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<title>UTas ePrints - On the Legality of Gene Patents</title>
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<meta content="This article considers the legal and policy deliberations on gene patenting that have occurred since the issue came to the fore in the early 1990s. The analysis is contextualised with brief overviews of the science of genetics and genomics and the law of patents. Legislation, administrative guidelines and case law are analysed, focusing on the jurisdictions of Australia, the US and the UK. This article concludes that, despite ongoing legal and policy developments, clear guidance as to the legality of gene patents remains elusive. It is obviously desirable to have proper and certain gene patenting laws. In time, this is likely to happen. In the interim, it is argued that other mechanisms are also available for dealing with gene patents, negating the desirability of a radical overhaul of gene patenting laws." name="eprints.abstract" />
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<meta content="[1] Marrakesh Agreement Establishing the World Trade Organization, opened for signature 15 April 1994, 1867 UNTS 3, annex 1C (Agreement on Trade-Related Aspects of Intellectual Property Rights) (entered into force 1 January 1995) (‘TRIPS’).
[2] Some countries also have a lesser form of patent grant. In Australia, for example, innovation patents are granted for up to eight years: Patents Act 1990 (Cth) ss 62, 68. A lower level of inventiveness is required for innovation patents than for standard patents: Patents Act 1990 (Cth) ss 7(2)–(3) (inventive step requirements), 7(4)–(5) (innovative step requirements).
[3] Various theories have been postulated to justify patents, primarily focusing on economic rationales rather than the natural or moral rights of the inventor. Currently, the dominant paradigm is the incentive to innovate. For a full discussion, see Roberto Mazzoleni and Richard R Nelson, ‘Economic Theories about the Benefits and Costs of Patents’ (1998) 32 Journal of Economic Issues 1031. See also Lee Bendekgey and Diana Hamlet-Cox, ‘Gene Patents and Innovation’ (2002) 77 Academic Medicine 1373.
[4] The precise boundaries of the term ‘gene patent’ are also uncertain. In this article, the term is intended to encompass any patent that includes a claim to a deoxyribonucleic acid (‘DNA’) sequence.
[5] ALRC, Genes and Ingenuity: Gene Patenting and Human Health, Report No 99 (2004). The final report of the inquiry was tabled in federal Parliament in August 2004. The only other areas that have attracted similar levels of debate are software patents and business method patents.
[6] It is interesting to note, however, that there has been hardly any discussion of such matters in the Australian courts.
[7] The World Health Organization provides some useful data on the general rise in patents in biotechnology in World Health Organization, Genetics, Genomics and the Patenting of DNA: Review of Potential Implications for Health in Developing Countries (2005) 20.
[8] Kyle Jensen and Fiona Murray, ‘Intellectual Property Landscape of the Human Genome’ (2005) 310 Science 239, 239. Over 75 per cent of these gene patents have only one patent owner, but the remainder have fragmented ownership. The authors report that the two genes with the most fragmented ownership have eight assignees for nine patents, and 12 assignees for 14 patents: at 240. Such fragmented ownership is likely to increase significantly the cost of access for downstream innovators. See also Birgit Verbeure, Gert Matthijs and Geertrui Van Overwalle, ‘Analysing DNA Patents in relation with Diagnostic Genetic Testing’ (12 October 2005) European Journal of Human Genetics 1 <http://www.nature.com/ejhg/journal/vaop/ncurrent/pdf/5201503a
.pdf>.
[9] This is also our hereditary information, and another function of DNA is to pass on this information to our descendants.
[10] There is not a direct one-to-one correspondence of genes to proteins. In humans, for example, the latest estimates of the number of genes are as low as 20 000, yet there are far more proteins. Hence, a particular gene might carry the information to make several proteins. See International Human Genome Sequencing Consortium, ‘Finishing the Euchromatic Sequence of the Human Genome’ (2004) 431 Nature 931.
[11] John Barton provides some useful scenarios which assist in further clarifying this issue: John H Barton, ‘Changing Intellectual Property Issues in the Biotechnology Industry’ (1999) 18 Biotechnology Law Report 3, 4.
[12] See National Research Council, Intellectual Property Rights and the Dissemination of Research Tools in Molecular Biology (1997) 40–2.
[13] For a history of the Human Genome Project, see the National Human Genome Research Institute, All about the Human Genome Project (HGP) (2005) <http://www.genome.gov/1000
1772>.
[14] For a useful discussion of this technology, see Bendekgey and Hamlet-Cox, above n 3, 1373–5.
[15] Linda Maher, ‘The Patent Environment: Domestic and European Community Frameworks for Biotechnology’ (1992) 33 Jurimetrics Journal 67, 128.
[16] See, eg, Rebecca Eisenberg, ‘Genes, Patents and Product Development’ (1992) 257 Science 903.
[17] One of the lead funding agencies of both projects, the Wellcome Trust, describes these ventures as two global partnerships that are characterising variations in the human genome. It states that single nucleotide polymorphisms (‘SNPs’) are changes to single letters of the DNA code, which occur in about one in every 1000 nucleotides. The SNP Consortium is mapping these SNPs, whereas the HapMap Project is investigating the combinations of SNPs that are inherited together: Wellcome Trust, The SNP Consortium and the International HapMap Project (2005) <http://www.wellcome.ac.uk/doc_WTD003500.html>.
[18] In the medical sector, many of the complex ethical, legal and social issues arising from these developments were canvassed by the ALRC and the Australian Health Ethics Committee in their joint report entitled Essentially Yours: The Protection of Human Genetic Information in Australia, Report No 96 (2003). In the agricultural sector, see, eg, the recent US report of the Committee on Genetically Modified Pest-Protected Plants, Board on Agriculture and Natural Resources, National Research Council, Genetically Modified Pest-Protected Plants: Science and Regulation (2000), and the earlier Australian report of the House of Representatives Standing Committee on Industry, Science and Technology, Parliament of Australia, Genetic Manipulation: The Threat or the Glory (1992).
[19] For example, in Australia, the federal government has expressed strong support for the development of an Australian biotechnology industry: see Biotechnology Australia, Australian Biotechnology: A National Strategy (2000). See also 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.
[20] At around the same time, Monsanto and other agricultural companies were developing techniques for genetically modifying crop species.
[21] Barton, ‘Changing Intellectual Property Issues in the Biotechnology Industry’, above n 11, 3.
[22] Rebecca S Eisenberg, ‘Why the Gene Patenting Controversy Persists’ (2002) 77 Academic Medicine 1381, 1381.
[23] Barton, ‘Changing Intellectual Property Issues in the Biotechnology Industry’, above n 11, 5–9.
[24] In November 2004, Myriad Diagnostics sold its BRCA patents to the University of Utah Research Foundation, but it continues to hold exclusive licences to the patents: see Institut Curie, ‘Breast and Ovarian Cancer Susceptibility Gene BRCA1: Another Victory for Opponents of Patents Held by Myriad Genetics: European Patent Office Rejects the Essential Points of BRCA1 Gene Patents’ (Press Release, 31 January 2005) <http://www.curie.fr/upload/presse/
myriadpatents310105.pdf>.
[25] Eisenberg, ‘Why the Gene Patenting Controversy Persists’, above n 22, 1382.
[26] Ibid 1383–5. See also Rebecca S Eisenberg, ‘How Can You Patent Genes?’ (2002) 2(3) American Journal of Bioethics 3.
[27] John H Barton, ‘Patents, Genomics, Research and Diagnostics’ (2002) 77 Academic Medicine 1339, 1339–40. He also adds SNPs to his list: at 1339.
[28] See especially Suzanne Scotchmer, ‘Standing on the Shoulders of Giants: Cumulative Research and the Patent Law’ (1991) 5(1) Journal of Economic Perspectives 29, 32–3. See also Michael A Heller and Rebecca S Eisenberg, ‘Can Patents Deter Innovation? The Anticommons in Biomedical Research’ (1998) 280 Science 698; Rebecca S Eisenberg, ‘Bargaining over the Transfer of Proprietary Research Tools: Is This Market Failing or Emerging?’ in Rochelle Cooper Dreyfuss, Dianne Leenheer Zimmerman and Harry First (eds), Expanding the Boundaries of Intellectual Property: Innovation Policy for the Knowledge Society (2001).
[29] Rebecca S 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.
[30] Jensen and Murray, above n 8, 240. The authors estimate that 28 per cent of patents that include claims to human genes are owned by public sector organisations, including governments, schools, universities, research institutions and hospitals. See also Frederick M Scherer, ‘The Economics of Human Gene Patents’ (2002) 77 Academic Medicine 1348, 1357–8.
[31] See, eg, Eliot Marshall, ‘Intellectual Property: Companies Rush to Patent DNA’ (1997) 275 Science 780.
[32] Bernadine Healy, ‘Special Report on Gene Patenting’ (1992) 327 New England Journal of Medicine 664, 665.
[33] By 1992, such public discussions were already underway: a public meeting had been called by the Genome Patenting Working Group in the US, and the Patent and Trademark Office had given notice of public hearings and requested comments on patent protection for biotechnological inventions. See Genome Patenting Working Group, Committee on Life Sciences and Health, Federal Coordinating Council for Science, Engineering and Technology, Office of Science and Technology Policy, Federally Funded Genome Research: Science and Technology Transfer Issues: Proceedings of a Public Meeting, May 21, 1992 (1992).
[34] It should be noted that despite a tradition of allowing such claims in some jurisdictions, their legality is now questionable. See Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2005] 1 All ER 667 (‘Kirin-Amgen’). See below Part IV(D)(1).
[35] See, eg, Nuffield Council on Bioethics, The Ethics of Patenting DNA: A Discussion Paper (2002) 71 <http://www.nuffieldbioethics.org/fileLibrary/pdf/theethicsofpatentingdna.pdf>; Danish Council of Ethics, Patenting Human Genes and Stem Cells (2004) 101–2 <http://www.etiskraad.dk/graphics/03_udgivelser/engelske_publikationer/patenting_human_genes/patents04/patenting_human_genes.pdf>. For a detailed evaluation of the pros and cons of restricting gene patents to purpose-bound claims, see Sven J R Bostyn, Patenting DNA Sequences (Polynucleotides) and Scope of Protection in the European Union: An Evaluation (2004) 56–67 <http://www.ivir.nl/publications/bostyn/patentingdna.pdf>. On 26 October 2005, the European Parliament passed a resolution entitled Patents for Biotechnology Inventions, cl 5 of which calls on the European Patent Office to only grant patents in connection with concrete applications and to only allow purpose bound protection: <http://www.europarl.eu.int/omk/
sipade3?TYPE-DOC=TA&REF=P6-TA-2005-0407&MODE=SIP&L=ENLSTDOC=N>.
[36] Genetics Institute Inc v Kirin-Amgen Inc [No 3] (1998) 156 ALR 30, 38 (Heerey J) (‘Genetics Institute’).
[37] Kirin-Amgen [2005] 1 All ER 667, 676 (Lord Hoffmann).
[38] See below Part IV(B).
[39] The Nuffield Council identifies four distinct applications of DNA sequence claims: diagnostic testing, research tools or methods, gene therapy or methods, or the production of therapeutic proteins to be used as medicines: Nuffield Council on Bioethics, above n 35, 47–8.
[40] See especially Jorge A Goldstein and Elina Golod, ‘Human Gene Patents’ (2002) 77 Academic Medicine 1315, 1326–7; Arti K Rai, ‘Genome Patents: A Case Study in Patenting Research Tools’ (2002) 77 Academic Medicine 1368, 1369–70.
[41] Heller and Eisenberg, above n 28.
[42] See Rai, ‘Genome Patents’, above n 40, 1369–70, where she argues that there is, in fact, no bright line between broad research platforms and more downstream research tools.
[43] This is illustrated by empirical studies on the impact of gene patent enforcement on the provision of diagnostic services and diagnostic research in the US: see especially Mildred K Cho et al, ‘Effect of Patents and Licenses on the Provision of Clinical Genetic Testing Services’ (2003) 5 Journal of Molecular Diagnostics 3; Jon F Merz et al, ‘Diagnostic Testing Fails the Test’ (2002) 415 Nature 577.
[44] See Jordan Paradise, ‘European Opposition to Exclusive Control over Predictive Breast Cancer Testing and the Inherent Implications for US Patent Law and Public Policy: A Case Study of the Myriad Genetics’ BRCA Patent Controversy’ (2004) 59 Food and Drug Law Journal 133.
[45] Patent EP0699754 relating to BRCA1 was successfully opposed and was revoked on 11 November 2004, but is the subject of an appeal: European Patent Office, ‘Public Opposition Hearing on “Myriad/Breast Cancer” Patent at the European Patent Office (17–19 May)’ (Press Release, 13 May 2004) <http://www.european-patent-office.org/news/pressrel/2004_05_13_e.
htm>. The main claims in Patent EP0705902, also relating to BRCA1, were revoked on 12 September 2005, but this decision is also the subject of an appeal. The patent had originally claimed a number of mutations in the BRCA1 gene and diagnostic methods for determining a predisposition to breast cancer. The patent is now limited to a gene probe for detecting a specific mutation: European Patent Office, ‘European Patent on Mutations in Breast and Ovarian Cancer Susceptibility Gene Amended after Public Hearing’ (Press Release, 25 January 2005) <http://www.european-patent-office.org/news/pressrel/2005_01_25_e.htm>. However, opposition to patent EP0785216 relating to BRCA2 was unsuccessful and the patent was allowed to be maintained in its amended form. The patent now relates to use of a particular mutation in BRCA2 for diagnosing predisposition to breast cancer in Ashkenazi-Jewish women: European Patent Office, ‘Patent on “Breast Cancer Gene 2” Patent Maintained in Amended Form after Public Hearing’ (Press Release, 29 June 2005) <http://www.european-patent-office.org/news/
pressrel/2005_06_29_e.htm>.
[46] See Goldstein and Golod, above n 40, 1319.
[47] Genentech Inc v Chiron Corp, 112 F 3d 495, 501 (Rich J) (Fed Cir, 1997).
[48] Goldstein and Golod, above n 40, 1319.
[49] The distinction between the ‘bricks and mortar’ world of traditional patent law and the intangible world of the information economy is extensively discussed in Eisenberg, ‘How Can You Patent Genes?’, above n 26. See also Mark Sagoff et al, ‘Open Peer Commentary’ (2002) 2(3) American Journal of Bioethics 12.
[50] While other jurisdictions could have been considered, it was never intended that this article should be a comprehensive treatise on comparative patent law. Further, Australia, the US and the UK were chosen as these are the major marketplaces for the Australian biotechnology industry and are the sites of major gene patent battlefields.
[51] See, eg, Patents Act 1990 (Cth) s 18(1) and the definition of invention in sch 1.
[52] See, eg, ALRC, above n 5, [6.20]–[6.30].
[53] (1959) 102 CLR 252 (‘NRDC’).
[54] Ibid 253 (Dixon CJ, Kitto and Windeyer JJ).
[55] Patents Act, 35 USC §101 (1952).
[56] 447 US 303, 309 (1980) (‘Chakrabarty’).
[57] The UK, together with most other European states, is a signatory to the Convention on the Grant of European Patents, opened for signature 5 October 1973, 1065 UNTS 254 (entered into force 7 October 1977) (‘European Patent Convention’), which prescribes the requirements for the patent laws of all signatory states. Hence, European patent law is significantly more harmonised than most other states.
[58] See, eg, the English Court of Appeal decision in Genentech Inc’s Patent [1989] RPC 147, 194 (Purchas LJ) (‘Genentech’).
[59] Ibid.
[60] See, eg, Patents Act 1977 (UK) c 37, ss 1(3) (the art 27.2 exclusion where the French words ‘ordre public’ are replaced by the words ‘public policy’), 4(2) (the art 27.3(b) exclusion).
[61] See, eg, Bristol-Myers Squibb v F H Faulding & Co Ltd (2000) 97 FCR 524.
[62] Ibid. See also Rescare Ltd v Anaesthetic Supplies Pty Ltd (1992) 111 ALR 205; rev’d (1994) 50 FCR 1.
[63] Miranda Forsyth, ‘Biotechnology, Patents and Public Policy: A Proposal for Reform in Australia’ (2000) 11 Australian Intellectual Property Journal 202, 215–18.
[64] Patents Act 1990 (Cth) s 7(1), sch 1 (definitions of ‘prior art information’ and ‘prior art base’).
[65] Patents Act 1990 (Cth) ss 7(2), (3).
[66] Patents Act 1990 (Cth) s 18(1)(c).
[67] Rehm v Websters Security Systems (1988) 81 ALR 79, 96 (Gummow J); Rescare Ltd v Anaesthetic Supplies Pty Ltd (1992) 111 ALR 205, 231 (Gummow J).
[68] Brenner v Manson, 383 US 519 (1966). More recent developments on the law relating to utility are discussed below in Part IV(D).
[69] In Australia, see especially Populin v HB Nominees Pty Ltd (1982) 41 ALR 471; Flexible Steel Lacing Co v Beltreco Ltd (2000) 49 IPR 331. In the UK, see Catnic Components Ltd v Hill & Smith Ltd [1982] RPC 183; Kirin-Amgen [2005] 1 All ER 667.
[70] Graver Tank & Manufacturing Co Inc v Linde Air Products Co, 339 US 605 (1950). Problems with the US doctrine were highlighted in Festo Corp v Shoketsu Kinzoku Kogyo Kabushiki Co Ltd, 234 F 3d 558 (Fed Cir, 2000).
[71] Patents Act, 35 USC §112 (1952).
[72] Patents Act 1990 (Cth) s 40.
[73] Patents Act 1977 (UK) c 37, s 14.
[74] See, eg, Lane-Fox v Kensington & Knightsbridge Electric Lighting Co Ltd [1892] 3 Ch 424.
[75] In Australia, in Rank Hovis McDougall Ltd’s Application (1976) 46 AOJP 3915 the Assistant Commissioner of Patents granted a patent for a new strain of micro-organism that could be used in a process for the production of an edible protein. The process itself was patentable, however, a patent was refused for the original micro-organism because it was naturally occurring. See also IP Australia, Australian Patent Office Manual of Practice and Procedure (2005) vol 2 [8.2.2], [8.2.5.3], [8.2.14] <http://www.ipaustralia.gov.au/resources/manuals_patents2.shtml>.
[76] 447 US 303, 308 (1980).
[77] Ibid 309.
[78] Ibid 310.
[79] See, eg, Jeffrey L Ihnen, ‘Patenting Biotechnology: A Practical Approach’ (1985) 11 Rutgers Computer and Technology Law Journal 407, 409.
[80] This distinction is illustrated by a 1993 case in which an anonymous applicant unsuccessfully attempted to obtain a patent for a DNA sequence produced by normal cells. See the discussion of this case in Goldstein and Golod, above n 40, 1316.
[81] Chakrabarty was referred to with approval by the Australian High Court in Grain Pool of Western Australia v Commonwealth (2000) 202 CLR 479, 502 (Gleeson CJ, Gaudron, McHugh, Gummow, Hayne and Callinan JJ), 532 (Kirby J). See also Matthew Rimmer, ‘Franklin Barley: Patent Law and Plant Breeders’ Rights’ (2003) 10(4) E Law — Murdoch University Electronic Journal of Law [12] <http://www.murdoch.edu.au/elaw/issues/v10n4/rimmer104.html>.
[82] (1995) 33 IPR 557. The later court decision in the same case did not consider this issue: see Genetics Institute (1998) 156 ALR 30. For further discussion of this and other Patent Office decisions of similar vintage, see Charles Lawson and Catherine Pickering, ‘Patenting Genetic Materials — Failing to Reflect the Value of Variation in DNA, RNA and Amino Acids’ (2000) 11 Australian Intellectual Property Journal 69.
[83] IP Australia, Australian Patents for Biological Inventions (2005) 2 <http://www.ipaustralia.gov.
au/pdfs/patents/specific/biotech.pdf>.
[84] We will come back to this crucial point again shortly. See also Bostyn, above n 35, 12–16.
[85] The patent was held to be invalid by all three judges, but for different reasons. It appears that Mustill LJ was even somewhat reluctant to accept the proposition that methods embracing discoveries are patentable: [1989] RPC 147, 268–9.
[86] Kirin-Amgen [2005] 1 All ER 667.
[87] Ibid 691.
[88] Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of Biotechnological Inventions [1998] OJ L 213/13 (‘Biotechnology Directive’). See also Commission of the European Communities, Report of the Commission to the European Parliament and the Council: Development and Implications of Patent Law in the Field of Biotechnology and Genetic Engineering (2002) <http://www.europa.eu.int/eur-lex/en/com/rpt/2002/
com2002_0545en01.pdf>; Commission of the European Communities, Report of the Commission to the Council and the European Parliament: Development and Implications of Patent Law in the Field of Biotechnology and Genetic Engineering (2005) (‘European Commission Second Report’) <http://www.europa.eu.int/comm/internal_market/en/indprop/invent/com_2005_312fin
al_en.pdf>.
[89] (Emphasis added).
[90] Danish Council of Ethics, above n 35, 24. Cf Kingdom of the Netherlands v European Parliament and Council of the European Union (C-377/98) [2001] ECR I-7079, I-7106–9 (Advocate General Jacobs). See also Bostyn, above n 35, 40–4.
[91] It should be noted that although Kirin-Amgen was heard after the Biotechnology Directive was finalised, it was decided under old law.
[92] Kirin-Amgen [2005] 1 All ER 667, 692.
[93] See, eg, ALRC, above n 5, [7.81]. The ALRC concluded that it is better to regulate research activities directly than to address ethical and social concerns by excluding the subject matter, and further that the social and ethical concerns that are raised by the use or exploitation of patented inventions are better addressed by specific measures to facilitate use: at [7.84]–[7.88]. The Nuffield Council, while recommending that patents asserting rights over DNA sequences should be the ‘exception rather than the norm’, saw that the avenues for achieving this end were by discouraging the granting of certain patents and rigorously applying the patent criteria, rather than by exclusion: Nuffield Council on Bioethics, above n 35, xi–xii. Similarly, the Danish Council of Ethics recommended that it should not be possible to award broad gene patents but that, despite the special status of genes, it should continue to be possible to obtain gene patents in future: Danish Council of Ethics, above n 35, 100–1.
[94] Chakrabarty, 447 US 303, 316–17 (1980).
[95] (2000) 97 FCR 524, 559–60.
[96] There is some authority for this proposition. See, eg, Joos v Commissioner of Patents (1972) 126 CLR 611, 623, in which Barwick CJ held that if we were to have an exclusion for methods of medical treatment, it would be on ethical grounds, through general inconvenience. Forsyth, above n 63, 209–11 also makes a strong case for the introduction of public policy considerations using general inconvenience.
[97] Including, in the Australasian region, Japan, Hong Kong, Thailand, and the Philippines.
[98] [1995] EPOR 357.
[99] Ibid 369 (Examiners Kinkeldey, Galligani and Moser).
[100] [1995] EPOR 541.
[101] ALRC, above n 5, ch 21. Even in Europe, where such method patents are excluded, the exclusion is limited to methods performed on the human body, which would not exclude genetic testing carried out on bodily samples removed from the body: see Bostyn, above n 35, 77–9.
[102] See Bostyn, above n 35, 17–18, 44–6.
[103] Kirin Amgen [2005] 1 All ER 667, 694 (Lord Hoffmann).
[104] Ibid 676.
[105] Ibid 696.
[106] 991 F 2d 781, 1529 (Lourie J) (Fed Cir, 1993).
[107] 51 F 3d 1552 (Fed Cir, 1995).
[108] UK Patent Office, Examination Guidelines for Patent Applications relating to Biotechnological Inventions in the UK Patent Office (2005) 9–10 <http://www.patent.gov.uk/patent/reference/bio
techguide/biotech.pdf>.
[109] Genentech [1989] RPC 147, 235.
[110] For a review of the relevant case law, see UK Patent Office, above n 108, 9–10.
[111] Ibid 2–3.
[112] Ibid 7.
[113] (2002) 212 CLR 411, 429 (Gleeson CJ, Gaudron, Gummow and Hayne JJ).
[114] See, eg, Stephen A Merrill, Richard C Levin and Mark B Myers (eds), A Patent System for the 21st Century (2004) 92 <http://www.nap.edu/html/patentsystem/0309089107.pdf>.
[115] See, eg, Nuffield Council on Bioethics, above n 35, 30.
[116] Similarly, in the US, the National Research Council recommended that the USPTO and the Federal Circuit should abandon the so-called ‘per se’ rule announced in Re Bell and Re Deuel that prevents consideration of the technical difficulty faced in obtaining pre-existing gene sequences and consider the approach in other industrialised countries: Merrill, Levin and Myers, above n 114, 95.
[117] Utility Examination Guidelines, 66 Fed Reg 1092, 1095 (2001).
[118] See Bostyn, above n 35, 53–5.
[119] IP Australia, above n 83, 2.
[120] Intellectual Property and Competition Review Committee, Review of Intellectual Property Legislation under the Competition Principles Agreement (2000) 151–4.
[121] See ALRC, above n 5, Recommendation 6-3. Article 17(9)(13) of the Australia–US Free Trade Agreement also requires that both parties adopt this test. Whilst the Patent Office states that it already requires that this test be satisfied, there is little guidance as to how this achieved: ALRC, above n 5, 148.
[122] See, eg, John A Robertson, ‘Sequence Patents Are Not the Issue’ (2002) 2(3) American Journal of Bioethics 22.
[123] The Nuffield Council, for example, expresses concern that the ‘credibility’ test may be set too low if all that is required is ‘theoretical possibility’: Nuffield Council on Bioethics, above n 35, 31.
[124] Barton, ‘Changing Intellectual Property Issues in the Biotechnology Industry’, above n 11, 7.
[125] 421 F 3d 1365 (Fed Cir, 2005). As noted in the decision, the real party in interest is Monsanto Technology LLC, owned by the Monsanto Company.
[126] Ibid 1371 (Michel CJ).
[127] Ibid.
[128] Ibid.
[129] Ibid.
[130] Ibid 1373.
[131] Ibid.
[132] On the other hand, Rader J, in his minority judgment, saw no clear distinction between ESTs and microscopes, because both ‘supply information about molecular structure’ and both ‘advance research and bring scientists closer to unlocking the secrets of the corn genome to provide better food production for the hungry world’: ibid 1380.
[133] (1998) 156 ALR 30.
[134] [1997] RPC 1, 48–9, cited ibid 143–5.
[135] Kirin-Amgen [2005] 1 All ER 667, 688.
[136] Ibid 697–9.
[137] Support for this test is provided in Bostyn, above n 35, 31–5.
[138] 927 F 2d 1200 (Fed Cir, 1991) (‘Amgen’).
[139] Ibid 1206 (Lourie J).
[140] 119 F 3d 1559 (Fed Cir, 1997) (‘Eli Lilly’).
[141] Guidelines for Examination of Patent Applications under the 35 USC 112, ¶ 1, ‘Written Description’ Requirement, 66 Fed Reg 1099 (2001). Merrill, Levin and Myers, above n 114, 94, note that Eli Lilly could also have an impact on inventive step: ‘By narrowing the scope of some gene patents to the actual sequence disclosed it is possible that Eli Lilly might inherently prevent patents on some technologically obvious genes for which Bell would otherwise permit a patent.’ The passage goes on to say, however, that this is not an adequate solution to the problems associated with the current inventive step test in the US.
[142] Guidelines for Examination of Patent Applications under the 35 USC 112, ¶ 1, ‘Written Description’ Requirement, 66 Fed Reg 1099, 1106 (2001). See also Enzo Biochem Inc v Gen-Probe Inc, 296 F 3d 1316 (Fed Cir, 2002).
[143] 378 F 3d 1330 (Fed Cir, 2004).
[144] Ibid 1333 (Lourie J).
[145] See, eg, Luigi Palombi, ‘The Impact of TRIPS on the Validity of the European Biotechnology Directive’ (2005) 2 Journal of International Biotechnology Law 62.
[146] R Stephen Crespi, ‘Erythropoietin in the UK: A Setback for Gene Patents?’ (2005) 23 Nature Biotechnology 367.
[147] ALRC, above n 5, 13.
[148] On the importance of granting high quality patents, see Organisation for Economic Co-operation and Development, Patents and Innovation: Trends and Policy Challenges (2004) 28–9.
[149] However, it seems likely that this decision will be appealed, and it may be that the minority decision of Rader J is preferred.
[150] See above n 35.
[151] See Commission of the European Communities, European Commission Second Report, above n 88, 4.
[152] Ibid 5.
[153] Melanie J Howlett and Andrew F Christie, ‘An Analysis of the Approach of the European, Japanese and United States Patent Offices to Patenting Partial DNA Sequences (ESTs)’ (2003) 34 International Review of Industrial Property and Copyright 581, 601–2; Melanie J Howlett and Andrew F Christie, ‘An Analysis of the Approaches of the Trilateral and Australian Patent Offices to Patenting Partial DNA Sequences (ESTs)’ (2004) 15 Australian Intellectual Property Journal 156, 171–2.
[154] Jordan Paradise, Lori Andrews and Timothy Holbrook, ‘Patents on Human Genes: An Analysis of Scope and Claims’ (2005) 307 Science 1566, 1566–7. See also Merrill, Levin and Myers, above n 114, 47–9 for other examples.
[155] Paradise, Andrews and Holbrook, ‘Patents on Human Genes’, above n 154, 1566–7.
[156] Kate H Murashige, ‘Problems in Patenting Human Genes’ (2005) 308 Science 1868; Joseph J Rolla, ‘Problems in Patenting Human Genes’ (2005) 308 Science 1869. See also Jordan Paradise, Lori Andrews and Timothy Holbrook, ‘Response’ (2005) 308 Science 1869.
[157] Mark A Lemley, ‘Rational Ignorance at the Patent Office’ (2001) 95 Northwestern University Law Review 1495.
[158] Ibid 1531–2.
[159] See, eg, Arti K Rai, ‘Engaging Facts and Policy: A Multi-Institutional Approach to Patent System Reform’ (2003) 103 Columbia Law Review 1035, 1080–4.
[160] John P Walsh, Ashish Arora and Wesley M Cohen, ‘Effects of Research Tool Patenting and Licensing on Biomedical Innovation’ in Wesley M Cohen and Stephen A Merrill (eds), Patents in the Knowledge-Based Economy (2003) 285, 331. See also John P Walsh, Ashish Arora and Wesley M Cohen, ‘Working Through the Patent Problem’ (2003) 299 Science 1021; Joseph Straus, Henrik Holzapfel and Matthias Lindenmeir, Empirical Survey on ‘Genetic Inventions and Patent Law’ (2002); Dianne Nicol and Jane Nielsen, ‘Patents and Medical Biotechnology: An Empirical Analysis of Issues Facing the Australian Industry’ (Occasional Paper No 6, Centre for Law and Genetics, 2003) 57 <http://www.ipria.org/publications/pubfliers/BiotechReport
Final.pdf>; Dianne Nicol and Jane Nielsen, ‘Australian Medical Biotechnology: Navigating a Complex Patent Landscape’ [2005] European Intellectual Property Review 313, 316; Intellectual Property Institute on behalf of the Department of Trade and Industry, UK, Patents for Genetic Sequences: The Competitiveness of Current UK Law and Practice (2004) 65 <http://www.dti.
gov.uk/5397_DTi_Patent_Study.pdf>.
[161] Article 31 of TRIPS prescribes stringent limitations on the extent to which member states can provide for such rights in their patent legislation.
[162] Recommendations for reform of both the Crown use and the compulsory licensing provisions were made in ALRC, above n 5, chs 26, 27. See especially Recommendations 26-2, 26-3 and 27-1. However, there was no suggestion in the Report that there should be a major overhaul of these provisions.
[163] In Australia, there is no express exemption in the legislation, and no relevant case law. In the ALRC Report a recommendation was made for an express experimental use exemption: ibid Recommendation 13-1. The Advisory Council on Intellectual Property has also conducted a separate inquiry and made similar recommendations in its final report: Advisory Council on Intellectual Property, Patents and Experimental Use (2005). See also Matthew Rimmer, ‘The Freedom to Tinker: Patent Law and Experimental Use’ (2005) 15 Expert Opinion on Therapeutic Patents 167.
[164] The Wellcome Trust, Summary of Principles Agreed at the International Strategy Meeting on Human Genome Sequencing (1996) <http://www.gene.ucl.ac.uk/hugo/bermuda.htm>.
[165] See, eg, USPTO, Patent Pools: A Solution to the Problem of Access in Biotechnology Patents? (2000) 8–11 <http://www.uspto.gov/web/offices/pac/dapp/opla/patentpool.pdf>.
[166] See, eg, Gregory Graff and David Zilberman, ‘Towards an Intellectual Property Clearinghouse for Agricultural Biotechnology’ (2001) 3 Intellectual Property Strategy Today 1; Gregory Graff et al, ‘Intellectual Property Clearinghouse Mechanisms for Agriculture: Summary of an Industry, Academia, and International Development Round Table’ (2001) 3 Intellectual Property Strategy Today 15; Richard C Atkinson et al, ‘Public Sector Collaboration for Agricultural IP Management’ (2003) 301 Science 174, 175.
[167] See, eg, Janet Hope, Open Source Biotechnology (PhD Thesis, The Australian National University, 2005) <http://opensource.mit.edu/papers/hope.pdf>; Yochai Benkler, ‘Commons-Based Strategies and the Problems of Patents’ (2004) 305 Science 1110, 1111; Sara Boettiger and Dan L Burk, ‘Open Source Patenting’ (2004) 1 Journal of International Biotechnology Law 221.
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<h1 class="ep_tm_pagetitle">On the Legality of Gene Patents</h1>
<p style="margin-bottom: 1em" class="not_ep_block"><span class="person_name">Nicol, Dianne</span> (2005) <xhtml:em>On the Legality of Gene Patents.</xhtml:em> Melbourne University Law Review, 29 (3). pp. 809-842. ISSN 0025-8938</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 onmouseover="EPJS_ShowPreview( event, 'doc_preview_3357' );" href="http://eprints.utas.edu.au/2551/1/Nicol.pdf" onmouseout="EPJS_HidePreview( event, 'doc_preview_3357' );"><img alt="[img]" src="http://eprints.utas.edu.au/style/images/fileicons/application_pdf.png" class="ep_doc_icon" border="0" /></a><div class="ep_preview" id="doc_preview_3357"><table><tr><td><img alt="" src="http://eprints.utas.edu.au/2551/thumbnails/1/preview.png" class="ep_preview_image" border="0" /><div class="ep_preview_title">Preview</div></td></tr></table></div></td><td valign="top"><a href="http://eprints.utas.edu.au/2551/1/Nicol.pdf"><span class="ep_document_citation">PDF</span></a> - Requires a PDF viewer<br />255Kb</td></tr></table><p style="margin-bottom: 1em" class="not_ep_block">Official URL: <a href="http://www.austlii.edu.au/au/journals/MULR/2005/25.html">http://www.austlii.edu.au/au/journals/MULR/2005/25.html</a></p><div class="not_ep_block"><h2>Abstract</h2><p style="padding-bottom: 16px; text-align: left; margin: 1em auto 0em auto">This article considers the legal and policy deliberations on gene patenting that have occurred since the issue came to the fore in the early 1990s. The analysis is contextualised with brief overviews of the science of genetics and genomics and the law of patents. Legislation, administrative guidelines and case law are analysed, focusing on the jurisdictions of Australia, the US and the UK. This article concludes that, despite ongoing legal and policy developments, clear guidance as to the legality of gene patents remains elusive. It is obviously desirable to have proper and certain gene patenting laws. In time, this is likely to happen. In the interim, it is argued that other mechanisms are also available for dealing with gene patents, negating the desirability of a radical overhaul of gene patenting laws.</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">Article</td></tr><tr><th valign="top" class="ep_row">Additional Information:</th><td valign="top" class="ep_row">http://mulr.law.unimelb.edu.au/</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">2551</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">11 Dec 2007 23:38</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=2551;">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=2551">item control page</a></p>
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