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.

  • Feature
  • Published:

The licensing of DNA patents by US academic institutions: an empirical survey

Nature Biotechnology volume 24, pages 31–39 (2006)Cite this article

A survey of technology transfer of DNA inventions at 19 top US research universities reveals consensus, diversity and flexibility in intellectual property management. Patent filing and license terms are influenced by intended uses of inventions, outside market interest and NIH guidelines.

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

Figure 1
Figure 2
Figure 3
Figure 4
Figure 5
Figure 6: Percent of time there were competing interests at the time the license was signed.

References

  1. Rai, A.K. & Eisenberg, R.S. Bayh-Dole reform and the progress of biomedicine. Law Contemp. Probl. 66, 289–314 (2003).

    Google Scholar 

  2. Eisenberg, R.S. Structure and function in gene patenting. Nat. Genet. 15, 125–130 (1997).

    Article  CAS  PubMed  Google Scholar 

  3. Jensen, K. & Murray, F. The intellectual property landscape of the human genome. Science 310, 239–240 (2005).

    Article  CAS  PubMed  Google Scholar 

  4. Cho, M.K., Illangasekare, S., Weaver, M.A., Leonard, D.G.B. & Merz, J.F. Effects of patents and licenses on the provision of clinical genetic testing services. J. Mol. Diagn. 5, 3–8 (2003).

    Article  PubMed  PubMed Central  Google Scholar 

  5. Paradise J., Andrews, L. & Holbrook, T. Patents on human genes: an analysis of scope and claims. Science 307, 1566–1567 (2005).

    Article  CAS  PubMed  Google Scholar 

  6. Andrews, L.B. & Paradise, J. Gene patents: the need for bioethics scrutiny and legal change. Yale J. Health Policy Law Ethics 5, 403–412 (2005).

    PubMed  Google Scholar 

  7. Nuffield Council on Bioethics. The Ethics of Patenting DNA (Nuffield Council on Bioethics, London, 2002). http://www.nuffieldbioethics.org/go/screen/ourwork/patentingdna/introduction

  8. Commission on Intellectual Property Rights. Integrating Intellectual Property Rights and Development Policy (Commission on Intellectual Property Rights, London, September 2002). http://www.iprcommission.org/papers/pdfs/final_report/CIPRfullfinal.pdf (accessed October 13, 2005).

  9. Human Genetics Program, World Health Organization. Genetics, Genomics, and the Patenting of DNA (WHO, Geneva, 2005). http://www.who.int/genomics/patentingDNA/en/ (accessed October 13, 2005).

  10. Australian Law Reform Commission. Genes and Ingenuity: Gene Patenting and Human Health. Report 99 (Australian Law Reform Commission, Sydney, Australia, June 2004).

  11. Ontario Report to the Provinces and Territories. Genetics, Testing and Gene Patenting: Charting New Territory in Healthcare (Toronto, January 2002). http://www.health.gov.on.ca/english/public/pub/ministry_reports/geneticsrep02/report_e.pdf (accessed October 13, 2005).

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

    Article  CAS  PubMed  Google Scholar 

  13. Walsh, J., Cho, C. & Cohen, W.M. Patents, Material Transfers and Access to Research Inputs in Biomedical Research (Final Report to the National Academy of Sciences' Committee [on] Intellectual Property Rights in Genomic and Protein-Related Research Inventions, 20 September 2005). http://tigger.uic.edu/~jwalsh/WalshChoCohenFinal050922.pdf; (accessed November 21, 2005).

    Google Scholar 

  14. Walsh, J.P., Cho, C. & Cohen, W.M. View from the bench: patents and material transfers. Science 309, 2002–2003 (2005).

    Article  CAS  PubMed  Google Scholar 

  15. National Research Council. Intellectual Property Rights and Research Tools in Molecular Biology. Summary of a Workshop Held at the National Academy of Sciences, February 15–16, 1996. (National Academy Press, Washington, DC, USA, 1997).

  16. National Institutes of Health Working Group on Research Tools. Report of the National Institutes of Health Working Group on Research Tools, Presented to the Advisory Committee to the Director, June 4, 1998. (NIH, Bethesda, MD, 1998). http://www.nih.gov/news/researchtools/ (accessed 14 October 2005).

  17. Anonymous. Principles and guidelines for recipients of NIH research grants and contracts on obtaining and disseminating biomedical research resources. Federal Register 64, 72090–72096 (1999).

  18. Anonymous. Best practices for the licensing of genomic inventions. Federal Register 70, 18413–18415 (2005).

  19. Driscoll, C. Evolving NIH Patent and Licensing Policies and Practices for Genomic Inventions in the Post-Human Genome Project Era, as presented at “Toward Consensus on Benefits Sharing in Genetics Reserach”, Center for Bioethics, University of Pennsylvania, PA, March 3, 2003. Available at: http://www.genome.duke.edu/centers/gelp/downloads/cdriscoll_03mar03.pdf

  20. Spiegel, J. Best practices for the licensing of genomic inventions (draft), distributed at the AUTM annual meeting, Nov. 11, 2005. http://www.genome.duke.edu/centers/gelp/downloads/jspiegel_07feb04.pdf

  21. Malakoff, D. NIH roils academe with advice on licensing DNA patents. Science 303, 1757–1758 (2004).

    PubMed  Google Scholar 

  22. National Research Council, Committee on Intellectual Property Rights in Genomic and Protein Research and Innovation, Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health (report released 17 November 2005); available at http://books.nap.edu/catalog/11487.html (accessed 9 December 2005).

  23. Finnegan, Henderson, Farabow, Garrett & Dunner, LLP. The Finnegan Henderson 2005 Biotechnology Innovation Report. (Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, DC, USA, 2005).

    Google Scholar 

  24. Rosenberg, L. Intellectual Property Rights and Research Tools in Molecular Biology, Summary of a Workshop Held at the National Academy of Sciences, February 15–16, 1996, National Research Council, National Academy Press, Washington DC, 1997.

  25. US Court of Appeals for the Federal Circuit. Madey v. Duke, decided 3 October 2002 [307 F.3d 1351; 2002 US App. LEXIS 20823; 64 USP.Q.2D (BNA) 1737] (http://cyber.law.harvard.edu/people/tfisher/2002Madeyedit.html).

  26. Association of University Technology Managers, AUTM U.S. Licensing Survey, FY 2004: A Survey Summary of Technology Licensing (and Related) Performance for U.S. Academic and Nonprofit Institutions, and Technology Investment firms, editors Stevens, A.J., Toneguzzo, F. & Bostrom, D.” (http://www.autm.net/surveys/dsp.surveyDetail.cfm?pid=16; accessed 9 December 2005).

  27. Cohen, S.N. & Boyer, H.W. Process for producing biologically functional molecular chimeras. US patent 4237224 (1980).

  28. Cohen, S.N. & Boyer, H.W. Biologically functional molecular chimeras. US patent 4468464 (1984).

  29. Cohen, S.N. & Boyer, H.W. Biologically functional molecular chimeras. US patent 4740470 (1988).

  30. Hughes, S.S. Making dollars out of DNA. The first major patent in biotechnology and the commercialization of molecular biology. Isis. 92, 541–575 (2002).

    Article  Google Scholar 

  31. Axel, R., Wigler, M.H. & Silverstein, S.J. Processes for inserting DNA into eucaryotic cells and for producing proteinaceous materials. US patent 4399216 (1983).

  32. Axel, R., Wigler, M.H. & Silverstein, S.J. Processes for inserting DNA into eucaryotic cells and for producing proteinaceous materials. US patent 4634665 (1987).

  33. Axel, R. & Roberts, J.M. Method for introducing cloned, amplifiable genes into eucaryotic cells and for producing proteinaceous products. US patent 5149636 (1992).

  34. Axel, R., Wigler, M.H. & Silverstein, S.J. Processes for inserting DNA into eucaryotic cells and for producing proteinaceous materials. US patent 5179017 (1993).

  35. Axel, R., Wigler, M.H. & Silverstein, S.J. DNA construct for producing proteinaceous materials in eucaryotic cells. US patent 6455275 (2002).

  36. Mowery, D.C., Nelson, R.R., Sampat, B.N. & Ziedonis, A.A. Ivory Tower and Industrial Innovation. University-Industry Technology Transfer Before and After the Bayh-Dole Act (Stanford University Press, Stanford, CA, 2004) p. 158.

    Google Scholar 

Download references

Acknowledgements

The authors wish to thank the respondents at the 19 academic institutions that participated in this survey. The authors gratefully acknowledge the support of the National Human Genome Research Institute (grant no. 1 R03 HG02683) and the Department of Energy (grant no. DE-FG02-01ER63171) to Georgetown University (L.W.) and of both the National Human Genome Research Institute and the Department of Energy for a Centers of Excellence for Ethical, Legal, and Social Implications Research grant (CEER grant no. P50 HG003391) to Duke University (R.M.C.-D.). We also thank our advisory board members for expert suggestions as we designed the survey instrument, Bi Ade for her capable research assistance and Marian Nella Daggett for her helpful comments on an earlier draft of this article.

Author information

Authors and Affiliations

  1. Consultant to the Kennedy Institute of Ethics, 4 Crawford St., Cambridge, 02139, Massachusetts, USA

    Lori Pressman

  2. IP Data Corporation, 2003 Old Mission Road, New Smyrna Beach, 32162, Florida, USA

    Richard Burgess

  3. Institute for Genome Sciences & Policy, Duke University, Box 90141, Durham, 27708-0141, North Carolina, USA

    Robert M Cook-Deegan

  4. NeuroSystec Corporation, Alfred E. Mann Foundation for Biomedical Engineering, 25134 Rye Canyon Loop, Valencia, 91355, California, USA

    Stephen J McCormack

  5. Joseph and Rose Kennedy Institute of Ethics, Georgetown University, Washington, 20057-1212, DC, USA

    Io Nami-Wolk & Melissa Soucy

  6. Kennedy Institute of Ethics and Georgetown University, Washington, 20057-1212, DC, USA

    LeRoy Walters

Authors
  1. Lori Pressman
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Richard Burgess
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Robert M Cook-Deegan
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Stephen J McCormack
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Io Nami-Wolk
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Melissa Soucy
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. LeRoy Walters
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to LeRoy Walters.

Supplementary information

Supplementary Fig. 1

Issue dates of patents characterized by license status compared with issue dates of all patents (DOC 219 kb)

Supplementary Fig. 2

Issue dates of patents in the main questionnaire compared with issue dates of all patents (DOC 224 kb)

Supplementary Table 1

Respondents’ comments on diligence and termination (DOC 32 kb)

Supplementary Table 2

Respondents’ replies when asked to describe reasons for license termination in the Main Questionnaire (DOC 20 kb)

Supplementary Methods (DOC 97 kb)

Rights and permissions

Reprints and permissions

About this article

Cite this article

Pressman, L., Burgess, R., Cook-Deegan, R. et al. The licensing of DNA patents by US academic institutions: an empirical survey. Nat Biotechnol 24, 31–39 (2006). https://doi.org/10.1038/nbt0106-31

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1038/nbt0106-31

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