BRCA1 and 2: The Myriad Case and Beyond

AuthorDavid Koepsell
ProfessionAuthor, philosopher, attorney, and educator whose recent research focuses on the nexus of science, technology, ethics, and public policy
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
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

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