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Legal, Social and Policy Implications of Genetic Patents: Issues of Accessibility, Quality of Research and Public Health

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Abstract

Patenting of human gene and gene fragments has significant legal, social and policy implications as it exerts a wide range of effects on the accessibility of genetic research tools, genetic innovation, health policies, patients’ rights, clinical practice and the society at large. The potential of genetic research to produce commercial results has led to the rapid commercialisation of basic genetic research through commercial agreements and patents. The commercialisation of basic genetic research has threatened the free flow and open sharing of academic knowledge. The increased commercialisation of upstream (basic) genetic research has led to patenting of gene fragments such as expressed sequence tags (ESTs) and single nucleotide polymers (SNPs), which are basically research tools. Patenting of these genetic research tools may stifle genetic innovation as a researcher has to negotiate with the patentee about the license terms before using such a research tool. Patenting of genetic testing especially in the field of diagnostics has also become a very controversial issue. Overbroad patent claims and aggressive licensing strategies stifle the innovation process. A US-based multinational healthcare company Myriad Genetics’ patents on breast and ovarian cancer genes, BRCA1 and BRCA2, reflect various social and policy implications involved in patenting of genetic testing.

Keywords

Gene patents Genetic research Genetic research tools Research exemptions Diagnostic testing BRCA1 and BRCA2 gene Social and policy implications 

References

  1. Caulfield Timothy (2005) Policy Conflicts: Gene Patents and Health Care in Canada. Community Genetics 8:223.Google Scholar
  2. Cornish W. (1998) Experimental use of Patented Inventions. IIC 29:735.Google Scholar
  3. Duffy John F. (2002) Patent System Reform: Harmony and Diversity in Global Patent Law. Berkeley Technology Law Journal 17:685Google Scholar
  4. Dutfield Graham (2006) DNA patenting: implications for public health research. Bulletin of World Health Organisation 84: 389.Google Scholar
  5. Garforth Kathryn (2005) Health Care and Access to Patented Technologies. Health Law Journal 13: 77–97.Google Scholar
  6. Gold E. Richard, Joly Yann, Caulfield Tim (2005) Genetic Research Tool, The Research Exception and Open Science. GenEdit 3: 1.Google Scholar
  7. Heller Michael A. and Rebecca S. Eisenberg (1998) Can Patents Deter Innovation? The Anticommons in Biomedical Research. Science 280: 698Google Scholar
  8. Mueller Janice M. (2001) No “Dilettante Affair”: Rethinking the Experimental use exception to patent infringement for biomedical research tools. WashingtonLaw Review 76: 1Google Scholar
  9. Nuffield Council of Bioethics (2002) The ethics of patenting DNA, 5.24 http://www.nuffieldbioethics.org/sites/default/files/The%20ethics%20of%20patenting%20DNA%20a%20discussion%20paper.pdf. Accessed 18 May 2011.
  10. Paradise Jordan (2004) European Opposition to Exclusive Control Over Predictive Breast Cancer Testing and the Inherent implications for U.S. Patent law and Public Policy: A Case Study of the Myriad genetics’ BRCA 1 Patent Controversy. FOOD AND DRUG LAW JOURNAL 59: 135Google Scholar
  11. Patenting and the Research Exemption http://www.transknowlia.org/content/patenting-and-research-exemption. Accessed 12 August 2012
  12. Richard Gold, Timothy A. Caulfield, Ray Peter N. (2002) Gene patents and the standard of care. Canadian Medical Association Journal 167: 256.Google Scholar
  13. Rimmer Matthew (2008) Intellectual Property and Biotechnology: Biological Inventions. Edward Elgar Publishing, Inc., Massachsetts p. 187.Google Scholar
  14. Safrin Sabrina (2004) Hyperownership in a Time of Biotechnological Promise: The International Conflict to Control the Building Blocks of Life. The American Journal of International Law 98: 669Google Scholar
  15. Silverstein Tina, Joly Yann, Harmsen E. et al (2009) The Commercialisation of Genomic Academic Research: Conflicting Trend In: E. Richard Gold & Bartha Maria Knoppers (eds.) Biotechnology IP & Ethics LexisNexis Canada Inc., Markham, Ontario, p. 133.Google Scholar
  16. Sumikura Koichi (2009) Intellectual property rights policy for gene-related inventions-toward optimum balance between public and private ownership. In: David Castle (Ed.) The Role of Intellectual Property Rights in Biotechnology Innovation. Edward Elgar Publishing Limited, Cheltenham U.K./Massachusetts U.S.A. p. 77Google Scholar
  17. Thumm Nikolaus (2005) Patents for genetic inventions: a tool to promote technological advance or limitation for upstream inventions? Technovation 25:1410Google Scholar
  18. Vicky Clark, Pitfalls in drafting royalty provisions in patent licences. Bio-Science Law Review http://www.pharmalicensing.com/public/articles/view/1087832097_40d70021d738c. Accessed 10 May 2012
  19. Walsh John P., Arora Ashish, Cohen Wesley M. (2003) Working Through the Patent Problem. SCIENCE 299: 14Google Scholar
  20. Williams Bryn (2002) History of a Gene Patent: Tracing the Development and Application of Commercial BRCA Testing. Health Law Journal 10:137.Google Scholar
  21. Zekos Georgios I. (2005) Discrepancies in Biotechnology/Chemical Patenting. Journal of Intellectual Property Rights 10: 1Google Scholar

Copyright information

© Springer India 2015

Authors and Affiliations

  1. 1.Amity Law SchoolNoidaIndia

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