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<title>UTas ePrints - Genetic Research and Commercialisation</title>
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<meta content="The results of the human genome project (HGP) and other biomedical research are being used in the development of new drugs, diagnostics and therapies by the medical biotechnology industry in Australia and elsewhere. However, both the research and commercial components of human genetic technology raise some unique ethical, legal and social implications, which may become particularly acute where these two components intersect and overlap. The consequences of this overlap between research and development are being subjected to some intensive scrutiny, along with the many other ethical, legal and social implications arising from developments in human genetic technology. In this chapter, the focus of inquiry is on the disputes and dilemmas that arise for public sector researchers and organisations in this new commercialised research environment." name="eprints.abstract" />
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<meta content="1 For a history of the human genome project and information on some of the current and future research
programs in this area see: Genome Programs of the US Department of Energy Office of Science at:
http://doegenomes.org/ (last accessed 6 April 2005).
2 This, of course, is a significant issue in its own right. Although it is beyond the scope of this chapter
to canvass access to healthcare in any depth, other chapters discuss this issue more fully. See
particularly Chapter 30.
3 Many of these complex ethical, legal and social issues wee canvassed in an inquiry jointly conducted
by the Australian Law Reform Commission and Australian Health Ethics Committee Report 96
Essentially Yours: the Protection of Human Genetic Information (Commonwealth of Australia:
Canberra; 2003) available at: http://www.austlii.edu.au/au/other/alrc/publications/reports/96/ (last
accessed 1 April 2005)
4 Australian Law Reform Commission Report 99, Genes and Ingenuity: Gene Patenting and Human
Health (Commonwealth of Australia: Canberra; 2004) available at:
http://www.austlii.edu.au/au/other/alrc/publications/reports/99/ (last accessed 1 April 2005) (hereafter
ALRC). See also the summary of the Report in Chapter 14 of this volume.
5 Sheldon Krimsky Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical
Research? (Rowman and Littlefield: US; 2003) at 1.
6 Dianne Nicol ‘The Golden Path from the Ivory Tower of Academic Science. Review essay: Sheldon
Krimsky Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research?’
(2004) Australian Review of Public Affairs 1 November 2004, available at:
http://www.australianreview.net/ (last accessed 4 April 2004).
7 Dianne Nicol and Jane Nielsen ‘The Australian Medical Biotechnology Industry and Access to
Intellectual Property: Issues for Patent Law Development’ (2001) 23 Sydney Law Review 347 at 360-
362. The UK-based Royal Society has referred to this as ‘a most unhealthy gold rush mentality’: Royal
Society Keeping Science Open: The Effects of Intellectual Property Policy on the Conduct of Science
(2003) available at: http://www.royalsoc.ac.uk/document.asp?tip=0&id=1374 (last accessed 5 April
2005).
8 See, for example, CHI Research Inc Inventing Our Future: the Link Between Australian Patenting
and Basic Science (Canberra: AGPS; 2000).
9 Diamond v Chakrabarty 447 US 303 (1980) at 309.
10 See, for example, Daniel Kevles and Ari Berkowitz ‘The Gene Patenting Controversy: a
Convergence of Law, Economic Interests and Ethics’ (2001) 67 Brooklyn Law Review 233 att 240–1;
Dan Burk, ‘Patenting Transgenic Human Embryos: A Nonuse Cost Perspective’ (1993) 30 Houston
Law Review 1597 at 1599.
11 Intellectual Property Australia, Australian Patents For: Microorganisms; Cell Lines; Hybridomas;
Related Biological Materials and Their Use; and Genetically Manipulated Organisms (1998). Note that
Diamond v Chakrabarty above n9, the leading US case on patentability of living organisms, was
referred to with approval by the High Court in Grain Pool of Western Australia v The Commonwealth
(2000) 46 IPR 515. See particularly paragraphs 46 and 47 of the majority judgment and paragraph 134
of Justice Kirby’s judgment. Paragraphs 46 and 47 of the majority judgment could be read as referring
only to the applicability of Chakrabarty in US law, or could be read more broadly, applying in
Australian law as well. See Matthew Rimmer, ‘Franklin Barley: Patent Law and Plant Breeders’
Rights’ (2003) 10(4) Murdoch Electronic Law Journal available at: http://www.murdoch.edu.au/elaw
12 The case of Bristol Myers Squibb v FH Faulding & Co Ltd (2000) 46 IPR 553, permitting patenting
of methods of medical treatment, being one notable exception.
13 Research tools can be defined as ‘resources used by scientists, where those resources have no
immediate therapeutic or diagnostic value’: ALRC, above n4 at 301.
14 Arti Rai “Genome Patents: A Case Study in Patenting Research Tools’ (2002) 77 Academic
Medicine 1368 at 1369.
15 Details as to the nature of these and other research tools and ownership of the patents associated with
them can be found in Dianne Nicol and Jane Nielsen Patents and Medical Biotechnology: An
Empirical Analysis of Issues Facing the Australian Industry Centre for Law and Genetics Occasional
Paper No. 6 (2003) (the Nicol-Nielsen study) at 10-12 and 40-49.
16 Health and Medical Research Strategic Review, The Virtuous Cycle: Working Together for Health
and Medical Research: Health & Medical Research Strategic Review: Final Report (Canberra: AGPS,
1999) (referred to as the Wills Review, after the Chair of the review committee, Mr Peter Wills) at 1.
17 Ibid.
18 Ibid. See also ALRC, above n4, Chapter 17.
19 Information about the program is available at: http://backingaus.innovation.gov.au/default2004.htm
(last accessed 4 April 2005)
20 Ibid.
21 Information available at:
http://www.biotechnology.gov.au/content/controlfiles/display_details.cfm?ObjectID=37A08524-
9B9E-4E18-909721AF09DF2F87 (last accessed 4 April 2005)
22 See particularly Rebecca Eisenberg and Richard Nelson, ‘Public vs. Proprietary Science: a Fruitful
Tension?’ (2002) 77 Academic Medicine 1392; see also Don Chalmers and Dianne Nicol,
‘Commercialisation of Biotechnology: Public Trust and Research’ (2004) 6 International Journal of
Biotechnology 116
23 Working party comprising the Australian Research Council; the Australian Tertiary Institutions
Commercial Companies Association; the Australian Vice-Chancellors’ Committee; the Department of
Education, Training and Youth Affairs; the Department of Industry, Science and Resources; IP
Australia; and the National Health and Medical Research Council, National Principles of Intellectual
Property Management for Publicly Funded Research (2001) 6 available at:
http://www.arc.gov.au/pdf/01_01.pdf (last accessed 6 April 2005).
24 See , for example, the comments by Senator Robert Ray to this effect in the second reading speech to
the Patents Bill 1990 in: Parliamentary Debates 29 May 1990 Senate, 1271.
25 Although it is impossible to list all relevant sources, see particularly Michael Heller and Rebecca
Eisenberg ‘Can Patents Deter Innovation? The Anti-commons in Bio-medical Research’ (1998) 280
Science 698. Other notable sources include: Nuffield Council on Bioethics, The Ethics of Patenting
DNA: A Discussion Paper (London: Nuffield Council; 2002); National Research Council (NRC),
Intellectual Property Rights and Research Tools in Molecular Biology (Washington DC: National
Academy of Sciences, 1997); ALRC, above n4, particularly Chapter 12. See the Nicol-Nielsen study,
above n15 at 50-63 for further references.
26 Listed in the Nicol-Nielsen study, above n15 at 40-49.
27 See particularly John Walsh, Ashish Arora and Wesley Cohen ‘Effects of Research Tool Patenting
and Licensing on Biomedical Innovation’ in W.M. Cohen and S.A. Merrill (eds.), Patents in the
Knowledge-Based Economy (Washington: National Academies Press, 2003) at 287, available at:
http://books.nap.edu/books/0309086361/html/285.html#pagetop (last accessed 5 April 2005); see also
John Walsh, Ashish Arora and Wesley Cohen ‘Working Through the Patent Problem’ (2003) 299
Science 1021.
28 National Research Council Intellectual Property Rights and Research Tools in Molecular Biology
Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996, available
at: http://www.nap.edu/readingroom/books/property/ (last accessed on 8 April2005) Chapter 5 (no page
numbers in electronic version).
29 Ibid.
30 Nicol-Nielsen study, above n15 at 40-49. The results of this study on this point are closely aligned
with those in the study by Walsh et al, above n27. See particularly the Nicol-Nielsen study at 254-257.
31 ALRC, above n4 at 314.
32 This quote the Centre for Law and Genetics’ submission to the ALRC inquiry, extracted by the
ALRC, above n4 at 315.
33 The Allen Consulting Group A Wealth of Knowledge: The Return on Investment from ARC-funded
research Report to the Australian Research Council 4 September 2003 available at:
http://www.arc.gov.au/publications/arc_publications.htm#2003 (last accessed 5 April 2005) at 44 and
49-50.
34 Ibid, at 42-43.
35 Ibid.
36 Ibid, at 46.
37 Ann Monotti and Sam Rickeston Universities and Intellectual Property: Ownership and Exploitation
(Oxford University Press; 2003) at 446-451.
38 Yochai Benkler ‘Commons-based Strategies and the Problems of Patents’ (2004) 305 Science 1110
at 1110-1111.
39 The Allen Consulting Group, above n33 at 49.
40 Prime Minister’s Science, Engineering and Innovation Council Commercialisation of Public Sector
Research (Canberra: Commonwealth of Australia; 2001) Report of Working Group presented at the
Council’s Seventh Meeting 28 June 2001 at 3, available at: http://www.dest.gov.au/science/pmseic
(last accessed 4 April 2005) at 3.
41 Monotti and Ricketson, above n37 at 451-456. See also Department of Education, Science and
Training Best Practice Processes for University Research Commercialisation (Canberra:
Commonwealth of Australia; 2002) at 28; ALRC, above n4 at 419.
42 Note, however, that the UK Royal Society has pointed out that the merits of universities obtaining
intellectual property as opposed to disseminating knowledge have not been well documented and are
worthy of further study: The Royal Society, above n7 at v.
43 ALRC, above n4 at 289.
44 This quote is part of the Centre for Law and Genetics’ submission to the ALRC inquiry, extracted by
the ALRC, above n4 at 285.
45 Monotti and Ricketson above n37 at 433-434.
46 Nicol-Nielsen study, above n15.
47 For detailed results, see Nicol-Nielsen study, above n15 at 122-136. This component of the study
was written by the author. To avoid excessive footnoting, individual page numbers are not referred to
in the following summary.
48 For discussions on the impact of commercialisation on the traditional norms of science, as identified
by Robert Merton in The Sociology of Science (Chicago: University of Chicago Press; 1973), see
particularly: Rebecca Eisenberg ‘Proprietary Rights and the Norms of Science in Biotechnology
Research’ (1987) 97 Yale University Law Journal 177; Robert Merges ‘Property Rights and the
Commons: the Case of Scientific Research’ (1996) 13 Social Philosophy and Policy 145; Arti Rai
‘Regulating Scientific Research: Intellectual Property Rights and the Norms of Science’ (1999) 94
Northwestern University Law Review 77;
49 Monotti and Ricketson above n37 at 542. Note that Australia now has a ‘grace period’ meaning that
publications by or with consent of the patentee within 12 months prior to filing the patent do not
compromise the novelty of the invention. However, the fact that a number of other countries do not
have provision for a grace period is problematic. For information on grace periods see:
http://www.ipaustralia.gov.au/patents/what_quiet_grace.shtml (last accessed 5 April 2005).
50 Andrew Christie, Stuart D’Aloisio, Katerina Gaita, Melanie Howlett and E. Webster Analysis of the
Legal Framework for Patent Ownership in Publicly Funded Research Institutions (Canberra:
Commonwealth of Australia; 2003).
51 Ibid, at 212
52 Melbourne University is specifically referred to because a number of respondents drew attention to
the University’s unique arrangements regarding ownership. Christie et al, above n50 also make specific
reference to the ownership arrangements at Melbourne University.
53 See generally ALRC, above n4.
54 For a review of exemption from infringement for non-profit research see C. Nottenbaum, P.G.
Pardey and B.D. Wright, ‘Accessing Other People’s Technology for Non-profit Research’ (2002) 43
Australian Journal of Agricultural and Resource Economics 3.
55 Section 60(5) Patents Act 1977 (UK).
56 This line of authority starts with Whittemore v. Cutter1 Gall. 429, 29 F. Cas. 1120, 1121 (C.C.D.
Mass. 1813), as cited in Roche Products, Inc v Bolar Pharmaceutical Co, Inc 733 F.2d 858 (1984) and
extends to the recent decisions of Madey v Duke University 307 F 3d 1351, 1360–1 (Fed Cir, 2002)
and Integra Lifesciences I, Ltd v Merck KgaA 331 F.3d 860 (Fed. Cir. 2003).
57 As cited in Roche v Bolar, ibid at. 862.
58 The first, in s60(5)(a) Patents Act 1977 (UK), relates to private, non-commercial use of the
invention, the second, in s60(5)(b), relates to experimental use of the invention for purposes relating to
the subject matter of the invention.
59 See generally Nicol-Nielsen study above n15 at 218-222.
60 Above n4.
61 For further details see http://www.acip.gov.au/reviews.htm#expuse (last accessed 5 April 2005).
62 See above n25 and associated text.
63 Madey, above n56.
64 Madey, above n56 at 1362.
65 Ibid.
66 Ibid.
67 ALRC, above n4 Recommendation 13-1.
68 ALRC, above n4 at 340.
69 ACIP Patents and Experimental Use Options Paper (Canberra: Australian Government; 2004) at 6.
The discussion in this part of the chapter formed the basis of part of the author’s contribution to the
Centre for Law and Genetics’ submission to the ALRC and ACIP inquiries.
70 Rebecca Eisenberg ‘Patents and the Progress of Science: Exclusive Rights and Experimental Use’
(1989) 56 University of Chicago Law Review 1017.
71 Katherine Strandburg, ‘What Does the Public Get? Experimental Use and the Patent Bargain’ (2004)
Wisconsin Law Review 81.
72 Rochelle Cooper Dreyfuss, ‘Varying the Course in Patenting Genetic Material: A Counter-Proposal
to Richard Epstein’s Steady Course’ (April 8, 2003). NYU Law School, Public Law Research Paper
No. 59. http://ssrn.com/abstract=394000 (last accessed 16 April 2004). See also an unpublished article
by Richard Nelson cited in Strandburg, above n71, at her n207 and her discussion at 136-137.
73 See Dreyfuss, above n at 9.
74 Strandburg has isolated these requirements from the work of Rochelle Dreyfuss, above n72 and from
Richard Nelson, in an unpublished article. See Strandburg above n71 at 137. See also Janice Mueller,
‘No “Dilettante Affair”: Rethinking the Experimental Use Exception to Patent Infringement for
Biomedical Research Tools’ (2001) 76 Washington Law Review 1at 54-66.
75 Dreyfuss, above n72 at 11.
76 Se ALRC above n4 at 330.
77 Some of these issues were canvassed by the ALRC, above n4 Chapter 17.
78 See ALRC, above n4 Chapters 26 and 27 for detailed discussion on these points.
79 See, for example, Benkler, above n; R. Atkinson. et al. (multiple authors), ‘Public Sector
Collaboration for Agricultural IP Management.’ (2003) 301 Science 174." name="eprints.referencetext" />
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<h1 class="ep_tm_pagetitle">Genetic Research and Commercialisation</h1>
<p style="margin-bottom: 1em" class="not_ep_block"><span class="person_name">Nicol, Dianne</span> (2006) <xhtml:em>Genetic Research and Commercialisation.</xhtml:em> In: Disputes and Dilemmas in Health Law. . The Federation Press, Sydney, pp. 259-276. ISBN 1862875537</p><p style="margin-bottom: 1em" class="not_ep_block"></p><table style="margin-bottom: 1em" class="not_ep_block"><tr><td valign="top" style="text-align:center"><a href="http://eprints.utas.edu.au/2571/1/Nicol_Disputes.pdf"><img alt="[img]" src="http://eprints.utas.edu.au/style/images/fileicons/application_pdf.png" class="ep_doc_icon" border="0" /></a></td><td valign="top"><a href="http://eprints.utas.edu.au/2571/1/Nicol_Disputes.pdf"><span class="ep_document_citation">PDF</span></a> - Full text restricted - Requires a PDF viewer<br />253Kb</td><td><form method="get" accept-charset="utf-8" action="http://eprints.utas.edu.au/cgi/request_doc"><input accept-charset="utf-8" value="3379" name="docid" type="hidden" /><div class=""><input value="Request a copy" name="_action_null" class="ep_form_action_button" onclick="return EPJS_button_pushed( '_action_null' )" type="submit" /> </div></form></td></tr></table><p style="margin-bottom: 1em" class="not_ep_block">Official URL: <a href="http://www.federationpress.com.au/bookstore/book.asp?isbn=9781862875531">http://www.federationpress.com.au/bookstore/book.asp?isbn=9781862875531</a></p><div class="not_ep_block"><h2>Abstract</h2><p style="padding-bottom: 16px; text-align: left; margin: 1em auto 0em auto">The results of the human genome project (HGP) and other biomedical research are being used in the development of new drugs, diagnostics and therapies by the medical biotechnology industry in Australia and elsewhere. However, both the research and commercial components of human genetic technology raise some unique ethical, legal and social implications, which may become particularly acute where these two components intersect and overlap. The consequences of this overlap between research and development are being subjected to some intensive scrutiny, along with the many other ethical, legal and social implications arising from developments in human genetic technology. In this chapter, the focus of inquiry is on the disputes and dilemmas that arise for public sector researchers and organisations in this new commercialised research environment.</p></div><table style="margin-bottom: 1em" cellpadding="3" class="not_ep_block" border="0"><tr><th valign="top" class="ep_row">Item Type:</th><td valign="top" class="ep_row">Book Chapter</td></tr><tr><th valign="top" class="ep_row">Subjects:</th><td valign="top" class="ep_row"><a href="http://eprints.utas.edu.au/view/subjects/390114.html">390000 Law, Justice and Law Enforcement > 390100 Law > 390114 Intellectual Property</a></td></tr><tr><th valign="top" class="ep_row">ID Code:</th><td valign="top" class="ep_row">2571</td></tr><tr><th valign="top" class="ep_row">Deposited By:</th><td valign="top" class="ep_row"><span class="ep_name_citation"><span class="person_name">A/Prof Dianne Nicol</span></span></td></tr><tr><th valign="top" class="ep_row">Deposited On:</th><td valign="top" class="ep_row">02 Jan 2008 11:24</td></tr><tr><th valign="top" class="ep_row">Last Modified:</th><td valign="top" class="ep_row">09 Jan 2008 02:30</td></tr><tr><th valign="top" class="ep_row">ePrint Statistics:</th><td valign="top" class="ep_row"><a target="ePrintStats" href="/es/index.php?action=show_detail_eprint;id=2571;">View statistics for this ePrint</a></td></tr></table><p align="right">Repository Staff Only: <a href="http://eprints.utas.edu.au/cgi/users/home?screen=EPrint::View&eprintid=2571">item control page</a></p>
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