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Debunking the myth that whole-genome sequencing infringes thousands of gene patents

Nature Biotechnology volume 30, pages 240–244 (2012)Cite this article

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The fear that human gene patents pose a threat to whole-genome sequencing is based largely on widely held misconceptions.

Thanks to rapid advances in DNA sequencing technology, the cost of whole-genome sequencing (WGS) is plummeting, and it is anticipated that the much heralded '$1,000 genome' will soon be a reality. Increasingly, however, there is concern that gene patents will impede the implementation of personal genome sequencing, to the detriment of multigenic diagnostic testing and personalized medicine.

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References

  1. Association for Molecular Pathology v. U.S. Patent and Trademark Office, 653 F.3d 1329 (Fed. Cir. 2011) http://www.patentdocs.org/2011/07/federal-circuit-issues-decision-in-amp-v-uspto.html (accessed 16 January 2012).

  2. Utility Examination Guidelines, 66 Fed. Reg. 1092 (January 5, 2001).

  3. US patents are freely available online from a number of sources, such as the US Patent and Trademark Office website (http://patft.uspto.gov/) and Google Patent (http://www.google.com/patents).

  4. Jensen, K. & Murray, F. Science 310, 239–240 (2005).

    Article  CAS  Google Scholar 

  5. More specifically, they conducted an automated search to identify all US patents reciting the canonical term “SEQ ID NO.” in the claims, and wherein the “SEQ ID NO.” term is used in conjunction with a specific genetic sequence corresponding to a known human gene. Jensen & Murray's Supporting Online Material, available at http://www.sciencemag.org/cgi/data/310/5746/239/DC1/1 (last visited January 16, 2012).

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

    Article  CAS  Google Scholar 

  7. The query employed by Jensen & Murray identified as 'gene patents' patents that claimed proteins by reference to the DNA sequence encoding the protein, or by reference to a SEQ ID NO. that identified not only a DNA sequence, but also the amino acid sequence encoded by the DNA sequence.

  8. Price, W.N. II Cardozo L. Rev. 33, (2012). http://ssrn.com/abstract=1914560

  9. Holman, C.M. IP Theory 2, 4–7 (2011).

    Google Scholar 

  10. Anonymous. Single Molecule Real Time (SMRT™) DNA Sequencing (Pacific Biosciences, 2009) http://www.pacificbiosciences.com/assets/files/pacbio_technology_backgrounder.pdf (accessed 16 January 2012).

  11. Personal communication, R. Cook-Deegan.

  12. Brief of Amici Curiae Christopher M. Holman and Robert Cook-Deegan, Association for Molecular Pathology v. US PTO, Federal Circuit Docket Number 2010–1406, 2010 WL 4853323 (2010).

  13. Billups-Rothenberg, Inc. v. Associated Regional and University Pathologists, Inc., 1401.pdf 642 F.3d 1031 (Fed. Cir 2011) http://www.patentlyo.com/files/10-1401.pdf (accessed 16 January 2012).

  14. Oral argument in Association for Molecular Pathology v. US Patent and Trademark Office, Federal Circuit Docket Number 10–1406 http://www.cafc.uscourts.gov/oral-argument-recordings/search/audio.html at 55–56 minutes into the proceedings (accessed 16 January 2012).

  15. Kepler, T.B., Crossman, C. & Cook-Deegan, R. Genomics 95, 312–314 (2010).

    Article  CAS  Google Scholar 

  16. Davies, K. The $1,000 Genome: the Revolution in DNA Sequencing and the New Era of Personalized Medicine (Free Press, New York, 2010).

    Google Scholar 

  17. Holman, C. Myriad Genetics files amicus briefs in joint infringement cases Akamai and McKesson. Holman's Biotech IP Blog (24 July 2011) http://holmansbiotechipblog.blogspot.com/2011/07/myriad-genetics-files-amicus-briefs-in.html

    Google Scholar 

  18. Secretary's Advisory Committee on Genetics, Health, and Society. Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests. (US Department of Health and Human Services, April 2010) http://oba.od.nih.gov/oba/sacghs/reports/SACGHS_patents_report_2010.pdf (accessed 16 January 2012).

  19. Huys, I. et al. Nat. Biotechnol. 27, 903–909 (2009).

    Article  CAS  Google Scholar 

  20. Cook-Deegan, R. & Heaney, C. Annu. Rev. Genomics Hum. Genet. 11, 383–414 (2010).

    Article  CAS  Google Scholar 

  21. Amgen v. Chugai, 927 F.2d 1200 (Fed. Cir. 1991).

  22. http://portal.uspto.gov/external/portal/pair (accessed 16 January 2012).

  23. Moran, N. Nat. Biotechnol. 30, 3–5 (2012).

    Article  CAS  Google Scholar 

  24. Holman, C.M. Gene patents under fire: weighing the costs and benefits. in Biotechnology and Software Patent Law: a Comparative Review of New Developments. (Arezzo, E. & Ghidini, G., eds.) (Edward Elgar Publishing, 2011). Draft manuscript, http://ssrn.com/abstract=1710150 (accessed 16 January 2012).

    Google Scholar 

Download references

Acknowledgements

This research was conducted with financial support from the Biotechnology Industry Organization (BIO). The design, analysis and composition of this manuscript was conducted independently by me, and I am responsible for any errors or omissions. The views and conclusions expressed herein are my own, and do not necessarily reflect the views of BIO or any of its members. I am grateful to K. Jensen and F. Murray for sharing their patent data, and R. Cook-Deegan for helpful commentary.

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  1. Christopher M. Holman is at the University of Missouri-Kansas City School of Law, Kansas City, Missouri, USA.,

    Christopher M Holman

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Correspondence to Christopher M Holman.

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Holman, C. Debunking the myth that whole-genome sequencing infringes thousands of gene patents. Nat Biotechnol 30, 240–244 (2012). https://doi.org/10.1038/nbt.2146

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