Hostname: page-component-586b7cd67f-tf8b9 Total loading time: 0 Render date: 2024-11-25T00:21:45.205Z Has data issue: false hasContentIssue false
  • English
  • Français

Patents and Genome-Wide DNA Sequence Analysis: Is it Safe to Go into the Human Genome?

Published online by Cambridge University Press:  01 January 2021

Robert Cook-Deegan  and
Subhashini Chandrasekharan
Get access Rights & Permissions [Opens in a new window]

Extract

Whether, and to what degree, do patents granted on human genes cast a shadow of uncertainty over genomics and its applications? Will owners of patents on individual genes or clusters of genes sue those performing whole-genome analyses on human samples for patent infringement? These are related questions that have haunted molecular diagnostics companies and services, coloring scientific, clinical, and business decisions. Can the profusion of whole-genome analysis methods proceed without fear of patent infringement liability?

Whole-genome sequencing (WGS) is proceeding apace. Academic centers have been performing whole-genome and -exome sequencing (WES) in research for at least five years, and academic clinical laboratories with national reach have been doing sequencing for clinical applications for almost as long. Companies have also been offering WGS and WES as a clinical service for a few years now. So far as we know, no one has been sued for infringement of “gene patents” for performing WGS.

Type
JLME Supplement
Information
Journal of Law, Medicine & Ethics , Volume 42 , Issue S1 , Fall 2014 , pp. 42 - 50
Copyright
Copyright © American Society of Law, Medicine and Ethics 2014

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

See Curnutte, M., McGuire, A. L., and Kaufman, D. J., “Development of the Clinical NGS Industry in a Shifting Policy Climate,” Nature Biotechnology (forthcoming, October 2014) and McGuire, A. L. et al., “Clinical Integration of Next Generation Sequencing: A Policy Analysis,” Journal of Law, Medicine & Ethics 42, no. 3, Supp. (2014): 5–8.Google Scholar
Graff, G. D., Phillips, D., and Lei, Z. et al., “Not Quite a Myriad of Gene Patents,” Nature Biotechnology 31, no. 5 (2013): 404–410.CrossRefGoogle Scholar
Jensen, K. and Murray, F., “Intellectual Property Landscape of the Human Genome,” Science 310, no. 5746 (2005): 239–240; Hopkins, M. M., Mahdi, S., Thomas, S. M. and Patel, P., “The Patenting of Human DNA: Global Trends in Public and Private Sector Activity (The PATGEN Project),” A report for the European Commission, compiled by Science Policy Research Unit, University of Sussex, Brighton, UK, November 2006, available at <http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2395987> (last visited July 29, 2014); Schauinger, S., Human Gene Patent Report, 2012, available at <http://hgpr.org/finalHGPR.pdf> (last visited June 13, 2014); Holman, C. M., “Debunking the Myth that Whole-Genome Sequencing Infringes Thousands of Gene Patents,” Nature Biotechnology 30, no. 3 (2012): 240–244; Price, W. N., “Unblocked Future: Why Gene Patents Won't Hinder Whole-Genome Sequencing and Personalized Medicine,” Cardozo Law Review 33, no. 4 (2012): 1601–1632.CrossRefGoogle Scholar
Id. (Holman) supra note 3; also see Price, supra note 3.Google Scholar
Feldman, R. and Price, W. N. II, “Patent Trolling – Why Bio & Pharmaceuticals Are at Risk,” Social Sciences Research Network, UC Hastings Research Paper #93 (2014), available at <http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2395987> (last visited July 29, 2014).CrossRef+(last+visited+July+29,+2014).>Google Scholar
Rai, A. K. and Cook-Deegan, R., “Moving beyond ‘Isolated’ Gene Patents,” Science 341, no. 6142 (2013): 137–138; Gold, R. E., Cook-Deegan, R., and Bubela, T., “AMP v. Myriad: A Surgical Strike on Blockbuster Business Models,” Science Translational Medicine 5, no. 192 (2013): 192ed199; Kesselheim, A. S., Cook-Deegan, R. M., Winickoff, D. E., and Mello, M. M., “Gene Patenting – The Supreme Court Finally Speaks,” New England Journal of Medicine 369, no. 9 (2013): 869–875.CrossRefGoogle Scholar
Myriad Genetics., BRCA Patent Owners and Gene by Gene, Ltd. Resolve Patent Suit Press Release, February 7, 2014.Google Scholar
Oral Arguments in Association for Molecular Pathology v. US Patent and Trademark Office, Court of Appeals for the Federal Circuit. 2011 (April 4, 2011).Google Scholar
Id.Google Scholar
Id.Google Scholar
Heller, M. A. and Eisenberg, R. S., “Can Patents Deter Innovation? The Anticommons in Biomedical Research,” Science 280, no. 5364 (1998): 698–701.CrossRefGoogle Scholar
See supra note 2.Google Scholar
See Heller, and Eisenberg, , supra note 10; Doll, J. J., “Talking Gene Patents,” Scientific American 285, no. 2 (2001): 28; Healy, B., “On Gene Patenting,” New England Journal of Medicine 327, no. 9 (1992): 664–668; Kiley, T. D., “Patents on Random Complementary DNA Fragments?” Science 257, no. 5072 (1992): 915–918.Google Scholar
Cancer Voices Australia and Yvonne D'Arcy v. Myriad Genetics and Genetic Technologies Ltd. In.: Federal Court of Australia, New South Wales District, 2013.Google Scholar
Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. _ 132 S.Ct. 1289 (2012).Google Scholar
Huys, I., Berthels, N., Matthijs, G., and Van Overwalle, G., “Legal Uncertainty in the Area of Genetic Diagnostic Testing,” Nature Biotechnology 27, no. 10 (2009): 903–909.CrossRefGoogle Scholar
See Mayo Collaborative Services v. Prometheus Laboratories, Inc., supra note 14.Google Scholar
Association for Molecular Pathology v. U.S. Patent and Trademark Office, US Distrct Court for the Southern District of New York.Google Scholar
Association of Molecular Pathology v. US Patent and Trademark Office, Rev'd in part; aff'd in part edn: U.S. District Court, Southern District of New York, 2010.Google Scholar
Association of Molecular Pathology v. US Patent and Trademark Office, U.S. Court of Appeals for the Federal Circuit, 2011.Google Scholar
Association for Molecular Pathology v. Myriad Genetics, Reversed in part, affirmed in part edn: U.S. Supreme Court, 2013.Google Scholar
Id.Google Scholar
Green, R. C., Berg, J. S., Grody, K. W., Kalia, S. S., Korf, B. R., Martin, C. L., McGuire, A. L., Nussbaum, R. L., O'Daniel, J. M., and Ormond, K. E. et al., “ACMG Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing,” Genetics in Medicine 15, no. 7 (2013): 565–574.CrossRefGoogle Scholar
See Association of Molecular Pathology v. US Patent and Trademark Office, supra note 19.Google Scholar
University of Utah, v. Ambry Genetics, U.S. District Court for Utah.Google Scholar
U.S. Judicial Panel on Multidistrict Litigation: In Re: BRCAlAND BRCA2-Based Hereditary Cancer Test Patent Litigaton, February 27, 2014.Google Scholar
University of Utah, v. Ambry Genetics, U.S. District Court for Utah, Case 2:13-cv-00640-RJS.Google Scholar
Memorandum decision and order denying plaintiffs motion for preliminary injunction, Case 2:13-cv-00640-RJS Document 185, U.S. District Court for Utah, 2014.Google Scholar
Myriad Genetics Notice of Appeal to Court of Appeals for the Federal Circuit, Case: 14–1361 Document: 2–1, U.S. Court of Appeals for the Federal Circuit, 2014.Google Scholar
See supra note 28.Google Scholar
See supra note 29.Google Scholar