Footnotes

CHAPTER 1 - INTRODUCTION

[1]        A private members' Bill with the same title and similar provisions as the Bill before the committee was introduced into the House of Representatives on 21 February 2011, sponsored by the Hon Peter Dutton MP, the Hon Malcolm Turnbull MP, Mr John Forrest MP and Mr Rob Oakeshott MP.

[2]        Senate Community Affairs References Committee, Gene Patents, November 2010, Recommendation 3.

CHAPTER 2 - BACKGROUND

[1]        Senate Community Affairs References Committee, Gene Patents, November 2010, pp 8-19.

[2]        Patents Act 1990, sections 18 and 40. The requirements outlined here are not exhaustive and focus on aspects of patent law most relevant to the Bill.

[3]        Patents Act 1990, paragraph 18(1)(a).

[4]        William van Caenegem, Intellectual and Industrial Property in Australia, 2009, p. 155.

[5]        EM, p. 2.

[6]        (1959) 102 CLR 252.

[7]        National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 at 269.

[8]        Australian Law Reform Commission, Genes and Ingenuity: Gene Patenting and Human Health, Report 99, June 2004, p. 118.

[9]        This exclusion was an amendment moved by Senator Brian Harradine when the Patents Act was passed. Senator Brian Harradine, Senate Hansard, 20 September 1990, p. 2654.

[10]      Patents Act 1990, subsections 18(2), (3) and (4).

[11]      Senate Community Affairs References Committee, Gene Patents, November 2010, pp 12-13.

[12]      Mark Davison, Anne Monotti and Leanne Wiseman, Australian Intellectual Property Law, 2008, p. 410.

[13]      Senate Community Affairs References Committee, Gene Patents, November 2010, p. 14; Advisory Council on Intellectual Property, Patentable Subject Matter, Final Report, December 2010, p.11.

[14]      Senate Community Affairs References Committee, Gene Patents, November 2010, p. 15.

[15]      Senate Community Affairs References Committee, Gene Patents, November 2010, p. 120.

[16]      Senate Community Affairs References Committee, Gene Patents, November 2010, p. 122.

[17]      Patents Act 1990, section 135.

[18]      Genetic Technologies Ltd, 'A report to shareholders', 9 July 2003, p. 1.

[19]      Genetic Technologies Ltd, 'New position re BRCA testing', 2 December 2008, p. 1.

[20]      Senate Community Affairs References Committee, Gene Patents, November 2010, pp 6-7.

[21]      Senate Community Affairs References Committee, Gene Patents, November 2010, pp 6-7.

[22]      ALRC, Genes and Ingenuity: Gene Patenting and Human Health, Report 99, June 2004, p. 119.

[23]      Senate Community Affairs References Committee, Gene Patents, November 2010, pp 99-100.

[24]      Senate Community Affairs References Committee, Gene Patents, November 2010, p. 100.

[25]      Senate Community Affairs References Committee, Gene Patents, November 2010, pp 100-101.

[26]      Senate Community Affairs References Committee, Gene Patents, November 2010, p. 100.

[27]      ACIP, Patentable Subject Matter – Options Paper, September 2009; ACIP, Patentable Subject Matter, Final Report, December 2010.

[28]      ACIP, Patentable Subject Matter, Final Report, December 2010, pp 2-20.

[29]      For example, see IP Australia, Getting the Balance Right, Consultation Paper, March 2009; IP Australia, Exemptions to Patent Infringement, Consultation Paper, March 2009; IP Australia, Towards a Stronger and More Efficient IP Rights System, Consultation Paper, November 2009.

[30]      Journals of the Senate, 22 June 2011, p. 1068.

[31]      Intellectual Property Law Amendment (Raising the Bar) Bill 2011, Explanatory Memorandum, pp 8-9.

[32]      Intellectual Property Law Amendment (Raising the Bar) Bill 2011, Explanatory Memorandum, pp 9-10.

[33]      The Association of Molecular Pathology and Others v The United States Trademark Office and Myriad Genetics, Inc and Others, 09 Civ. 4515, S.D.N.Y, 29 March 2010, 4, available at http://www.genomicslawreport.com/wp-content/uploads/2010/03/Myriad-SJ-Opinion.pdf, accessed 2 August 2011.

[34]      Senate Community Affairs References Committee, Gene Patents, November 2010, p. 74.

[35]      An amicus curiae, or 'friend of the court', is a person not a party to a case who volunteers information to assist a court in deciding a matter before it.

[36]      United States Department of Justice, Brief for the United States as amicus curiae in support of neither party, 29 October 2010, pp 9-11.

[37]      The Association of Molecular Pathology and Others v The United States Trademark Office and Myriad Genetics, Inc and Others, 2010-1406, 29 July 2011, 8, available at http://www.cafc.uscourts.gov/images/stories/opinions-orders/10-1406.pdf, accessed 2 August 2011.

[38]      Andrew Pollack, 'Ruling Upholds Gene Patent in Cancer Test', New York Times, 30 July 2011, p. B1.

[39]      Cancer Voices Australia & Anor v Myriad Genetics Inc & Ors, Federal Court of Australia, NSD643/2010, available at http://www.comcourts.gov.au/file/Federal/P/NSD643/2010/actions, accessed 8 June 2011.

CHAPTER 3 - OVERVIEW OF THE BILL

[1]        Possible amendments to the Bill were also proposed during the inquiry. These are addressed in chapter 4.

[2]        EM, p. 2.

CHAPTER 4 - KEY ISSUES RAISED IN EVIDENCE

[1]        For example, Group of Eight, Submission 28, p. 2; AusBiotech, Submission 97, p. 5; Professor Douglas Hilton, Walter and Eliza Hall Institute of Medical Research, Committee Hansard, 28 April 2011, p. 4; Dr Brendan Shaw, Medicines Australia, Committee Hansard, 28 April 2011, p. 45.

[2]        Committee Hansard, 28 April 2011, p. 57.

[3]        Submission 77, p. 1.

[4]        Submission 47, p. 1 [underlining in original].

[5]        Submission 103, p. 1.

[6]        Anaesthetic Supplies Pty Ltd v Rescare Ltd [1994] FCA 1065 and Bristol-Myers Squibb Co v F H Faulding & Co Ltd (2000) FCR 524. These decisions relate to the patentability of human medical treatments.

[7]        Submission 103, p. 1.

[8]        Submission 80, p. 12.

[9]        Submission 18, p. 4.

[10]      Submission 39, pp 32-33.

[11]      Committee Hansard, 28 April 2011, p. 61.

[12]      Submission 41, p. 3.

[13]      Submission 17, pp 6-7.

[14]      Submission 1, pp 1-2.

[15]      Submission 94, p. 17.

[16]      ACIP, Patentable Subject Matter, Final Report, December 2010, p. 11.

[17]      ACIP, Patentable Subject Matter, Final Report, December 2010, p. 18.

[18]      Submission 39, p. 7.

[19]      Submission 17, pp 7-9.

[20]      For example, Institute of Patent and Trade Mark Attorneys, Submission 49, p. 7; Professor Ian Frazer, Submission 92, p.1; Professor Douglas Hilton, Walter and Eliza Hall Institute of Medical Research, Committee Hansard, 28 April 2011, p. 10.

[21]      Submission 18, p. 10.

[22]      Committee Hansard, 29 April 2011, pp 27-28.

[23]      Submission 46, p. 1.

[24]      Submission 30, p. 4.

[25]      Submission 103, p. 2.

[26]      Submission 103, p. 3.

[27]      Committee Hansard, 29 April 2011, p. 17.

[28]      Submission 97, p. 5.

[29]      Submission 49, p. 9 [underline in original].

[30]      Submission 39, p. 13.

[31]      Submission 47, p. 4.

[32]      Submission 103, Supplementary Submission, pp 5-6.

[33]      Submission 72, p. 2.

[34]      Submission 72, pp 2-3.

[35]      Amendment to the Bill tabled by Senator the Hon Bill Heffernan on 28 April 2011.

[36]      For example, Dr Martin Cross, Generic Medicines Industry Association, Committee Hansard, 28 April 2011, p. 53.

[37]      For example, Dr Trevor Davies, Institute of Patent and Trade Mark Attorneys, Committee Hansard, 28 April 2011, p. 31; Mr Matthew Cossey, Croplife Australia, Committee Hansard, 29 April 2011, p. 12.

[38]      Answer to question on notice, provided 12 May 2011.

[39]      Submission 25, p. 2.

[40]      Submission 55, p. 6.

[41]      Submission 33, p. 2.

[42]      EM, p. 2.

[43]      For example, see Institute of Patent and Trade Mark Attorneys, Submission 49, p. 8; CSIRO, Submission 78, pp 6-7.

[44]      Submission 18, p. 10.

[45]      Submission 48, p.2.

[46]      Committee Hansard, 28 April 2011, p. 30.

[47]      Submission 77, p. 5.

[48]      Submission 39, p. 3.

[49]      See, for example, ALRC, Submission 30, p. 2; Professor Dianne Nicol, Mr Johnathan Liddicoat, Dr Jane Neilsen and Mr Ben Mee, Submission 39, p. 41; AusBiotech, Submission 97, p. 2.

[50]      ALRC, Genes and Ingenuity, Report 99, June 2004, p. 13.

[51]      Submission 41, p. 3.

[52]      Submission 48, p. 3.

[53]      Submission 63, p. 3.

[54]      Submission 57, pp 7-9; see also CSIRO, Submission 78, p. 2.

[55]      Submission 68, p. 2.

[56]      Submission 94, p. 23.

[57]      Submission 27, p. 1.

[58]      Submission 37, p. 5.

[59]      Submission 103, p. 6.

[60]      Submission 103, p. 8.

[61]      Senate Hansard, 24 November 2010, p. 2100.

[62]      Submission 103, p. 2.

[63]      For example, see CSIRO, Submission 78, p. 6; Australian Academy of Science, Submission 100, p. 2; Biotechnology Industry Organisation, Submission 86, p. 4; Prima BioMed, Submission 73, pp 2-3.

[64]      Submission 97, p. 5.

[65]      Submission 97, p. 5.

[66]      Submission 92, p. 1.

[67]      Submission 77, p .2.

[68]      Submission 94, p. 4.

[69]      Submission 52, p. 2.

[70]      Submission 59, pp 16 & 20.

[71]      Submission 24, p. 4.

[72]      Submission 18, p. 11.

[73]      Submission 65, p. 7.

[74]      Submission 65, p. 9.

[75]      Submission 51, p. 1.

[76]      Submission 49, pp 6-7.

[77]      Committee Hansard, 28 April 2011, pp 29-30.

[78]      Submission 72, p. 6.

[79]      Committee Hansard, 28 April 2011, p. 16.

[80]      Committee Hansard, 28 April 2011, p. 23.

[81]      For example, Walter and Eliza Hall Institute for Medical Research, Submission 59, p. 3; Pfizer Australia, Submission 60, p. 2; CropLife Australia, Submission 65, p. 4.

[82]      Submission 57, p. 8.

[83]      Submission 94, p. 5.

[84]      Submission 59, pp 9-13.

[85]      Submission 97, p. 6.

[86]      Submission 69, p. 2.

[87]      Submission 71, p. 1.

[88]      Answer to question on notice, provided 12 May 2011, p. 3.

[89]      Submission 71, pp 3-6.

[90]      Dr Martin Cross, Generic Medicines Industry Association, Committee Hansard, 28 April 2011, p. 51.

[91]      Submission 70, p. 3.

[92]      Committee Hansard, 28 April 2011, p. 16.

[93]      Committee Hansard, 29 April 2011, p. 5.

[94]      Submission 72, p. 6.

[95]      Committee Hansard, 28 April 2011, pp 25-26.

[96]      EM, p. 1.

[97]      Submission 40, p. 8.

[98]      Submission 70, p. 3.

[99]      Submission 28, p. 1.

[100]    Submission 19, p. 3.

[101]    Committee Hansard, 28 April 2011, p. 30.

[102]    Committee Hansard, 29 April 2011, p. 14.

[103]    Answer to question on notice, provided 3 May 2011.

[104]    For example, see Department of Health and Ageing, Submission 68, p. 2; Tasmanian Government, Submission 96, p. 1.

[105]    Submission 68, Supplementary submission, pp 1-2.

[106]    Committee Hansard, 29 April 2011, p. 36.

[107]    Submission 53, pp 1 & 3.

[108]    Submission 69, p. 5.

[109]    Committee Hansard, 29 April 2011, p. 4.

[110]    For example, see Human Genetics Society of Australasia, Submission 5, pp 1-4; South Australian Government, Submission 15, pp 2-4.

[111]    Submission 2, pp 1-2.

[112]    Submission 4, p. 2.

[113]    Submission 8, p. 2.

[114]    Submission 61, p. 2.

[115]    Submission 103, p. 6.

[116]    Submission 75, p. 2.

[117]    Submission 16, pp 1-2.

[118]    For example, see Dr Malcolm Lyons, Submission 20, p. 1; Dr Brendan Shaw, Medicines Australia, Committee Hansard, 28 April 2011, p. 36.

[119]    Submission 94, p. 23.

[120]    Medicines Australia, Submission 89, pp 5-6.

[121]    Committee Hansard, 28 April 2011, p. 36.

[122]    Medicines Australia, Submission 89, p. 5.

[123]    Submission 105, p. 2.

[124]    Submission 60, p. 3.

[125]    Submission 97, pp 6-7.

[126]    Submission 42, p. 8.

[127]    For example, Chemskill, Submission 31, p. 1; Metabolic Pharmaceuticals, Submission 38, p. 2; Grasslanz Technology, Submission 45, pp 5-6; Hexima, Submission 58, p. 1; Pfizer Australia, Submission 60, p. 1; Prima BioMed, Submission 73, p. 3. 

[128]    Submission 31, p. 1.

[129]    For example, Australian Institute of Innovation, Submission 34, p. 1.

[130]    Submission 32, p. 1.

[131]    Submission 94, p. 5.

[132]    Submission 89, p. 4.

[133]    Committee Hansard, 28 April 2011, p. 57.

[134]    Committee Hansard, 28 April 2011, p. 60.

[135]    Submission 65, p. 16.

[136]    Australian Law Reform Commission, Genes and Ingenuity: Gene Patenting and Human Health, Report 99, June 2004, p. 173.

[137]    Committee Hansard, 29 April 2011, p. 23.

[138]    Committee Hansard, 28 April 2011, p. 22.

[139]    Dr Julian Clarke, Walter and Eliza Hall Institute of Medical Research, Committee Hansard, 28 April 2011, p. 6; Ms Deborah Monk, Medicines Australia, Committee Hansard, 28 April 2011, p. 39.

[140]    For example, see Group of Eight, Submission 28, p. 2; Roche, Submission 42, p. 8; Dr Teresa Schafer, Mr Tim Clark and Mr George Raitt (partners in Piper Alderman), Submission 50, p. 5.

[141]    Submission 49, pp 10-11.

[142]    Submission 39, p.13.

[143]    For example, see Amgen Australia, Submission 12, p. 1; Garvan Institute of Medical Research, Submission 64, p. 1; Baxter Healthcare, Submission 91, p. 1.

[144]    Submission 13, p. 1.

[145]    University of Western Sydney, University of Sydney, University of New South Wales, Macquarie University, University of Wollongong and Newcastle University, Submission 54, p. 2.

[146]    Submission 66, p. 2.

[147]    Committee Hansard, 28 April 2011, p. 19.

[148]    Submission 29, p. 3.

[149]    Submission 97, p. 7.

[150]    Submission 65, p. 5.

[151]    Submission 65, p. 6.

[152]    Submission 45, pp 5-8.

[153]    Submission 77, p. 6.

[154]    Submission 34, p. 2.

[155]    For example, Prima BioMed, Submission 73, p. 1; Dr Anna Lavelle, AusBiotech, Committee Hansard, 29 April 2011, p. 4.

[156]    Submission 64, p. 2; see also Sydnovate, Submission 66, p. 1.

[157]    Submission 23, p. 3.

[158]    Submission 24, p. 4.

[159]    Submission 46, p. 2.

[160]    Submission 79, p. 1.

[161]    Submission 122, p. 1.

[162]    Submission 103, p. 6.

[163]    Submission 84, p. 1.

[164]    Submission 48, p. 4.

[165]    ACIP, Patentable Subject Matter, Final Report, December 2010, p. 1.

[166]    Agreement on Trade-Related Aspects of Intellectual Property Rights, Article 27 (1); for example see Davies Collison Cave, Submission 17, pp 9-10; Dr Ann Kurts, Dr Mark Lutherborrow and Professor Natalie Stoianoff, Submission 18, p. 13; International Federation of Intellectual Property Attorneys, Submission 35, pp 2-5.

[167]    Submission 35, p. 6.

[168]    Submission 50, p. 2.

[169]    Submission 25, p. 1.

[170]    Submission 25, p. 1.

[171]    Submission 39, p. 40.

[172]    Submission 49, p. 16. 

[173]    For example, Institute of Patent and Trade Mark Attorneys, Submission 49, pp 12-14; Professor Peter Drahos, Committee Hansard, 28 April 2011, pp 23-24.

[174]    Submission 94, p. 11.

[175]    Committee Hansard, 29 April 2011, p. 34.

[176]    Directive on the legal protection of biotechnological inventions, Directive 98/44/EC, Article 3(2).

[177]    Committee Hansard, 28 April 2011, p. 30; see also Ms Fatima Beattie, IP Australia, Committee Hansard, 29 April 2011, p. 34.

[178]    Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, (Budapest 1977), http://www.wipo.int/treaties/en/registration/budapest/trtdocs_wo002.html, accessed 18 April 2011. Australia became a treaty country in 1987.

[179]    Submission 21, pp 7-8. 

[180]    For example, Foursight Associates, Submission 36, pp 1-2; CSL, Submission 56, p. 2; Croplife Australia, Submission 65, p. 13; Ms Fatima Beattie, IP Australia, Committee Hansard, 29 April 2011, p. 34

[181]    Submission 7, p. 2.

[182]    Submission 72, p. 7.

[183]    For example, Institute of Patent and Trade Mark Attorneys, Submission 49, p. 20; CSL, Submission 56, p. 3; AusBiotech, Submission 97, p. 8; Industry and Investment NSW, Submission 105, p. 3; Dr Julian Clark, Walter and Eliza Hall Institute of Medical Research, Committee Hansard, 28 April 2011, p. 13; Mr Johnathon Liddicoat, Committee Hansard, 28 April 2011, p. 58.

[184]    Submission 89, p. 8.

[185]    Submission 12, p. 7.

[186]    For example, CSL, Submission 56, p. 3; Dr Tania Obranovich, Institute of Patent and Trade Mark Attorneys, Committee Hansard, 28 April 2011, p. 30; Dr Anna Lavelle, AusBiotech, Committee Hansard, 29 April 2011, p. 9.

[187]    For example, Group of Eight, Submission 28, p. 2; IVD Australia, Submission 57, p. 10; Hexima, Submission 58, p. 2; CSIRO, Submission 78, p. 2.

[188]    Submission 47, p. 2. See also Prima BioMed, Submission 73, p. 1.

[189]    Submission 97, p. 8.

[190]    Submission 72, p. 5.

[191]    Submission 41, p. 4.

[192]    ALRC, Genes and Ingenuity: Gene Patenting and Human Health, Report 99, June 2004, p. 474.

[193]    Submission 97, p. 2. Dr Anna Lavelle, AusBiotech, Committee Hansard, 29 April 2011, pp 5-6.

[194]    Committee Hansard, 28 April 2011, p. 25.

[195]    Submission 94, p. 24.

[196]    Committee Hansard, 28 April 2011, p. 14; see also, Secretary's Advisory Committee on Genetics, Health and Society, Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests, April 2010, p. 94, http://oba.od.nih.gov/oba/sacghs/reports/SACGHS_patents_report_2010.pdf, accessed 6 June 2011.

[197]    Cancer Council Australia and Clinical Oncological Society, Submission 72, p. 6; Human Genetics Society of Australasia, Submission 5, p. 4.

CHAPTER 5 - CONCLUSIONS AND RECOMMENDATIONS

[1]        ACIP, Patentable Subject Matter, Final Report, December 2010, p. 42.

[2]        Committee Hansard, 28 April 2011, p. 20.

[3]        ACIP, Patentable Subject Matter, Final Report, December 2010, p. 17.

[4]        Mr Chris Reid, Department of Health and Ageing, Committee Hansard, 29 April 2011, p. 36.

[5]        Senate Community Affairs References Committee, Gene Patents, November 2010, p. 102.