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Imagined Nature: Narratives and Metaphors in the Co-Production of Biotech Patentable Inventions

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Imagined Nature: Narratives and Metaphors in the Co-Production of Biotech Patentable Inventions Imagined Nature: Narratives and Metaphors in the Co-Production of Biotech Patentable Inventions By Emanuela Gambini A Thesis Submitted for the Degree of Doctor of Philosophy Queen Mary, University of London July 2018 1 Statement of Originality I, Emanuela Gambini, confirm that the research included within this thesis is my own work or that where it has been carried out in collaboration with, or supported by others, that this is duly acknowledged below and my contribution indicated. I attest that I have exercised reasonable care to ensure that the work is original and does not to the best of my knowledge break any UK law, infringe any third party’s copyright or other intellectual property right, or contain any confidential material. I accept that the College has the right to use plagiarism detection software to check the electronic version of the thesis. I confirm that this thesis has not been previously submitted for the award of a degree by this or any other university. The copyright of this thesis rests with the author and no quotation from it or information derived from it may be published without the prior written consent of the author. Signature: Emanuela Gambini Date: 2 July 2018 2 Abstract Since the 1970s, modern biotechnology and its innovative products have been central to the development of what is considered to fall within the scope of patent eligible subject matter. In major patent systems, an interpretation of the definition of patentable invention has evolved to allow matter qualifying as patent eligible to include techno-scientific products and processes that could not have been envisaged when patent systems were first established. However, modern biotechnology and its bio-artifacts have proved challenging, as they have increasingly raised social opposition and ethical concerns from non-governmental organisations and civil society. Biotech patent claims on genetically modified organisms, DNA sequences and genes, isolated human biological materials and human embryonic stem cells have questioned more radically than other technological claims the meaning of nature and artifact, subject and object, discovery and invention. In the United States, Canada and under the European Patent Convention (EPC), several landmark biotech patent cases involving these kinds of inventions have settled the patent eligibility of these products. In these cases, judges, parties, patent officers and amici curiae have drawn on a rich repertoire of metaphors that, by defining the “nature” and ontology of the claimed invention, sustained or rejected the allocation of intellectual property rights over it. This thesis addresses whether and how metaphors and the analogies they entail have been resorted to in judicial decisions and the administrative discourse of patent offices (practices and guidelines) to expand and limit the scope of patentable subject matter. Moreover, the thesis is engaged in explaining the discrepancies that marked the development of what is a patentable invention in these three jurisdictions. The main hypothesis of the thesis is that the use of the metaphors of the machine, molecule and code has proved pivotal in expanding the scope and stabilizing the meaning of patent eligible matter. These metaphors have been endorsed in technoscientific domains of research and they could be deemed what Ruse has called “root metaphors”, metaphors that were pivotal in orienting the study of the phenomena of life. All these metaphors, as this work illustrates, imply an atomistic and reductionist view of the living organisms, which has largely sustained their patent eligibility. Drawing on the insights offered by cognitive linguistics, the thesis explains that, by prompting analogies, metaphors define the “is” and the “ought” of a concept. Their analysis, therefore, enables an account of how descriptive and normative issues have been entangled in sustaining and settling the meaning of molecular biotech products, so that the metaphorical definition of the nature of the invention conveyed or not its patent eligibility. The thesis argues and shows, furthermore, that the judicial and administrative narratives in which these metaphors have been employed have been likewise influential and backed particular sociotechnical imaginaries of life and nature, which have been pivotal in defining what is natural and artificial and in framing individual and collective identities in molecular terms. This work relies, in particular, on Science and Technology Studies’ framework centered on concept of co-production, namely the insight that the natural and social orders are produced together. According to this framework, the is and ought of the world are continuously established, through the authoritative discourses of science and law, which define what is a claimed invention within a technological field and how it should be governed. The co-productionist framework is fundamental to pinpoint and understand the relevant nexus that narrative analysis should address and explain in the thesis (which has been articulated by Calvert and Joly): the relationship between making knowledge – the creation of ontologies – and the production of intellectual property. 3 Acknowledgements I am very grateful to my first supervisor, Professor Duncan Matthews, for the generous time he devoted to examining and discussing this thesis with me and, moreover, for the kind and patient support I received from him throughout these years. I would like to thank my second supervisor, Professor Peter Drahos, for all the fruitful suggestions and conversations I had with him about this work. I am grateful to the Centre for Commercial Law Studies and Queen Mary University for awarding me a Herchel Smith and CCLS Scholarships during 2014-2018. I would also like to thank Sheila Jasanoff and Mariachiara Tallachini for introducing me to STS and fostering my interest in this theoretical approach. I would also like to thank Malcolm Langley who gave me invaluable help in my research. I am grateful to Stylios, Paraskevi, Giusi, Pinar, Qiyao, Tina and Eda for their friendship. I express my infinite gratitude to my husband Tony and my family, who sustained my efforts during these years with love. This is for you. 4 Table of Cases EPO G-2/06 Use of Embryos/WARF, [2009] OJ EPO 169-180 G1/98 Transgenic Plant/Novartis II, [2000] OJ EPO 111-141 G-2/07 Broccoli/PLANT BIOSCIENCE, 9 December 2010 G-1/08 Tomatoes/STATE OF ISRAEL, 9 December 2010 T-19/90 Onco-mouse/Harvard, [1990] OJ EPO 476-491 T-356/93 Plant cells/PLANT GENETIC SYSTEMS, [1995] OJ EPO 545-585 T-272/95 Relaxin/HOWARD FLOREY INSTITUTE, 23 October 2002 T-1054/96 (I) Transgenic Plant/NOVARTIS, [1998] OJ EPO 511-553 T-315/03 Transgenic animals/HARVARD, [2006] OJ EPO 15-82 T-1474/04 (I) Stem cells/WARF, [2007] OJ EPO 313-343 T-80/05 Method of diagnosis/UNIVERSITY OF UTAH, 19 November 2008 T-83/05 (I) Broccoli/PLANT BIOSCIENCE, [2007] OJ EPO 644-669 T-666/05 Mutation/UNIVERSITY OF UTAH, 13 November 2008 T-1213/05 Breast and ovarian cancer/UNIVERSITY OF UTAH, 27 September 2007 T-1242/06 (I) Tomatoes/STATE OF ISRAEL, [2008] OJ EPO 523-540 T-1242/06(12) Tomatoes II/STATE OF ISRAEL, 31 May 2012 USA American Fruit Growers Inc, v. Brogdex Co, 2 March 1931, 283 U.S. 1 (1931) Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200 (Fed.Cir. 1991). AMP, et al, v. Myriad Genetics, et al., 133 S.Ct. 2107 (2013) AMP, et al, v. Myriad, et al., F.3d 1329 (Fed. Cir. 2011), 1351 AMP, et al., v. United States Patent and Trademark Office, et al., U.S. District Court, S.D. New York, 702 F.Supp.2d 181 (S.D.N.Y.) 195 (2010) Animal Legal Defense Fund v. Quigg, 9 USPQ2d 1816 (1989) Berkey v. Third Ave. Ry. Co. 155 North Eastern Reporter 58, 61 (244 N.Y. 84) Daniel Greenberg, et al. v. Miami Children Hospital Research Institute, Inc., et al., U.S. District Court, S.D. Florida, 264 Fed. Suppl. 2d Series 1064 (2003) Diamond v. Chakrabarty 447 U.S. 303 (1980) 206 USPQ 193 Ex parte Allen, 2 USPQ2d 1425 (1987) Ex parte Hibberd, 227 USPQ 443 (Bd Pat. App. & Inter. 1985) 5 Funk Brothers Seed Co. v. Kalo Inoculant Co., 16 February 1948, 333 U.S. 127 (1948) In re Bergy, Coats and Malik; In re Chakrabarty 201 USPQ 352 (1979) J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, 124 Mayo Collaborative Services, et al. v. Prometheus Laboratories 132 S.Ct. 1289 (2012) Moore v. Regents of University of California 51 Cal. 3d 120, 15 USPQ2d 1753 Court of Appeal, Second District, Division 4, California Moore v. Regents of the University of California (21 July 1988) Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95 (S.D.N.Y.1911) U.S. Commissioner of Patents, Ex parte Latimer, 12 March 1889, 46 O.G. 1638 Vernon Hugh Bowman v. Monsanto Company et al. 569 U.S. 1 (2013). Washington University v. William J. Catalona, 490 F.3d 667 (8th Cir. 2007) 670 CANADA Children’s Hospital of Eastern Ontario v. Transgenomic, Inc., which was settled on 9 March 2016 Commissioner of Patents v. President and Fellows of Harvard College (2002) 4 R.C.S. 425 Monsanto Canada Inc v Schmeiser [2004] 1 S.C.R. 902, 2004 SCC 34. Percy Schmeiser and Schmeiser Enterprises Ltd. v. Monsanto Canada Inc. and Monsanto Company [2004] 1 S.C.R. 902, Pioneer Hi-Bred Ltd. V. Canada (Commissioner of Patents) (1987) 14 C.P.R. (3d) 491 President and Fellows of Harvard College v. Commissioner of Patents (2000) 7 C.P.R. (4th) 1 President and Fellows of Harvard College v. Commissioner of Patents 79 C.P.R. (3d) 98 (1998) Re Application of Abitibi CO, 62 C.P.R. (2d) 81 (1982) AUSTRALIA Cancer Voices Australia and Another v Myriad Genetics Inc and Another, 15 February 2013, [2013] FCA 65, 99 IPR 567 D’Arcy v Myriad Genetics and Another [2014] FCAFC 115, 107 IPR 478.
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