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Genetic property rights on trial as doubts linger
Publish Date: Sunday,28 February, 2010, at 12:59 PM Doha Time
By Donna Dickenson/London
In early February 2010, a United States federal district court in New
York began deciding a landmark case as to whether individuals have a "right to
know" about how their own genomes can dictate their future health. The case,
American Civil Liberties Union v. Myriad Genetics, may have a tremendous impact
on medicine and science.
The questions on which the case turns are whether genetic patents help or
hamper research, and whether patients should have to pay a licence fee to a
biotechnology corporation to be tested for predisposition to disease.
One of the plaintiffs is Lisbeth Ceriani, a 43-year-old woman with breast
cancer whose doctors recommended that she be tested for two genetic mutations
involved in some hereditary forms of the disease. Myriad Genetics, the sole
test provider in the US - it holds a patent on the genes themselves, not just
on the diagnostic test - did not accept her insurance, and Ceriani could not
afford to pay for the test. So she remained ignorant, as did her physicians -
with possible ramifications for her clinical care. Five other plaintiffs -
along with major medical bodies - tell similar stories.
Those who oppose genetic patents claim that they also deny US
constitutional rights, making this the first time a genetic patent has been
challenged on human rights grounds. As so often happens in biotechnology, what
looks at first like an abstruse technical issue raises many questions that cut
to the core of our humanity.
One human gene out of approximately every five is now the subject of a
patent, the majority of which are held by private firms. This case concerns two
such genes, BRCA1 and BRCA2. Women with the "wrong" version of these genes have
a heightened risk of developing breast cancer (up to 85%, against the normal
12%, although the genes account for only a minority of breast cancers). These
women also run a greater risk of ovarian cancer.
Myriad Genetics also has tried to pursue patent rights in Europe, but
there its claims have been largely rejected. Although the gene's function in
causing breast and ovarian cancer was uncovered by Cancer Research UK in 1995,
Myriad, along with nearly 30 other defendants, argues that the patent is a
necessary reward for its research costs. In fact, without patent protections,
the firm and its allies claim, medical research would shudder to a halt.
But, whatever the merits of the claim that genetic patents benefit
research and treatment, that is a practical, rather than a legal, argument. In
order to gain legal "standing" to sue Myriad Genetics, critics of genetic
patents - including the American Medical Association, the American Society of
Human Genetics, and the American Civil Liberties Union - had to find an issue
that could be adjudicated on a constitutional basis.
Their innovative strategy is to draw on the First Amendment, which
protects freedoms such as speech and religion, to argue that patents restrict
patients' freedom of access to information that might enable us to take action
to protect our health.
That is a clever argument, but is it really the source of people's
profound disquiet about genetic patenting? In talking about similar issues
raised in my recent book Body Shopping, I have heard many shocked reactions to
the growing commodification of human tissue, but none more generally shared
than this one: how can you take out a patent on life?
Is a genetic variant a "product of nature" or a "discovery"? While the
plaintiffs assert that "genes are identified, not invented", the defendants
claim that the basis of patent law is precisely the opposite. Their argument is
that what is patented is not the gene as it occurs in our bodies, but rather a
sort of "cloned" version produced in the laboratory. Rather than a "patent on
life", the companies say, they are patenting something more like a chemical.
If that is true, how can Ceriani rightfully be kept in the dark about
what form the gene takes in her body? This is not just a problem for people who
think - wrongly, in legal terms - that they own their bodies, as most people
do. With a few limited and recent exceptions, there is no such thing as
property in tissue once it has left your body. We know that from such cases as
that of John Moore, who tried unsuccessfully to claim property rights in a
valuable cell line developed from his immune cells.
But what about a gene that has not left my body? Don't I somehow still
"own" it? Don't I have rights of control over my own body? How can a commercial
firm not only deny me the right to know my own genetic profile unless I pay
their fee for the diagnostic test, which might be fair enough, but also to
prevent any other firm from offering me a similar test unless those firms pay
it a licence fee?
Proprietary rights for commercial firms over the most basic element of an
individual's genetic identity should not be enforceable. We do not have to
believe in genetic determinism to find that argument compelling. - Project
Syndicate
**** Donna Dickenson, Emeritus Professor of Medical Ethics and Humanities
at the University of London, was the 2006 winner of the International Spinoza
Lens Award for contributions to public debate on ethics. Her latest book is
Body Shopping: The Economy Fuelled by Flesh and Blood.
