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The Case against the Privatization of Knowledge: Some Thoughts on the Myriad Genetics Controversy

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Biotech Innovations and Fundamental Rights

Abstract

In the current debate on intellectual property, the work of Karl Polanyi is frequently referred to by jurists, mainly in connection with the story of the ‘old’ and ‘new’ enclosures. In this paper I suggest that the critical account of the rise of the ‘market economy’ provided by Polanyi can shed some light on other important issues in intellectual property law. In particular, I advance the hypothesis that the paradigm of the ‘double movement’ might contribute to a better understanding of the contemporary movements of resistance against the increasing commodification of knowledge. Using the Myriad Genetics controversy as a paradigmatic example, I reflect on the importance of fundamental rights as an institutional safeguard against the expansionary tendency of intellectual property law and on the role of the judiciary as guarantor of social cohesion, endangered by the disruptive effects of market rationality.

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Notes

  1. 1.

    See C. May, The Global Political Economy of Intellectual Property Rights. The New Enclosures, Oxon- New York, 2010, 12, 52; J. Boyle, Public Domain. Enclosing the Commons of the Mind, New Haven, 2008, 42 ss.; Id., The Second Enclosure Movement and the Construction of the Public Domain, in 66 Law & Cont. Prob’s 33, 37 (2003); Id., Fencing Off Ideas, in Daedalus 13 (2002); Id., Enclosing the Genome: What Squabbles over Genetic Patents Could Teach Us, in F. Scott Kieff, Perspectives on Properties of the Human Genome Project, San Diego, 2003, 97 ss.; N. Kranich, Countering the Enclosure: Reclaiming the Knowledge Commons, in C. Hess — E. Ostrom, Eds., Understanding Knowledge as a Commons. From Theory to Practice, Cambridge, 2007, 85 ss.; M. Cassier, New ‘Enclosures’ and the Creation of New ‘Common Rights’ in the Genome and in Software, in 15 Contemporary European History 255 (2006); H. Travis, Pirates of the Information Infrastructure: Blackstonian Copyright and the First Amendment, in 15 Berkeley Tech. L.J. 777, 785, 827 (2000).

  2. 2.

    See J. A. Yelling, Common Field and Enclosure in England 1450–1850, Hamden, 1977; R. Kain - J. Chapman - R. Oliver, The Enclosure Maps of England and Wales. 1595–1918, Cambridge, 2004.

  3. 3.

    The best description of this phenomenon is given by J. Boyle, The Second Enclosure Movement and the Construction of the Public Domain, cit., 33 ss.

  4. 4.

    See A. Peukert, Güterzuordnung und Freiheitsschutz, in R.M. Hilty - T. Jaeger - V. Kitz, Eds., Geistiges Eigentum. Herausforderung Durchsetzung, Berlin - Heidelberg, 2008, 47 ss.

  5. 5.

    For a more detailed discussion, refer to G. Resta, Nuovi beni immateriali e numerus clausus dei diritti esclusivi, in G. Resta, Ed., Diritti esclusivi e nuovi beni immateriali, Torino, 2010, 3 ss., 15.

  6. 6.

    S. Levmore, Property’s Uneasy Path and Expanding Future, in 70 U. Chicago L. Rev. 181, 190–194 (2003); J. Lapousterle, L’influence des groupes de pression sur l’élaboration des normes. Illustration á partir du droit de la propriété littéraire et artistique, Paris, 2009; P. Drahos - J. Braithwaite, Information Feudalism. Who Owns the Knowledge Economy?, London, 2002, 14.

  7. 7.

    C. May, The Global Political Economy of Intellectual Property Rights, cit., 69.

  8. 8.

    K. Polanyi, The Livelihood of Man, edited by H.W. Pearson, New York, 1977, 10; Id., La mentalité de marché est obsolète!, in Essais de Karl Polanyi, Paris, 2008, 505 ss., 507.

  9. 9.

    K. Polanyi, La grande trasformazione. Le origini economiche e politiche della nostra epoca, Torino, 1974, 94, 168.

  10. 10.

    See K. Polanyi, The Economy as Instituted Process, in K. Polanyi - C.M. Arensberg - A. W. Pearson, Trade and Market in the Early Empires. Economies in History and Theory, New York, 1957, 243 ss., 250.

  11. 11.

    K. Polanyi, La grande trasformazione, cit., 74; for a close analysis of this interpretative perspective see, now, M. Cangiani, Karl Polanyi’s Institutional Theory: Market Society and Its ‘Disembedded’ Economy, in 45 J. Econ. Issues 177 (2011).

  12. 12.

    See B. Jessop, Knowledge as a Fictitious Commodity: Insights and Limits of a Polanyian Perspective, in A. Buğra - K. Ağartan, Eds., Reading Karl Polanyi for the Twenty-First Century. Market Economy as a Political Project, New York, 2007, 115 ss.; C. May, The Global Political Economy of Intellectual Property Rights, cit., 22–48; and T. MacNeill, The End of Transformation? Culture as the Final Fictitious Commodity, in 12 Problématique. Journal of Political Studies 17, 25 (2009).

  13. 13.

    On such distinctions, see B. Jessop, Knowledge as a Fictitious Commodity: Insights and Limits of a Polanyian Perspective, cit., 118.

  14. 14.

    See G. Irzik, Commercialization of Science in a Neoliberal World, in A. Buğra - K. Ağartan, Eds., Reading Karl Polanyi for the Twenty-First Century. Market Economy as a Political Project, cit., 135 ss.

  15. 15.

    See A. Rai - R. Eisenberg, Bayh-Dole Reform And The Progress of Biomedicine, in 66 Law & Cont. Probs. 289 (2003); B. Williams-Jones - V. Ozdemir, Enclosing the ‘Knowledge Commons’: Patenting Genes for Disease Risk and Drug Response at the University - Industry Interface, in C. Lenk - N. Hoppe - R. Andorno, Ethics and Law of Intellectual Property. Current Problems in Politics, Science and Technology, Aldershot, 2007, 137; R. Caso, Ed., Ricerca scientifica pubblica, trasferimento tecnologico e proprietà intellettuale, Bologna, 2005.

  16. 16.

    On this topic, see, among many others, J.H. Reichman - P.F. Uhlir, A Contractually Reconstructed Research Commons for Scientific Data in a Highly Protectionist Intellectual Property Environment, in 66 Law & Cont. Prob’s 314, 361–461 (2003). A further particularly relevant issue is that of geospatial data and public sector information: see M. van Eechoud, The Commercialization of Public Sector Information. Delineating the Issue, in P.B. Hugenholtz - L. Guibault, The Future of the Public Domain, The Hague, 2006, 279; P. Weiss, Borders in Cyberspace: Conflicting Government Information Policies and their Economic Impacts, in Open Access and the Public Domain in Digital Data and Information for Science: Proceedings of an International Symposium, Washington, D.C, 2004, 69 ss.

  17. 17.

    See infra, parr. 4–5.

  18. 18.

    See, in general Du. Kennedy, The Political Stakes in “Merely Technical” Issues of Contract Law, in 1 Eur. R. Priv. L. 7 (2001); with specific reference to the debate on methods of comparative law, see Dav. Kennedy, The Politics and Methods of Comparative Law, in P. Legrand - R. Munday, Eds., Comparative Legal Studies: Traditions and Transitions, Cambridge, 2003, 345 ss.

  19. 19.

    See A. Kapczynski, Access to Knowledge: A Conceptual Genealogy, in G. Krikorian - A. Kapczynski, Eds., Access to Knowledge in the Age of Intellectual Property, New York, 2010, 17 ss., 26 ss.; also J. Boyle, The Second Enclosure Movement and the Construction of the Public Domain, cit., 51 ss.

  20. 20.

    See V. Jänich, Geistiges Eigentum — eine Komplementärerscheinung zum Sacheigentum?, Tübingen, 2002, 183.

  21. 21.

    J. Boyle, The Public Domain, cit., 54 ss.

  22. 22.

    See K. Polanyi, La grande trasformazione, cit., 141–164; Id., The machine and the discovery of society, manuscript of 24 April 1957, now published in the French translation in Essais de Karl Polanyi, cit., 547; on the point G. Dale, Karl Polanyi, cit., 52–58.

  23. 23.

    See C. May, The Global Political Economy of Intellectual Property Rights, cit., 11 ss.; T. MacNeill, The End of Transformation? Culture as the Final Fictitious Commodity, cit., 28.

  24. 24.

    For a description of the theoretical models of reference, see. P. Menell - S. Scotchmer, Intellectual Property, in A. Mitchell Polinksy - S. Shavell, Handbook of Law & Economics, II, Amsterdam, 2007, 1475 ss., 1482; W. Gordon, Intellectual Property, in P. Cane - M. Tushnet, The Oxford Handbook of Legal Studies, Oxford, 2003, 617 ss., 638.

  25. 25.

    See on this point the lucid analysis of A. Kapczynski, Access to Knowledge: A Conceptual Genealogy, cit., 26 ss.

  26. 26.

    G. Hardin, The Tragedy of the Commons, in 162 Science 1243 (1968).

  27. 27.

    R. Cooter - T. Ulen, Law & Economics, III ed., Reading-Menlo Park, 2000 ss., 126.

  28. 28.

    P. Menell - S. Scotchmer, Intellectual Property, cit., 1530 ss.

  29. 29.

    See U. Mattei, Basic Principles of Property Law. A Comparative Legal and Economic Introduction, Westport-London, 2000, 1 ss.

  30. 30.

    P. Menell - S. Scotchmer, Intellectual Property, cit., 1477; J. Boyle, Public Domain, cit., 2.

  31. 31.

    As lucidly emerges from the pages of J. Boyle, Enclosing the Genome: What Squabbles over Genetic Patents Could Teach Us, cit., 106 ss., spec. 113 ss.

  32. 32.

    See, again, J. Boyle, Enclosing the Genome: What Squabbles over Genetic Patents Could Teach Us, cit., 113.

  33. 33.

    For a discussion of the benefits in terms of efficiency related to the enclosure movement, see, D.N. McCloskey, The Enclosure of Open Fields: Preface to a Study of Its Impact on the Efficiency of English Agriculture in the Eighteenth Century, in 132 J. Econ. History 15 (1972).

  34. 34.

    See K. Polanyi, La grande trasformazione, cit., passim; see, also, R.C. Allen, Enclosure and the Yeoman, New York, 1992; Id., The Efficiency and Distributional Consequences of Eighteenth Century Enclosures, in 92 Econ. J. 937 (1982).

  35. 35.

    K. Polanyi, La grande trasformazione, cit., 45–56.

  36. 36.

    K. Polanyi, La grande trasformazione, cit., 47.

  37. 37.

    For a critical view on intellectual property ‘politics’ over the past decades, see, in particular, P. Drahos, “IP World” — Made by TNC Inc., in G. Krikorian - A. Kapczynski, Eds., Access to Knowledge in the Age of Intellectual Property, cit., 197 ss., spec. 205 ss.

  38. 38.

    J. Boyle, Public Domain, cit., 47 ss.

  39. 39.

    C. Rose, The Comedy of the Commons: Custom, Commerce and Inherently Public Property, in 53 U. Chicago L. Rev. 711 (1986); E. Ostrom, Governing the Commons: The Evolution of Institutions for Collective Action, Cambridge, 1990.

  40. 40.

    J. Boyle, Public Domain, cit., 3 ss.

  41. 41.

    See K. Polanyi, The Economy as Instituted Process, cit., 243 ss.; and, albeit from a different perspective, D.C. North, Markets and Other Allocation Systems in History: The Challenge of Karl Polanyi, in 6 J. Eur. Econ. History 703 (1977).

  42. 42.

    J. Boyle, Public Domain. Enclosing the Commons of the Mind, cit., 48 ss.; M. Boldrin - D.K. Levine, Against Intellectual Monopoly, Cambridge, 2008, 68 ss., 184 ss., 243.

  43. 43.

    M.A. Heller - R.S. Eisenberg, Can Patents Deter Innovation? The Anticommons in Biomedical Research, in 280 Science 698 (1998).

  44. 44.

    M. Heller, The Gridlock Economy. How Too Much Ownership Wrecks Markets, Stops Innovation, and Costs Lives, New York, 2008, passim.

  45. 45.

    See, for example, J. Boyle, The Second Enclosure Movement and the Construction of the Public Domain, cit., 33 ss.

  46. 46.

    K. Polanyi, La grande trasformazione, cit., 167–278.

  47. 47.

    K. Polanyi, La grande trasformazione, cit., 98.

  48. 48.

    On Polanyi’s thesis of ‘double movement’, see M. Cangiani, Economia e democrazia. Saggio su Karl Polanyi, Padova, 1998, 58 ss.; G. Berthoud, Repenser le ‘double mouvement’, in M. Servet-J.Macourant — A. Tiran, Eds., La modernité de Karl Polanyi, Paris, 1998, 363 ss.

  49. 49.

    On this, see G. Dale, Karl Polanyi. The Limits of the Market, Cambridge, 2010, 72–88.

  50. 50.

    J. Habermas, The Postnational Constellation and the Future of Democracy, in Id., The Postnational Constellation. Politcal Essays, translated by M. Pensky, Cambridge, 2001, 58 ss., 84–85.

  51. 51.

    See for example, A. Buğra, Polanyi’s Concept of Double Movement and Politics in the Contemporary Market Society, in A. Buğra-K. Ağartan, Eds., Reading Karl Polanyi for the Twenty-First Century, cit., 173 ss.; M. Bienefeld, Suppressing the Double Movement to Secure the Dictatorship of Finance, ivi, 13 ss.; F. Block, Polanyi’s Double Movement and the Reconstruction of Critical Theory, in 38 Rev. Interventions économiques [En ligne], 38 (2008); B.J. Silver - G. Arrighi, Polanyi’s “Double Movement”: The Belle Époques of British and U.S. Hegemony Compared, in 31 Politics & Society 325 (2003).

  52. 52.

    On TRIPS as a watershed in the evolution of the intellectual property experience, see L. Helfer, Regime Shifting: The TRIPs Agreement and New Dynamics of International Intellectual Property Lawmaking, in 29 Yale J. Int. L. 1 (2004); G. Krikorian, Free-Trade Agreements and Neoliberalism: How to Derail the Political Rationales that Impose Strong Intellectual Property Protection, in G. Krikorian - A. Kapczynski, Eds., Access to Knowledge in the Age of Intellectual Property, cit., 293 ss.

  53. 53.

    See, in general, S. Rodotà, Proprietà: una parola controversa, in ParoleChiave, 2003, 1 ss.

  54. 54.

    See N. Kranich, Countering the Enclosure: Reclaiming the Knowledge Commons, cit., 94 ss.; P. Levine, Collective Action, Civic Engagement, and the Knowledge Commons, in C. Hess - E. Ostrom, Understanding Knowledge as a Commons, cit., 247 ss.; P. Suber, Creating and Intellectual Commons through Open Access, ivi, 171 ss.

  55. 55.

    A. Kapczynski, The Access to Knowledge Mobilization and the New Politics of Intellectual Property, in 117 Yale L. J. 804 (2008).

  56. 56.

    For the necessary references, see, in particular, Y. Benkler, The Idea of Access to Knowledge and the Information Commons: Long-Term Trends and Basic Elements, in G. Krikorian - A. Kapczynski, Eds., Access to Knowledge in the Age of Intellectual Property, cit., 217 ss.; G. Krikorian, Access to Knowledge as a Field of Activism, ivi, 57 ss.; A. Abdel Latif, The Emergence of the A2K Movement: Reminiscences and Reflections of a Developing-Country Delegate, ivi, 99 ss.

  57. 57.

    See C. Hess - E. Ostrom, Eds., Understanding Knowledge as a Commons, cit.; J. Boyle, Public Domain, cit., 230 ss.

  58. 58.

    On this theme see S. Shashikant, The Doha Declaration on TRIPS and Public Health: An Impetus for Access to Medicines, in G. Krikorian - A. Kapczynski, Eds., Access to Knowledge in the Age of Intellectual Property, cit., 141 ss.

  59. 59.

    In this respect, see V. Muñoz Tellez - S. Musungu, A2K at WIPO: The Development Agenda and the Debate on the Proposed Broadcasting Treaty, in G. Krikorian - A. Kapczynski, Eds., Access to Knowledge in the Age of Intellectual Property, cit., 175 ss.

  60. 60.

    See P. Aigrin, An Uncertain Victory: The 2005 Rejection of Software Patents by the European Parliament, in G. Krikorian - A. Kapczynski, Eds., Access to Knowledge in the Age of Intellectual Property, cit., 161 ss.

  61. 61.

    See for example, F. Block, Polanyi’s Double Movement and the Reconstruction of Critical Theory, cit., 5–6.

  62. 62.

    See U. Breccia, Immagini della giuridicità contemporanea tra disordine delle fonti e ritorno al diritto, in Riv. crit. dir. priv., 2006, 361; N. Lipari, Le fonti del diritto, Milano, 2008.

  63. 63.

    See A. Zoppini, Ed., La concorrenza tra ordinamenti giuridici, Roma-Bari, 2004.

  64. 64.

    S. Levmore, Property’s Uneasy Path and Expanding Future, cit., 190–194.

  65. 65.

    The principle is assimilated in numerous legal systems and supported by the TRIPS agreements: see G. Van Overwalle, Biotechnology and Patents: Global Standards, European Approaches and National Accents, in D. Wüger - T. Cottier, Genetic Engineering and the World Trade System, Cambridge, 1998, 91 ss.; C.A. Fowler, Ending Genetic Monopolies: How the TRIPS Agreement’s Failure to Exclude Gene Patents Thwarts Innovation and Hurts Consumers Worldwide, in 25 Am. U. Int’L L. Rev. 1073 (2010); L. Andrews, Genes and patent policy: rethinking intellectual property rights, in 3 Nature Genetics 803 (2002).

  66. 66.

    See, on the point under consideration, M. Cho, Patently unpatentable: implications of the Myriad court decision on genetic diagnostics, in 28 Trends in Biotechnology 548 (2010); M. Yoon, Gene Patenting Debate: The Meaning of Myriad, in 9 J. Marshall Rev. Int. Prop. L. 953 (2010).

  67. 67.

    Association for Molecular Pathology v. United States Patent and Trademark Office, No. 09 Civ. 4515 (S.D.N.Y., Mar. 29, 2010).

  68. 68.

    See R. Gold - J. Carbone, Myriad Genetics. In the Eye of the Policy Storm, in 12 Genetics in Medicine 39 (2010); B. Williams-Jones, History of a Gene Patent: Tracing the Development and Application of Commercial BRCA Testing, in 10 Health L. J. 123 (2002).

  69. 69.

    B.Williams-Jones, History of a Gene Patent: Tracing the Development and Application of Commercial BRCA Testing, cit., 129.

  70. 70.

    R. Gold - J. Carbone, Myriad Genetics. In the Eye of the Policy Storm, cit., 41.

  71. 71.

    B.Williams-Jones, History of a Gene Patent: Tracing the Development and Application of Commercial BRCA Testing, cit., 131; Association for Molecular Pathology v. United States Patent and Trademark Office, cit., p. 51.

  72. 72.

    R. Gold - J. Carbone, Myriad Genetics. In the Eye of the Policy Storm, cit., 41.

  73. 73.

    For details, see R. Gold - J. Carbone, Myriad Genetics. In the Eye of the Policy Storm, cit., 41.

  74. 74.

    See Y. Miki et al., A Strong Candidate for the Breast and Ovarian Cancer Susceptibility Gene BRCA1, in 266 Science 66 (1994).

  75. 75.

    See Association for Molecular Pathology v. United States Patent and Trademark Office, cit., 53.

  76. 76.

    R. Wooster - G. Bignell et al., Identification of the Breast Cancer Susceptibility Gene BRCA2, in 378 Nature 789 (1995).

  77. 77.

    R. Gold - J. Carbone, Myriad Genetics. In the Eye of the Policy Storm, cit., 42.

  78. 78.

    See J. Murray, Owning Genes: Disputes Involving DNA Sequence Patents, in 75 Chicago Kent L. Rev. 231, 249 (1999).

  79. 79.

    For further detail, see R. Gold - J. Carbone, Myriad Genetics. In the Eye of the Policy Storm, cit., 42.

  80. 80.

    B. Williams-Jones, History of a Gene Patent: Tracing the Development and Application of Commercial BRCA Testing, cit., 133.

  81. 81.

    For a detailed description and a critical appraisal of the implications of this marketing strategy on genetic tests, see B. Williams-Jones, ‘Be ready against cancer, now’: direct-to-consumer advertising for genetic testing, in 25 New Genetics and Society, 89, 93 (2006).

  82. 82.

    R. Gold - J. Carbone, Myriad Genetics. In the Eye of the Policy Storm, cit., 42–44.

  83. 83.

    This was one of the various objections lodged by the scientific community, in particular by Dr. Stoppa-Lyonnet of the Institute Curie, against Myriad’s business model (R. Gold - J. Carbone, Myriad Genetics. In the Eye of the Policy Storm, cit., 45).

  84. 84.

    B.Williams-Jones, History of a Gene Patent: Tracing the Development and Application of Commercial BRCA Testing, cit., 134.

  85. 85.

    American College of Medical Genetics, Position Statement on Gene Patents and Accessibility of Gene Testing, 2 August 1999. For further references, see B. Williams-Jones, History of a Gene Patent: Tracing the Development and Application of Commercial BRCA Testing, cit., 137.

  86. 86.

    A.S. Kesselheim — M.M. Mello, Gene Patenting. Is the Pendulum Swinging Back?, in 362 N. Eng. J. Med. 1855 (2010).

  87. 87.

    R. Gold — J. Carbone, Myriad Genetics. In the Eye of the Policy Storm, cit., 49 ss., 54 ss., 62 ss., 66.

  88. 88.

    G. Matthijs, The European opposition against the BRCA gene patents, in 5 Familial Cancer 95 (2006).

  89. 89.

    R. Gold — J. Carbone, Myriad Genetics. In the Eye of the Policy Storm, cit., 45; G. Matthijs, The European opposition against the BRCA gene patents, cit., 99 ss.; B. Verbeure - G. Matthijs - G. Van Overwalle, Analysing DNA patents in relation with diagnostic genetic testing, in 14 European J. Human Genetics 26, 30 (2006).

  90. 90.

    On this see P. Drahos, The Global Governance of Knowledge. Patent Offices and their Clients, Cambridge, 2010, 148 ss.

  91. 91.

    P. Drahos, The Global Governance of Knowledge, cit., 149; see also American Intellectual Property Law Association, Comments on the Equities of Inter Partes Reexamination Proceedings in Response to the Notice and Invitation Published at 68 Fed. Reg. 75217 (December 30, 2003), available at www.aipla.org (last visited June 5, 2011).

  92. 92.

    T. Caulfield et al., Myriad and the Mass Media: The Coverage of a Gene Patent Controversy, in 9 Genetics in Medicine 850 (2007).

  93. 93.

    Precisely: the Association for Molecular Pathology; the American College for Medical Genetics; the American Society for Clinical Pathology; the College of American Pathologists.

  94. 94.

    Suffice it to recall, among many, the American Medical Association and the American Society of Human Genetics.

  95. 95.

    See M. Geller, Every Woman Deserves Her Own Pair of Genes: The Constitutionality of Patenting the BRCA Genes in Association for Molecular Pathology v. U.S. Patent & Trademark Office 765, 776 (2010); more cautious K. Kauble, Patenting Everything Under the Sun: Invoking the First Amendment to Limit the Use of Gene Patents, in 58 UCLA L. Rev. 1123 (2011).

  96. 96.

    L.M. Dunne, Come, Let Us Return to Reason: Association of Molecular Pathology v. USPTO, in 20 DePaul J. Art Tech. & Intell. Prop. L. 473, 488 (2010).

  97. 97.

    See USPTO, Utility Examination Guidelines, 66 Fed. Reg. 1092 (5 Jan. 2001), available at http://www.uspto.gov/web/offices/com/sol/notices/utilexmguide.pdf (last visited June 5, 2011): “A patent claim directed to an isolated and purified DNA molecule could cover, e.g., a gene excised from a natural chromosome or a synthesized DNA molecule. An isolated and purified DNA molecule that has the same sequence as a naturally occurring gene is eligible for a patent because (1) an excised gene is eligible for a patent as a composition of matter or as an article of manufacture because that DNA molecule does not occur in that isolated form in nature, or (2) synthetic DNA preparations are eligible for patents because their purified state is different from the naturally occurring compound” (p. 1093).

  98. 98.

    See Memorandum of Law in Support of Defendant United States Patent and Trademark Office’s Motion of Judgment on the Pleadings and in Opposition to Plaintiff’s Motion for Summary Judgment, 4.

  99. 99.

    Association for Molecular Pathology v. United States Patent and Trademark Office, cit., 149 ss.

  100. 100.

    Diamond v. Diehr, 450 U.S. 175, 182 (1981).

  101. 101.

    See Diamond v. Chakrabarty, 447 U.S. 303 (1980), stating that the relevant distinction is between “products of nature, whether living or not, and human-made inventions”; Bilski v. Kappos, 130 S. Ct. 3218, 3225 (2010), excluding from patent “laws of nature, physical phenomena, and abstract ideas”. On the products of nature doctrine, see J.M. Conley, Gene Patents and the Product of Nature Doctrine, in 84 Ch.-Kent L. Rev. 109, 112 (2009); J.M. Conley - R. Makowski, Back to the Future: Rethinking the Product of Nature Doctrine as a Barrier to Biotechnology Patents, II, in 85 J. Pat. Trad. Off. Soc. 371 (2003).

  102. 102.

    In this regard see, for example, P.G. Monateri, entry Interpretazione del diritto, in Digesto delle discipline privatistiche, sez. civ., X, Torino, 1993, 32 ss.

  103. 103.

    J.A. Boughman — K.M. Brown, The Geneticist’s Approach to Bilski, in 6 J. Bus. & Tech. L. 59, 76 (2011).

  104. 104.

    C. Schmitt, Der Nomos der Erde im V¨olkerrecht des Jus Publicum Europaeum, 2nd ed., Berlin, 1974, 39.

  105. 105.

    See Plaintiff’s Memorandum of Law in Support of Motion for Summary Judgement, 19–29.

  106. 106.

    See Myriad Defendants’ Memorandum of Law (1) in Support of Their Motion for Summary Judgement and (2) in Opposition to Plaintiff’s Motion for Summary Judgement, 20–34.

  107. 107.

    On this see, recently, J. Calvert - P.B. Joly, How did the gene become a chemical compound? The ontology of the gene and the patenting of DNA, in 50 Social Science Information 157 (2011).

  108. 108.

    For a discussion of the two approaches, see R.S. Eisenberg, How Can You Patent Genes?, in 2 Am. J. Biotech. 3, 4 (2002); A.K. Rai, Intellectual Property Rights in Biotechnology: Addressing New Technology, in 34 Wake Forest L. Rev. 827 (1999); L.M. Dunne, Come, Let Us Return to Reason: Association of Molecular Pathology v. USPTO, cit., 495 ss.

  109. 109.

    See USPTO, Utility Examination Guidelines, cit., 1092–1093; L.M. Dunne, Come, Let Us Return to Reason: Association of Molecular Pathology v. USPTO, cit., 485.

  110. 110.

    See art. 5, c. 2 and whereas n. 21 (on this see also G. Van Overwalle, Legal and Ethical Aspects of Bio-Patenting: Critical Analysis of the EU Biotechnology Directive, in P. Drahos, Ed., Death of Patents, London, 2005, 212 ss., 219–221).

  111. 111.

    European Court of Justice, 9-10-2001, C-377/98, Kingdom of the Netherlands vs. Parliament and Council, in Foro it., 2002, IV, 25. For comments, K. Frahm - J. Gebauer, Patent auf Leben? — Der Luxemburger Gerichtshof und die Biopatent-Richtlinie, in EuR, 2002, 78 ss.

  112. 112.

    Abundant references can be found in N. Hawkins, Human Gene Patents and Genetic Testing in Europe: A Reappraisal, in 7 SCRIPTed 453, 456 (2010).

  113. 113.

    See J.A. Boughman - K.M. Brown, The Geneticist’s Approach to Bilski, in 6 J. Bus. & Tech. L. 59, 76 (2011).

  114. 114.

    Ibidem.

  115. 115.

    See in general Y. Thomas, La vérité, le temps, le juge et l’historien, in Le débat, 1998, 17 ss., 22.

  116. 116.

    For a careful analysis see J.D. Jackson, Something Like the Sun: Why Even “Isolated and Purified” Genes Are Still Products of Nature, in 89 Texas L. Rev. 1453, 1463 (2011).

  117. 117.

    Association for Molecular Pathology v. United States Patent and Trademark Office, cit., pp. 121–135.

  118. 118.

    Association for Molecular Pathology v. United States Patent and Trademark Office, cit., p. 132: “[t]his conclusion is driven by the overriding importance of DNA’s nucleotide sequence to both its natural biological function as well as the utility associated with DNA in its isolated form”.

  119. 119.

    Association for Molecular Pathology v. United States Patent and Trademark Office, cit., p. 79: “[t]here exists a sharp dispute concerning the impact of patents directed to isolated DNA on genetic research and consequently the health of society. As with the dispute concerning the effect of the patents-in-suit on BRCA1/2 genetic testing, the resolution of these disputes of fact and policy are not possible within the context of these motions”.

  120. 120.

    See R. Gold - J. Carbone, Myriad Genetics. In the Eye of the Policy Storm, cit., 43-57; J.D. Jackson, Something Like the Sun: Why Even “Isolated and Purified” Genes Are Still Products of Nature, cit., 1480.

  121. 121.

    See L. Andrews, Genes and patent policy: rethinking intellectual property rights, in 3 Nature Genetics 803, 804 (2002).

  122. 122.

    For an overview of most relevant empirical studies, see R. Gold — W. Kaplan et al., Are Patents Impeding Medical Care and Innovation?, in 7 PLoS Medicine 1 (2009); K. Skeehan et al., Impact of gene patents and licensing practices on access to genetic testing for Alzheimer disease, in 12 Gent. Med. 71 (2010); S. Chandrasekharan et al., Impact of gene patents and licensing practices on access to genetic testing for cystic fibrosis, in 12 Genetics in Medicine 194 (2010); T. Caulfield, Human Gene Patents: Proof of Problems?, in 84 Chi.-Kent L. Rev. 133 (2009); M. Cho et al., Effects of patents and licenses on the provision of clinical genetic testing services, in 5 J. Mol. Diag. 3 (2003).

  123. 123.

    See K. Jensen — F. Murray, Intellectual Property Landscape of the Human Genome, in 310 Science 239 (2005).

  124. 124.

    See Secretary—s Advisory Committee on Genetics, Health and Society, Gene Patent and Licensing Practices and Their Impact on Patient Access to Genetic Tests, 2010; National Academy of Sciences, Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health, 2005; Nuffield Council on Bioethics, The Ethics of Patenting DNA: A Discussion Paper, 2002.

  125. 125.

    See T. Caulfield et al., Evidence and Anecdotes: An Analysis of Human Gene Patenting Controversies, in 24 Nature Biotechnology 1091 (2006); I. Huys et al., Legal Uncertainty in the Area of Genetic Diagnostic Testing, 27 Nature Biotechnology 903 (2009); N. Hawkins, Human Gene Patents and Genetic Testing in Europe: A Reappraisal, cit., 471.

  126. 126.

    M. Cho, Patently unpatentable: implications of the Myriad court decision on genetic diagnostics, cit., 551.

  127. 127.

    See N. Hawkins, Human Gene Patents and Genetic Testing in Europe: A Reappraisal, cit., 472: “[v]ertical patent thickets arise where there is a broad patent granted over the gene-disease link, and later additional patents on specific mutations within that gene. Horizontal thickets arise where a disorder is caused by multiple genes, either independently or cooperatively, and multiple genes need to be examined in a test”.

  128. 128.

    A. Rai — R. Eisenberg, Bayh-Dole Reform And The Progress Of Biomedicine, cit., 290; R. Cooper Dreyfuss, Patents and human rights: where is the paradox?, in W. Grosheide, Ed., Intellectual Property and Human Rights. A Paradox, Cheltenham, 2010, 72, 86.

  129. 129.

    Brief for the United States as Amicus Curiae in Support of Neither Party, available at http://www.aclu.org/free-speech-womens-rights/brca-brief-united-states-amicus-curiae-supportneither-party (last visited June 5, 2011).

  130. 130.

    Brief for the United States as Amicus Curiae in Support of Neither Party, p. 18.

  131. 131.

    See supra, footnote 124.

  132. 132.

    See Secretary—s Advisory Committee on Genetics, Health and Society, Gene Patent and Licensing Practices and Their Impact on Patient Access to Genetic Tests, cit., 54 ss.; K.J. Strandburg, What Does the Public Get? Experimental Use and the Patent Bargain, 2004 Wis. L. Rev. 81 (2004); for a comparison with the different European approach, see N. Hawkins, Human Gene Patents and Genetic Testing in Europe: A Reappraisal, cit., 470; G. van Overwalle et al., Models for Facilitating Access to Patents on Genetic Inventions, in 7 Nature Rev. Genetics 143 (2006).

  133. 133.

    On the different solutions adopted in some European countries see G. Van Overwalle, The Implementation of the Biotechnology Directive in Belgium and its Aftereffects. The Introduction of a New Research Exemption and a Compulsory License for Public Health, in IIC, 2006, 889 ss., 908.

  134. 134.

    See R. Gold — J. Carbone, Myriad Genetics. In the Eye of the Policy Storm. Appendix b: detailed legal analysis of gene patents, competition law and privacy law, Montreal, 2008, 5 ss.

  135. 135.

    See art. 81 quater lett. d) and art. 81 quinquies, d.lgs. 10-2-2005, n. 30 (see R. Romano, Brevettabilità del vivente e “artificializzazione”, in Trattato di Biodiritto, S. Rodotà — P. Zatti eds., vol. I, Ambito e fonti del biodiritto, Milano, 2010, 589); see also § 1a Patentgesetz (on this C. Kilger — J. Feldges — H.R. Jaenichen, The Erosion Of Compound Protection In Germany: Implementation Of The EU Directive On The Legal Protection Of Biotechnological Inventions. The German Way, in 87 J. Pat. & Trademark Off. Society 571 [2005]).

  136. 136.

    For the different models of social security and their impact on the Myriad Genetics case, see R. Gold — J. Carbone, Myriad Genetics. In the Eye of the Policy Storm, cit., 49 ss.

  137. 137.

    See J. Carbone — R. Gold et al., DNA patents and Diagnostics: Not a Pretty Picture, cit., 785–786: “[m]any concerns originate in the following context: currently, universities frequently seek patents over early stage inventions and license patents exclusively half the time. […] These case studies strongly suggest both that universities are often not managing research and patents in a way that promotes dissemination and that companies deploy their patents or exclusive licenses to remove academic health center genetic testing laboratories and low margin national reference laboratories from the market. This is demonstrably a viable business model, or at least it has proven to be until recently, but is it good national policy, and does it add value to the national health system?”. For a critical analysis of the politics underlying the Bayh-Dole Act see A. Rai — R. Eisenberg, Bayh-Dole Reform And The Progress Of Biomedicine, cit., 290 ss.; G. Irzik, Commercialization of Science in a Neoliberal World, in A. Buğra — K. Ağartan, Eds., Reading Karl Polanyi for the Twenty-First Century. Market Economy as a Political Project, 135 ss.; see also Justice Breyer’s dissenting opinion in Board Of Trustees of Leland Stanford Junior Univ. v. Roche Molecular Systems, Inc. (U.S. Supreme Court, 6 June 2011).

  138. 138.

    See S. Rodotà, Il terribile diritto. Studi sulla proprietà privata, 2nd ed., Bologna, 1990, 15; Id., Le proprietà comuni dell’umanità, in AA.VV., Le strutture del capitalismo e l’impresa nella società contemporanea, Milano, 1991, 262 ss., spec. 266.

  139. 139.

    UNESCO, Universal Declaration on the Human Genome and Human Rights (1998), art. 1: “The human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity”.

  140. 140.

    For a critical discussion of the idea of the genome as a common heritage, see P.N. Ossorio, The Human Genome as Common Heritage: Common Sense or Legal Nonsense?, in 35 Journ. L. Med. & Ethics 425 (2007).

  141. 141.

    L.M. Dunne, Come, Let Us Return to Reason: Association of Molecular Pathology v. USPTO, cit., 473 ss.

  142. 142.

    T. Caulfield — R. Gold—M. Cho, Patenting human genetic material: refocusing the debate, in 1 Nature Genetics 227, 229–230 (2000).

  143. 143.

    See M. Boldrin — D.K. Levine, Against Intellectual Monopoly, cit., 184–208.

  144. 144.

    Secretary’s Advisory Committee on Genetics, Health and Society, Gene Patent and Licensing Practices and Their Impact on Patient Access to Genetic Tests, cit., 34–89.

  145. 145.

    J. Stiglitz — J. Sulston, The Case Against Gene Patents, in The Wall Street Journal, April 16, 2010.

  146. 146.

    On this point, see J.M. Mueller, Facilitating Patient Access to Patent-Protected Genetic Testing, in 6 Journ. Busin. & Tech. L. 83 (2011); as well as the memorandum presented, as amicus curiae, by the American Intellectual Property Law Association: Brief for amicus curiae American Intellectual Property Law Association In Support of Reversal, But In Support of Neither Party, available on the website of the American Bar Association (www.americanbar.org), 24 ss.

  147. 147.

    See in general S. Rodotà, Magistratura e politica in Italia, in E. Bruti-Liberati - A. Ceretti - A. Giansanti, Governo dei giudici. La magistratura tra diritto e politica, Milano, 1996, 17 ss.

  148. 148.

    See M. Geller, Every Woman Deserves Her Own Pair of Genes, cit., 776–788.

  149. 149.

    J.D. Jackson, Something Like the Sun: Why Even “Isolated and Purified” Genes Are Still Products of Nature, cit., 1486–1489.

  150. 150.

    P.L.C. Torremans, Intellectual Property and Human Rights, Alphen an den Rijn, 2008, passim; W. Grosheide, Ed., Intellectual Property and Human Rights. A Paradox, cit., passim; G. Resta, Proprietà intellettuale e diritti fondamentali: una relazione ambigua, in Persona, Derecho y Libertad - Nuevas Perspectivas. Escritos en Homenaje al Profesor Carlos Fernández Sessarego, Lima, 2009, 787 ss.

  151. 151.

    See L. R. Helfer, The New Innovation Frontier? Intellectual Property and the European Court of Human Rights, in 49 Harv. Int. L. J. 1 (2008); Id., Human Rights and Intellectual Property: Conflict or Coexistence?, in 5 Minn. Int. Prop. Rev. 47 (2003).

  152. 152.

    See J.R. Thomas, On Proprietary Rights and Personal Liberties: Constitutional Responses to Post- Industrial Patenting, in P. Drahos, Ed., Death of Patents, London, 2005, 110 ss.; G. Van Overwalle, Human rights’ limitations in patent law, in W. Grosheide, Ed., Intellectual Property and Human Rights. A Paradox, cit., 236, 243 ss.; C. Geiger, ‘Constitutionalising’ Intellectual Property Law? The Influence of Fundamental Rights on Intellectual Property in the European Union, in IIC, 2006, 371.

  153. 153.

    For a useful taxonomy see G. Van Overwalle, Human rights’ limitations in patent law, in W. Grosheide, Ed., Intellectual Property and Human Rights. A Paradox, cit., 238 ss.

  154. 154.

    See J.D. Jackson, Something Like the Sun: Why Even “Isolated and Purified” Genes Are Still Products of Nature, cit., 1481 ss.; K. Kauble, Patenting Everything Under the Sun: Invoking the First Amendment to Limit the Use of Gene Patents, cit., 1145 ss.

  155. 155.

    G. Van Overwalle, Human rights’ limitations in patent law, cit., 251 ss.; D. Beyleveld–M.J. Taylor, Data Protection, Genetics and Patent for Biotechnology, in 14 Eur. J. Health L. 177, 183–184 (2007).

  156. 156.

    G. Van Overwalle, Human rights’ limitations in patent law, cit., 257 ss.; Ead., The Implementation of the Biotechnology Directive in Belgium and its Aftereffects. The Introduction of a New Research Exemption and a Compulsory License for Public Health, cit., 908 ss.

  157. 157.

    See P. Spada, Liceità dell’invenzione brevettabile ed esorcismo dell’innovazione, in Riv. dir. priv., 2000, 5 ss., 13; R. Romano, Brevettabilità del vivente e “artificializzazione’, cit., 586.

  158. 158.

    G. Van Overwalle, Human rights’ limitations in patent law, cit., 237; J. Boyle, Enclosing the Genome: What Squabbles over Genetic Patents Could Teach Us, cit., 110 ss.

  159. 159.

    See Y. Benkler, La ricchezza della rete. La produzione sociale trasforma il mercato e aumenta la libertà, Milano, 2007.

  160. 160.

    A. Kapczynski, The Access to Knowledge Mobilization and the New Politics of Intellectual Property, cit.

  161. 161.

    In general see R. Badinter e S. Breyer, Judges in Contemporary Democracy. An International Conversation, New York — London, 2004; for a useful historical contextualisation, see Du. Kennedy, Two Globalizations of Law & Legal Thought: 1850–1968, in 36 Suffolk U. L. Rev. 631, 674–679 (2003).

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    See, for instance, Conseil const., 10-6-2009, n. 2009-580 DC, in Foro it., 2009, IV, c. 472, in which, see L. Marino, Le droit d’accèsà internet, nouveau droit fondamental, in D.,2009, 2045.

  163. 163.

    R.A. Kagan, Adversarial Legalism: The American Way of Law, Cambridge, 2003.

  164. 164.

    D. Wielsch, Zugangsregeln. Die Rechtsverfassung der Wissensteilung, Tübingen, 2008, 8–9, 66 ss.; see also C. Geiger, The Constitutional Dimension of Intellectual Property, in P.L.C. Torremans, Intellectual Property and Human Rights, cit., 101 ss.

  165. 165.

    See S. Rodotà, Linee guida per un nuovo codice dei beni pubblici, in U. Mattei - E. Reviglio - S. Rodotà, eds., Invertire la rotta. Idee per una riforma della proprietà pubblica, Bologna, 2007, 356; F. Cassano, Homo civicus. La ragionevole follia dei beni comuni, Bari, 2004; D. Bollier, The Growth of the Commons Paradigm, in C. Hess - E. Ostrom, Understanding Knowledge as a Commons. From Theory to Practice, cit., 97 ss.

  166. 166.

    Supra, par. 3.

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    Giorgio Resta (Associate Professor of Comparative Private Law and Visiting Professor)

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    Giorgio Resta (Associate Professor of Comparative Private Law and Visiting Professor)

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Resta, G. (2012). The Case against the Privatization of Knowledge: Some Thoughts on the Myriad Genetics Controversy. In: Bin, R., Lorenzon, S., Lucchi, N. (eds) Biotech Innovations and Fundamental Rights. Springer, Milano. https://doi.org/10.1007/978-88-470-2032-0_2

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