Law, Science, and the New Biology

  • George P. SmithII


Today, scientific work is less a basic expression of the “ancient aristocratic ethos of the love of knowledge” than a mere job to be done—by entrepreneurs, employees, or others who have independent funding.1 In 1980, Genentech—a San Francisco based biotechnology company—was the first such company to issue shares on the over-the-counter market. Among its products are a hormone capable of stimulating human growth, mass-produced human insulin which would allow a substantial reduction in cost of the treatment of diabetes, and interferon which may prove to be the long awaited “miracle” drug to combat cancer. In 1984, the Office of Technology Assessment estimated conservatively that some 225 firms are engaged in “commercializing biotechnology.”2


United States Patent Human Suffering Social Good United States Supreme Bubonic Plague 
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  1. 1.
    Compton, Science, Anti Science and Human Values, 1 Amicus 33 (1980).Google Scholar
  2. 2.
    Inventors Dream of Genes, Time, Oct. 20, 1980, at 72. The potential profits derived from manipulating the genetic code—be it either to create new forms of life sufficient to clean up toxic chemical wastes or to produce anti-cancer agents on a grant scale—spurred President Derek Bok of Harvard University to suggest that his University start its own genetic engineering firm. Strong faculty opposition, however, forced him to give up these plans. A Firm No, Time, Dec. 1, 1980, at 59. Office of Technology Assessment, U.S. Cong., Commercial Biotechnology: An International Analysis 542-546, (OTA-BA-218, Jan. 1984).Google Scholar
  3. See Cinelli, Biotechnological Research and Development: The Joint Venture as a Viable Corporate Entity in a High Risk Industry, 13 J. Corp. L. 549 (1988).Google Scholar
  4. 3.
    Diamond v. Chakrabarty, 447 U.S. 303 (1980).Google Scholar
  5. 4.
    Annas, Life Forms: The Law and The Profits, Hastings Center Rep. 21, 22 (Oct. 1978).Google Scholar
  6. 5.
    Supra note 1, at 37.Google Scholar
  7. 6.
  8. 7.
    See Hilts, ‘Rules’ Drawn for Marketing Gene Research, Wash. Post, Mar. 28, 1982 at Al, col. 3; Will, The Spiral of Patents Pending, Wash. Post, June 22, 1980, at B7, col. 6.Google Scholar
  9. 8.
    Stone, Knowledge, Survival and The Duties of Science, 23 Am. U. L. Rev. 231 (1973).Google Scholar
  10. 9.
    See generally G. Smith, Genetics, Ethics and the Law 1, (1981).Google Scholar
  11. 10.
    J. Fletcher, The Ethics of Genetic Control 5 (1974).Google Scholar
  12. 11.
    Rivers, Genetic Engineering Portends a Grave New World, Sat. Rev. April 8, 1972, at 23. See Smith, Intimations of Immortality: Clones, Cryons and The Law, 6 U. New So. Wales L. Rev. 119 (1983); Smith, Beyond the Land of Oz: Clones, Cyborgs and Chimeras, 2 Reps. 6th World Cong. Med. L. 15 (1982).Google Scholar
  13. 12.
    See generally A. Toynbee, Surviving the Future (1971); The Prospects of Western Civilization (1949).Google Scholar
  14. 13.
    DNA is the basic genetic material that transmits inherited characteristics.Google Scholar
  15. 14.
    Clark, Begley & Hager, The Miracle of Spliced Genes, Newsweek, Mar. 17, 1980, at 62.Google Scholar
  16. See generally Baker & Clough, The Technological Use and Methodology of Recombinant DNA, 51 S. Cal. L. Rev. 1009 (1978).Google Scholar
  17. Berger, Government Regulation of the Pursuit of Knowledge: The Recombinant DNA Controversy, 3 Sup. CT. L. Rev. 83 (1978).Google Scholar
  18. 15.
    Scientists Want Limit Dropped on Gene Splitting Experiments, Wash. Post, Nov. 26, 1980, at C3, col. 5 But see Fields, Bizarre Circumstances Surround Chance Cloning of Banner Virus, Chronicle of Higher Education, Aug. 25, 1980, at 1, col. 1 (in violation of federal guidelines that bar genetic copying, a researcher at the University of California at San Diego cloned a virus); Holtzman, Patenting Certain Forms of Life: A Moral Justification, Hastings Center Rep. 9 (June 1979).Google Scholar
  19. See generally Deatherage, Scientific Uncertainty in Regulating Deliberate Release of Genetically Engineered Organisms: Substantive Judicial Review and Institutional Alternatives 11 Harv. Envt’l L. Rev. 203 (1987).Google Scholar
  20. 16.
    Neville, Philosophic Perspective on Freedom of Inquiry, 51 S. Cal. L. Rev. 1115, 1121 (1978).Google Scholar
  21. 17.
    Cohen, Restrictions of Research with Recombinant DNA: The Dangers of Inquiry and the Burden of Proof, 51 S. Cal. L. Rev. 1081, 1082, 1099 (1978).Google Scholar
  22. See Comment, Designer Genes That Don’t Fit: A Tort Regime for Commercial Releases of Genetic Engineering Products, 100 Haw. L. Rev. 1086 (1987).Google Scholar
  23. 18.
    Fletcher, Ethics and Recombinant DNA Research, 51 S. Cal. L. Rev. 1131, 1139 (1978). Fletcher observes that there is nothing fundamentally unnatural or intrinsically wrong, or hazardous for the species, in the ambition that drives man to develop the technology to understand himself. It would in fact seem more offensive to fail to use and develop man’s natural curiosity and talen for asking questions or worse to try to suppress it.Google Scholar
  24. 19.
    See Toulmin, Science and Ethics: Can They be Reconnected: 73 U. Chi. Mag. 2 (1981).Google Scholar
  25. 20.
    See Roe v. Wade, 410 U.S. 113 (1973).Google Scholar
  26. 21.
    See J. Roslansky, Genetics and the Future of Man 46 (1966).Google Scholar
  27. 22.
    See G. Smith, supra note 9, at 2.Google Scholar
  28. 23.
    See generally R. Howard & J. Rifkin, Who Should Play God? (1977); Hilts, Genetic Scientist is Punished for Test Violations, Wash. Post, Mar. 23, 1981, at A1, col. 1.Google Scholar
  29. 24.
    Sinsheimer, Recombinant DNA—On Our Own, 26 Bio-Science 599 (1976).Google Scholar
  30. 25.
    Sinsheimer, Potential Risks, in Research with Recombinant DNA (Nat’l Academy of Science ed. 1977).Google Scholar
  31. 26.
    V. Goodfield, Playing God 71 (1977).Google Scholar
  32. 27.
    Fletcher, supra note 18, at 1138-1139.Google Scholar
  33. 28.
    Id. at 1138.Google Scholar
  34. 29.
    See generally T. Beauchamp & L. Walters, Contemporary Issues in Bioethics (1978).Google Scholar
  35. Smith, Uncertainties on the Spiral Staircase: Metaethics and The New Biology, 41 Pharos Med. J. 10 (1978).Google Scholar
  36. 30.
    See Irons & Sears, Patent ‘Re-examination’: A Case for Administrative Arrogation, 1980 Utah L. Rev. 287-288. By the Patent Clause, Congress is authorized “[t]o promote the Progress of Science and useful Arts, by securing for limited Times... Inventors the exclusive Right to their... Discoveries.” U.S. Const. Art. I, § 8, col. 8.Google Scholar
  37. 31.
    See Sakraida v. AgPro, Inc., 425 U.S. 273, 279 (1976); Graham v. John Deere Co., 383 U.S. 1, 5–6 (1966); Atlantic Works v. Brady, 107 U.S. 192, 200 (1882) Interestingly, about 65–70% of litigated patents are invalidated. T. Beauchamp & I. Walters, supra note 29, at 305.Google Scholar
  38. 32.
    Diamond v. Chakrabarty, 447 U.S. 303 (1980).Google Scholar
  39. 33.
    Justice Brennan, writing in dissent, surveyed the Patent Act of 1793, as re-enacted in 1952, the Plant Patent Act of 1930, and the Plant Variety Protection Act of 1970 and concluded that there existed a strong congressional limitation against patenting bacteria. Id. at 322.Google Scholar
  40. 34.
    35 U.S.C. § 101 (1976).Google Scholar
  41. 35.
    Diamond v. Chakrabarty, 447 U.S., at 307.Google Scholar
  42. 36.
    Gore, The Awesome Worlds Within a Cell, 150 Nat’l Geographic 355, 374-375 (1976).Google Scholar
  43. 37.
    Irons & Sears, Patents in Relation to Microbiology, 29 Ann. Rev. Microbiology 319, 331 (1975).CrossRefGoogle Scholar
  44. See generally Kiley, Common Sense and the Uncommon Bacterium—Is ‘Life’ Patentable, 60 J. Pat. Off. Soc’y 468 (1978).Google Scholar
  45. Wegner, The Patentability of ‘New’ Manufacturers—The Living Invention, in Paient Law ConferenceCoursebook (Bureau of National Affairs ed. 1978). In a suit maintained by an individual who was successfully treated for leukemia by the University of California’s Medical Center for the “commercial exploitation” of products medical researchers had obtained from his body tissue, the Court of Appeal of California held that human tissues and cells remain a person’s property when taken for medical purposes and that the individual patient is entitled to share in the profits if they are used commercially. Moore v. The Regents of California, 249 Cal. Rptr. 494 (1988).Google Scholar
  46. 38.
    Application of Chakrabarty, 517 F. 2d 40 (C.C.P.A.) dismissed 439 U.S. 801 (1978), rev’d sub nom. Application of Bergy, 596 F.2d 952 (C.C.P.A.), cert. granted, 444 U.S. 924 (1979).Google Scholar
  47. 39.
    Student Papers, Microbiological Plant Patents, 10 Idea 87 (1966).Google Scholar
  48. 40.
    Id. See Cooper, Patent Protection for New Forms of Life, 38 Fed. Bar. J. 34 (1979).Google Scholar
  49. Kip, The Patentability of Natural Phenomena, 20 Geo. Wash. L. Rev. 371 (1952).Google Scholar
  50. 41.
    DeMott & Thomas, Test-Tube Life: Reg. U.S. Pat. Off., Time, June 30, 1980, at 52.Google Scholar
  51. 42.
    See Nelkin, Threats and Promises: Negotiating the Control of Research, 107 Daedalus 191 (1978).Google Scholar
  52. 43.
    447 U.S. at 308 (1980).Google Scholar
  53. 44.
  54. 45.
    Id. at 310. See generally Delgado & Miller, God, Galileo and Government: Toward Constitutional Protection for Scientific Inquiry, in 1 Ethical, Legal and Social Challenges to a Brave New World 231 (G. Smith ed. 1982).Google Scholar
  55. 46.
    447 U.S. at 315.Google Scholar
  56. 47.
    Id. at 316-317. See Gladwell, Report Boosts Biotechnology Experiments: Risks of Small-Scale Tests Outdoors Called Minimal, Wash. Post, May 5, 1988, at El, col. 2.Google Scholar
  57. 48.
  58. 49.
    Id. at 317.Google Scholar
  59. 50.
    Id. at 311.Google Scholar
  60. 51.
    Sinsheimer, The Dawn of Genetic Engineering, 190 Science 768 (1975).Google Scholar
  61. See Fletcher, Moral Problems and Ethical Issues in Prospective Human Gene Therapy, 69 Va. L. Rev. 515 (1983).CrossRefGoogle Scholar
  62. 52.
    See Smith, Manipulating the Genetic Code: Jurisprudential Conundrums, 64 Geo. L. J. 697 (1976).Google Scholar
  63. See also Office of Technology Assessment, Impact of Applied Genetics (1981); Note, Building a Better Bacterium: Genectic Engineering and the Patent Law After Diamond v. Chakrabarty, 81 Colum. L. Rev. 159 (1981).Google Scholar
  64. 53.
    Lederberg, Orthobiosis: The Perfection of Man in Place of Value in a World of Facts 29 (A. Tiselius & S. Nilsson eds. 1980).Google Scholar

Copyright information

© Springer Science+Business Media New York 1989

Authors and Affiliations

  • George P. SmithII
    • 1
  1. 1.The Catholic University of America School of LawUSA

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