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Rimmer, Matthew --- "The New Conquistadors: Patent Law and Expressed Sequence Tags" [2005] JlLawInfoSci 2; (2005) 16 Journal of Law, Information and Science 10

[∗] Matthew Rimmer, BA (Hons)/ LLB (Hons) (ANU), PhD (UNSW), is an associate director of the Australian Centre for Intellectual Property in Agriculture (ACIPA), and a senior lecturer and the director of higher degree research at the Australian National University College of Law. He is a chief investigator in the ARC Discovery Project, ‘Gene Patents In Australia: Options For Reform’. The author is grateful for the comments and the feedback from the peer reviewers.

[1] Stacy Lawrence, ‘US Court Case to Define EST Patentability’ (2005), Nature Biotechnology, <http://www.nature.com/news/2005/050502/ full/nbt0505-513.html> at 1 May 2007.

[2] ‘An EST is a short nucleotide sequence that represents a fragment of a cDNA clone. It is typically generated by isolating a cDNA clone and sequencing a small number of nucleotides located at the end of one of the two cDNA strands. When an EST is introduced into a sample containing a mixture of DNA, the EST may hybridize with a portion of DNA. Such binding shows that the gene corresponding to the EST was being expressed at the time of mRNA extraction.’ Michel CJ, In re Fisher [2005] USCAFED 189; 421 F.3d 1365 at 1367 (C.A.Fed.,2005).

[3] Human Genome Organisation Intellectual Property Committee, Statement on Patenting Issues Related to the Early Release of Sequence Data (1997), <http://www.hugointernational.org/PDFs/Statement%20on% 20Patenting%20Issues%20Relating%20to%20Raw%20Sequence%20Dat.pdf> at 1 May 2007.

[4] Human Genome Organisation Intellectual Property Committee, Statement on Patenting DNA Sequences In Particular Response to the European Biotechnology Directive (2000): <http://www.hugo international.org/PDFs/Statement%20on%20Patenting%20of%20DNA%20Sequences%202000.pdf> at 1 May 2007.

[5] Ibid.

[6] Nuffield Council on Bioethics, The Ethics of Patenting DNA, A Discussion/Paper: (2002), <http://www.nuffieldbioethics.org/go/ ourwork/patentingdna/publication_310.html> at 1 May 2007 at 58.

[7] Australian Law Reform Commission, Gene Patenting and Human Health, Issue Paper 27. (2003): (2003),. <http://www.austlii.edu.au/au/other/ alrc/publications/issues/27/> at 1 May 2007 at 136.

[8] Howlett, Melanie and Andrew 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 581-602.

[9] Ibid.

[10] In re Fisher [2005] USCAFED 189; 421 F.3d 1365 (C.A.Fed., 2005).

[11] Ex parte Fisher 72 U.S.P.Q.2d 1020, 2004 WL 2185929 (United States Patent and Trademark Office Board of Patent Appeals and Interferences), http://patentlaw.typepad.com/patent/Ex_20Parte_20Fisher.pdf

[12] In re Fisher [2005] USCAFED 189; 421 F.3d 1365 (C.A.Fed., 2005).

[13] Ex Parte Raymond H. Boutin 2006 WL 2822238, *4+ (Bd.Pat.App & Interf. Sep 28, 2006) (NO. APL 2006-1879, APP 10/010,114); Ex Parte Preeti Lal, Neil Corley et. al 2006 WL 2710996, *3+ (Bd.Pat.App & Interf. Sep 18, 2006) (NO. APL 2006-1035, APP 09/925,140); Ex Parte d. Wade Walke 2006 WL 2711006, *2+ (Bd.Pat.App & Interf. Sep 18, 2006) (NO. APL 2006-2131, APP 10/309,422); Ex Parte Preeti Lal, Jennifer Hillman, et al., 2006 WL 1665364, *3+ (Bd.Pat.App & Interf. Jan 01, 2006) (NO. APL 2005-0102, APP 09/840,787); Ex Parte Gary C. Starling, 2006 WL 1665405, *2+ (Bd.Pat.App & Interf. Jan 01, 2006) (NO. APL 2005-2121, APP 09/745,605).

[14] KSR International Co. v Teleflex, Inc. 2007 WL 1237837, 82 U.S.P.Q.2d 1385 (2007).

[15] J. Craig Venter, ‘The Human Genome Project’, Congressional Testimony Before the Subcommittee on Energy and Environment, United States House of Representatives Committee on Science’, (1998), 17 June.

[16] Edmund Andrews, ‘Making a Difference; Dr. Healy's Big Push on Patents’, The New York Times (New York), 16 February 1992 at 12.

[17] Ibid.

[18] Bernadine Healy, ‘On Patenting Genes’ (1992) 327 (9) New England Journal of Medicine 664-668 at 665.

[19] Ibid at 667.

[20] Ibid at 667.

[21] Ibid at 667.

[22] Ibid at 668.

[23] Kevin Davies, The Sequence: Inside The Race For The Human Genome (2001) at 62.

[24] Ibid.

[25] Leslie Roberts, ‘Genome Patent Fight Erupts: An NIH Plan to Patent Thousands of Random DNA Sequences Will Discourage Industrial Investment and Undercut the Genome Project Itself, the Plan's Critics Charge’ (1991) 254 (5029) Science 184.

[26] Ibid.

[27] Watson, James with Andrew Barry (2004), DNA: The Secret of Life, 180.

[28] Leslie Roberts, ‘Why Watson Quit As Project Head’ (1992) 256 Science 301-302.

[29] Robert Cook-Deegan, The Gene Wars: Science, Politics And The Human Genome (1994) at 333-340; Kevin Davies, The Sequence: Inside The Race For The Human Genome (2001) at 30-31; Glyn Moody, Digital Code of Life: How Bioinformatics is Revolutionizing Science, Medicine, and Business (2004) at 50-51; and James Shreeve, The Genome War: How Craig Venter Tried to Capture the Code of Life and Save the World (2004) at 80-85.

[30] Diamond v Chakrabarty [1980] USSC 119; 447 US 303 (1980).

[31] Rebecca Eisenberg, ‘Genes, Patents, and Product Development’ (1992) 257 (5072) Science 903.

[32] Ibid.

[33] Ibid.

[34] Kevin Davies, above n 29 at 63.

[35] Scott Veggeberg, ‘HHS Secretary Sullivan to Determine if NIH Gene Patent Quest is Over’, (1992) 6 (21) The Scientist at 3.

[36] Ibid.

[37] Healy was later to become the director of the Red Cross. She resigned amidst controversy over the handling of donations in the wake of the September 11 attack on the World Trade Centre.

[38] Harold Varmus, Chapter 6 of Intellectual Property Rights and Research Tools in Molecular Biology, in National Research Council, Summary of a Workshop Held at the National Academy of Sciences (1996), <http://www.nap.edu/ readingroom/books/property/6.html> at 1 May 2007.

[39] Ibid.

[40] Robin McKie, ‘I’m the Human Genome, Says ‘Darth Venter’ of Genetics’, The Guardian (London), 28 April 2002 at 28.

[41] Glyn, Moody, Digital Code of Life: How Bioinformatics is Revolutionizing Science, Medicine, and Business (2004) at 58.

[42] Brenner v Manson[1966] USSC 48; , 383 US 519 (1966).

[43] Ibid at 534.

[44] Ibid.

[45] Ibid.

[46] Ibid at 536.

[47] Ibid.

[48] United States Patent and Trademark Office, ‘Utility Examination Guidelines’, (2001) 66 Federal Register 1092: http://www.uspto.gov/ web/offices/com/sol/notices/utilexmguide.pdf at 1 May 2007.

[49] Todd Dickinson, ‘Statement of Todd Dickinson Before the Subcommittee on Courts and Intellectual Property of the House Committee on the Judiciary’, 13 July 2000, http://www.house.gov/judiciary/dick0713.htm at 1 May 2007.

[50] Ibid.

[51] Ibid.

[52] Ibid.

[53] Ibid.

[54] United States Patent and Trademark Office, ‘Public Comments on the United States Patent and Trademark Office Revised Interim Utility Examination Guidelines’ (2000) 65 Federal Register 3425, http://www.uspto.gov/web/offices/com/sol/comments/utilguide/index.html at 1 May 2007.

[55] United States Patent and Trademark Office, 'Revised Interim Utility Examination Guidelines' (1999) 64 (244) Federal Register, http://www.uspto.gov/web/offices/com/sol/notices/utilexmguide.pdf at 1 May 2007.

[56] Ibid.

[57] Ibid.

[58] Ibid.

[59] Ibid.

[60] Julie Grisham, ‘New Rules for Gene Patents’ (2000) 18 Nature Biotechnology 921; Joshua Benson, ‘Resuscitating the Patent Utility Requirement, Again: A Return to Brenner v Manson’, (2002) 36 University of California Davis Law Review 267-295; Mary Breen Smith, ‘An End to Gene Patents? The Human Genome Project Versus the United States Patent and Trademark Office’s 1999 Utility Guidelines’ (2002) 73 University of Colorado Law Review 747-785; Tanya Wei, ‘Patenting Genomic Technology — 2001 Utility Examination Guidelines: An Incomplete Remedy in Need of Prompt Reform’ (2003) 44 Santa Clara Law Review 307-333; Cynthia Lopez-Beverage, ‘Should Congress Do Something About Upstream Clogging Caused By The Deficient Utility of Expressed Sequence Tag Patents?’ (2005) 10 Journal of Technology Law and Policy 35-92; and Sean Pippen, ‘Dollars and Lives: Finding Balance in the Patent ‘Gene Utility’ Doctrine’ (2006) 12 Boston Journal of Science and Technology Law 193-226.

[61] Eliot Marshal, Elizabeth Pennisi, and Leslie Roberts (2000), ‘In the Crossfire: Collins on Genomes, Patents, and ‘Rivalry”’ (2000) 287 (5462) Science 2396-2398.

[62] Ibid.

[63] Harold Varmus, (2000), ‘Testimony for Hearing on Gene Patents and Other Genomic Inventions’, House of Representatives Subcommittee on Courts and/Intellectual/Property,/13/July/2000, <http://judiciary.house.gov/Legacy/varm0713.htm> at 1 May 2007.

[64] Ibid.

[65] Nuffield Council on Bioethics, The Ethics of Patenting DNA, A Discussion Paper (2002): http://www.nuffieldbioethics.org/go/ourwork/patenting dna/publication_310.html at 1 May 2007 at 45.

[66] Ibid at 60.

[67] Andrea Ryan, ‘Testimony for Hearing on Gene Patents and Other Genomic Inventions’, House of Representatives Subcommittee on Courts and Intellectual Property, 7 July 2000, <http://www.aipla.org/Content/ContentGroups/Legislative_Action/106th_Congress/Testimony4/Statement_at_Oversight_Hearing_on_Gene_Patents_and_other_Genomic_Inventions,_by_M_Andrea_Ryan,_July_.htm> , at 1 May 2007.

[68] Ibid.

[69] Charles Ludlam, ‘Biotechnology Industry Organization Comment on Interim Utility and Written Description Guidelines’, 22 March 2000, <http://www.uspto.gov/web/offices/com/sol/comments/utilitywd/bio.pdf> at 1 May 2007.

[70] Ibid.

[71] Randal Scott, ‘Testimony for Hearing on Gene Patents and Other Genomic Inventions’, House of Representatives Subcommittee on Courts and Intellectual Property, 7 July 2000, <http://judiciary.house.gov/Legacy/ scot0713.htm> at 1 May 2007.

[72] Ibid.

[73] Ibid.

[74] Victoria Slind Flor, 'Both Sides Now: MoFo IP Partners Kate Murashige and Gerald Dodson Diverge on the PTO's New Guidelines for Biotech Patents', (2001) IP Worldwide, 14 June.

[75] Ibid.

[76] Ibid.

[77] Ibid.

[78] Dane Fisher, and Raghunath Lalgudi, ‘Nucleic Acid Molecules and Other Molecules Associated with Plants’ (2001), US Patent Application Serial No.: 09/619,643.

[79] Ibid.

[80] As cited in In re Fisher [2005] USCAFED 189; 421 F.3d 1365 at 1374 (C.A.Fed., 2005).

[81] Monsanto elaborates upon such uses in its briefs. Monsanto Inc., ‘Corrected Brief for Appellants Dane K. Fisher and Raghunath V. Lalgudi’, 2004 WL 4996614, 27 September 2004, 12-20.

[82] As reported in Ex parte Fisher above n 11.

[83] Ibid.

[84] Ibid.

[85] Above n 81.

[86] Ibid.

[87] In re Kovalic, No. 05-1007; In re Lalgudi, No. 05-1010; In re Byrum, No. 1011; In re Anderson, No. 1012; In re Adab, No. 05-1013; and In re Boukharov, No. 05-1014.

[88] Stacy Lawrence, ‘US Court Case to Define EST Patentability’ (2005), Nature Biotechnology, <http://www.nature.com/news/2005/050502/full/nbt0505 -513.html> at 1 May 2007.

[89] Above n 81.

[90] Ibid at 24-25.

[91] Ibid at 25.

[92] Ibid.

[93] Ibid at 33.

[94] Ibid.

[95] For a history of the microscope in the golden age of scientific discovery, see Lisa Jardine, Ingenious Pursuits: Building the Scientific Revolution (1999).

[96] Above n 81.

[97] Ibid at 40.

[98] Ibid.

[99] Ibid at 41.

[100] Ibid.

[101] Ibid at 42.

[102] Ibid.

[103] United States Patent and Trademark Office, ‘Brief and Addendum for Appellee, Director of the United States Patent and Trademark Office In re Fisher’, 7 December 2004 at 13.

[104] Ibid at 46.

[105] Ibid at 26-27.

[106] Ibid at 26-27.

[107] Ibid.

[108] Ibid.

[109] Ibid at 14.

[110] Ibid.

[111]> Ibid.

[112] Ibid at 44.

[113] Ibid at 45.

[114] Ibid.

[115] Ibid.

[116] Robert Cook-Deegan, above n 29, at 316-317; and see also Kevin Davies, above n 29.

[117] Robert Cook-Deegan, above n 29 at 321.

[118] Arthur Levinson, 'Genentech CEO Says Amgen/TKT Trial Outcome Not A Bellwether For Biotech - Broader Issue of Gene Patents Addressed at Congressional Hearings This Week', Genentech Press Release, San Francisco And South San Francisco, California, (Press Release, 13 July 2000), <http://www.gene.com/gene/news/detail. jsp?detail=4624 & pNo =9> at 1 May 2007.

[119] Dennis Henner, 'Statement of the Genentech Senior Vice President of Research', United States Judiciary Subcommittee on Courts And Intellectual Property, 13 July 2000, <http://www.bio.org/laws/ comments071200. html> at 1 May 2007.

[120] Ibid.

[121] Genentech Inc, ‘Submission on the Revised Interim Guidelines Concerning the Revised Written Description Requirement and the Revised Utility Examination Guidelines’, 22 March 2000, <http://www.uspto.gov/web/offices/com/sol/comments/utilitywd/genentech.pdf> at 1 May 2007.

[122] Lawrence Kass, and Michael Nitabach, 'A Roadmap For Biotechnology Patents? Federal Circuit Precedent And The PTO's New Examination Guidelines' (2002) 30 (2) AIPLA Quarterly Journal 233; and Mary Breen Smith, ‘An End to Gene Patents? The Human Genome Project Versus the United States Patent and Trademark Office’s 1999 Utility Guidelines’ (2002) 73 University of Colorado Law Review 747-785.

[123] Genentech Inc., ‘Brief of Genentech Inc. as Amicus Curiae Supporting Affirmance and Supporting the United States Patent and Trademark Office In re Fisher’, 15 December 2004 at 1.

[124] Ibid at 7.

[125] Ibid at 15.

[126] Ibid at 21.

[127] Ibid at 22.

[128] Ibid.

[129] Affymetrix Inc., ‘Brief for Amicus Curiae Affymetrix, Inc. in Support of Appellee In re Fisher’, 2004 WL 4996615, 14 December 2004.

[130] Ibid at 2.

[131] Ibid at 8-9.

[132] Ibid at 9.

[133] Ibid at 13.

[134] Ibid at 12-13.

[135] Ibid.

[136] Ibid at 2.

[137] Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc.

126 S.Ct. 2921 (2006).

[138] Eli Lilly et al., ‘Brief for Amici Curiae Eli Lilly and Company, Association of American Medical Colleges, Baxter Healthcare Corporation, National Academy of Sciences Dow AgroSciences LLC, and American College of Medical Genetics in Support of the United States Patent and Trademark Office in Support of Affirmance In re Fisher’ 2004 WL 4996616, 14 December 2004.

[139] Ibid at 1.

[140] Ibid at 2.

[141] Ibid at 7.

[142] Ibid.

[143] Ibid at 4-5.

[144] Stephen Breyer (2000) ‘Genetic Advances and Legal Institutions’ (2000) 28 Journal of Law, Medicine, and Ethics 23-28.

[145] Eli Lilly et al., above n 138 at 6.

[146] Ibid at 9-10.

[147] Ibid at 18-19.

[148] Ibid at 20-21.

[149] Ibid at 3.

[150] Ibid at 29.

[151] Ibid at 3.

[152] Kenneth Dam, ‘The Economic Underpinnings of Patent Law’ (1994) 23 Journal of Legal Studies 247 at 270.

[153] Peter Drahos and John Braithwaite, Information Feudalism (2002) at 162.

[154] Rebecca Eisenberg, ‘Biotech Patents: Looking Backward While Moving Forward’, (2006) 24 (3) Nature Biotechnology at 317-319.

[155] Janice Mueller (2004), 'The Evanescent Experimental Use Exemption from U.S. Patent Infringement Liability: Implications for University/Nonprofit Research and Development,' (2004) 56 Baylor Law Review 918-980 at 963.

[156] Madey v Duke University[2002] USCAFED 222; , 307 F.3d 1351 (2002); and Integra Lifesciences Ltd v Merck KgaA[2003] USCAFED 118; , 331 F. 3d 860 (2003).

[157] For instance, Scalia J in Merck KGaA v Integra Lifesciences I, Ltd. 545 U.S. 193 (2005); and Breyer J in Laboratory Corp. of America Holdings v Metabolite Laboratories, Inc. 126 S.Ct. 2921 (2006).

[158] For a theoretical discussion of the use of metaphor in the biological sciences, see Evelyn Fox Keller, Refiguring Life: Metaphors of Twentieth-Century Biology (1995); Evelyn Fox Keller, The Century of the Gene (2000); and Evelyn Fox Keller, Making Sense of Life: Explaining Biological Development with Models, Metaphors, and Machines (2002).

[159] In re Fisher, Fed. Cir., No. 04-1465, 5/3/05 oral argument.

[160] Ibid.

[161] In re Fisher [2005] USCAFED 189; 421 F.3d 1365 at 1374 (C.A.Fed., 2005).

[162] Brenner v Manson[1966] USSC 48; , 383 US 519 (1966).

[163] In re Fisher [2005] USCAFED 189; 421 F.3d 1365 at 1374 (C.A.Fed.,2005).

[164] Ibid at 1373

[165] Ibid at 1374.

[166] Ibid at 1373

[167] Ibid at 1377-1378.

[168] Ibid at 1378.

[169] Ibid at 1379.

[170] Ibid at 1379.

[171] In re Kirk 54 C.C.P.A. 1119, 376 F.2d 936 (1967).

[172] In re Fisher [2005] USCAFED 189; 421 F.3d 1365 at 1380 (C.A.Fed.,2005).

[173] Ibid at 1380.

[174] Ibid at 1380-81.

[175] Ibid at 1380.

[176] Ibid.

[177] Ibid.

[178] Ibid.

[179] Ibid at 1381.

[180] Ibid.

[181] Ibid.

[182] Ibid.

[183] E. Richard Gold, and Karen Durell, ‘Innovating the Skilled Reader: Tailoring Patents to New Technologies’ (2005) 19 (1) Intellectual Property Journal 189-226.

[184] Yann Joly, ‘Wind of Change: In re Fisher and the Evolution of American Biotechnology Patent Law‘, in Matthew Rimmer (ed). Patent Law and Biological Inventions (2006) 24 (1) Law in Context 67-84 at 80.

[185] Dianne Nicol, ‘On the Legality of Gene Patents’ (2005) 29 (3) The University of Melbourne Law Review 809-841 at 835.

[186] Paula Davis, James Kelly, Steven Caltrider, and Stephen Heinig, ‘ESTs Stumble at the Utility Threshold’ (2005) 23 Nature Biotechnology 1227-1229.

[187] Jim Brogan, ‘Federal Court Rules Gene Fragments Not Patentable’ (2005) Cooley Alert, <http://www.cooley.com/files/tbl_s24News %5CPDFUpload152%5C1646%5CALERT_GeneFragPatents.pdf> at 1 May 2007.

[188] Ex Parte Raymond H. Boutin 2006 WL 2822238, *4+ (Bd.Pat.App & Interf. Sep 28, 2006) (NO. APL 2006-1879, APP 10/010,114)

[189] Ibid at 6.

[190] Ex Parte Preeti Lal, Neil Corley et. al 2006 WL 2710996, *3+ (Bd.Pat.App & Interf. Sep 18, 2006) (NO. APL 2006-1035, APP 09/925,140).

[191] Ibid at 4.

[192] Ibid at 5.

[193] Ex Parte d. Wade Walke 2006 WL 2711006, *2+ (Bd.Pat.App & Interf. Sep 18, 2006) (NO. APL 2006-2131, APP 10/309,422).

[194] Ibid at 5.

[195] Ibid at 6.

[196] Ibid.

[197] Ibid.

[198] Ex Parte Preeti Lal, Jennifer Hillman, et al., 2006 WL 1665364, *3+ (Bd.Pat.App & Interf. Jan 01, 2006) (NO. APL 2005-0102, APP 09/840,787).

[199] Ibid.

[200] Ex Parte Gary C. Starling, 2006 WL 1665405, *2+ (Bd.Pat.App & Interf. Jan 01, 2006) (NO. APL 2005-2121, APP 09/745,605).

[201] Ibid.

[202] David Resnik, ‘Comments on the United States Patent and Trademark Office Utility Guidelines’, 16 March 2000: <http://www.uspto.gov/web/ offices/com/sol/comments/utilguide/dresnick.pdf> at 1 May 2007.

[203] The matter concerns the validity of Steven Engelgau, ‘Adjustable Pedal Assembly With Electronic Throttle Control’ (2000), US Patent No. 6,237,565 B1. At issue is claim 4, which comprises (i) a pre-existing ‘adjustable pedal assembly,’ combined with (ii) a pre-existing ‘electronic control.’ The Supreme Court of the United States is considering whether the Federal Circuit has erred in holding that a claimed invention cannot be held ‘obvious’, and thus unpatentable under 35 U.S.C. § 103(a), in the absence of some proven 'teaching, suggestion, or motivation' that would have led a person of ordinary skill in the art to combine the relevant prior art teachings in the manner claimed.’ KSR International Co. v Teleflex, Inc. 2007 WL 1237837, 82 U.S.P.Q.2d 1385 (2007).

[204] KSR International Co. v Teleflex, Inc. 2007 WL 1237837, 82 U.S.P.Q.2d 1385 (2007) at 19.

[205] Ibid at 14.

[206] Ibid.

[207] Ibid.

[208] Ibid.

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