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Original Articles

Ethics, Patents and the Sustainability of the Biotech Business Model

Pages 203-218 | Published online: 21 Jul 2010

References

  • McMillan , John . 2002 . Reinventing the Bazaar: A Natural History of Market , 27 New York : W. W. Norton .
  • Ibid.
  • 2001 . 'Science and profit' . The Economist , 17 February : 21
  • Ibid.
  • Hamilton , David P . 2002 . 'Gene machines: as others sink, 2 biotech players have hit it big" . The Wall Street Journal , 1 18 November : l The Wall Street Journal defined biotechnology as 'a field in which companies … produce drugs through genetic science'. The Economist, however, observes that: 'a biotech company is a pharma company without sales'.
  • 2003 . 'Climbing the helical staircase' . The Economist , 29 March : 4
  • Grabowski , Henry . 2002 . 'Patents, innovation, and access to new pharmaceuticals' . Journal of International Economic Law , 5 ( 4 ) : 849 – 860 . 851
  • 2001 . 'Tufts Center for the Study of Drug Development pegs cost of a new prescription medicine at $ 802 million' . Tufts Center News Release , 30 November
  • Nuffield Council on Bioethics . 2002 . 'The ethics of patenting DNA: a discussion paper' . July : 14 http://www.nuffieldbioethics.org, suggesting that US $110 million might be a more accurate figure
  • Ibid at p 851.
  • Ibid.
  • 2002 . Francis Fukuyama Our Posthuman Future: Consequences of the Biotechnology Revolution Farrar , 214 New York : Straus and Giroux . Francis Fukuyama notes that through the early 1990s there was a period in which virtually all biomedical research in the USA was funded by the federal government.
  • Glasgow , Lara J . 2001 . 'Stretching the limits intellectual property rights: has the pharmaceutical industry gone too far?' . IDEA: The Journal of Law and Technology , 21 : 227 Indeed, in recent years, drug companies have attempted to extend sales by producing closely related alternatives as patents expire. See, eg
  • Penhoet , Edward . 1996 . 'Science and technology policy: a CEO's view' . California Western Law Review , 33 : 15 – 29 . 24 – 25 . (Chemical entities are granted relatively narrow patent protection and are relatively easy to design around; biotechnology patents, granted on complex macromolecules such as proteins, are more to difficult to engineer around in part because it is more difficult to make non-obvious changes without losing the desired activity.)
  • Eisenberg , Rebecca S . 2002 . 'Will pharmacogenomics alter the role of patents in drug development?' . Pharmacogenomics , 3 ( 5 ) : 571 – 74 . 571
  • Lawlor , Michael . 2003 . 'Biotechnology and government funding' . Challenge , 46 : 15 – 37 . 17
  • Maxwell , J Mehlman . 1999 . 'How will we regulate genetic enhancement?' . Wake Forest Law Review , 34 : 671 – 714 . 672 describing for example the production of human growth hormone, which was previously available only from cadavers
  • 2003 . 'A voyage of discovery: biotechnology may yet renew the pharmaceutical industry' . The Economist , 29 March : 7 'Red' biotechnology refers to medical products such as drugs in contrast to 'green' biotechnology, which addresses agricultural products, or 'white' biotechnology, which involves industrial uses
  • Brower , Vicki . 2000 . 'Analysis: have genome, will travel… how?' . United Press International , 30 October
  • June 2001 . “ 'Millenium in motion: global trends shaping the health sciences industry' ” . June , available at http://www.ey.com/global/download.nsf/International/Millennium_in_Motion:_Global_Trends/ $file/E&YGlobalTrends.pdf, p 13 (last visited 22 April 2003)
  • Finkelstein , Stan N , Sinskey , Anthony J and Cooper , Scott M . 2003 . 'A public/private partnership for dual-use antibiotics' . Pharmagenomics , March/April : 18 – 22 .
  • Sage , William M and Hammer , Peter J . 2002 . 'A Copernican view of health care antitrust' . Law and Contemporary Problems , 65 Fall : 241 276 The government, for example, provides 50 per cent of overall health care funding in the USA. See
  • Ghosh , Shuba . 2001 . 'Pills, patents, and power: state creation of gray markets as a limit on patent rights' . Florida Law Review , 53 : 789 – 829 . (defining gray markets as the 'unauthorized distribution of a good or service')
  • Cadette , Walter . 2003 . 'The health care paradox' . Challenge , 46 : 38 – 54 . 49
  • Heffler , Stephen , Smith , Sheila , Keehan , Sean , Clemens , M Kent , Won , Greg and Zezza , Mark . 2003 . 'Health spending projections for 2002-2012' . Health Affairs: Web Exclusives , 7 February http:// www.healthaffairs.org/WebExclusives/Heffler_Web_Excl_020703.htm. See also statement of Douglas Holtz-Eakin, Director 'Prescription drug coverage and Medicare's fiscal challenges' before the Committee on Ways and Means, US House of Representatives, 9 April 2003 http://www.cbo.gov/ showdoc.cfm?index =41598csequence =O 'Nationally, health care expenditures as a percentage of GDP have more than doubled over the past several decades, growing from 7.0 per cent in 1970 to 14.8 per cent in 2002. On a per capita basis, national spending for health care (in 2002 dollars) increased from $1321 in 1970 to $5366 in 2002, or at an average rate of about 4.5 per cent per year-which is about 2.4 percentage points faster than the growth of the underlying economy. The total percentage of health care spending on drugs is expected to rise to 14.5 per cent by 2012.'
  • Rai , Arti K . 2001 . 'The information revolution reaches pharmaceuticals: balancing innovation incentives, cost, and access in the post-genomics era' . University of Illinois Law Review , 173 : 176
  • Fuchs , Victor R . 1993 . The Future of Health Policy , 12 Cambridge , MA : Harvard University Press .
  • Ibid.
  • Scherer , FM and Watal , Jayashree . 2002 . 'Post-TRIPS options for access to patented medicines in developing nations' . Journal of Economic Law , 5 ( 4 ) : 913 – 939 . 919 Fuchs, op dt, note 40 at p 161. Indeed, Canada had a compulsory licensing system before 1982 that resulted in drug prices on average 47 per cent lower than US prices. Valium sold in Canada, for example, at $4.10 per 1000 units at a time when it sold in the USA for US $42 for the same quantity.
  • Hammer , Peter M . 2002 . 'Differential pricing of essential AIDS drugs: markets, politics, and public health' . Journal of Economic Law , 5 ( 4 ) : 883 – 912 . 888
  • Ibid.
  • Ibid.
  • Ibid at p 891.
  • Ibid at p 893.
  • Ibid at p 894.
  • Ibid at p 891.
  • Lanjouw , Jean O . 2002 . 'Intellectual property and the availability of pharmaceuticals in poor countries' . Innovation Policy and the Economy , 3 forthcoming.
  • Rai , Arti K . 2001 . 'Fostering cumulative innovation in the biopharmaceutical industry: the role of patents and antitrust' . Berkeley Technology Law Journal , 16 : 813 – 853 . 846 – 847 .
  • Heller , Michael A and Eisenberg , Rebecca S . 1998 . 'Can patents deter innovation? The anti-commons in biomedical research' . Science , 280 : 698 – 701 .
  • Ibid at p 700.
  • Scherer , Frederic M . 2002 . 'The economics of human gene patents' . Academic Medicine , 77 : 1348 – 1367 . 1364
  • Ibid at p 1352.
  • Ibid at p 1364.
  • Waldron , Jeremy . 2000 . On the road: good Samaritans and compelling duties' . Santa Clara Law Review , 40 : 1053 1070 (citations omitted)
  • Nagel , Thomas . 1991 . Equality and Partiality , 70 New York : Oxford University Press .
  • Ibid at pp 178-179
  • 2003 . 'Race to patent SARS virus renews debate" . USA Today , 6 May http://www.usatoday.com/ news/health/2003-05-06-sars-patent_x.htm
  • Ibid.
  • Tavis , Lee A . 2003 . 'Novartis and the U.N. Global Compact Initiative' . Vanderbilt Journal of Transnational Law , 36 March : 735

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