has been widely discussed, the major impact of the reduction of the 150 % tax deductibility for R & D to 125 % is that it sends the signal that long term reliance on this deduction as a form of assistance cannot be relied upon. Hence, it can now no longer be considered an incentive and the biotechnology industry has lost a valuable selling point in attracting both Australian and foreign investment. There are arguments on both sides as to whether syndication deserved a longer life, especially since many of the opportunities for rorting had already been removed, but the abolition of this tax driven scheme certainly cannot be interpreted as being supportive of R & D companies. The government deserves credit for the creation of the new START scheme, despite its being put in place rather hastily. However, its name is a misnomer, being a scheme that will best suit companies that are already established. It also fails to allow them to utilise their tax losses as a means of generating income that was an attraction of the syndication scheme. Probably the most concerning aspect of the year's developments is that industry still does not know whether the government understands the need to create an environment that is supportive of the setting up and nurturing of knowledge-based enterprises. The preoccupation of Treasury with the short term means that revenue foregone through industry support is viewed as a cost rather than as an investment. While it is accepted that the balancing of the budget is important, without a well spelt out vision of what government can and should be doing for industry, any cost cutting measures will ipso facto be quite arbitrary. Most of the actions of the government in the R & D area in 1996 indicate that they have been focussed on short term costs. The main question for 1997 is: will there be a longer term vision that drives good policy? There is a glimmer of hope is this regard. The government has instituted a whole of government review of the business programmes through which it supports industry. Under the chairmanship of David Mortimer, Chief Executive of TNT, this review has the wide ranging brief to examine the efficiency and effectiveness of all types of Commonwealth business programmes and to recommend action to improve government incentives for, and assistance to, industry. It covers all Australian industry programmes, most of which are targeted to traditional primary and secondary industries and estimated to be worth approximately $ 10 billion. It is therefore important that R&D companies in all fields contribute to this review and argue strongly for the recognition that companies founded on innovation are critical to the long term future of this country with respect to driving economic growth, increasing competitiveness and creating employment. It follows that there must be credible and well thought out government programmes that nurture such companies. This is a simple message but is one that currently industry is unsure has been heard by the government. The ABA will be making a submission to this review but this should certainly not preclude individual biotechnology companies from making their own representations. The louder the voice the better. Graeme Woodrow, ABA President NEWS Use of Transgenic Commodities in Foods: Resistance and Response A trade association representing food retailers and wholesalers in 20 European countries has taken a stand against purchasing U.S. soybeans this year unless genetically engineered soybeans are clearly separated and labeled. At a news conference in Washington October 6, a spokesman for EuroCommerce warned that several of the organization's major members would not buy soybeans from the U.S. without assurance that they would not receive genetically altered ones. The European Union (EU) has already approved entry of Monsanto's herbicide tolerant Roundup Ready soybeans, which are likely to arrive mixed in with conventional soybeans. EU approval for Bt corn is still pending, due to opposition by 13 of the 15 EU members. In Switzerland, the two biggest food retailers are likewise demanding that the U.S. producers separate transgenic soybeans so that all derivative products can be labeled. Entry into the country, a non-EU member, is being fought by Greenpeace and other environmental groups which are petitioning the Swiss government to bar imports of any genetically engineered foodstuffs. The Chicago Board of Trade, the world's largest futures market, has said it would accept the genetically modified corn and soybeans to satisfy its grain contracts. Cargill and Archer Daniels Midland, major U.S. exporters, said they will accept the soybeans from growers without reservation. Officials at Central Soya Co. will accept Roundup Ready Soybeans at all six of their crushing plants, but will reserve one of their Ohio elevators for non-engineered soybeans to allow later comparative testing in processed products. The U.S.-based Corn Refiners Association announced that food and feed products derived from Bt corn meet all current safety regulations of the FDA, USDA, EPA, and the European Union. The group's policy states that no statutory, regulatory, compositional, environmental, food or feed safety issues exist to prevent utilization of Bt corn, as approved by the U.S. government, in the corn wet milling industry. At the same Washington news conference, consumer activist Jeremy Rifkin, head of the Foundation on Economic Trends (FET), announced that FET has targeted 10 food products for a worldwide boycott unless the makers pledge not to use any genetically modified soybeans or corn. Companies producing Kraft salad dressings, Coca Cola, Nestle Crunch, Quaker Oats corn meal, Green Giant Harvest Burgers, Similac infant formula, Karo corn syrup, MacDonald's french fries, Fleischmann's margarine, and Fritos were warned that if their food products contained any Roundup Ready soybeans (Monsanto) or Bt corn (Ciba Seeds/Mycogen), consumers would be called to boycott the products. Rifkin asserted that consumers may suffer allergic reactions to the genetically altered herbicide tolerant soybeans, and that their use will lead to greater applications of chemicals in agricultural fields. Widespread use of corn engineered with Bt genes for control of European corn borer, he argued, would undermine the effectiveness of a valuable biopesticide by allowing insects to become resistant to it. Monsanto disputes the allegations against Roundup Ready soybeans. The company points out that the potential for allergic reactions was evaluated as part of the regulatory approval process. Reviews in Japan, Europe, and South America similarly concluded that a person not allergic to soybeans will not be allergic to the herbicide tolerant variety. The company also maintains that total herbicide usage will decrease because farmers will be able to use Roundup herbicide. In a low-key response to Rifkin's letters threatening a boycott, Monsanto has talked with the food companies to make sure they understand the product. The Institute of Food Technologists (IFT) responded to the news conference by issuing a press release asserting that there is no scientific evidence of environmental and health risks associated with gene-spliced soybeans and corn, and that Rifkin's allegation of such hazards is without merit and his call for labeling of modified U.S. crops is unnecessary to ensure consumer safety. According to Joyce A. Nettleton, D.Sc., R.D., director of Science Communications at IFT, there is no evidence that genetic transfers between unrelated organisms pose hazards that are different from those encountered with any new plant or animal variety. Plants produced by rDNA technology, such as soybeans and corn, must meet exactly the same safety standards as unmodified plants or those genetically engineered by another method. In addition to complying with U.S. food safety standards, genetic engineering technologies in agriculture are compatible with conservation and protection of the environment as well as with sustainable methods of agricultural production. (Reprinted with acknowledgement from Pat Traynor, Information Systems for Biotechnology. ISB/NBIAP News Report, November 1996) Expression of Foreign Genes in Transgenic Fish Commercial production of transgenic fish engineered with desirable characteristics such as enhanced growth or disease resistance is coming closer to reality in several species, including catfish, trout, salmon, carp, goldfish, and tilapia. Significant effort has been invested in preparing and evaluating vectors for expression of foreign genes in transgenic fish. The process of developing vectors and expression systems involves identification of a suitable reporter gene as well as regulatory elements for the desired trait gene. The lacZ and CAT reporter genes have been Bresagen strip widely used, and a recent report suggests that green fluorescent protein is also useful. Various promoters, including those from sockeye salmon histone H3 and metallothionein-B genes and the antifreeze protein gene promoter from ocean pout, have been used successfully to drive expression of introduced genes. A vector containing regulatory sequences from the carp beta-actin gene enhancer/promoter directed expression in nearly all tissues of zebrafish, beginning within 12 hours of fertilization. Similar vectors containing also the polyadenylation signal from the salmon growth hormone gene were useful for expression of foreign genes in microinjected fish eggs and fish and mammalian cell cultures. Most researchers agree that vectors for use in fish should contain DNA sequences from fish genes, or at least sequences from mammalian genes that are demonstrably compatible with the biochemical elements found in fish cells. In most cases, non-fish elements seem to be relatively inefficient, possibly due to improper processing of mammalian introns. Even elements from mammalian genes may be recognized inappropriately or in an unpredictable manner. For example, the high degree of sequence conservation among regulatory elements of animal beta-actin genes suggested that their function would be conserved, allowing transgenic constructs with similar transcriptional control elements to induce equivalent transgene expression in different species. However, it was found that the initiation, degree, and longevity of gene expression in zebrafish and goldfish were affected by combinations of transcriptional control elements. Nonetheless, non-fish elements, from both avian and insect species, have been used successfully in some cases. Optimization of transformation methods remains one of the important challenges for the immediate future of aquatic biotechnology. Improved overall integration of foreign DNA, possibly enhanced by inclusion of viral integration proteins in the transformation system, will increase the likelihood of integration into germ line cells and thus reduce the frequency of genetic mosaics. (Reproduced from J. Glenn Songer, University of Arizona) Microbiology News Focus on the latest issue of Microbiology Australia (the journal of the Australian Society for Microbiology) is on microbiology in the environment, and includes articles on biodiversity in the Antarctic, microbial diversity of thermophiles and dentrifying bacteria in Port Phillip Bay. News includes soil microbes, field monitoring of genetically manipulated organisms, methane cycling in wetlands, and fungal mycorrhizas. The national office of ASM is now on email: TheASM@asm.auz.com. The ASM is also constructing a web page. Queenslander Wins Nobel Prize Earlier this year (October 7) it was announced that Professor Peter Doherty, who is now located at the University of Tennessee, had jointly won the 1996 Nobel Prize for Medicine with Swiss Professor Rolf Zinkernagel for 20 years' research on how the immune system recognises virus-infected cells. This discovery took place at the John Curtin School of Medical Research at the ANU in Canberra. Peter Doherty is a veterinary graduate (1962) of the University of Queensland. He obtained his PhD from the University of Edinburgh. Our congratulations to Peter Doherty on this rare distinction. World Horse Care Breakthrough by South Australian Biotech Company Field trials have begun on an Australian-developed protein which could revolutionise the $50 billion horse industry world-wide. The protein Equine Somatotropin (eST), developed by South Australian based biotechnology company BresaGen, has the potential to substantially reduce crippling breakdowns suffered by young horses in training, speed up healing and improve the condition of older animals. BresaGen has sought registration for eST from the National Registration Authority (NRA) and the field trials are part of the process to obtain this certification. BresaGen is the only company in the world producing recombinant eST. Dr Meera Verma, General Manager of BresaGen's Protein Pharmaceutical Division said eST offered enormous benefit for the general veterinary care of horses. "Preliminary results have been very encouraging and indicate the product may be of significant benefit in improving bone and muscle condition, overcoming joint and tendon problems and improving poor body condition and wasting," she said. "In nature, the production of growth hormone in horses decreases with age. BresaGen eST would only be administered by licensed veterinarians. Recommended safe doses would elevate hormone levels to the upper end of the normal range for horses." Dr Verma said eST is almost an exact copy of the horse's natural growth hormone and had similar biological actions. It is species-specific and should have no impact on any other animal. She said BresaGen had been working with leading equine scientists in Australia and the United States to assess the potential value of the protein and the research trials were being conducted under the Company's direction in both countries. "Australian racing industry figures indicated that more than one third of young horses don't reach the starting barrier," she said. "The protein would help improve bone strength, cartilage and muscle development which we believe would reduce this wastage and may help to prevent the breakdown of older horses. However, the benefits are not just restricted to racing and the protein promises to provide enormous benefit in the care of older horses, ponies, stockhorses and the general recreational horse industry". Dr Verma said early trials had shown no indication that eST could produce a "superhorse" or was performance-enhancing. However, it was expected to allow horses to perform on their merits more frequently by helping treat clinical conditions which impair performance, such as microfractures, tendon injuries and muscular problems. She said initial discussions with veterinarians and representatives from the horse industry had shown strong support for the product. eST is produced by BresaGen at its Thebarton headquarters through the use of genetically engineered bacteria, providing a pure form of the protein. Dr Verma said that BresaGen would continue to produce eST in Adelaide for world distribution should it gain registration. Further information: Dr Meera Verma, or Dr John Smeaton, Managing Director, BresaGen (Tel: (08) 8234 2660). BioResearch Ireland Product Licensed to DAKO A/S BioResearch Ireland has licensed a monoclonal antibody to DAKO A/S, Copenhagen, Denmark. The BRI antibody is used for the detection of cancer cells which are resistant to anti-cancer drugs i.e. multi-drug resistant (MDR) cells. In treatment of cancer patients, it is important to determine such resistance before the appropriate chemotherapy treatment is chosen. The licensed product, BRI MAB MDR-1 is a monoclonal antibody to the human MDR-1 gene product. Overexpression of MDR-1, also known as p-glycoprotein (P-170), is consistently associated with MDR. The product is one of a range of monoclonal antibodies which BRI has developed for the detection of MDR in cancer cells. Through the agreement DAKO have been granted the rights to produce a monoclonal antibody to MDR-1 using BRI's 6/16 hybridoma cell line and to sell this antibody on a non-exclusive world-wide basis. In consideration, Dako will pay BRI an upfront licensing fee and a royalty based on net sales of antibody. In addition Dako will support a clinical study, set up by BRI in association with two cancer treatment centres in Dublin, which will investigate the correlation between expression of MDR genes and clinical drug resistance in cancer patients. Field Tests for GMO's Reviewed Anatole Kraffinger (Cornell Univ., USA) recently published an extensive article entitled `The Field Testing and Commercialisation of Genetically Modified Plants: A Review of World Wide Data (1986 to 1993/94) in "Biosafety for Sustainable Agriculture: Sharing Biotechnology Regulatory Experiences of the Western Hemisphere" (ISAAA, Ithaca and SEI: Stockholm) Cost $US28. Fax: +41 22 789 2538 for ordering details. The article was reprinted in UNIDO's Genetic Engineering and Biotechnology Monitor Vol 2, No 4 p1-12. EDBT - What is it? No it isn't another bit of financial jargon. It's EU jargon. EDBT stands for the European Doctorate in Biotechnology. Its a title that you are increasingly likely to see on the business cards of European biotechnologists. This qualification can be gained by PhD students in Europe. To obtain an EDBT, students must be completing a PhD thesis in Europe, and must complete a further 1 to 2 week intensive course on biotechnology. They must also spend at least 3 months in another European country, and they must abide by a Code of Conduct for Biotechnologists. The "degree" has the support of EFB, EMBO and the Universities Rectors Conference. India - Biobusiness Contact Biobusiness Development Agency is a marketing company and technical consultancy company in biotechnology. They are seeking exclusive arrangements with Australian companies trading in India. They can also put your company in touch with Indian Scientists on different specialties. More information is available from Jagadish Singh, Managing Director on fax 091 11 514 4316. Queensland Clunies Ross Centre for Science & Technology In late 1995 a special agreement was signed which allowed the Queensland Government to work in a joint venture with the Ian Clunies Ross Memorial Foundation to provide a $7 million Centre for science and industry on the Brisbane Technology Park. This new Centre is being funded by the Government and will not be managed using the resources and experience of the Foundation. The initiative provides administration, accommodation, meeting facilities and a conference centre designed to be a working, meeting and convention hub for science and industry in Queensland - and from around Australia. Doors will open in early 1997. The Centre has 1500 sq. metres of accommodation for administration/project work, a large central atrium and a 500 seat conference centre, supported by a bistro and banqueting/catering facilities. The Centre is already positioned to become a major networking and information facility supporting Queensland business and industry. Further information including enquiries from potential tenants and conference organisers: Lionel Wisbey or Susan Haynes Grant (Tel: (07) 3364 0772 or mobile: 0414 252 500.) Change of Address for JBA Japan Bioindustry Association (JBA) transferred to new premises in September 1996. The new contact details are: Japan Bioindustry Association
New Chairman for CSIRO The Prime Minister, Mr Howard announced in early November that Mr Charles Allen, AO has been appointed the new Chairman of CSIRO. Dr Malcolm McIntosh, CEO of CSIRO, welcomed the appointment of Mr Allen, who was Managing Director of Woodside Petroleum from 1982-96 and Chairman of the North-West Shelf Project for 15 years. Dr McIntosh paid tribute to Professor Clarke for her enormous contribution to CSIRO during her ten years as Board Member and five years as Chairman. He said "She has really done a great deal for CSIRO. She was prepared to roll up her sleeves and help, much more than a chairman might be expected to do, when the Organisation was having its external troubles. She really worked extremely hard to overcome them. She has been a very good public representative and Chairman of the Board, but I think what will be remembered most is the way she helped in our hour of need." "I believe there will be great pleasure in CSIRO at the selection of Mr Charles Allen as our new Chairman, as he is well known to many of our scientific leaders. I believe he will serve us extremely well. He has a solid science and engineering background, and is clearly a very capable individual. He's just the man for CSIRO as we move into the 21st century. I'm looking forward to working with him." Archaebacterium Sequenced Archaea, along with prokaryotes (bacteria) and eukaryotes (including yeasts, plants, animals, humans) form the three branches of life. On 23 August 1996, Science (273:1058-73) reported the first complete sequence of the genome of Methanococcus jannaschii, a member of the Archaea branch of microorganisms. Only about 38% of the genome of M. jannaschii match a gene with a known cellular function already encountered in sequence databases. Carl Woese, one of the early researchers on methane bacteria, noted that Archaea can be regarded as living fossils of our prokaryotic (bacterial) ancestors. Many of the Archaea are found under extreme conditions (high temperatures and pressures). These extremes make such bacteria of commercial interest for bioprocessing and bioremediation. Editor's (MJP) note: An interesting aside is the important role played since the sixties by the Department of Dairy Science at the Urbana Campaign Campus of the University of Illinois in studies on methane producing bacteria. This resulted in the development of great strength in research on Archaebacteria at Illinois through the efforts of well known researchers on rumen bacteria such as Professors Marvin Bryant and Ralph Wolfe. So much for the vision of R&D priority-setters who place rumen microbiology low on their list in this era of economic rationalism. Centre for Plant Conservation Genetics The Centre was established in mid 1996 at the Southern Cross University at is Lismore Campus in northern NSW. Its mission is "application of molecular techniques to the conservation and exploitation of plant genetic resources". Research activities include:
Further information: Prof Robert Henry, Head, Centre for Plant Conservation Genetics, PO Box 157, Lismore, NSW 2480 (Tel: (066) 20 3010; Fax: (066) 22 2080; Email: rhenry@scu.edu.au). Bio-Rad forms CHEF Users Group Bio-Rad Laboratories held the inaugural CHEF Users Group meeting on Wednesday 27 November 1996 at University of Melbourne. The speakers were: Prof Warren Grubb, School of Biomedical Sciences, Curtin University of Technology, Perth, Dr Jenny Thompson, Walter & Eliza Hall Institute and Dr Barbara Howlett, Department of Botany, University of Melbourne. The group will provide an opportunity to discuss ideas and applications on pulsed Field Gel Electrophoresis. We welcome all those interested in the technology, in addition scientists currently employing pulsed field applications, to join the users group. Further information: Leah Kennett, Bio-Rad Laboratories, (Tel: (02) 9914 2800; Fax: (02) 9914 2888). Florigene Launches Moondust Carnation The first genetically modified cut flower product to be approved for sale anywhere in the world has been released by an Australian company. At a product launch in Melbourne recently, plant biotechnology firm Florigene unveiled its mauve coloured Moondust Carnation. The carnation was introduced by Dr Edwina Cornish, Managing Director of Florigene, who was congratulated by John Button. The Launch was attended by a large contingent from the media, as well as a number of prominent scientists including Professor Nancy Millis. Barbara Arnold and Anne Greig from the Australian Biotechnology Association were two of the invited guests who were welcomed with champagne as the sun shone on the beautiful display of the unique flowers. Florigene is the company that made worldwide headlines in 1991 after isolating the gene responsible for blue pigmentation in flowers, prompting wide speculation about the future development of a blue rose. Florigene Managing Director, Dr Edwina Cornish, said the development and commercialisation of a mauve carnation was a major step forward for the company. "Production of commercial quantities of colour modified carnations is confirmation of the potential of the technology," Dr Cornish said. "In scientific terms, the pigmentation we have introduced to carnations is in the blue family and as such has provided us with confidence that we are getting much closer to field production of a range of uniquely blue flowers." The Moondust Carnation cut flower will be sold at Florists throughout Australia and will be released onto the large European and Japanese markets next year, where Florigene hopes to gain a slice of the $10 billion world market for carnations. "We are positioning the product at the higher end of the market and expect it to realise a premium price over standard carnations," Dr Cornish said. The Premier of Victoria, Mr Jeff Kennett, said the launch of the Moondust Carnation reflected Victoria's depth of expertise in the area of advanced technology. "It is very encouraging to see a Victorian-based biotechnology company achieving a world first in such a competitive and commercially significant international industry," Mr Kennett said. "I am sure Florigene's achievements will serve as an incentive to other Victorian companies that are attempting to make inroads into world markets." Dr Cornish said the move into cut flower selling both locally and Internationally was in line with Florigene's overall commercial strategy, which is to capture a niche in the annual $30 billion world cut flower market. News from the ABA is that the carnations decorating the office are
still as bright and fresh, and have retained their perfume, three weeks
after being received at the launch.
ABA NEWS Report from the Directors All nine ABA Directors met in Sydney on 3rd December, and were hosted by Dr Joan Dawes, a newly elected Director, at the CRC for Biopharmaceutical Research. Dr Graeme Woodrow (Biotech Australia) was affirmed as President for 1996 and 1997. Dr Ian Nisbet (CSL) was elected as Vice President. GTIU The leader of the Gene Technology Information Unit, David Leyonhjelm, and Rosanne Ransley, GTIU's Project Manager, presented information to Directors on their present work and achievements, and of their future plans. They have developed :
They are currently preparing a food kit with a dispassionate view of the food labelling issue. They have identified major target audiences and are concentrating on them. An interesting comment was the view that many professionals show a degree of ignorance of the regulatory systems in place. It was suggested that we should run informatory articles in this journal. The GTIU has started a homepage on the Internet. The address is: Directors meet Minister Dr John Smeaton and Dr Joan Dawes were invited to meet with Mr Peter McGauran, Federal Minister for Science, and senior departmental staff to discuss the need for effective regulatory systems for recombinant products near to market. A second ministerial meeting is planned with Dr Edwina Cornish and Dr Graeme Woodrow in the near future. Current ABA view is to retain the voluntary GMAC structure and link that as a source of advice to the statutory regulatory bodies (ANZFA, NRA and TGA). The ABA regarded the difficulties and delays in setting up the Gene Technology Authority as a legal statutory entity covering all Australian states, as putting a prohibitive cost for the progressive development of biotechnology products in Australia. Labelling issues were also discussed with the Minister. The ABA Directors are continuing to develop an industry-wide view on these matters. Next Australian Biotechnology Conference The 14th Australasian Biotechnology Conference (as it will now be known) will be held from April 19 - 23, 1998, in Adelaide. Plans are well advanced, with an organising committee which has a detailed timetable, a provisional programme and a theme which is "Biotechnology Driving Food and Health for the 21st Century". Plenary sessions are being prepared on : bioengineering; regulation of transgenic crops; reproductive technology and population control; aquaculture; water quality and the environment; control of infectious diseases. A special session on wine biotechnology and visits to a winery are planned. A debate, open to the public, on reproductive technologies and ethics will be a highlight of the conference. Put the week in your diary now - 19-23 April 1998. Further information, contact Dr Chris Franco (Fax: (08) 8277 0085). Branch News Both Western Australia and Queensland branches reported a year of successful activities. The WA Student Essay Competition is also planned for 1997. WA Director, Mr Gary Cox, recommended that similar essay competitions be set up in other states. Dr Saliba Sassine of Biotech International, WA, is to be congratulated for his initiative in establishing and sponsoring the competition. The Queensland Branch, which is chaired by Dr Peter Riddles (Qld Director), is planning two meetings to complete a busy year's activities. These are an Honours Students' Evening with a presentation of their biotech projects, and an evening with company representatives and new graduates to describe job opportunities in biotech companies. Although South Australia does not have a formal branch structure, SA members arranged for the ABA to co-sponsor a series of three public lectures organised by the University of Adelaide Alumni Association. Each was attended by 500 to 700 people. Membership Current ABA membership totals 557. There are 61 corporate company members, 413 ordinary members and 81 student members. The membership retains a high proportion of industry representatives and employees (239 out of 557). Next Council Meeting The next meeting of the ABA Directors is planned for 17th February in Melbourne. Most quotable quote of the afternoon's discussion came from Past President Smeaton - "a constant variable" - which is perhaps a very good description of the ABA! Strategy for the ABA New President, Graeme Woodrow, has initiated a reassessment of the vision, mission and future directions of the ABA. Much of the time available at the December council meeting was devoted to an evaluation of the ABA, its present strengths and weaknesses and the issues facing biotechnology, both nationally and internationally. The journal will be reporting more on this as Directors formulate a position and a new strategy. Reader input will be sought. Comments and discussion on this topic should be addressed to Dr Graeme Woodrow (Tel: (02) 9928 8800) or to his fellow Directors. Journal News New special features for 1997 were decided at a recent editorial meeting. They are : Feb: Index Issue
April:
June:
Aug:
Oct:
Dec:
Editors, Martin Playne and David Tribe, are also planning some new
features, including more company profiles. Company members wishing to have
their company profiled and examined in depth during 1997 by the journal
should contact Martin Playne soon (Tel: (03) 9252 6485). The journal is
also seeking suitable articles of up to four printed pages (approx. 3000
words) on any topic of biotechnology for publication. Research papers will
be refereed, and authors should remember that all papers submitted should
be able to be understood by our general biotechnology readership. We also
seek short reviews, and articles expressing a particular point of view. It
is advisable to contact one of the Editors prior to preparation of your
article to discuss your ideas. Also be sure to read the Guide to Authors.
EDUCATION NEWS New Master's Course at UNSW Information has just been released on a Master of Applied Science in Biopharmaceuticals which will be conducted at the University of New South Wales under the auspices of the Cooperative Research Centre (CRC) for Biopharmaceutical Research. It is specifically designed to prepare graduates for work in the biopharmaceutical industry and is unique to Australia. Enrolments can be for full-time or part-time study or by distance education. University of Melbourne University of Melbourne's School of Medicine advises that enrolment in the Graduate Diploma in Biotechnology closes on 31 January 1997. Duration is one year full-time or two years part-time. The course consists of an advanced biotechnology research project, which can be undertaken under supervision on or off campus, with a wide range of core and non-core course subjects. Course coordinator is Dr David Tribe who may be contacted for more information on Tel: (03) 9344 5688, or Email: david_tribe@muwayf.unimel b.edu.au COMPANY NEWS New Chairman for Peptech Peptech announced recently that Mr Hookway has resigned as Chairman of Peptech in favour of Mr Tony Bates, but will remain a director of the Company. Mr Bates will work closely with the existing Executive Directors to achieve a secondary listing on the London Stock Exchange and the achievement of the Company's objective to research and develop peptide-based drugs. Mr Bates was formerly Managing Director of Cyanamid Australia and New Zealand, as well as Chairman of Arthur Webster Pty Ltd and is currently Deputy President of the Australian Business Chamber and Chairman of the Australian Health Industry Development Forum. He has broad experience in the international pharmaceutical industry and joined the Peptech board in July this year. Mr Bates has had extensive Board, CEO and management experience in the Life Sciences Sector over many years at international level. He is Chairman of Technico Pty Ltd, and a Director of the Dairy Research and Development Corporation, Great Southern Energy and Asia Pacific Specialty Chemicals Limited. Mr Bates said "I am very pleased to be asked to take on the Chairmanship of Peptech. In the short time I have been on the Board, I have been impressed with the quality of the Company's project portfolio. Recent changes and the new business plan give me a great deal of optimism for the future." Q-One Biotech Ltd is Awarded MRC Contract for Gene Therapy Products Q-One Biotech Ltd, based in Glasgow, UK, has been awarded a 3 year contract from the British Medical Research Council (MRC) for the manufacture and testing of viral vectors for MRC funded gene therapy projects. Established in 1990, Q-One Biotech offers GLP biosafety testing worldwide to the biopharmaceutical industry for the characterisation and validation of monoclonal antibodies, recombinant DNA, transgenics, vaccines, blood and gene therapy products. In 1994 a facility was commissioned to produce master cell banks, working cell banks and other clinical trials materials for gene therapy projects. An audit of the facility in November 1994 by the Medicines Inspectorate of the Medicines Control Agency (MCA) found the operations to be in general compliance with the principles and guidelines of GMP. Expansion into a new facility is currently underway to accommodate increased demand. This new facility will also be subject to inspection by the UK MCA for compliance with GMP on completion. AMRAD Highlights for 1995-96 The latest Annual Report of AMRAD Corporation Ltd lists the company's highlights for the past year. These are: Total operating revenue of the AMRAD Corporation Limited Group of companies (AMRAD) rose to $109.3 million, a 37% increase on 1994/95. Group sales were $87.4 million, an increase of 23% over 1994/95. The loss after tax was $2.2 million which was lower than planned. AMRAD's discovery programs of natural products screening and cytokine discovery focused on virology and cytokine/cytokine mimetics in which AMRAD has core competencies. Following the signing of the collaborative cytokine research agreement with Chugai Pharmaceutical Co Ltd (Chugai) in 1995, AMRAD's cytokine discovery program commenced in conjunction with The Walter & Eliza Hall Institute of Medical Research, the Ludwig Institute for Cancer Research, the Queensland Institute of Medical Research and Chugai at AMRAD Burnley. AMRAD's rights to its series of anti-HIV compounds emanating from Conocurvone were secured by the signing of an exclusive world-wide licence with the US National Institutes of Health. AMRAD's research and development activities were consolidated at newly refurbished modern laboratory facilities at AMRAD Burnley. The range of off-patent pharmaceuticals marketed by AMRAD Pharmaceuticals Pty Ltd increased to 14 and the heartburn treatment PEPCID* was launched. However, sales were less than anticipated. AMRAD Pharmacia Biotech derived its first profit in 1995/96. AMRAD acquired the Australian marketing rights to a range of research products from DuPont Australia Limited for sale through AMRAD Pharmacia Biotech. *Trademark used under licence ForBio Limited Australian World First in Robotic Technology Unveiled in Sydney The world's first commercially produced automated tissue culture robot, the Australian developed and built Vitron, was unveiled in Sydney in October by the NSW Minister for Land and Water Conservation, the Hon Kim Yeadon MLA. Developed by the world's largest independent forest biotechnology company, Brisbane-based ForBio Limited, the first commercial Vitron robot will be installed in the company's tissue culture laboratory near Gosford, the largest facility of its type in Australia. ForBio's Vitron robots will shortly be installed in Indonesia with others planned for joint ventures in China, Malaysia and the United States. The Vitron robots, using ForBio's patented robotic tissue culture (cloning) systems, offer the opportunity to quickly and efficiently mass produce large quantities of high value plant seedlings - technology which can be applied to a rapidly expanding range of plant varieties. ForBio Limited is a publicly listed biotechnology company specialising in plant genetics, robotics and mass propagation of high value plants, with emphasis on the forest plantation industry. The Vitron robot is the product of ForBio's state-of-the-art research laboratories and robotics development facilities in Brisbane. ForBio Limited Chief Executive Officer, Dr Bill Henderson said robots
had already been commis "Initially the business focus in Indonesia will be on tropical hardwoods such as acacia, with industry requirements predicted to top one billion seedlings annually by the year 2000," according to Dr Henderson. "This and other genetically improved tropical hardwoods have the potential to lessen the pressure on native hardwood forests and assist in the major reafforestation program already underway in Indonesia," he said. Professor Robert (Bob) Teasdale
CEO ForBio Research (since 1990) ForBio Limited Qualifications:
Bachelor of Science (Honours, Monash) Master of Science (ANU) Doctor of Philosophy (Deakin) Experience: Dr William (Bill) Henderson Deputy Chairman - ForBio Limited Qualifications:
Doctor of Legal Science, Bond University Inspector of Taxes Inland Revenue, UK
Dr Henderson commenced his career as a trainee inspector of taxes with
the Inland Revenue in Aberdeen and Worcester. He then qualified as a
Chartered Accountant with Arthur Young McClelland Moores and later he
joined Ernst & Whinney in the UK. Dr Henderson transferred to Ernst &
Whinney in Perth, Western Australia in 1982 and specialised in
international planning and advising to foreign companies. In 1985 Dr
Henderson left the accounting world and became involved in establishing and
running new technology development companies, both public and private. In
1990 he came to Queensland to attend Bond University and there met
Professor Bob Teasdale, with whom he founded the ForBio concept. Dr
Henderson's particular experience is in structuring, financing and
internationalising new business ventures. He has had wide exposure to this,
particularly in Asia and North America, and this experience is now being
exclusively applied to growing ForBio's business on an international
basis. --------------------------------------------------------------------------- ForBio Limited Fact Sheet Head Office 825 Stanley Street
Date established - Previously Queensland Science and Technology Ltd a publicly listed company 1984-1991 Changed its name to ForBio Limited, January 1995 Shareholding Publicly listed company since 24 January 1996 Number of Shareholders = 1,773 Top Shareholders FB Investments Pty Ltd = 48.11% Dr John Warwick Cox = 6.51% Directors
Dr John Cox (alternative) Hon Samuel Doumany Dr William Henderson Dato Dr Salleh Mohd Nor (alternate) Professor Bob Teasdale
Core Business
Subsidiaries
ForBio Research Pty Ltd ForBio Robotics Pty Ltd ForBio Systems Pty Ltd Plant Biotics Inc
- Net operating profit after tax $1.46 million
--------------------------------------------------------------------------- CSL's Annual Report About the Company CSL Limited is an Australian public company specialising in the development, manufacture and marketing of biologically-based healthcare products which benefit the community. Our products include human and veterinary pharmaceuticals (notably vaccines), products derived from human plasma, diagnostics, and cell culture reagents. CSL is firmly committed to research and development, quality assurance and the development of international product and marketing alliances. The Company is the largest investor in Australian pharmaceutical research and development, and one of the largest employers in Australia's pharmaceutical manufacturing industry. The Company's earnings are supported by established brands with strong domestic market shares. The Company also has a long term contract with the Australian Government for the manufacture of plasma-derived products for the Australian Red Cross. The Year at a Glance Group Sales of $281m by CSL's five trading units in 1995-96 (up 12%) produced an after tax profit of $29m - an increase of 18% on the previous year. Pre tax profit was $41m (up 29%). The Bioplasma Division increased sales revenue by 14% to $96.1m with growth in both domestic (6%) and international (22%) markets. Our new facility is producing high quality outputs and planned capacity increases have already commenced. Pharmaceutical Division delivered sales revenue of $105.3m in another successful year. An encouraging feature is increased community acceptance of the value of influenza immunisation. Veterinary Division performed well in all markets including exports to record sales revenue of $24.8m - an increase of 10% on the previous year. JRH Biosciences Inc generated strong sales revenue of $42.2m in its first full year under CSL management. Biosciences Division's $12.7m sales result is underpinned by its 20% growth in domestic markets for blood grouping, infectious disease, cell culture and haemostasis products. JRH Biosciences' global operations and CSL exports, particularly Bioplasma and Veterinary, now comprise 27% of the Group's total sales revenue (up from 20%). Group investment increased 11.4% to $30.2m, supported by Factor (f) and collaborative research partners. Programs are aimed at securing new and improved products. REGULATORY NEWS Gene Technology and the Food Regulators Australia New Zealand Food Authority (ANZFA) is presently considering a proposal to develop a standard to regulate foods developed with an involvement of gene technology. In order to guide the Authority in dealing with this complex issue, the Parliamentary Secretary to the Minister for Health and Family Services, Senator the Hon Bob Woods, requested that it dconvene the forum `Gene Technology and Food - The Challenge Ahead' on 1 and 2 August, 1996. The forum was attended by representatives from industry, consumer, community, religious, ethical and government groups. Day 1 consisted of opening addresses by Senator Woods and ANZFA Chairman, Winsome McCaughey, followed by workshops that considered four questions with the aim of formulating guidelines and principles in the form of a charter. This charter formed the basis for the working party's deliberations on the second day. The working party on day 2 was made up of twenty one individuals, again representing a wide cross section of views and interests. The working party produced a number of guiding principles which will be circulated widely as they are relevant to the food industry as a whole to other government agencies and to consumers and community interest groups. ANZFA supports the use of these guiding principles by all of these groups and the wider community. Of particular interest were the views expressed by forum and working party participants on the need for an overarching management system for gene technology in Australia to cover a range of sectors, including food. Participants concluded that such a system needs to be managed by a statutory national body, such as the proposed Gene Technology Authority, that should be responsible for the management of a range of functions including the consideration of ethical and environmental issues associated with particular gene technology developments. The guiding principles are assessed as being of great value to ANZFA as it proceeds to develop a draft standard to regulate food derived from gene technologies. There was general agreement on the part of the forum and working party participants that such a standard was needed to help to ensure that:
The Working Party agreed that ANZFA should proceed to develop a draft standard to regulate food from gene technology. The proposed standard would require every new GMO or the product of a GMO to be approved for inclusion in the Food Standards Code before they could be used as food (ie on a case by case basis). Inclusion in the proposed standard would be as the result of an application and assessment by ANZFA through its statutory processes. ANZFA should not include assessment of the risks related to recombinant DNA technology or the release into the environment of GMOs that may be used as food (this assessment should remain with GMAC). The timetable for ANZFA's approval processes should be concurrent with those of GMAC's. It was agreed that in assessing an application for a GMO food or food ingredient to be added to the standard, ANZFA should assess the safety of the food, determine the consumer information required, including labelling requirements and expiry date, if any, for a labelling requirement. The Working Party requested that the proposed draft standard should take into consideration the two models that were discussed, together with the policies of the US, European Union and other significant trading partners of Australia and New Zealand. The FDA's New Stealth Policy for Biotech Foods - A View by Dr Henry Miller
American presidents' rhetoric is often belied by their actions. Wilson and FDR both promised they would keep us out of wars. Bush said "read my lips, no new taxes." Clinton pronounced that he had attained "the end of the era of big government." The disconnect between the Clinton administration's words and deeds is nowhere more profound than in federal regulation. While claiming to reduce government intrusiveness and burdens, high-level administration officials instead create expanded roles for federal agencies. Consider, for example, unnecessary regulation of new, improved and safer foods. At the direction of Vice President Gore's domestic policy adviser, Gregory Simon, in 1993 FDA announced a policy that would require selected foods to be registered with the agency before being sold to consumers. Extra government scrutiny makes sense when there is uncertainty about health risks or a reason to suspect a problem such as the presence of toxins or allergenic components. In this proposal, however, the FDA decided to require registration only of those foods made with the most precise state-of-the-art biotechnology techniques. It would confer no public-health advantage but would discourage research that could produce foods of better quality and greater variety. The inevitable result of such regulation is more responsibility and bureaucracy for FDA but more limited choices for consumers at the supermarket or greengrocer. Scientific and professional groups including the Chicago-based Institute of Food Technologists objected strenuously to the unscientific basis of the proposal. Only after the Republican-controlled 104th Congress made pointed inquiries about it did the FDA officially withdraw the proposal in early 1995. The proposal was gone but not forgotten. In July of this year, FDA began surreptitiously to circulate the word about new requirements. A seven page document, "Foods Derived from New Plant Varieties: Consultation Procedures" went out to state officials. In it, FDA adopts a pretence that the new policy is applicable to all new plant varieties and not just those produced with the new biotechnology. But the agency's intent is transparent: oversight of the consultation process rests with the Biotechnology Evaluation Team (BET), and the degree of detail requested from the plant's developer would only be available for those crafted with new biotechnology. FDA is betting that Congress is too busy with the November election to notice that the agency is up to its old tricks again. New biotechnology, which uses gene-splicing techniques to mimic and speed up nature's own movement of genes between organisms, should have been freed of such excess regulatory red tape years ago. In 1989, the United States National Research Council, the research arm of the National Academy of Sciences, concluded in a landmark report that new biotechnology-derived products are at least as safe as other products. The council said that with classical techniques of gene transfer a variable number of genes can be transferred but that predicting the precise numbers and kinds of traits that have been transferred is difficult. Moreover, with these older techniques one cannot always predict the behaviour or composition of the resulting plant. With the new single-gene transfer methods, the council added, one is in a significantly better position to make carefully tailored improvements in food plants. The council also observed that for decades plant breeders have moved genes from one species or genus to another, transcending natural breeding boundaries. Products of this older form of genetic engineering include the oats, wheat, corn, tomatoes, turnips, potatoes, black currants and pumpkins that we buy at the market. FDA's recent attempts to overregulate biotech foods reverse its own 15 year old guiding principle for the agency's oversight of biotechnology: regulation should focus on real risks and should not turn on the use of one technique or another. That tenet has provided effective oversight for more than 1,000 new biotechnology products, including drugs, vaccines, diagnostic tests and foods. Ironically, as recently as May 1992 the FDA formally reiterated this policy for foods, affirming that new biotechnology foods would be treated no differently from those produced with other techniques. In several ways the policy will discourage the application of biotechnology to foods. The data requirements are substantial: FDA lists nine categories of obligatory information and the detail is far greater than would be required for food products made with less-precise, less-sophisticated techniques. The policy will entail significant costs for the government and industry and, by extension, the public: according to the FDA's description of the new regulatory scheme the Biotechnology Evaluation Team will always consist of no fewer than six FDA staff, drawn from different parts of the agency. There will be endless and conflicting demands for information about each product, causing delay and uncertainty among manufacturers. FDA new "stealth policy" is intentionally murky about whether developers of new-biotech foods are required to consult with the agency, but the reality is unequivocal: a "suggestion" from the Nation’s most ubiquitous and draconian regulator is akin to an armed mugger "suggesting" you turn over your wallet. In practice, this is mandatory premarket regulation. Another disadvantage of the new regulatory regime is that every biotechnology product will be placed squarely in the sights of anti-biotechnology activists: the results of consultations with industry will be available on the Internet. The bottom line is that the policy will discourage research on more varied, appetising and nutritious foods - research that has given us low-saturated-fat oils, seedless grapes, tangelos and the like. American farmers and food processors will be less competitive and consumers will be deprived of new choices. It is in the nature of regulators to be over-zealous. Congress' antidote was to require that new regulatory requirements be published for public comment and then promulgated in a prescribed way - none of which FDA bothered to do. Beyond the technicalities, however, regulations should also be scientifically based, have intrinsic value and serve a large public good. This one fails every criterion. If the new regulation were an FDA-regulated product, it would be recalled. This article is reprinted from a press release issued by Dr Henry Miller via BRIDGE news wire. We acknowledge this source. Dr Miller is a Senior Research Fellow at the Hoover Institution, a consulting professor at Stanford University's Institute for International Studies, and author of "Policy Controversy in Biotechnology: An Insider's View" (Austin, TX: R.G. Landes Co, 1977). From 1979-94 he held various positions at the FDA, including founding director of its Office of Biotechnology. ASIAN NEWS News from Indonesia New Molecules of Gadjah Mada University Researchers at Faculty of Pharmacy, Gadjah Mada University (GMU) announced their finding of eight molecules substance, called National Molecules. The substance is a locally synthesized product, and is not a modification of curcumin structure. However, the finding of the product was preceded by the findings of 47 new curcumine derivatives, under joint cooperation between GMU and Vrije Universiteit, Amsterdam since 1989. The substance performs anti inflammation activities to replace phenylbetazone. Phenylbetazone itself is a powerful anti inflammation which has a side effect of hepatoxicity. The team of researchers (among others are Prof. Samhoedi Reksohadiprodjo, Mr. Supardjan Amir Margono and Dr. Umar Jenie) are expecting that in three years time they will produce modern drugs. To achieve this expectation, they are currently establishing a joint cooperation work with BPPT and two national medical industries (PT Indorarma and PT Ralbe Farma). More information about the projects might be obtained from Dr. Umar A. Jenie, Gadjah Mada University, Yogyakarta, Indonesia. Centre for Tropical Fruits Studies, Indonesia Tropical Fruits the National Assets Lying astride the equator in South East Asian Region, Indonesia is one of the tropical countries with great biological diversity. Numerous edible fruit species are distributed over the archipelago, offering wide variation of nutritional quality, taste, flavour, and time of availability. Some of the fruit species have become commercially valuable but have not been explored. Recently, market potential of tropical fruits, both for foreign as well as domestic, increases significantly due to population growth, better living condition, and promotion of international tourism. Export of mangosteen for instance increases from US $6,580 in 1986 to US $2,484,246, while mango from US $16,631 (1986) to US $938,864 and duku from none (1986) to US $33,437 (1994). To fulfil their economic potential, fruit production should be supported
by intensive and integrative research program covering production system,
propagation methods, cultivar breeding, plant growth regulator application,
pest management, postharvest handling, food technology, and production
economics. Overall cultural information is lacking for most
2. Collaboration with private sectors; 3. Dissemination of research findings.
The program is supported by the Ministry of Research and Technology as part of a National Strategic Program. The Centre has been mandated to coordinate research programs of six fruit species including manggis (mangosteen, Garcinia mangostana), mangga (mango, Mangifera indica), salak (Salacca zalacca), duku (Lansium domesticum), jeruk besar (Zitrus grandis), and jambu (Syzigium malaccensis). Selection of fruit species studied is in accordance with :
b) Economic potential of each species; c) Possibility of positive impact on improvement of small scale grower and rural nutritional level; d)Agricultural sustainability; e)Preservation of indigenous species.
The research and development program activities represent a mix of short, intermediate, and long-term objectives including:
2. Development of new varieties through breeding; 3. Development of effective and efficient propagation protocols; 4. Harvest and postharvest handling; 5. Food processing; 6. Agricultural economics problem and diagnosis; 7. Transfer information to growers.
Research program will combine the strength of conventional approach with the power of new technology. Coupled with the research is the educational aspect for preparing qualified scientists, producing scientific literatures, and at the same time increasing the skill of technicians. Collaboration with various international agencies and experts particularly those working with tropical woody species will be anticipated. Facilities and Staff
The Centre has access to many national facilities at IPB. Experimental stations at various locations, germplasm collection sites, nurseries, physiology and cellular and molecular biology laboratories are available. Staff include university research and teaching staff, and research staff from various agencies. Total staff supporting the research program are 69 consisting of five professors, 22 PhDs, 26 Masters, and 16 BSc holders. Their expertise ranges from plant breeding, tropical horticulture, crop physiology, plant biotechnology, biochemistry, food technology, agricultural economics to agricultural sociology. Affiliation Other institutions and companies affiliated to the Centre are:
2. Faculty of Agriculture, Sriwijaya University, Palembang, South Sumatra. 3. Centre Research Institute for Horticulture, Ministry of Agriculture, Republic Indonesia. 4. Centre for Agro-Socioeconomics Research, Ministry of Agriculture, Republic Indonesia. 5. PT Mekar Unggul Sari (Private Company). 6. PT Inagro (Private Company).
For more information about international cooperation, please contact Dr. Sjafrida Manuwoto, Faculty of Agriculture, IPB. Tel: 62 251 326429 or 62 251 328799; Fax: 62 251 312032; Email: pertaipb@indo.net.id E. Gumbira Sa'id
News from Malaysia WHO Calls for Grant Applications for Vaccine Development from the Asia-Pacific Region
Due to a recent global resurgence, infectious diseases remains as important public health problems in many parts of the Asia-Pacific region, including developed nations like Australia. Malaria, dengue fever, hepatitis B. diarrhoeal diseases, tuberculosis, typhoid and cholera remain endemic in many countries of the Asia-Pacific region. Rapid economic development, international travel, movement of migrant workers, increased urbanization, and the appearance of more virulent and antibiotic-resistant strains have exacerbated the problem. Prevention and control strategies are mainly based on public health measures, effective epidemiological surveillance, rapid diagnosis, novel therapeutics, and immunization programmes. Of all these approaches, development of safe and effective vaccines remains as one of the more attractive and economical long term strategies. In recognition of the importance of vaccines in the control of infectious diseases, the World Health Organization's recently formed Steering Committee on New Vaccination Approaches aims to:
2. Improve vaccine coverage (eg by improving potency, delivery route, schedules, safety margins); 3. Helping populations at risk for vaccine failure (eg neonates and immunodeficient individuals).
The Steering Committee coordinates its efforts closely with the WHO's EPI (Expanded Programme for Immunization). Most importantly, the Steering Committee also aims to create and promote links with industry, and to involve other organizations which have similar programmes. In line with its stated mission, the Steering Committee is seeking applications for research funding in this important area of vaccine development. The Steering Committee is particularly interested in soliciting grants in two major areas :
2. New delivery systems; new adjuvants, live vectors.
Enquiries can be directed to: Dr M.-T. Aguado, Secretary, Steering
Committee on New Tikki Pang Biotechnology in Asia "Nature Biotechnology", in its August 1996 issue, published two useful and thought-provoking articles. One, by Ted Tanaka on "Partnering in Japan" (p958-959) dealt at length with the view that successful alliances mean patiently forging personal relationships. The second article by Deborah Miller, entitled "Biotechnology in Southeast Asia" (p960-961), reviewed biotechnology developments in Singapore, Taiwan and Hong Kong and provided a recent up-to-date view.
PATENT NEWS Contributed by Dr. Vivien Santer, Griffith Hack & Co., Melbourne Attempts in the United States to Restrict Patentability of Surgical and Medical MethodsAn amendment to an Appropriations Bill which was passed by the United States House of Representatives on 25 July 1996 would prevent the US Patent and Trade Marks Office from using funds to grant any patent directed to a "technique, or process for performing a surgical or medical procedure", unless the method claimed "is performed by or is a necessary component of [a patentable]... machine, manufacture or composition of matter" or is directed to "a new use of a composition of matter or biotechnological process". The Bill, introduced by Congressman Ganske, was considered only briefly by the House Judiciary Committee, because it was introduced as an amendment to an Appropriations Bill. It is likely that the Senate would consider the amendment during hearings on the Appropriations Bill during September or October. A related Bill was submitted to the US Senate Committee on the judiciary on 18 October 1995. The Bill, sponsored by Senator Frist, has not yet been considered by a full committee. It would not exclude any subject matter from patentability, but would provide limited immunity from patent infringement to certain persons, such as patients, physicians and other licensed health care practitioners, or health care entities with whom such practitioners are officially associated, who use or induce others to use a patented method for performing a surgical or medical procedure, administering a surgical or medical therapy, or making a medical diagnosis. However, immunity would not extend to sale or inducement to use a patented method by any person engaged in commercial manufacture, sale, or offer for sale of a drug, medical device, process or other product that is subject to regulation under the Federal Food Drug and Cosmetic Act or the Public Health Service Act. The proposed legislation was prompted by an infringement action brought
in 1993 by a group of physicians who allegedly infringed a US patent
relating to a method for cataract surgery. A motion for summary judgement
on the grounds that the patent was invalid because others had allegedly
used the same method in the United States before Public hearings have been held by the US Patent and Trade Marks Office, and it is thought likely that some compromise between the two Bills will be incorporated into the Appropriations Bill which is finally submitted to President Clinton for signature. It is unclear what will be the impact of the recent US elections. Despite lobbying by a coalition of medical organisations, it is thought likely that concern over exclusion of specific technology from patent protection may favour an amendment to limit liability for infringement. US Patent and Trade Marks Office Public Hearings In addition to public discussions regarding patents for therapeutic methods, as described above, the US Patent and Trade Marks Office has held hearings regarding problems with examination of applications relating to DNA sequences. Considerable difficulty has arisen because of the increasing number of applications which claim very large numbers of nucleic acid sequences, and the extraordinary time and expense involved in searching and examining these cases. The US Patent and Trade Marks Office estimates that 100 sequences can be searched in approximately fifteen hours at a cost of US$1,800. 22,000 sequences were searched in 1995. With the current level of demand, it is estimated that the cost of examining such cases will be about US$12,000,000 per year. There are currently about 70 applications on file which claim more than 200,000 nucleic acid sequences. Representatives of the bioinformatics industry have suggested that a standard searching protocol be adopted, which uses an initial rapid and approximate search followed by subsequent searches of improved specificity, providing a nested filtering of information. It has also been suggested that applicants should be required to submit a preliminary compilation of references based on their own searching of the literature prior to filing, or that the requirement that all nucleic acid sequences be submitted should be modified so that only the claimed and prior art sequences are identified. It was generally considered that restriction of claims should not be used in response to this problem, since it would not resolve the difficulties of computer searching, and would be extremely costly to patent applicants. The US Patent and Trade Marks Office will consider the public comments, and may convene a working group or panel of experts in order to recommend a policy for examination of this type of application. Changes to Canadian Patent LawCanada has become a member of the Budapest Treaty as of 1 October 1996, and deposits may now be relied upon to support sufficiency of disclosure for the purposes of a Canadian application. The Canadian Patent Rules have been modified to require sequence listing for applications involving nucleotide or amino acid sequences, along the same lines as in the United States, Europe and Japan. A computer-readable sequence listing will also be required. The effect of these rule changes on patentability of higher life forms in Canada remains to be seen; the Canadian Patent Office currently rejects all claims for multicellular life forms, such as plants and animals, and this policy was affirmed by the decision of the Canadian Patent Appeal Board to reject the Harvard "oncomouse" application. Part of the Board's reasoning was that the invention could not satisfy the requirement that it "must be reproducible in a consistent manner", because the inventors "do not have full control over all the characteristics of the resulting mouse since the intervention of man ensures that reproducibility extends only as far as the cancer forming gene." This case has been appealed to the Federal Court, and is thought likely to be appealed ultimately to the Supreme Court of Canada. A further change which will assist many applicants has extended small entity status to universities. The rules previously excluded all non-profit organisations. However, the status of research institutions is still unclear. The definition of a small entity has been simplified, and now is defined to mean an organisation with 50 or fewer employees, regardless of revenue. Chiron-Murex Case Settled It was announced on 29 August 1996, coincidentally during the Tenth
International Biotechnology Symposium in Sydney, that the litigation
between Chiron Corporation and Murex Diagnostics Aus If the case had run its course, it would have been the first decision by an Australian Court on a genetic engineering case. The decision of the Court of Appeal on the corresponding case in the United Kingdom has been published in [1996] Reports of Patent Cases 535. It was held that the claims did not relate to a discovery as such, and therefore were not intrinsically unpatentable; the specification must enable a person skilled in the art to perform the claimed invention across its full width, and not just to carry out a single embodiment of the invention; the invention as claimed was capable of being performed by such a skilled person; and the claims were not to a result or to an obvious desideratum, and were not speculative. The decision incorporates the judgement of Aldous J. in the lower court, which includes an extensive discussion of the state of the art and the issue of obviousness. Dr Sydney Brenner C.H.,FRS, sat as scientific adviser to the Court of Appeal. House of Lords Dismisses Biogen's Appeal Against Medeva In a decision issued on 31 October 1996, the House of Lords rejected the appeal by Biogen Inc against the decision by the Court of Appeal to revoke its patent for recombinant Hepatitis B antigens. The successful appellants in the Court of Appeal were Medeva PLC, who had been sued for infringement by Biogen Inc. The original patent application was lodged in December 1978, a European patent was granted in July 1990, and a European opposition was dismissed by the European Patent Office Board of Appeals in July 1994. The infringement proceedings were commenced in 1992. In these proceedings, Medeva counter-claimed for revocation on the grounds that the patent was invalid because of obviousness, that the patentee was not entitled to the priority date of the original UK application, that the subject matter claimed did not represent an invention, and that the description in the specification was insufficient to enable performance. It was conceded by Biogen that the invention was obvious at the date of filing of the European patent application, but not on the date of the British priority application. In the first instance Aldous J. held that the claims were supported by the priority document, and that therefore Biogen was entitled to its priority date, and held the patent to be valid and infringed. The Court of Appeal reversed this, holding that the priority document (Biogen 1) did not support the claimed invention, and that the invention claimed was obvious at the priority date. The invention related to a method for expressing genomic DNA from Dane particles in E.coli, using the vector pBR 322. At that time it was known that cDNA encoding a eukaryotic protein, specifically preproinsulin, could be expressed in E.coli using this vector; however, it was not known whether genomic DNA could be so expressed because of the potential problem composed by the presence of introns. The genome of Hepatitis B virus had not been sequenced. The priority document describes the expression of polypeptides with HBV antigen specificity in E.coli, and describes the method disclosed as being suitable to make both Hepatitis B core antigen and Hepatitis B surface antigen. The DNA expressed may code for one or more antigens, and vectors other than pBR 332 and hosts other than E.coli, such as yeast or fungi, may be used. While the Court rejected the decision of the Court of Appeal that the strategy adopted by Biogen was obvious, being a "mere commercial decision... to pursue an identified goal by known means", and acknowledged that "an inventor need not pursue his experiments untouched by thoughts of gain" in deciding that what the inventor did was not obvious, it went on to hold that Biogen was not entitled to its priority date. The Court of Appeal had held that the specification must provide an enabling disclosure for the full width of the claim; the House of Lords extended this concept to hold that not only must the European specification provide such an enabling disclosure, so must the priority document in order to support the priority claim. Unless the invention represents a general principle which would work equally well no matter what the plasmid and host cell used and the polypeptide to be produced, the specification must enable the invention to be performed in respect of each discrete method or product claimed. In other words "if he patentee has hit upon a new product which has a beneficial effect but cannot demonstrate that there is a common principle by which that effect will be shared by other products of the same class, he will be entitled to a patent for that product but not for the class, even though some may subsequently turn out to have the same beneficial effect. ....on the other hand if he has disclosed a beneficial property which is common to the class, he will be entitled to a patent for all products within that class (assuming them to be new) even though he has not himself made more than one or two of them." Despite the fact that he conceded that the priority document taught how to make both the core antigen and the surface antigen in bacterial cells, and that this method would work in any otherwise suitable host cell, he held that the claim was not supported by the priority document because it was too broad; "its excessive breadth is due, not to the inability of the teaching to produce all the promised results, but to the fact that the same results could be produced by different means." The inventive step was the idea of expressing unsequenced eukaryotic DNA in a procaryotic host. However, once the DNA had been sequenced, no one would use the method disclosed in the application. Thus the application was not entitled to its priority date, and therefore was obvious. For the same reason, the specification was insufficient. The date at which sufficiency was required was the date of the European application. All the claims were revoked for obviousness and insufficiency. This decision raises serious implications for European applications in general, and for European applications designating the United Kingdom in particular. It will now be necessary to take great care to ensure that the priority document constitutes an enabling disclosure for the full breadth of the invention as it is expected ultimately to be claimed. This means that an Australian provisional specification will have to be drafted as if it were a complete specification. General Patent News (Please note that this is an incomplete and arbitrary selection) Applications Accepted: Application No. 671801 (19732/92) by Cell Genesys, Inc "Gene Manipulation and Expression Using Genomic Elements" Application No. 671820 (36936/93) by Promega Corporation "Non-Radioactive DNA Sequencing" Application No. 671838 (43342/93) by The Secretary of State for Defence of the United Kingdom of Great Britain and Northern Ireland "Clostridium Perfringens Vaccines" Application No. 671884 (55965/94) by Ludwig Institute for Cancer Research: Memorial Sloan-Kettering Cancer Centre "Monoclonal Antibody Which Specifically Binds to Tumor Vascular Endothelium and Uses Thereof" Application No. 671953 (23238/92) by Michigan State University "Transgenic Plants Producing Polyhydroxyalkanoates" Application No. 672019 (45139/93) by Meiji Milk Products Co Ltd "Method of Integrating Gene into Chromosome of (Lactobacillus Delbrueckii) Species and Product of Gene Integration" Application No. 672020 (45519/93) by International Flower Developments Pty Ltd "Genetic Sequences Encoding Glycosyltransferase Enzymes and Uses Therefor" Application No. 672138 (75949/94) by Infectech Inc "Method and Apparatus for Determining the Sensitivity of (Mycobacterium Avium-Intracellulare) to Different Antibiotics and Dosages Thereof" Application No. 671644 (42902/93) by Pioneer Hi-Bred International, Inc "Microwave Modification of Biological Macromolecules" Application No. 671623 (37463/93) by N.V. Innogenetics S.A. "Process for the Determination of Peptides Corresponding to Immunologically Important Epitopes and Biotinylated Peptides Used Therein" Application No. 671622 (37329/93) by The Regents of the University of Michigan "Method for Kidney Tubulogenesis" Application No. 671417 (12514/92) by Applied Research Systems ARS Holding N V "Human Follicle Stimulating Hormone Receptor" Application No. 671418 (14136/92) by Institut National De La Sante Et De La Recherche Medicale "Nucleic Acid Fragment of the X Chromosome Region Involved in the Fragile X Syndrome, Nucleotide Probe and Method of Diagnosing Mental Retardation with Fragile X" Application No. 672723 (77655/94) by Affymax Technologies N.V. "Method and Apparatus for Very Large Scale Immobilised Polymer Synthesis" Application No. 672694 (65325/94) by Commonwealth Scientific and Industrial Reserach Organisation "Tissue Characterisation Using Intravascular Echoscopy" Application No. 672689 (63553/94) by The University of Medicine and Dentistry of New Jersey "Over Expression of Single-Stranded Molecules" Application No. 672638 (51444/93) by Australian Membrane and Biotechnology Research Institute: University of Sydney "Improved Sensor Membranes" Application No. 672636 (5117/93) by Mogen International N.V. "Antifungal Chitin Binding Proteins and DNA Coding Therefor" Application No. 672618 (46738/93) by Pioneer Hi-Bred International, Inc "A Brassica Regulatory Sequence for Root-Specific or Root-Abundant Gene Expression" LEGAL NOTES Contributed by Natalie Stoianoff, Stoianoff & Associates, Business Editor In this issue, Legal Notes considers some of the key issues to protecting and commercialising your technology and know how, recently presented by the writer at an international business conference in Pusan, South Korea. Issue 1 Take the time to identify the intellectual property in your business and take steps to protect that intellectual property. This does not mean only potential patentable inventions but includes industrial designs, trade marks, copyright, trade secrets and know how. Where relevant, you need to ensure you have registered the intellectual property rights and, in the lead up to registration, maintained confidentiality systems to protect the technology and know how. Issue 2 In the process of commercialising your technology you need to identify your objectives. What is the market for the technology - domestic or international or both? You need to consider investment strategies to provide the necessary capital to fund the commercialisation process. Decisions need to be made as to whether the best avenue is to manufacture or licence or establish strategic alliances. Each case raises its unique legal considerations. Issue 3 You need to identify, firstly if there is any core technology that will be used and secondly who owns this core technology. If you do not own the core technology you need to consider the best way to license in core technology. Where you are part of a collaboration between several organisations you may need to consider the sharing of each organisation's core technology. Issue 4 Identify the field of further R&D. This is particularly relevant where there is a joint venture or strategic alliance between 2 or more groups. Once the field is identified, then the responsibilities of each party to the joint venture are defined. You need to then deal with the issue, what is the scenario if a party starts to work beyond the field of further R&D? Issue 5 When considering entering into collaborative arrangements, you need to address the following:
- valuation of contributions - legal structure and cross-licensing - management of collaboration - commercial exploitation - what happens on completion?
Issue 6 How is ownership of the new product or suite of products/processes to be determined? This brings us back to the intellectual property issues raised at the beginning of Legal Notes. Firstly, the employer/employee relationship needs to be clarified and, more often than not, a written contract is best to ensure the intellectual property developed by the employee in the course of employment is assigned to the employer. Collaborative arrangements will need special considerations and ultimately documentation of how the collaborators will share in the ownership of the new product(s) or process(es). You then need to consider ownership in further developments and the strategy in determining such ownership, not to mention the effect further investment may have on such ownership. Issue 7 Finally, you need to reduce Issues 1 to 6 into coherent business plan and establish the action plan you will use to implement your technology commercialisation and protection strategy. PLEASE NOTE that the information provided is exclusively for the general information of readers and should not be regarded as legal advice and no legal responsibility can be accepted for any opinions, advice or statements in these columns. Detailed professional advice should always be sought on any particular problems. Correspondence to Natalie should be marked PRIVATE AND CONFIDENTIAL and forwarded to: Natalie Stoianoff, Business Editor, Australasian Biotechnology, C/- Stoianoff & Associates, GPO Box 1482, Sydney, NSW 2001 (Tel: (02) 9267 7345; Fax: (02) 9267 7347). Copyright 1996 Australian Biotechnology Association Ltd. |
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