A new study assesses the impact of recent US Supreme Court rulings on the changing landscape of US patents claiming nucleic acids.
This is a preview of subscription content, access via your institution
Relevant articles
Open Access articles citing this article.
-
The 2014 Varsity Medical Ethics Debate: should we allow genetic information to be patented?
Philosophy, Ethics, and Humanities in Medicine Open Access 20 May 2015
Access options
Subscribe to this journal
Receive 12 print issues and online access
$209.00 per year
only $17.42 per issue
Buy this article
- Purchase on Springer Link
- Instant access to full article PDF
Prices may be subject to local taxes which are calculated during checkout
References
Fowler, C. Unnatural Selection (Gordon and Breach, Switzerland, 1994).
For clarity of exposition, we seek throughout to maintain a semantic distinction between the term “nucleic acid molecule” as a physical object and the term “nucleotide sequence” as abstract information or code describing the structure of such a molecule.
Heller, M.A. & Eisenberg, R.S. Science 280, 698–701 (1998).
Gold, E.R. Nature 18, 1217–1218 (2000).
Nuffield Council on Bioethics. The Ethics of Patenting DNA: a Discussion Paper (2002) <http://www.nuffieldbioethics.org/patenting-dna>.
Resnik, D. Owning the Genome: a Moral Analysis of DNA Patenting (State University of New York Press, Albany, NY, 2004).
National Research Council. Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health (National Academies Press, Washington, DC, 2006).
Holman, C.M. Univ. Missouri Kansas City Law Rev. 76, 295–361 (2007).
Association for Molecular Pathology v. USPTO, No. 2010–1406 (Fed. Cir. Aug. 16, 2012).
Cook-Deegan, R. Science 338, 745–747 (2012).
702 F. Supp. 2d 181 (S.D.N.Y. 2010).
653 F.3d 1329 (Fed. Cir. 2011).
132 S. Ct. 1289 (2012).
132 S. Ct. 1794 (2012).
Rogers, E.J. J. Pat. Trademark Off. Soc. 93, 19–56 (2010).
Caulfield, T., Gold, E.R. & Cho, M. Nat. Rev. Genet. 1, 227–231 (2000).
Jensen, K. & Murray, F. Science 310, 239–240 (2005).
Schauinger, S. The Human Gene Patent Report. <http://hgpr.org/finalHGPR.pdf> (2012).
Moreover, some claims specify sequences within a certain percentage of homology or similarity to a reference sequence, which for more highly conserved genetic sequences, can, in theory, encompass multiple species' versions of that gene.
Moreover, if interpreted more broadly, the “product of nature” exception being argued could logically be extended to composition-of-matter claims to other biological molecules with naturally occurring sequences or structures, including proteins and antibodies, but logically even fatty acids, vitamins, etc.
National Center for Biotechnology Information (NCBI). GenBank Nucleotide database. <http://www.ncbi.nlm.nih.gov/nuccore/>
Benson, D.A. et al. Nucleic Acids Res. 33, D34–D38 (2005).
Anonymous. Derwent World Patents Index (DWPI) CPI Manual Codes, Edn. 17, (Thomson Reuters, 2010). <http://ip-science.thomsonreuters.com/m/pdfs/cpi_manualcodes.pdf>
US patents in this analysis include all US patents referenced in NCBI's GenBank nucleotide sequence database, all US patents that responded to a full text query using all possible permutations of six-nucleotide (hexi-mer) sequences for both DNA and RNA as search terms, and all US patents identified by a select list of Derwent World Patent Index Manual Codes that refer to nucleotide sequences.
CAMBIA. PatentLens Sequence Search Facility. <http://www.patentlens.net/sequence/blast/blast.html>
Bacon, N. et al. (CAMBIA PatentLens, 2006). <http://www.patentlens.net/daisy/patentlens/2205.html>
Given the wide variety of ways in which a nucleotide sequence can be identified, such assessment is not straightforward. Bacon et al. analyzed 31,572 US patents granted between 2002 and 2010, almost all of which were referenced by nucleotide accessions to the GenBank nucleotide database. In 12,240 (39%) of these patents at least one nucleotide sequence is found in at least one of the claims of the patent. In the remaining 19,332 (61%), nucleotide sequences were not found in any of the claims. Our range of estimates is based upon the assumption that any additional patents found by our search algorithms have the same or lower probability of containing nucleotide sequence references in the claims as those included in the CAMBIA PatentLens data.
The precision and recall rates of the machine learning algorithms used (that is, the true positives relative to classification by the algorithm and to classification by experts, respectively, for subsets of the training sample) was greater than 93%.
Expiration was either (a) projected from patent application and grant dates or (b) determined from the International Patent Documentation Center (INPADOC) Legal Status data of the European Patent Office (EPO) (<http://www.epo.org/searching/subscription/raw/product-14-11.html>), such as for failure to pay maintenance fees.
Interestingly, all three of the patents being challenged in the Myriad case (US patents 5,747,282, 5,837,492, and 5,693,473) involve both public and private sector assignees. See Supplementary Notes 1 and 2, appendix S1, for copies of the front pages of these three patents.
Graff, G.D. et al. Nat. Biotechnol. 21, 989–995 (2003).
Pressman, L. et al. Nat. Biotechnol. 24, 31–39 (2006).
Venter, J.C. et al. Science 291, 1304–1351 (2001).
Goldfarb, B., Kirsch, D. & Miller, D. J. Financial Econ. 86, 100–144 (2007).
Interim Utility Examination Guidelines, 64 Fed. Reg. 71440 (December 21, 1999).
Utility Examination Guidelines, 66 Fed. Reg. 1092 (January 5, 2001).
Kling, J. EMBO Rep. 6, 1012–1014 (2005).
USPTO, 1316 O.G.13 (March 27, 2007).
In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009).
Acknowledgements
The authors sincerely thank E. Hicks, K. Lee and C. Pratt for capable research assistance, and K. Silverstein for helpful advice. This research was supported by the US National Institutes of Health grant number 5 R01 HG004041-03.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Competing interests
The authors declare no competing financial interests.
Supplementary information
Supplementary Text and Figures
Supplementary Notes 1 (PDF 841 kb)
Rights and permissions
About this article
Cite this article
Graff, G., Phillips, D., Lei, Z. et al. Not quite a myriad of gene patents. Nat Biotechnol 31, 404–410 (2013). https://doi.org/10.1038/nbt.2568
Published:
Issue Date:
DOI: https://doi.org/10.1038/nbt.2568
This article is cited by
-
After Myriad, what makes a gene patent claim 'markedly different' from nature?
Nature Biotechnology (2017)
-
Mapping the Patent Landscape in the Field of Personalized Medicine
Journal of Pharmaceutical Innovation (2017)
-
The emerging patent landscape of CRISPR–Cas gene editing technology
Nature Biotechnology (2016)
-
Myriad's impact on gene patents
Nature Biotechnology (2016)
-
The 2014 Varsity Medical Ethics Debate: should we allow genetic information to be patented?
Philosophy, Ethics, and Humanities in Medicine (2015)