Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Commentary
  • Published:

DNA patents and diagnostics: not a pretty picture

Nature Biotechnology volume 28, pages 784–791 (2010)Cite this article

Subjects

Restrictive licensing practices on DNA patents are stymieing clinical access and research on genetic diagnostic testing. Diagnostic companies, university tech transfer offices and their respective associations need to pay more attention.

This is a preview of subscription content, access via your institution

Access options

Buy this article

  • Purchase on Springer Link
  • Instant access to full article PDF
Buy now

Prices may be subject to local taxes which are calculated during checkout

References

  1. Diamond v. Chakrabarty, 447 U.S. 303 (1980).

  2. Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al. (USDC SDNY 09 Civ. 4515, 2010).

  3. Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (560 F3d 1366 (Fed Cir 2009).

  4. Secretary's Advisory Committee on Genetics Health and Society, National Institutes of Health. Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests (SACGHS, Washginton, DC, 2010).

  5. Merz, J.F. Clin. Chem. 45, 324–330 (1999).

    CAS  PubMed  Google Scholar 

  6. Heller, M.A. & Eisenberg, R.A. Science 280, 698–701 (1998).

    Article  CAS  Google Scholar 

  7. Chandrasekharan, S. & Cook-Deegan, R. Genome Med. 1, 92 (2009).

    Article  Google Scholar 

  8. Holman, C.M. Science 322, 198–199 (2008).

    Article  CAS  Google Scholar 

  9. Nelson, R. J. Technol. Transf. 26, 13–19 (2001).

    Article  Google Scholar 

  10. Mowery, D.C. et al. Res. Policy 30, 99–119 (2001).

    Article  Google Scholar 

  11. Pressman, L. et al. Nat. Biotechnol. 24, 31–39 (2006).

    Article  CAS  Google Scholar 

  12. Schissel, A., Merz, J.F. & Cho, M.K. Nature 402, 118 (1999).

    Article  CAS  Google Scholar 

  13. Henry, M.R., Cho, M.K., Weaver, M.A. & Merz, J.F. Science 297, 1279 (2002).

    Article  CAS  Google Scholar 

  14. Gold, E.R. & Carbone, J. Genet. Med. 12 Suppl, S39–S70 (2010).

    Article  CAS  Google Scholar 

  15. Skeehan, K., Heaney, C. & Cook-Deegan, R. Genet. Med. 12 Suppl, S71–S82 (2010).

    Article  CAS  Google Scholar 

  16. Merz, J.F. in The Penn Center Guide to Bioethics (eds. Ravitsky, F., Feister, A. & Caplan, A.L.) 383–385 (Springer, New York, 2009).

    Google Scholar 

  17. Nuffield Council on Bioethics. The Ethics of Patenting DNA (Nuffield Council on Bioethics, London, 2002).

  18. Cook-Deegan, R. et al. Genet. Med. 12 Suppl, S15–S38 (2010).

    Article  Google Scholar 

  19. Angrist, M., Chandrasekharan, S., Heaney, C. & Cook-Deegan, R. Genet. Med. 12 Suppl, S111–S154 (2010).

    Article  CAS  Google Scholar 

  20. Chandrasekharan, S. & Fiffer, M. Genet. Med. 12 Suppl, S171–S193 (2010).

    Article  CAS  Google Scholar 

  21. Chandrasekharan, S., Heaney, C., James, T., Conover, C. & Cook-Deegan, R. Genet. Med. 12 Suppl, S194–S211 (2010).

    Article  CAS  Google Scholar 

  22. Chandrasekharan, S., Pitlick, E., Heaney, C. & Cook-Deegan, R. Genet. Med. 12 Suppl, S155–S170 (2010).

    Article  CAS  Google Scholar 

  23. Colaianni, A., Chandrasekharan, S. & Cook-Deegan, R. Genet. Med. 12 Suppl, S5–S14 (2010).

    Article  Google Scholar 

  24. Powell, A., Chandrasekharan, S. & Cook-Deegan, R. Genet. Med. 12 Suppl, S83–S110 (2010).

    Article  Google Scholar 

  25. Cook-Deegan, R., Chandrasekharan, S. & Angrist, M. Nature 458, 405–406 (2009).

    Article  CAS  Google Scholar 

  26. Caulfield, T., Cook-Deegan, R.M., Kieff, F.S. & Walsh, J.P. Nat. Biotechnol. 24, 1091–1094 (2006).

    Article  CAS  Google Scholar 

  27. National Research Council. Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation and Public Health (National Research Council, Washington, DC, 2006).

  28. Ontario Report to the Provinces and Territories. Genetics, Testing and Gene Patenting: Charting New Territory in Healthcare (Government of Ontario, Toronto, Ontario, Canada, 2002).

  29. Australian Law Reform Commission. Essentially Yours: The Protection of Human Genetic Information in Australia (ALRC 96) (ALRC, Sydney, New South Wales, Australia, 2003).

  30. Gold, E.R., Bubela, T., Miller, F.A., Nicol, D. & Piper, T. Nat. Biotechnol. 25, 388–389 (2007).

    Article  CAS  Google Scholar 

  31. Gold, E.R. Nat. Biotechnol. 18, 1319–1320 (2000).

    Article  CAS  Google Scholar 

  32. Nicol, D. & Nielsen, J. Patents and Medical Biotechnology: An Empirical Analysis of Issues Facing the Australian Industry (Occasional Paper no. 6) (Centre for Law & Genetics, Sandy Bay, Tasmania, Australia, 2003).

    Google Scholar 

  33. Cho, M.K., Illangasekare, S., Weaver, M.A., Leonard, D.G.B. & Merz, J.F. J. Mol. Diagn. 5, 3–8 (2003).

    Article  Google Scholar 

  34. Rai, A. Northwest. Univ. Law Rev. 94, 77–152 (1999).

    CAS  PubMed  Google Scholar 

  35. Merz, J.F., Kriss, A.G., Leonard, D.G. & Cho, M.K. Nature 415, 577–579 (2002).

    Article  CAS  Google Scholar 

  36. Merz, J.F., Cho, M.K., Robertson, M.J. & Leonard, D.G. Mol. Diagn. 2, 299–304 (1997).

    Article  CAS  Google Scholar 

  37. Merz, J.F. & Cho, M.K. Camb. Q. Healthc. Ethics 7, 425–428 (1998).

    Article  CAS  Google Scholar 

  38. Andrews, L.B. Nat. Rev. Genet. 3, 803–808 (2002).

    Article  CAS  Google Scholar 

  39. LOI no 613–16 as amended in 2004.

  40. Overwalle, G.V. Int. Rev. Intellect. Property Competition Law 889, 908–918 (2006).

    Google Scholar 

  41. Fed. Reg. 66, 1092–1099 (2001).

  42. Fed. Reg. 70, 18413–18415 (2005).

  43. Organisation for Economic Co-operation and Development. Guidelines for the Licensing of Genetic Inventions (OECD, Paris, 2006).

  44. In the Public Interest: Nine Points to Consider in Licensing University Technology (AUTM, Deerfield, Illinois, USA, 2007).

  45. Association of University Technology Managers. University Principles on Global Access to Medicines (AUTM, Deerfield, Illinois, USA, 2009).

  46. Rimmer, M. Eur. Intellectual Prop. Rev. 25, 20–33 (2003).

    Google Scholar 

  47. American Medical Association. Report 9 of the Council on Scientific Affairs (AMA, Chicago, 2000).

  48. Huys, I., Berthels, N., Matthijs, G. & Van Overwalle, G. Nat. Biotechnol. 27, 903–909 (2009).

    Article  CAS  Google Scholar 

  49. Laboratory Corporation of America Holdings, dba Labcorp v. Metabo-Lite Laboratories, Inc. et al., 548 U.S. 124 (2006).

  50. eBay Inc. v. MercExchange, LLC, 547 U.S. 388 (2006).

  51. Bilski v. Kappos, 561 U.S. ____ 20010 (No. 08–964), affirming F.3d 943 3d 943 (Fed. Cir. 2008).

  52. In re Kubin (Fed Cir. 2009).

  53. KSR International Co. v. Teleflex, Inc., 550 U.S. 398 (2007).

  54. Van Overwalle, G., van Zimmeren, E., Verbeure, B. & Matthijs, G. Nat. Rev. Genet. 7, 143–148 (2006).

    Article  CAS  Google Scholar 

  55. Walsh, J.P., Ashish, A. & Cohen, W. in Effects Of Research Tool Patents And Licensing On Biomedical Innovation (eds. Cohen, W. & Merrill, S.) 285–336 (National Academies Press, Washington, DC, 2003).

    Google Scholar 

  56. Gold, E.R. et al. The Research or Experimental Use Exception: A Comparative Analysis (Centre for Intellectual Property Policy/Health Law Institute, Montreal, Quebec, Canada, 2005).

    Google Scholar 

  57. Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005).

  58. Siegel, D.S. & Wright, M. Oxford Rev. Econ. Policy 23, 529–540 (2007).

    Article  Google Scholar 

  59. http://www.mpegla.com/Lists/MPEG%20LA%20News%20List/Attachments/230/n-10–04–08.pdf, Last Accessed May 4, 2010.

  60. http://www.bio.org/news/pressreleases/newsitem.asp?id=2010_0205_01 (5 February 2010).

  61. http://bio.org/ip/genepat/documents/SACGHSsign-onletter2-4-2010final_000.pdf

  62. Bayh-Doyle Act, 37 C.F.R. Part 401.

Download references

Author information

Authors and Affiliations

  1. Julia Carbone is at Duke University's School of Law, Durham, North Carolina, USA.,

    Julia Carbone

  2. E. Richard Gold is at McGill University's Faculty of Law and Faculty of Medicine, Montreal, Québec, Canada,

    E Richard Gold

  3. Bhaven Sampat is at Columbia University's Department of Health Policy and Management, New York, NY, USA.,

    Bhaven Sampat

  4. Subhashini Chandrasekharan is at Duke University's Center for Genome Ethics, Law & Policy, Institute for Genome Sciences and Policy, Durham, NC, USA,

    Subhashini Chandrasekharan

  5. Lori Knowles is at the University of Alberta's Health Law Institute, Edmonton, Alberta, Canada.,

    Lori Knowles

  6. Misha Angrist is at Duke University's Institute for Genome Sciences & Policy, Durham, NC, USA.,

    Misha Angrist

  7. Robert Cook-Deegan is at Duke University's Center for Genome Ethics, Law & Policy, Institute for Genome Sciences and Policy, Durham, NC, USA.,

    Robert Cook-Deegan

Authors
  1. Julia Carbone
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. E Richard Gold
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Bhaven Sampat
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Subhashini Chandrasekharan
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Lori Knowles
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Misha Angrist
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Robert Cook-Deegan
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Robert Cook-Deegan.

Ethics declarations

Competing interests

The authors declare no competing financial interests.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Carbone, J., Gold, E., Sampat, B. et al. DNA patents and diagnostics: not a pretty picture. Nat Biotechnol 28, 784–791 (2010). https://doi.org/10.1038/nbt0810-784

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1038/nbt0810-784

This article is cited by

Search

Advanced search

Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing