A new study assesses the impact of recent US Supreme Court rulings on the changing landscape of US patents claiming nucleic acids.
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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.
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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.
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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.
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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.
The authors declare no competing financial interests.
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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
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