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Issues and Rights in DNA-based Inventions

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Biotech Innovations and Fundamental Rights

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Abstract

The paper discusses how the legal system has reacted to the new challenge posed by modern biotechnology. In particular it examines some emerging global issues that result from the patenting of biotech inventions with a specific emphasis on the effects of Expressed Sequence Tags (ESTs) patents and their potential to interfere with fundamental individual rights and civil liberties.

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Notes

  1. 1.

    For a comparative overview, see R. Leenes et al. (eds.), Constitutional Rights and New Technologies: A Comparative Study (TMC Asser Press 2008).

  2. 2.

    See A. Plomer et. al., Challenges to Human Embryonic Stem Cell Patents, 2 Cell Stem Cell 13, 13–15 (2008).

  3. 3.

    See, e.g., G. van Overwalle, Of Thickets, Blocks and Gaps. Designing Tools to Resolve Obstacles in the Gene Patents Landscape, in Gene Patents and Collaborative Licensing Models 383 (G. van Overwalle ed., 2009); A. Nordgren, Responsible Genetics: The Moral Responsibility of Geneticists for the Consequences of Human Genetics Research 114 (Kluwer Acad. Publishers 2001); but see contra D. E. Adelman & K. L. DeAngelis, Patent Metrics: The Mismeasure of Innovation in the Biotech Patent Debate, 85 Tex. L. Rev. 1677, 1681 n. 11 (2007) (pointing out that the effect of the growth in biotech patenting on innovation is more limited than believed).

  4. 4.

    See e.g. World Health Organization, Genetics, Genomics and the Patenting of DNA: Review of Potential Implications for Health in Developing Countries 20 (2005), available at http://www.who.int/genomics/FullReport.pdf.

  5. 5.

    On the anticommons problem, see M. A. Heller & R. S. Eisenberg, Can Patents Deter Innovation? The Anticommons in Biomedical Research, 280 Science 698 (1998) (arguing that the recent trends in patenting will deter innovation by creating “anti-commons” problems); M. A. Heller, The Tragedy of the Anticommons: Property in the Transition from Marx to Markets, 111 Harv. L. Rev. 621 (1998); F. Murray & S. Stern, Do Formal Intellectual Property Rights Hinder the Free Flow of Scientific Knowledge? An Empirical Test of the Anti-Commons Hypothesis, 63 J. Econ. Behav. & Org. 648 (2007). In opposition to these arguments we can observe that some empirical studies exclude a negative impact of patents in genomics. On this point, see generally J. Straus et al., Genetic Inventions and Patent Law, An Empirical Survey of Selected German R&D Institutions, Munich, 2004.

  6. 6.

    This concern constitutes a typical example of what has been defined as the “democratic management of technoscience and techno-scientific products”. See D. Pestre, Challenges for the Democratic Management of Technoscience: Governance, Participation and the Political Today, 17 Science as Culture 101 (2008).

  7. 7.

    For an interesting discussion in this topic, see L. Zucca, Constitutional Dilemmas: Conflicts of Fundamental Legal Rights in Europe and the USA, 3–12 (OUP 2007).

  8. 8.

    See M. Albright, Life Patents and Democratic Values, in Rights and Liberties in the Biotech Age: Why We Need a Genetic Bill of Rights 29, 35 (S. Krimsky & P. Shorett, eds., 2005).

  9. 9.

    See S. Jasanoff, A social Contract for the Life Sciences: The US Case, in Trattato di biodiritto, diretto da S. Rodotà e P. Zatti, vol. I, 103 Ambito e fonti del biodiritto (S. Rodotà & M. Tallacchini eds.), Giuffrè, Milano, 2010, 115.

  10. 10.

    See M. L. Sturges, Who Should Hold Property Rights to the Human Genome? An Application of the Common Heritage of Humankind, 13 Am. U. Int’l L. Rev. 219, 246 (1997).

  11. 11.

    See S. Soini et al., Patenting and Licensing in Genetic Testing: Ethical, Legal and Social Issues, 16 Eur. J. Hum. Gen. S10, S33 (2008).

  12. 12.

    For a general discussion of the issues, see, among others, M. Heller & R. Eisenberg, Can Patents Deter Innovation? The Anticommons in Biomedical Research, 280 Science 698 (1998); L. B. Andrews, The Gene Patent Dilemma: Balancing Commercial Incentives with Health Needs, 2 Hous. J. Health L. & Pol’y 65, 101 (2002); T. Caulfield et al., Genetic Technologies, Health Care Policy and the Patent Bargain, 63 Clinical Genetics 15 (2002); K. Jensen, F. Murray, Intellectual Property Landscape of the Human Genome, 310 Science 239, 239–40 (2004); L. B. Andrews & J. Paradise, Gene Patents: The Need for Bioethics Scrutiny and Legal Change, 5 Yale J. Health Pol’Y L. & Ethics 403, 405–11 (2005); C. Holman, The Impact of Human Gene Patents on Innovation and Access: A survey of Human Gene Patent Litigation, 76 UMKC L. Rev. 295, 300 (2007); M. Westhoff, Gene Patents: Ethical Dilemmas and Possible Solutions, 20 Health L. 1, 10 (2008). See also generally S. Krimsky and P. Shorett (eds.), Rights and. Liberties in the Biotech Age: Why We Need a Genetic Bill of Rights (Lanham, MD: Rowman & Littlefield, 2005).

  13. 13.

    See Australian Law Reform Commission, Genes and Ingenuity: Gene Patenting and Human Health, Report No 99 (2004) 38, available at http://www.austlii.edu.au/au/other/alrc/publications/reports/99.

  14. 14.

    Ibidem.

  15. 15.

    See A. Coghlan, Europe revokes controversial gene patent, New Scientist, 19th May 2004.

  16. 16.

    M. J. Howlet & A. F. Christie, An Analysis of the Approach of the European, Japanese and United States Patents Offices to Patenting Partial DNA Sequences (EST), 34 Int’l Rev. Ind. Prop.& Conusidit 581 (2003). See also A. Reese & B. Opeskin, Current Issues in Gene Patenting, in Disputes and Dilemmas in Health Law 277, 280 (Ian Freckelton & K. Petersen eds.) (2006).

  17. 17.

    Diamond v. Chakrabarty, 447 U.S. 303 (1980). In this landmark decision the United States Supreme Court held that a live and human-engineered microorganism is patentable subject matter under Section 1010 of the United States Patent Act. The rule for which the decision is commonly known is that patents can be issued on “anything under the sun that is made by man”. For a detailed review of the case, see R. S. Eisemberg, The Story of Diamond v. Chakrabarty: Technological Change and the Subject Matter Boundaries of the Patent System, in Intellectual Property Stories 327 (J. C. Ginzburg & R. C. Dreyfuss eds. Foundation Press 2006).

  18. 18.

    See Comparative Study of Patent Practices in the Field of Biotechnology Related Mainly to Microbiological Inventions, 7 Biotechnology L. Rep. 159, 163 (1988).

  19. 19.

    See D. Robinson & N. Medlock, Diamond v. Chakrabarty: A Retrospective on 25 Years of Biotech Patents, 17 Intell. Prop. & Tech. J. 12, 14 (2005).

  20. 20.

    See e.g. J. J. Doll, The Patenting of DNA, 280 Science 689 (1998); D. J. Kevles & A. Berkowitz, The Gene Patenting Controversy: A Convergence of Law, Economic Interests, and Ethics, 67 Brook. L. Rev. 233 (2001). For a recent overview of the gene patenting controversies, see also L. Larrimore Ouellette, Access to Bio-Knowledge: From Gene Patents to Biomedical Materials, 2010 Stan. Tech. L. Rev. N1, http://stlr.stanford.edu/pdf/ouellette-access-to-bio-knowledge.pdf.

  21. 21.

    See O. Liivak, Maintaining Competition in Copying: Narrowing the Scope of Gene Patents, 41 U.C. Davis L. Rev. 177, fn 53 (2007).

  22. 22.

    Id.

  23. 23.

    Id.

  24. 24.

    See Amgen, Inc. v. Chugai Pharm. Co., 13 U.S.P.Q.2d (BNA) 1737, 1759 (D. Mass. 1989).

  25. 25.

    See O. Mills, Biotechnological Inventions. Moral Restraints and Patent Law, 2nd ed., 4 (Ashgate 2010); L. Bently & B. Sherman, Intellectual Property Law, 3rd ed., 391 (OUP 2009).

  26. 26.

    In his famous dissent, Justice Breyer stated that “too much patent protection can impede rather than promote the progress of science and the useful arts” that is the U.S. constitutional objective of copyright and patent protection. See Lab. Corp. of America Holdings v. Metabolite Labs., Inc., 548 U.S. 124, 126, 79 U.S.P.Q.2d (BNA) 1065, 1066 (2006) (per curiam) (Breyer, J., dissenting) (quoting U.S. Const. art. I, § 8, cl. 8). This dissent, joined by Justices Stevens and Souter, seems to suggest that at least three of the Supreme Court Justices are becoming increasingly concerned about the quality and quantity of the patents being issued by the United States Patent and Trademark Office. See Terry Wrigh, Patent Trends in the U.S. Supreme Court, http://brandlaw.org/2010/01/patent-trends-in-the-u-s-supreme-court/ (last visited Apr. 22, 2011).

  27. 27.

    D. M. Gitter, International Conflicts Over Patenting Human DNA Sequences in the United States and the European Union: An Argument for Compulsory Licensing and a Fair-Use Exemption, 76 N.Y.U. L. Rev. 1623, 1624 (2001).

  28. 28.

    See Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, art. 27, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 33 I.L.M. 1125 (1994) [hereinafter TRIPS]. On this point, see also J. Gibson, Patent Publics, Patent Cultures, in Patenting Lives: Life Patents, Culture and Development 1,3 (Johanna Gibson ed., Ashgate 2008).

  29. 29.

    According to Art. 27 of the TRIPS Agreement, “patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application”. See also Bently & Sherman, Intellectual Property Law, cit., at 393–394.

  30. 30.

    L. B. Andrews & J. Paradise, Essay, Gene Patents: The Need for Bioethics Scrutiny and Legal Change, 5 Yale J. Of Health Pol‘y, L. & Ethics 403, 404 (2005).

  31. 31.

    Council Directive 98/44/EC, art. 5(2), 1998 O.J. (L 213) 13 (EC).

  32. 32.

    Convention on the Grant of European Patents, art. 53(c), Oct. 5, 1973, 13 I.L.M. 270 [hereinafter EPC].

  33. 33.

    See decision T 964/99 (OJ EPO 2002, 4), starting from the interpretation set out in decision T 385/86, decision T 964/99.

  34. 34.

    See, e.g. Bement v. Nat’l Harrow Co., 186 U.S. 70, 90–92 (1902) (“The general rule is absolute freedom in the use or sale of rights under the patent laws of the United States”).

  35. 35.

    A patent simply grants the patentee the right to exclude others from making, using or selling the claimed invention for a limited period of time in return for the disclosure if technical information. See Bently & Sherman, Intellectual Property Law, cit., at 335.

  36. 36.

    See Bently & Sherman, Intellectual Property Law, cit. at 570. In the U.S., an intellectual property rights holder has no obligation to either use or license its property rights. On the point, see H. Hovenkamp, M. D. Janis & M. A. Lemely, Unilateral Refusals to License in the US, 2 J. Competition L. & Econ. 1, 13 (2006).

  37. 37.

    G. Van Overwalle, Turning Patent Swords into Shares, 330 Science 1630 (2010).

  38. 38.

    See D. B. Resnik, Owning the Genome: A Moral Analysis of DNA Patenting 141 (SUNY Press 2004).

  39. 39.

    See generally Amedeo Santosuosso et al., What Constitutional Protection for Freedom of Scientific Research?, 33 Journal of Medical Ethics 342 (2007).

  40. 40.

    See C. Long, Patents and Cumulative Innovation, 2 Wash. U. J.L. & Pol’y 229, 230–31 (2000).

  41. 41.

    See also D. L. Burk & M. A. Lemley, The Patent Crisis and How the Courts Can Solve It 73–75 (University of Chicago Press 2009) (discussing cumulative innovation in patent law).

  42. 42.

    See L. Lessig, The Architecture of Access to Scientific Knowledge, Lecture at Cern, Geneve, Switzerland, 18 April 2001, available at 〈http://www.youtube.com/watch?v=2me7hptVGzI〉.

  43. 43.

    See J. H. Reichman, Of Green Tulips and Legal Kudzu: Repackaging Rights in Subpatentable Innovation, 53 Vand. L. Rev. 1743, 1745 (2000).

  44. 44.

    See Burk & Lemley, The Patent Crisis and How the Courts Can Solve It, cit., at 76; M. A. Heller, The Tragedy of the Anticommons: Property in the Transition from Marx to Markets, cit., at 670; C. Shapiro, Navigating the Patent Thicket: Cross Licenses, Patent Pools, and Standard-Setting, in 1 Innovation Policy and the Economy 119–150 (A. Jaffe, J. Lerner, & S. Stern, eds., MIT Press, 2001).

  45. 45.

    Burk & Lemley, The Patent Crisis and How the Courts Can Solve It, cit., at 76.

  46. 46.

    The problem could be particularly troublesome when the development of a new product requires licensing of several complementary patents, held by different patentees. See A. Heller & R. S. Eisenberg, Can Patents Deter Innovation? The Anticommons in Biomedical Research, cit.

  47. 47.

    Michael A. Heller & Rebecca S. Eisenberg, Can Patents Deter Innovation? The Anticommons in Biomedical Research, cit., at 699.

  48. 48.

    See supra note 5.

  49. 49.

    For a general discussion on the problem of the patent thicket, see C. Shapiro, Navigating the Patent Thicket: Cross Licenses, Patent Pools, and Standard-Setting, cit.; for a better idea of how patent thickets can work to prevent use of patented information in innovation, see J. Besson, Patent Thickets: Strategic Patenting of Complex Technologies (Research on Innovation Working Papers, March 2003), available at http://www.researchoninnovation.org/thicket.pdf (last visited May 30, 2011).

  50. 50.

    See C. Shapiro, Navigating the Patent Thicket: Cross Licenses, Patent Pools, and Standard-Setting, cit., at 121.

  51. 51.

    Burk & Lemley, The Patent Crisis and How the Courts Can Solve It, cit., at 78 (oberving that while the anticommons analysis focuses on the need to aggregate fragmentary porperty rights owned by many different players and the difficulty of assembling those fragments into a coherent product, the patent thicket analysis focuses on the overlap of existing rights).

  52. 52.

    Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010). The case is now before the Federal Circuit and a final ruling is expected in late summer 2011. Experts expect the case will proceed — most likely — up to the United States Supreme Court.

  53. 53.

    See G. Van Overwalle, Turning Patent Swords into Shares, cit.; for a more detailed description of the case, see the contribution by Giorgio Resta (this volume).

  54. 54.

    Ass—n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181, 232 (S.D.N.Y. 2010), as amended (Apr. 5, 2010) (“Because the claimed isolated DNA is not markedly different from native DNA as it exists in nature, it constitutes unpatentable subject matter under 35 U.S.C. § 101.”).

  55. 55.

    G. Van Overwalle, Turning Patent Swords into Shares, cit. at 1630.

  56. 56.

    B. A. Jackosn, Innovation and Intellectual Property: The Case of Genomic Patenting, 22 J. Pol“y Analysis & Mgmt 5, 9–12 (2003).

  57. 57.

    See G. Van Overwalle et al., Models for Facilitating Access to Patents on Genetic Invention, 7 Nature Review Genetics 143 (2006); Id., Turning Patent Swords into Shares, cit., at 1630–31.

  58. 58.

    See G. Van Overwalle, Turning Patent Swords into Shares, cit., at 1630.

  59. 59.

    Id. at 1631.

  60. 60.

    See G. Van Overwalle et al., Models for Facilitating Access to Patents on Genetic Invention, cit. at 144.

  61. 61.

    See e.g. M. D. Adams et al., Complementary DNA Sequencing: Expressed Sequence Tags and Human Genome Project, 252 Science 1651 (1991); A. K. Rai, Regulating Science Research: Intellectual Property Rights and the Norms of Science, 94 Nw. U.L. Rev. 77, 104 (1999); M. A. Holman & Stephen R. Munzer, International Property Rights in Genes and Gene Fragments: A Registration Solution for Expressed Sequence Tags, 85 Iowa L. Rev. 735, 750 (2000); M. Rimmer, The New Conquistadors: Patent Law and Expressed Sequence Tags, 16 J. Law Inform. Sci. 10 (2007).

  62. 62.

    See S. Lawrence, US Court Case to Define EST Patentability, 23 Nature Biotechnology 513 (2005).

  63. 63.

    A DNA sequence obtained by reverse transcription of a messenger RNA (mRNA) sequence. See The National Library of Medicine, The NCBI Handbook, Expressed Sequence Tags (ESTs), available at http://www.ncbi.nlm.nih.gov/books/NBK21083/#A858.

  64. 64.

    See M. Rimmer, The New Conquistadors: Patent Law and Expressed Sequence Tags, cit., at 11; Stacy Lawrence, US Court Case to Define EST Patentability, cit., at 513.

  65. 65.

    See The National Library of Medicine, The NCBI Handbook, Expresses Sequence Tags (ESTs), cit.

  66. 66.

    Id.

  67. 67.

    The National Center for Biotechnology Information (NCBI) is a US government-funded national resource for molecular biology information. Information regarding the NCBI is available at http://www.ncbi.nlm.nih.gov/ (last visited May. 17, 2011).

  68. 68.

    See The National Library of Medicine, The NCBI Handbook, Expressed Sequence Tags, cit.

  69. 69.

    Id.

  70. 70.

    See J. M. Sikela & C. Auffray, Finding new genes faster than ever, 3 Nature Genetics 189 (1993).

  71. 71.

    A probe is a “dna sequence that is used to detect the presence of a complementary sequence by hybridization with a nuceic acid sample”. See B. W. Old and S. B. Primrose, Principles of gene manipulation: an introduction to genetic engineering (1980) at 124.

  72. 72.

    See A. K. Rai, Regulating Science Research: Intellectual Property Rights and the Norms of Science, op cit., at 104.

  73. 73.

    See A. Ottolia, Riflessioni sulla Brevettabilità delle Sequenze Parziali di Geni, Riv. Dir. Ind. 457 (2005). EST public libraries can be used to identify unknown genes as well as to compare the expression of genes in different cells or tissues. See A. K. Rai, Regulating Science Research: Intellectual Property Rights and the Norms of Science, cit., at 105 (observing how many EST applications are notable for the broad scope of their patent claims: the applications claim not only the EST but also the full gene of which it is a part and future uses of the gene).

  74. 74.

    On the argument, see A. K. Rai, Regulating Science Research: Intellectual Property Rights and the Norms of Science, cit. at 104–105. See also generally J. P. Pieroni, The Patentability of Expressed Sequence Tags, 9 Fed. Cir. B.J. 401, 412 (2000).

  75. 75.

    See R. S. Eisenberg & R. P. Merges, Opinion Letter as to the Patentability of Certain Inventions Associated with the Identification of Partial cDNA Sequences, 23 AIPLA Q.J. 1 (1995) (quoting the observation of the United States Patent and Trademark Office).

  76. 76.

    In re Fisher, 421 F.3d 1365 (Fed. Cir. 2005). For a detailed investigation of the case, see Yann Joly, Winds of Change: In re Fisher and the Evolution of the American Biotechnology Patent Law, 25 Law in Context 67 (2007).

  77. 77.

    See M. Grund et. al., Patenting of Biotech Inventions in Europe: New Developments, 6 Bio-Science Law Review 6, 9 (2004).

  78. 78.

    EPC, art. 57.

  79. 79.

    See Utility Examination Guidelines, 66 Fed. Reg. 1092, cmt. 7 at 1093 (Jan. 5, 2001).

  80. 80.

    See European Patent Office, Guidelines for Examination in the European Patent Office (2010), Part C, c. IV, s. 5.4, available at http://www.epo.org/law-practice/legal-texts/guidelines.html.

  81. 81.

    Council Directive 98/44/EC, 1998 O.J. (L 213) 13 (EC).

  82. 82.

    See T. Sampson, Achieving Ethically Acceptable Biotechnology Patents: A Lesson from the Clinical Trials Directive?, 25 Eur. Intell. Prop. Rev. 419, 421 (2003) (noting also that “The ‘utility’ provision of the US patent code and the USPTO Utility Guidelines achieve the same end by requiring that a patent application must disclose a “specific, credible and substantial” use or a “well established use” for the claimed invention); D. Schertenleib, The Patentability and Protection of DNA-based Inventions in the EPO and the European Union, 25 Eur. Intell. Prop. Rev 125 (2003).

  83. 83.

    See R. S. Eisemberg, Patents on DNA Sequences: Molecules and Information, in The Commodification of Information 417, 418 (N. Elkin-Koren & N.W. Netanel, eds., Kluwer Law 2002). The notion of DNA as information was originally introduced by Watson and Crick’s 1953 article. See J.D. Watson & F.H.C. Crick, Molecular Structure of Nucleic Acids: A Structure for Deoxyribose Nucleic Acid, 171 Nature 737 (1953).

  84. 84.

    See Eisemberg, Patents on DNA Sequences: Molecules and Information, cit., at 418.

  85. 85.

    K. Sunder Rajan, Biocapital: The Constitution of Postgenomic life 42 (Duke University Press 2006).

  86. 86.

    Ibidem.

  87. 87.

    See K. Jensen & F. Murray, Intellectual Property Landscape of the Human Genome, 310 Science 239 (2005) (referencing a study of 4,382 of the 23,688 genes in the National Center for Biotechnology Information’s database that showed that 63% of the patents are assigned to private firms and that, of the top ten gene patent assignees, nine were based in the United States).

  88. 88.

    See P. K. Gupta, Ultrafast and low-cost DNA sequencing methods for applied genomics research, 78 Proc. Natl. Acad. Sci. India sect. B. Biol. Sci. 91 (2008); E. R. Mardis, The impact of next-generation sequencing technology on genetics, 24 Trends Genet. 133 (2008).

  89. 89.

    D. Greenfield, Intangible or Embodied Information: The Non-Statutory Nature of Human Genetic Material, cit. at 470.

  90. 90.

    See A. Santosuosso et al., What Constitutional Protection for Freedom of Scientific Research?, cit., at 343.

  91. 91.

    See R. Gross, Intellectual Property Rights and the Information Commons, in Human Rights in the Global Information Society 107, 119 (Rikke Frank Jorgenson ed., MIT Press 2006).

  92. 92.

    See D. Greenfield, Intangible or Embodied Information: The Non-Statutory Nature of Human Genetic Material, 25 Santa Clara Computer & High Technology Law Journal 467 (2009).

  93. 93.

    Id. at 477.

  94. 94.

    Id. at 536.

  95. 95.

    See R. S. Eisenberg, How Can You Patent Genes?, Am J. Bioethics, Summer 2002, at 3.

  96. 96.

    See Sweezy v. New Hampshire, 354 U.S. 234, 262-63 (1957) (Frankfurter, J., concurring).

  97. 97.

    See R. S. Eisemb

  98. 98.

    See O. Liivak, Maintaining Competition in Copying: Narrowing the Scope of Gene Patents, 41. U.C. D. L. Rev. 177, 185 (2007).

  99. 99.

    See e.g. F. Murray & S. Stern, Do Formal Intellectual Property Rights Hinder the Free Flow of Scientific Knowledge? An Empirical Test of the Anti-Commons Hypothesis, 63 J. Econ. Behav. & Org. 648 (2007); J. P. Walsh, A. Arora & W. M. Cohen, Working Through the Patent Problem, 299 Science 1021 (2003).

  100. 100.

    See M. Crichton, This Essay Breaks the Law, N.Y. Times, Mar. 19, 2006, at 13.

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  1. Department of Juridical Sciences, University of Ferrara, Italy

    Nicola Lucchi (Research Associate)

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  1. Department of Juridical Sciences, University of Ferrara, Italy

    Roberto Bin , Sara Lorenzon  & Nicola Lucchi ,  & 

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Lucchi, N. (2012). Issues and Rights in DNA-based Inventions. 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_8

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