Examining the types of claim amendments that have transformed isolated gene claims from patent-ineligible into eligible subject matter provides clarity into the threshold of eligibility for gene-related patents.
References
Association for Molecular Pathology v. Myriad Genetics, Inc. 133 S. Ct. 2107 (2013).
Burk, D.L. J. Law Biosci. 2, 606–626 (2015).
USPTO. 2014 interim guidance on patent subject matter eligibility. Fed. Regist. 79, 74618–74633 (2014).
USPTO. July 2015 update: subject matter eligibility (USPTO, Alexandria, Virginia) https://www.uspto.gov/sites/default/files/documents/ieg-july-2015-update.pdf (2015).
Bahr, R. W. Formulating a subject matter eligibility rejection and evaluating the applicant's response to a subject matter eligibility rejection (USPTO, Alexandria, Virginia) https://www.uspto.gov/sites/default/files/documents/ieg-may-2016-memo.pdf (2016).
Mayo Collaborative Services v. Prometheus Laboratories, Inc. 132 S. Ct. 1289 (2012).
Alice Corp. v. CLS Bank International. 134 S. Ct. 2347 (2014)
USPTO. Subject matter eligibility (USPTO, Alexandria, Virginia) https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility (31 July 2017).
Sherkow, J.S. & Greely, H.T. Annu. Rev. Genet. 49, 161–182 (2015).
Guerrini, C.J., Majumder, M.A. & McGuire, A.L. Nat. Biotechnol. 34, 145–147 (2016).
Feldman, R. Stanford Law Policy Rev. 26, 16–22 (2014).
Ledford, H. Nature 498, 281–282 (2013).
Holbrook, T.R. & Janis, M.D. UC Irvine L. Rev. 5, 973 (2015).
Aboy, M., Liddell, K., Liddicoat, J. & Crespo, C. Nat. Biotechnol. 34, 1119–1123 (2016).
Graff, G.D. et al. Nat. Biotechnol. 31, 404–410 (2013).
Legal and Constitutional Affairs Legislation Committee, The Senate, Canberra, Australia. Patent Amendment (Human Genes and Biological Materials) Bill 2010 (September 2011).
Burk, D.L. Notre Dame Law Rev. 90, 505–542 (2016).
Rai, A.K. & Sherkow, J.S. Nat. Biotechnol. 34, 292–294 (2016).
American Intellectual Property Law Association. AIPLA Legislative Proposal and Report on Patent Eligible Subject Matter (2017).
Lundberg, S. Vol. 2016 Natl. Law Rev. (2016) https://www.natlawreview.com/article/dave-kappos-calls-abolition-section-101.
Thambisetty, S. Intellectual Property Quarterly (in the press).
Christie, A.F.D. et al. John Marshall Rev. Intellect. Prop. Law 16, 21–43 (2016).
Huys, I., Matthijs, G. & Van Overwalle, G. Nat. Rev. Genet. 13, 441–448 (2012).
USPTO. Nature-based products (USPTO, Alexandria, Virginia) https://www.uspto.gov/sites/default/files/documents/mdc_examples_nature-based_products.pdf (16 December 2014).
D'Arcy v. Myriad Genetics, Inc. 355 ALR 100 (2015).
Jefferson, O.A., Köllhofer, D., Ehrich, T.H. & Jefferson, R.A. Nat. Biotechnol. 31, 1086–1093 (2013).
Bubela, T. et al. Nat. Biotechnol. 31, 202–206 (2013).
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Competing interests
The authors declare no competing financial interests.
Supplementary information
Rights and permissions
About this article
Cite this article
Aboy, M., Liddicoat, J., Liddell, K. et al. After Myriad, what makes a gene patent claim 'markedly different' from nature?. Nat Biotechnol 35, 820–825 (2017). https://doi.org/10.1038/nbt.3953
Published:
Issue Date:
DOI: https://doi.org/10.1038/nbt.3953
- Springer Nature America, Inc.
This article is cited by
-
Mapping the patent landscape of medical machine learning
Nature Biotechnology (2023)
-
Relieving patent-eligibility barriers in biotech with a preparation or treatment method
Nature Biotechnology (2022)
-
European patent protection for medical uses of known products and drug repurposing
Nature Biotechnology (2022)
-
Mapping the European patent landscape for medical uses of known products
Nature Biotechnology (2021)
-
One year after Vanda, are diagnostics patents transforming into methods of treatment to overcome Mayo-based rejections?
Nature Biotechnology (2020)