Not quite a myriad of gene patents

Journal name:
Nature Biotechnology
Volume:
31,
Pages:
404–410
Year published:
DOI:
doi:10.1038/nbt.2568
Published online

A new study assesses the impact of recent US Supreme Court rulings on the changing landscape of US patents claiming nucleic acids.

At a glance

Figures

  1. The shifting structure of US patents referring to and claiming nucleotide sequences.
    Figure 1: The shifting structure of US patents referring to and claiming nucleotide sequences.

    The darker categories are those more likely at risk if the “product of nature” exception to patent eligibility is extended to isolated nucleic acid molecules with naturally occurring sequences.

  2. The primary sources of nucleotide sequences in the 15,359 gene patents (that is, patents with at least one composition-of-matter claim to a simple DNA or RNA molecule) granted in the United States.
    Figure 2: The primary sources of nucleotide sequences in the 15,359 gene patents (that is, patents with at least one composition-of-matter claim to a simple DNA or RNA molecule) granted in the United States.

    (a) Annual counts. (b) Annual shares.

  3. Current legal status of the 15,359 gene patents granted in the United States, by grant year.
    Figure 3: Current legal status of the 15,359 gene patents granted in the United States, by grant year.
  4. Shares of assignee types of the 15,359 gene patents granted in the United States.
    Figure 4: Shares of assignee types of the 15,359 gene patents granted in the United States.

    (a) Cumulative shares. (b) Annual counts. (c) Annual shares.

References

  1. Fowler, C. Unnatural Selection (Gordon and Breach, Switzerland, 1994).
  2. 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.
  3. Heller, M.A. & Eisenberg, R.S. Science 280, 698701 (1998).
  4. Gold, E.R. Nature 18, 12171218 (2000).
  5. Nuffield Council on Bioethics. The Ethics of Patenting DNA: a Discussion Paper (2002) <http://www.nuffieldbioethics.org/patenting-dna>.
  6. Resnik, D. Owning the Genome: a Moral Analysis of DNA Patenting (State University of New York Press, Albany, NY, 2004).
  7. National Research Council. Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health (National Academies Press, Washington, DC, 2006).
  8. Holman, C.M. Univ. Missouri Kansas City Law Rev. 76, 295361 (2007).
  9. Association for Molecular Pathology v. USPTO, No. 2010–1406 (Fed. Cir. Aug. 16, 2012).
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  11. 702 F. Supp. 2d 181 (S.D.N.Y. 2010).
  12. 653 F.3d 1329 (Fed. Cir. 2011).
  13. 132 S. Ct. 1289 (2012).
  14. 132 S. Ct. 1794 (2012).
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  19. 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.
  20. 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.
  21. National Center for Biotechnology Information (NCBI). GenBank Nucleotide database. <http://www.ncbi.nlm.nih.gov/nuccore/>
  22. Benson, D.A. et al. Nucleic Acids Res. 33, D34D38 (2005).
  23. Anonymous. Derwent World Patents Index (DWPI) CPI Manual Codes, Edn. 17, (Thomson Reuters, 2010). <http://ip-science.thomsonreuters.com/m/pdfs/cpi_manualcodes.pdf>
  24. 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.
  25. CAMBIA. PatentLens Sequence Search Facility. <http://www.patentlens.net/sequence/blast/blast.html>
  26. Bacon, N. et al. (CAMBIA PatentLens, 2006). <http://www.patentlens.net/daisy/patentlens/2205.html>
  27. Given the wide variety of ways in which a nucleotide sequence can be identified, such assessment is not straightforward. Bacon et al.26 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.
  28. 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%.
  29. 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.
  30. 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.
  31. Graff, G.D. et al. Nat. Biotechnol. 21, 989995 (2003).
  32. Pressman, L. et al. Nat. Biotechnol. 24, 3139 (2006).
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  34. Goldfarb, B., Kirsch, D. & Miller, D. J. Financial Econ. 86, 100144 (2007).
  35. Interim Utility Examination Guidelines, 64 Fed. Reg. 71440 (December 21, 1999).
  36. Utility Examination Guidelines, 66 Fed. Reg. 1092 (January 5, 2001).
  37. Kling, J. EMBO Rep. 6, 10121014 (2005).
  38. USPTO, 1316 O.G.13 (March 27, 2007).
  39. In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009).

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Author information

Affiliations

  1. Gregory D. Graff is in the Department of Agricultural and Resource Economics, Colorado State University, Fort Collins, Colorado, USA

  2. Devon Phillips and Philip G. Pardey are in the Department of Applied Economics, University of Minnesota, St. Paul, Minnesota, USA

  3. Zhen Lei is in the Department of Energy and Mineral Engineering and EMS Energy Institute, Pennsylvania State University, University Park, Pennsylvania, USA

  4. Sooyoung Oh is in the Department of Computer Science and Engineering, Pennsylvania State University, University Park, Pennsylvania, USA; and

  5. Carol Nottenburg is at Cougar Patent Law, Renton, Washington, USA.

  6. Gregory D. Graff, Zhen Lei, Carol Nottenburg and Philip G. Pardey are also at the International Science and Technology Practice and Policy (InSTePP) Center, Department of Applied Economics, University of Minnesota, St. Paul, Minnesota, USA.

Competing financial interests

The authors declare no competing financial interests.

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Supplementary information

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  1. Supplementary Text and Figures (864 KB)

    Supplementary Notes 1

Excel files

  1. Supplementary Notes 2 (4.7 MB)

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