02.08.2010
14.26 As discussed above, researchers are increasingly encouraged to participate in the process of patenting and commercialising genetic research.[33] The first stage in translating genetic research into healthcare benefits is the identification of new technology with potential healthcare applications. Once identified, the next stage is obtaining patent protection and subsequently developing the technology into a usable product. Hence, the initial identification stage is crucial to ensuring the benefits of genetic research reach the community.
14.27 While researchers are obviously well placed to identify new technologies, where they lack the skills to do so effectively, the potential health benefits of these technologies may not be realised. Researchers may also lack the commercial skills and experience to contribute effectively to the process of commercialisation.
14.28 The Gascoigne–Metcalfe Survey suggested that ‘thinking commercially does not come naturally to scientists. They do not see careers in the commercial world or recognise the problems that industry is trying to solve’.[34] Some participants in the Gascoigne–Metcalfe Survey commented that they found it difficult to recognise when their research had potential commercial value and lacked knowledge of the commercialisation process. One participant noted, ‘we don’t know what we don’t know’ and reported that this lack of knowledge extended to the process for obtaining patents and intellectual property management.[35]
14.29 Participants in the Gascoigne–Metcalfe Survey also reported that they needed access to advice on commercialisation and ‘translators’ able to ‘speak both the language of industry and the language of research’.[36] Responses to the Researcher Opinion Poll were similar, with a significant number of respondents stating that they did not feel they had the skills to commercialise their research results. About one third said they would not know how to find advice on developing the commercial potential of their discoveries.[37]
14.30 The National Principles require organisations to inform staff about their responsibilities in relation to intellectual property protection.[38] Most research organisations also have pre-publication review procedures, where papers to be submitted for publication are reviewed to identify potentially patentable inventions,[39] and technology transfer offices to manage intellectual property and commercialisation. These offices assist researchers in applying for and commercialising patents, and may take on a considerable portion of the responsibility for the process of commercialisation.[40] However, it appears that not all researchers are aware of the functions of these offices, and do not access the support available to them.
Education programs and support
14.31 Research organisations and industry bodies are addressing some of these concerns about researcher skills and experience through education programs.[41] Many organisations provide seminars and workshops on intellectual property protection and commercialisation for researchers.[42] Advice and educational resources for staff are also provided through technology transfer offices established in most organisations. Some organisations take a pro-active approach to assist researchers to identify commercially valuable technology by placing technology managers in each faculty where they are able to work closely with researchers.[43]
14.32 A number of recent reports on patenting and research commercialisation have recommended that the capture of valuable intellectual property could be improved by building researcher skills and expertise in recognising potentially patentable inventions. Suggested mechanisms for doing so include the provision of extra training and support personnel to identify inventions, the inclusion of subjects covering commercialisation and business skills in undergraduate and postgraduate courses, and mechanisms to encourage researchers to form links with industry partners.[44]
Submissions and consultations
14.33 Submissions and consultations also emphasised the need for ongoing skill building to ensure the value of Australian research is not lost through failure to obtain appropriate protection. Improving researchers’ skills in capturing and exploiting the results of research was also considered crucial to the development of a mature and internationally competitive biotechnology industry in Australia.[45]
14.34 DP 68 asked whether researchers in human genetics possess sufficient expertise to participate in the process of applying for and exploiting gene patents. Some comments received suggested that researchers lack the skills to identify new inventions that may be commercially valuable.[46] Others suggested that some researchers lack the expertise to be involved in the patenting process or are naïve about the process.[47]
14.35 However, it was also noted that researchers are becoming more active about commercialisation now that they are expected to make returns on their research.[48] Researchers’ awareness of, and skills in dealing with, patenting and commercialisation may be increasing.[49] There were suggestions that the difficulty is not a lack of awareness among researchers, but a lack of funding to support their efforts to commercialise.[50]
14.36 Submissions confirmed that there is considerable variability in skill levels among researchers.[51] The Walter and Eliza Hall Institute of Medical Research (WEHI) commented that research expertise in patenting is partly linked to the institution’s ability to capture and develop intellectual property.[52]
14.37 One problem cited was that patent protection may not be available for some valuable research results produced by public institutions if they are published before a patent application is filed. Researchers may be unaware of the need to protect their ideas, and once publication has occurred, subject to a grace period, the research is no longer novel and cannot be patented.[53] Grace period provisions are discussed below.
14.38 Educating scientists about patenting issues was recognised as a continuing challenge, and support was shown for including subjects covering intellectual property and commercialisation issues in health sciences and biotechnology degree programs.[54]
14.39 DP 68 proposed that:
universities and other publicly-funded research institutions should continue to take steps to raise the awareness of researchers in the health sciences and biotechnology about intellectual property issues and the commercialisation of research, and should provide relevant advice to researchers as required;[55] and
universities should ensure that students undertaking degrees in the health sciences or biotechnology are made familiar with intellectual property issues and the commercialisation of research.[56]
14.40 Submissions were overwhelmingly in favour of these proposals and supported the need for researchers and institutions to increase their awareness of intellectual property and commercialisation issues. Submissions also particularly supported the inclusion of subjects covering intellectual property and commercialisation as part of degrees in health sciences and biotechnology.[57]
14.41 Some noted that research institutions are already raising awareness through education programs.[58] Others commented that awareness-raising programs do appear to be improving researcher skills and awareness.[59] The ALRC also heard that research institutions are incorporating courses in intellectual property and commercialisation into science and biotechnology degrees at the undergraduate and postgraduate levels.[60]
14.42 IP Australia noted that it has the capability to assist research institutions in improving research skills through online resources and the provision of seminars.[61] The Department of Industry and Resources Western Australia suggested that the Australian Government, in collaboration with the States, should take a leading role in aiding research institutions to improve researcher skills.[62]
ALRC’s views
14.43 There is evidence that Australian research culture has shifted toward general acceptance of the role of patent protection for the results of genetic research. Significant steps are already being taken to improve researcher knowledge and skills in patenting and commercialising research. The ALRC recognises that many research organisations are already undertaking this task, and endorses this action. These programs should inform researchers about the basic elements of intellectual property law, including patenting, and the processes for obtaining patent protection for their research. Researchers should also be aided to improve their skills in identifying research results with commercial potential and dealing with the commercial aspects of patent exploitation and technology transfer.
14.44 Developing these skills may improve the exploitation of patented inventions. But, importantly, it may also assist researchers in avoiding the expenditure of time and effort in seeking to patent inventions that do not have sufficient potential for commercial development. The ALRC also considers there would be merit in ensuring that familiarisation with intellectual property and commercialisation begins at the undergraduate level.
Recommendation 14–1 Research organisations should continue to take steps to raise the awareness of researchers in health sciences and biotechnology about intellectual property issues and the commercialisation of research, and should provide relevant advice to researchers as required.
Recommendation 14–2 Universities should ensure that students undertaking degrees in health sciences or biotechnology are made familiar with intellectual property issues and the commercialisation of research.
[33] T Gascoigne and J Metcalfe, Scientists Commercialising their Research: Federation of Australian Scientific and Technological Societies (Occasional Paper No 2) (1999), 1.
[34] Ibid, 5.
[35] Ibid, 5, 7.
[36] Ibid, 5.
[37] Research Australia, Health & Medical Researcher Opinion Poll 2003 (2003), 7.
[38] Australian Research Council and others, National Principles of Intellectual Property Management for Publicly Funded Research (2001), Principle 2.
[39] Department of Education Science and Training, Analysis of the Legal Framework for Patent Ownership in Publicly Funded Research Institutions (2003), 72.
[40] The role of technology transfer offices in patenting and commercialising biotechnology research is discussed in Ch 17.
[41] For example, the Australian Technology Network, a coalition of five universities, has introduced online programs to develop the skills of research students in intellectual property and project management: Department of Education Science and Training, Review of Closer Collaboration between Universities and Major Publicly Funded Research Agencies (2004), 34.
[42] For example, the University of Melbourne Research and Innovation Office runs workshops for staff members covering commercialisation and license agreements and may tailor the contents of programs to suit the needs of faculties and departments: Melbourne Research and Innovation Office, Workshop and Information Sessions, University of Melbourne, <www.research.unimelb.edu.au/infosessions> at 16 June 2004. UniQuest, at the University of Queensland, also holds intensive workshops to assist students to gain an understanding of intellectual property principles and commercialisation: UniQuest, Consultation, Brisbane, 3 October 2003.
[43] See, eg, UniQuest, About UniQuest, <www.uniquest.com.au/?id=13> at 16 June 2004.
[44] Department of Education Science and Training, Analysis of the Legal Framework for Patent Ownership in Publicly Funded Research Institutions (2003), 72; T Gascoigne and J Metcalfe, Scientists Commercialising their Research: Federation of Australian Scientific and Technological Societies (Occasional Paper No 2) (1999), 5.
[45] Bio Innovation SA, Consultation, Adelaide, 16 September 2003; Western Australian Department of Health and others (research issues), Consultation, Perth, 17 September 2003; Western Australian Department of Health and others (legal issues), Consultation, Perth, 17 September 2003.
[46] Bio Innovation SA, Consultation, Adelaide, 16 September 2003; Medical Researchers, Consultation, Adelaide, 15 September 2003; J McKeough, Consultation, Sydney, 23 March 2004.
[47] Unisearch, Consultation, Sydney, 15 March 2004; Cancer Council Victoria, Submission P101, 20 April 2004.
[48] Western Australian Department of Health and others (legal issues), Consultation, Perth, 17 September 2003; Queensland Biotechnology Advisory Council, Consultation, Brisbane, 2 October 2003; Garvan Institute of Medical Research, Consultation, Sydney, 17 March 2004.
[49] Centre for Law and Genetics, Submission P104, 22 April 2004; Queensland Government, Submission P57, 5 January 2004; UniQuest, Consultation, Brisbane, 3 October 2003; AusBiotech Ltd, Consultation, Melbourne, 5 September 2003; AusBiotech Ltd, Submission P58, 7 November 2003.
[50] Western Australian Department of Health and others (legal issues), Consultation, Perth, 17 September 2003.
[51] Walter and Eliza Hall Institute of Medical Research, Submission P71, 13 April 2004.
[52] Ibid.
[53] Bio Innovation SA, Consultation, Adelaide, 16 September 2003.
[54] Western Australian Department of Health and others (legal issues), Consultation, Perth, 17 September 2003; Western Australian Department of Health and others (research issues), Consultation, Perth, 17 September 2003; Bio Innovation SA, Consultation, Adelaide, 16 September 2003; UniQuest, Consultation, Brisbane, 3 October 2003.
[55] Australian Law Reform Commission, Gene Patenting and Human Health, DP 68 (2004), Proposal 15–1.
[56] Ibid, Proposal 15–2.
[57] Human Genetics Society of Australasia, Submission P76, 16 April 2004; Walter and Eliza Hall Institute of Medical Research, Submission P71, 13 April 2004; Royal College of Pathologists of Australasia, Submission P82, 16 April 2004; South Australian Department of Human Services, Submission P74, 15 April 2004; Australian Centre for Intellectual Property in Agriculture, Submission P81, 16 April 2004; Department of Industry Tourism and Resources, Submission P97, 19 April 2004; Commonwealth Department of Health and Ageing, Submission P79, 16 April 2004; National Health and Medical Research Council, Submission P107, 19 April 2004; New South Wales Health Department, Submission P112, 30 April 2004; Caroline Chisholm Centre for Health Ethics Inc, Submission P69, 2 April 2004; Sydney IVF Limited, Submission P98, 19 April 2004; Cancer Council New South Wales, Submission P99, 20 April 2004; Cancer Council Victoria, Submission P101, 20 April 2004; Queensland Government, Submission P57, 5 January 2004; Centre for Law and Genetics, Submission P104, 22 April 2004; Western Australian Department of Industry and Resources, Submission P90, 16 April 2004.
[58] Centre for Law and Genetics, Submission P104, 22 April 2004; Queensland Government, Submission P57, 5 January 2004; Unisearch, Consultation, Sydney, 15 March 2004; UniQuest, Consultation, Brisbane, 3 October 2003.
[59] Department of Industry Tourism and Resources, Submission P97, 19 April 2004.
[60] J McKeough, Consultation, Sydney, 23 March 2004; Centre for Law and Genetics, Submission P104, 22 April 2004; IP Australia, Submission P86, 16 April 2004.
[61] IP Australia, Submission P86, 16 April 2004.
[62] Western Australian Department of Industry and Resources, Submission P90, 16 April 2004.