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Monitoring of Biomedical License Agreements

A Practical Guide

  • Practical Application
  • Published:
Pharmaceutical Development and Regulation

Abstract

Because technology licensed from research organizations can play a significant role in drug innovation and the generation of novel biomedical products, licensee performance under such agreements must be effectively monitored. This is necessary so that resultant benefits, including public health improvement, may be returned to the innovator(s) as well as society at large. The tasks that comprise monitoring are varied, but all come under the general heading of ‘enforcement of license provisions’.

Since 1996, the license monitoring and enforcement program established by the US National Institutes of Health (NIH) Group has collected about $US17 million in unpaid and underpaid license royalties through formal financial audits and other investigative activities. During the same period, the Office of Technology Transfer (OTT) settled more than 60 cases of suspected patent infringement, generating around 60 new licenses and collected both back and ongoing royalties. As these numbers show, an active and effective monitoring program is an essential part of any technology transfer or biomedical licensing program.

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References

  1. Ferguson SM. Products, partners and public health: transfer of biomedical technologies from the US government. J Biolaw Bus 2002, 39

    Google Scholar 

  2. Keller, GH. Biomedical technology transfer in the government sector. ASM News 1998; 64(8): 454–7

    Google Scholar 

  3. Office of Technology Transfer PHS/NIH. Monitoring and enforcement figures as tabulated by the authors: official royalty figures for the entire NIH licensing program [online]. Available from URL: http://ott.od.nih.gov/NewPages/TTstats02.pdf [Accessed 2003 Sep 3]

  4. Ferguson SM, Kim JP. Distribution and licensing of drug discovery tools: NIH perspective. Drug Discov Today 2002; 7(2): 1102–6

    Article  PubMed  Google Scholar 

  5. National Archives and Records Administration. Code of federal regulations: 37 CFR (Code of Federal Regulation) Part 404.5(b)(4) [online]. Available from URL: http://www.access.gpo.gov/nara/cfr [Accessed 2003 Sep 3]

  6. National Institutes of Health. The Office of Technology Transfer: case study 1. Rockville (MD): National Institutes of Health, 2003. (Data on file)

    Google Scholar 

  7. US Securities and Exchange Commission. The EDGAR database: the archive of historical EDGAR documents [online]. Available from URL: http://www.sec.gov/cgi-bin/srch-edgar [Accessed 2003 Sep 3]

  8. RECAP. Recombinant capital [online]. Available from URL: http://www.recap.com [Accessed 2003 Sep 3]

  9. US Department of Treasury. News from the Office of Legislative and Public Affairs: the Debt Collection Improvement Act of 1996 (DCIA) [online]. Available from URL: http://www.fms.treas.gov/news/factsheets/dcia.html [Accessed 2003 Sep 3]

  10. National Institutes of Health. The Office of Technology Transfer: case study 2. Rockville (MD): National Institutes of Health, 2003. (Data on file)

    Google Scholar 

  11. US Food and Drug Administration. Department of Health and Human Services [online]. Available from URL: http://www.fda.gov/search.html [Accessed 2003 Sep 3]

  12. Converium. Doctrine of laches and patent infringement litigation [online]. Available from URL: http://www.converium.com/web/converium/converium.nsf/articles/5731FF9F4372B6ED85256B43006EA07D [Accessed 2003 Sep 3]

  13. National Institutes of Health. The Office of Technology Transfer: case study 3. Rockville (MD): National Institutes of Health, 2003. (Data on file)

    Google Scholar 

  14. National Institutes of Health. The Office of Technology Transfer: case study 4. Rockville (MD): National Institutes of Health, 2003. (Data on file)

    Google Scholar 

  15. Free Advice. Chapter 7 and chapter 11 business bankruptcy [online]. Available from URL: http://bankruptcy-law.freeadvice.com/business_bankruptcy/ [Accessed 2003 Sep 3]

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Acknowledgements

No sources of funding were used to assist in the preparation of this manuscript. The authors have no conflicts of interest that are directly relevant to the content of this manuscript.

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Authors and Affiliations

  1. National Institutes of Health, Office of Technology Transfer, US Department of Health and Human Services, Rockville, Maryland, USA

    George H. Keller,  Steven M. Ferguson (Director) & Percy Pan

Authors
  1. George H. Keller
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  2. Steven M. Ferguson
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  3. Percy Pan
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Corresponding author

Correspondence to Steven M. Ferguson.

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Keller, G.H., Ferguson, S.M. & Pan, P. Monitoring of Biomedical License Agreements. Pharm Dev Regul 1, 191–203 (2003). https://doi.org/10.1007/BF03257378

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