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.

  • Opinion
  • Published:

Genes and patent policy: rethinking intellectual property rights

Nature Reviews Genetics volume 3, pages 803–808 (2002)Cite this article

Abstract

Concerns about human gene patents go beyond moral disquiet about creating a commodity from a part of the human body and also beyond legal questions about whether genes are unpatentable products of nature. New concerns are being raised about harm to public health and to research. In response to these concerns, various policy options, such as litigation, legislation, patent pools and compulsory licensing, are being explored to ensure that gene patents do not impede the practice of medicine and scientific progress.

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

Similar content being viewed by others

References

  1. Doll, J. The patenting of DNA. Science 280, 689–690 (1998).

    Article  CAS  Google Scholar 

  2. Cole-Turner, R. Religion and gene patenting. Science 270, 52 (1995).

    Article  CAS  Google Scholar 

  3. Sturges, M. L. Who should hold property rights to the human genome? An application of the common heritage of humankind. Am. Univ. Intl Law Rev. 13, 219–261 (1997).

    Google Scholar 

  4. Diamond v. Chakrabarty, 447 US 303, 309 (1980).

  5. Eisenberg, R. Re-examining the role of patents in appropriating the value of DNA sequences. Emory Law J. 49, 783–800 (2000).

    CAS  PubMed  Google Scholar 

  6. Borger, J. Rush to patent genes stalls cures for disease. Guardian (Lond.) 1 (15 December 1999).

  7. Butler, D. & Goodman, S. French researchers take a stand against cancer gene patent. Nature 413, 95–96 (2001).

    Article  CAS  Google Scholar 

  8. Benowitz, S. French challenge to BRCA1 patent underlies European discontent. J. Natl Cancer Inst. 94, 80–81 (2002).

    Article  Google Scholar 

  9. Gad, S. et al. Identification of a large rearrangement of the BRCA1 gene using colour bar code on combed DNA in an American breast/ovarian cancer family previously studied by direct sequencing. J. Med. Genet. 38, 388–392 (2001).

    Article  CAS  Google Scholar 

  10. Merz, J. F. & Silverman, L. M. Uncovering rare mutations: an unforeseen complication of routine genotyping of APOE. Clin. Chem. 45, 1579–1581 (1999).

    Google Scholar 

  11. Merz, J. F., Kriss, A. G., Leonard, D. G. B. & Cho, M. K. Diagnostic testing fails the test: the pitfalls of patents are illustrated by the case of haemochromatosis. Nature 415, 577–579 (2002).

    Article  CAS  Google Scholar 

  12. Krimsky, S. The profit of scientific discovery and its normative implications. Chicago–Kent Law Rev. 75, 15–39 (1999).

    Google Scholar 

  13. Anand, G. Big drug makers try to postpone custom regimens. Wall Street J. B1 (18 June 2001).

  14. Marshall, E. Whose DNA is it anyway? Science 278, 564–567 (1997).

    Article  CAS  Google Scholar 

  15. Caulfield, T., Gold, E. R. & Cho, M. K. Patenting human genetic material: refocusing the debate. Nature Rev. Genet. 1, 227–231 (2000).

    Article  CAS  Google Scholar 

  16. Andrews, L. Future Perfect: Confronting Decisions About Genetics 127 (Columbia University Press, New York, 2001).

    Book  Google Scholar 

  17. Heller, M. A. & Eisenberg, R. S. Can patents deter innovation? The anticommons in biomedical research. Science 280, 698–701 (1998).

    Article  CAS  Google Scholar 

  18. Shapiro, C. in Innovation Policy and the Economy Vol. 1 (eds Jaffe, A., Lerner, J. & Stern, S.) 119–150 (MIT Press, Cambridge, Massachusetts, 2001). Available at http://www.haas.berkeley.edu/~shapiro/thicket.pdf

    Google Scholar 

  19. Merz, J., Kriss, A., Leonard, D. & Cho, J. Diagnostic testing fails the test. Nature 415, 577–579 (2002).

    Article  CAS  Google Scholar 

  20. American College of Medical Genetics. Position Statement on Gene Patents and Accessibility of Gene Testing (2 August 1999). Available at http://www.faseb.org/genetics/acmg/pol-34.htm

  21. College of American Pathologists. Gene Patents Detrimental to Care, Training, Research (5 July 2000). Available at http://www.cap.org/html/advocacy/issues/genetalk.html

  22. Borsellino, M. World Medical Association tackling health database issue. Med. Post 36, 40 (2000).

    Google Scholar 

  23. O'Reilly v. Morse, 56 US (15 How.) 62 (1853).

  24. Diamond v. Diehr, 450 US 175 (1981).

  25. Bender, D. Patents Claiming Computerized Methods of Doing Business — Recent Developments. 670 PLI/Pat 7 (November 2001).

  26. Portman, R. Legislative restriction on medical and surgical procedure patents removes impediment to medical progress. Univ. Baltimore Intellectual Property Law J. 4, 91–119 (1996).

    Google Scholar 

  27. Moore v. Regents of the University of California, 793 P. 2d 479 (1990).

  28. Gitter, D. 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, NY Univ. Law Rev. 76, 1623–1691 (2001).

    CAS  Google Scholar 

  29. 35 United States Code § 203.

  30. 42 United States Code § 7608.

  31. European Parliament and of the Council of 6 July 1998. Directive 98/44/EC on the legal protection of biotechnological inventions [online], (cited 21/8/02) 〈http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=en&numdoc=31998L0044&model=guichett〉

  32. Ex parte Scherer, 103 U. S. P. Q. 107, 110 (Board of Patent Appeals and Interferences, 1954).

  33. 35 United States Code § 287(c).

  34. Schulman, S. Owning The Future 41 (Houghton Mifflin, New York, 1999).

    Google Scholar 

  35. Williams, M. The TRIPS and Public Health Debate: an Overview. Intl Gender Trade Netwk (August 2001). Available at 〈http://www.genderandtrade.net/WTO/TRIPS%20and%20Public%20Health.pdf〉

    Google Scholar 

  36. Cooper, H., Zimmerman, R. & McGinley, L. Patents pending: AIDS epidemic traps drug firms in a vice: treatment vs. profits. Wall Street J. A1 (2 March 2001).

  37. Simmons, A. Suit against cheap AIDS drugs ends in South Africa. LA Times A1 (20 April 2001).

  38. Parke-Davis v. H. K. Mulford, 196 F. 496 (2d circa 1912).

  39. Genomic Research and Diagnostic Accessibility Act of 2002, H. R. 3967, 107th Congress, Second Session [online], (cited 21/8/02) 〈http://thomas.loc.gov/cgi-bin/query/z?c107:H.R.3967:〉

Download references

Author information

Authors and Affiliations

  1. Princeton University and Chicago-Kent College of Law, 565 West Adams Street, Chicago, 60661-3691, Illinois, USA

    Lori B. Andrews

Authors
  1. Lori B. Andrews
    View author publications

    You can also search for this author in PubMed Google Scholar

Related links

Related links

DATABASES

LocusLink

APOE

aspartoacylase

BRCA1

BRCA2

HFE

OMIM

Alzheimer disease

Canavan disease

haemochromatosis

FURTHER INFORMATION

American College of Medical Genetics

College of American Pathologists

Cure Autism Now

European Patent Office

Food and Drug Administration

Institut Curie

Trade-Related Intellectual Property Rights

US Patent and Trademark Office

World Medical Association

World Trade Organization

Rights and permissions

Reprints and permissions

About this article

Cite this article

Andrews, L. Genes and patent policy: rethinking intellectual property rights. Nat Rev Genet 3, 803–808 (2002). https://doi.org/10.1038/nrg909

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1038/nrg909

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