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Updated: May 3, 2026

Characterizing Mutational Load and Clonal Composition of Human Blood
Published on: July 11, 2019
The clones war
1Life Sciences Group of Birch, Stewart, Kolasch & Birch, LLP.
Abstract:
The debate over patent-eligible subject matter has recently extended to whether isolated DNA sequences should properly be protected by the patent system. The recent district court case of Association for Molecular Pathology v. U S. Patent and Trademark Office, 94 U.S.P.Q.2d (BNA) 1683 (SDNY March 29, 2010)(hereinafter Myriad) has unsettled the expectations of technology innovators and patent practitioners alike by holding that isolated DNA is not patent eligible because it is a product of nature. This article addresses this recent decision and critically analyzes the legal precedent and scientific assumptions underlying it, concluding that the opinion incorrectly applies binding case law precedent by requiring a new, heightened standard for patent eligibility, and ignores structural characteristics of isolated DNA that distinguish it from DNA in its natural state within a cell.
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