What’s the Use? The "Utility" of DNA Sequences as Intellectual Property and Molecular Diagnostics

• In Event: Precision and Uncertainty in a World of Data - III

Abstract

Questions about the “utility” of DNA sequences surfaced in two distinct spheres of debate during the 1990s. The first concerned intellectual property law. Fears that the proliferation of DNA sequence patents was hindering research led to reconsideration of the utility requirement for patentable subject matter. By distinguishing scientific from practical utility, lawyers demarcated a domain of unpatentable biological products, but introduced new uncertainties about where the boundary lay.

The second sphere of debate concerned diagnostic use of DNA sequences. Cloning and sequencing disease genes opened up new diagnostic possibilities. But genomic tests also came with their own, potentially harmful uncertainties. To limit those harms, medical geneticists urged that the use of such tests should be conditional on evidence of clinical utility, in the sense of delivering net benefit to patient.

Straddling these two spheres was the patenting of the BRCA 1 and 2 genes by Myriad Genetics. Myriad’s aggressive enforcement of those patents fuelled concerns about both the patentable utility and clinical utility of DNA sequences, revealing complexities and contradictions inherent in ideas of utility. When the US Supreme Court reconsidered the BRCA patents in 2013, however it sidestepped these complexities by ruling the patents invalid on grounds, not of utility, but that DNA sequences are products of nature.

Since then, scrutiny of the clinical utility of DNA sequences has again diverged from political economic questions: utility for whom, in what settings, for what purposes? The debates of the 1990s suggest we would do well to bring them together again.

Author

• Steve Sturdy