Unlocking the Genome: The Legal Case against Genetic Diagnostic Patents

Unlocking the Genome: The Legal Case against Genetic Diagnostic Patents

By Tiana Leia Russell*

*J.D., 2005, New York University of Law; M.A., 2009, Aarhus University

Excerpt from Unlocking the Genome: The Legal Case against Genetic Diagnostic Patents, 16 Marq. Intell. Prop. L. Rev. 81 (Winter 2012)

I. Introduction

We are on the leading edge of a true revolution in medicine, one that promises to transform the traditional "one size fits all' approach into a much more powerful strategy that considers each individual as unique and as having special characteristics that should guide an approach to staying healthy. Although the scientific details to back up these broad claims are still evolving, the outline of a dramatic paradigm shift is coming into focus. 1

Francis S. Collins, Director of National Institutes of Health The growth of personalized medicine, which aims to better customize and target treatments to patients through the use of information about an individual's genes, proteins, and environment, is changing the healthcare industry and holds tremendous potential to improve patients' lives. The medical diagnostics field is a key attribute of personalized medicine, as simple tests measuring levels of proteins, genes, or mutations can be performed on patients to optimize specific therapies for that individual's condition. In many cases, this individualized treatment avoids costly, unnecessary, and potentially dangerous procedures.

Within the medical diagnostics field, genetic diagnostic methods are rapidly changing the way diseases are diagnosed, prevented, and treated. The ability to link genetic mutations to specific diseases can lead to improved diagnostics, higher quality health care and, in some instances, life-saving treatments. Current estimates place the number of inheritable diseases stemming from mutated genes at four thousand. 2 Thus far, genetic information has been used to assist physicians in individualizing treatments for their patients ...

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