BRCA1 and 2: The Myriad Case and Beyond

• Author: David Koepsell
• Profession: Author, philosopher, attorney, and educator whose recent research focuses on the nexus of science, technology, ethics, and public policy
• Pages: 88-100

Who Owns You?: Science, Innovation, and the Gene Patent Wars, Second Edition. David Koepsell.

© 2015 John Wiley & Sons, Ltd. Published 2015 by John Wiley & Sons, Ltd.

BRCA1 and 2

The Myriad Case and Beyond

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When the first edition of this book first came out, lawsuits about gene

ownership were scattered and unfocused. I intended the book to be a

unique exploration of the ontological issues behind gene patents, rather

than delving into more traditionally covered issues of normative ethics1

or subsequent journalistic, pop‐cultural exploration of the topic,2 both of

which approaches are valuable in their own rights. I also attempted to

steer clear of writing a legal analysis per se, although I did wish to

describe the legal ontology of genes and intellectual property law, a pure

legal analysis would be uncritical and positivistic, exploring the reasoning

behind the then legal practice of patenting isolated genes.3,4 I wrote

already about the Canavan disease gene and the lawsuit brought by the

Canavan foundation on behalf of patients with the disease. That suit,

however, focused on the issue of informed consent regarding samples

that were taken from those with the genetic disease, and the courts sided

with the defendants in holding that sufficient informed consent was

given, and the patients had no ownership claim to their samples or pre-

sumably their genes. Shortly after the first edition of this book came out,

however, the legal landscape began to change significantly because the

America Civil Liberties Union commenced a lawsuit in May of 2009

against Myriad Genetics (hereinafter Myriad) and the US Patent and

Trademark Office based upon patents that were granted for isolated

genes found to be correlated with high risk of ovarian and breast cancers:

the BRCA1 and 2 mutations (hereinafter, BRCA1&2).5