Individual and Collective Rights in Genomic Data: Preliminary Issues

• Author: David Koepsell
• Profession: Author, philosopher, attorney, and educator whose recent research focuses on the nexus of science, technology, ethics, and public policy
• Pages: 1-20

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.

Individual and Collective Rights

inGenomic Data

Preliminary Issues

1

Life on earth is bound together by a common heritage, centered around a

molecule that is present in almost every living cell of every living creature.

Deoxyribonucleic acid (DNA), composed of four base pairs, the nucleic

acids thymine, adenine, cytosine, and guanine, encodes the data that directs,

in conjunction with the environment, the development and metabolism of

all nondependent living creatures. (There are ribonucleic acid (RNA)–

based viruses and phages, but these are dependent upon other living crea-

tures for their development and propagation.) DNA is composed of genes,

each of which is a segment of an organism’s DNA (which for humans is

three billion base pairs long). Each gene does something specific, encoding

the instructions for a cell’s creation of a protein or an enzyme, which in turn

is responsible for cell differentiation, development, and reproduction. The

mechanisms are now well understood. We know what DNA does in a very

basic sense. The task that science is now completing is developing a full

understanding of the relation and role of each gene, and other information

encoded in DNA, to the development, functioning, and reproduction of

the whole organism. The human genome is of course the one that interests

us most, and understanding the role of each gene in causing us to grow

and function as we do will afford us greater prediction and control over

human health.

The first stage of that degree of understanding was mapping the genome.

Once we know where each individual gene falls on the three billion base pair

chain, we can start to understand differences among individuals and how

they relate to the health and particular characteristics of each organism. The

Human Genome Project (HGP) began in the early 1990s as a publicly funded

2 Individual and Collective Rights inGenomic Data

international project to develop that essential map. Along the way, something

happened that was only vaguely anticipated and that has resulted in private

ownership claims to portions of the human genome. Let us look carefully at

the history of the HGP and the emergence of human gene patents before

considering some of the ethical implications posed by this new trend.

The Current Conundrum

The human genome has been mapped, and daily more of its territory

becomes known and understood. The current map of the human genome is

general, giving us a high‐level view of the landscape, but much of it remains

virgin territory. We have yet to understand precisely how the expression of

the data represented by the map helps make us who we are and function as

we do. Even so, the outlines of the territories of the map are being claimed,

with nearly a fifth of the genome now staked out by various parties, pat-

ented against the claims of other newcomers.1 In fact, the ability to stake

those claims was largely responsible for the early completion of the HGP,

spurred on by market competitors and funded by the future value of own-

ership of DNA sequences and the pharmaceutical promise they hold.2

While Craig Venter’s company, Celera Corp., was investing millions in

developing new rapid sequencing technologies, part of its value statement

and justification to its shareholders for the tremendous capital outlays was

the proposition that genes discovered in the process could be patented and

become part of Celera’s general portfolio of patents. As the US Patent and

Trademark Office (PTO) began granting gene patents, other companies,

individuals and institutions got into the act. Only after the fact did philoso-

phers, lawyers, and activists begin to consider the practical, legal, and ethical

implications of gene patents.

Numerous authors have since considered the practical and ethical issues

involved in granting ownership over parts of the human genome. The range

of considerations has spanned concerns over autonomy, dignity, economic

efficiency, and other important ethical considerations. Most people, when

confronted with the fact that their genetic code has been partly patented by

a plethora of universities, corporations, and research institutes, visibly

blanch and insist that it ought not to be so. It assuredly is so, and a quick

search of the PTO filings will reveal thousands of patents currently owned

on portions of your genome and mine.3 How can this be? Is it right? Don’t