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Does Legal
Ownership of Genes, Stem Cells go Beyond the Pale?
by Scott LaFee
Provided with permission by Copley News Service
May 2006
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PATENT OFFENDING
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In October 1976, an Alaska pipeline engineer named
John Moore became seriously, mysteriously ill.
Eventually, he found himself at the UCLA Medical
Center, where he was diagnosed with a rare,
progressive form of blood cancer called hairy cell
leukemia.
To slow the disease and perhaps save his life,
Moore's physician - Dr. David Golde - recommended
removing Moore's spleen. The surgery was
successful. Moore recovered and eventually
returned to Alaska, with instructions to visit
Golde for annual checkups.
Over the next eight years, Moore did so. During
each visit, Golde would extract samples of Moore's
blood, skin, bone marrow and sperm. When Moore
complained about the cost and hassle of the
visits, he was told the UCLA visits were necessary
and could be performed only under Golde's
direction.
That was true, but not in the sense Moore
initially presumed. Golde had discovered that
Moore's diseased spleen had been overproducing
lymphokines - a key chemical constituent of the
body's immune system. The doctor and colleagues
were using blood and tissue samples taken from
Moore to develop a cell culture that produced
lymphokines, which could then be marketed to
companies working on cancer treatments and drugs.
Moore knew nothing of this research until 1984,
when he was finally asked to sign a consent form
and waive all rights to any product that might be
developed from his cells. Moore refused and hired
an attorney to investigate.
Not long after, Golde was granted U.S. Patent No.
4,438,032 for a "Unique T-Lymphocyte Line and
Products Derived Therefrom."
In other words, the doctor and the university
owned the rights to all biological material and
knowledge gleaned from Moore's spleen. The patent
was eventually sold to the Swiss pharmaceutical
company Sandoz Laboratories for several million
dollars in cash and stock.
Not surprisingly, Moore sued, alleging fraud and
loss of financial benefit from his own body. He
lost.
In 1990, the California Supreme Court ruled that
Golde had erred in not getting Moore's research
consent, but it also ruled that Moore had no
proprietary right to blood and tissue removed from
his body. To grant patients such a broad right,
the split court said, would be to dampen
scientific inquiry and medical progress.
PATENT RUSH
For the first 150 years or so of its existence,
the nuts and bolts of the U.S. Patent Office was
mostly nuts and bolts. Patent applications tended
to be inorganic, describing tangible inventions,
mechanical devices, better mousetraps.
A story like John Moore's was not really possible
until the science of biotechnology emerged in the
late 20th century. As researchers learned how to
isolate and manipulate DNA and other genetic
material, it became feasible to ask whether life
or its products could be invented and patented.
In 1980, the U.S. Supreme Court ruled in a 5-4
decision that a bioengineered, oil-eating
bacterium met the four basic requirements of a
patent: It was novel, useful, non-obvious and
"enabling," with fully disclosed details that
allowed others to use it.
The case overturned "fairly long-standing law,"
said Richard Gold, director of the Centre for
Intellectual Property Policy at McGill University
in Quebec, and spurred a patent rush that today
continues bigger than ever.
Thanks to continued scientific advancement, there
are hundreds of patents on genetically modified
organisms, from microbes to plants to mice. Almost
one-fifth of the 23,688 genes in every human being
is covered by a U.S. patent; 63 percent held by
private companies, 28 percent assigned to
universities.
The basic process for creating human embryonic
stem cells - widely touted as the potential means
for new medical treatments and cures - is
patented. To use these human stem cells in
research, one must first receive a license from
the Wisconsin Alumni Research Foundation (WARF)
and agree to meet designated royalties and other
contractual obligations.
The question, of course, is whether any of this is
a good thing. Do such patents, which promise
intellectual property protection and potential
reward, spur scientific innovation and medical
progress? Or do they, in fact, hinder it?
"There's the economic argument that says somebody
will be more likely to work harder on something if
there's an opportunity to make a profit," said
Michael Kalichman, a University of California San
Diego professor of pathology and co-founder of the
San Diego Center for Ethics in Science and
Technology. "That motivation suggests new
therapies and products appear sooner because
there's a financial incentive to be first to
market with something no one else has or can have
without your permission.
"On the other hand, instead of science being
conducted in an open fashion, with knowledge
disseminated quickly and widely, people with
patents can become more protective and
proprietary. They want to protect their investment
until they can cash in."
Unfortunately, there is little empirical proof to
support either position, says Robert Cook-Deegan,
director of the Center for Genome, Ethics, Law and
Policy at Duke University.
"Nation by nation, laboratory by laboratory,
regulation by regulation, we are still trying to
figure out who 'owns' the genome, what the owners
actually own, and how best to balance the pursuit
of knowledge and the allocation of rewards," Cook-Deegan
wrote in a recent essay with colleague Misha
Angrist.
"The system works, but no one knows how well,
because no one can address the crucial question:
compared to what?"
John Wetherell, a San Diego-based intellectual
property attorney with degrees in chemistry and
molecular biology, says gene patents and the like
have provided critical fuel to grow biotechnology.
"Absent court decisions, industry would not be
nearly as robust. We wouldn't be where we are
today."
Others disagree.
"You hear that kind of talk all of the time from
people in the industry and patent lawyers," said
Gold, who also is the author of "Body Parts:
Property Rights and the Ownership of Human
Biological Materials."
"But the biotech industry is intelligent. Even
without these patents and court decisions,
researchers would have found a way to move ahead."
Gold and others contend that such biopatents have
actually caused harm. In a 2002 paper in the
journal Nature, Lori B. Andrews, director of the
Institute for Science, Law and Technology at the
Chicago-Kent College of Law, cited several cases
where patent interests of biotech and
pharmaceutical companies impinged upon scientific
progress and medical treatment.
For example, the pharmaceutical giant
GlaxoSmithKline filed for a patent on a genetic
test to determine the effectiveness of one of its
drugs. But Andrews says the company has no
interest in developing the test - or letting
anyone else develop it - because such a test might
clarify exactly who benefits from the targeted
drug. The company could lose customers.
Along similar lines, San Francisco-based Athena
Neurosciences holds the patent on a gene
associated with Alzheimer's disease. Athena will
not allow any laboratory except its own to screen
for mutations in that gene.
"Doctors and laboratories across the country face
a lawsuit if they try to determine whether one of
their patients carries this genetic predisposition
to Alzheimer's disease, even though testing can
easily be done by anyone who knows the sequence of
the gene, without using any product or device made
by the patent holder," wrote Andrews.
Such restrictions, she argues, inhibit research
and degrade medical treatment because researchers
and doctors cannot afford to purchase the
necessary patent rights or pay the cost of either
a lawsuit or a legal challenge.
Effects on research
There are other, subtler effects, according to
Andrews and others. Most human gene patents cover
sequences whose precise function and utility have
yet to be determined. These isolated or purified
gene products may lead to new drugs, treatments or
medical breakthroughs, but perhaps not for
decades.
"These patents are about control, about
establishing boundaries for a product that doesn't
yet exist, if it ever does exist," said Dr. Neil
Thiese, a pathologist at Beth Israel Medical
Center in New York and one of the nation's leading
stem cell researchers.
In the meantime, critics suggest at least some
patents impede research. One example is the search
for the gene or genes related to autism. Two
decades ago, scientists gathered DNA samples from
affected children and families, but would not
share them, fearing someone else might beat them
to the patent.
Finally, in 1995, families of autistic patients
founded their own group, Cure Autism Now, which
independently raised millions of dollars to
establish a DNA bank available to all interested
scientists.
Patents can also scare away potential research
interests, said Kalichman. Up-and-coming
scientists tend to pursue areas of research where
they can actually do research. If studying a
particular topic means grappling with numerous,
expensive patents and possible infringement
lawsuits, they often choose to look elsewhere.
Wetherell, the attorney, said patent violations
and related legal problems are not significant at
the academic level, where much basic research is
conducted. "Most companies with patents aren't
going to go after the average professor doing
research. There's just no profit in it. Where
problems arise is between companies with competing
commercial interests."
But Steven Briggs, a professor of biology at UCSD
and former head of corporate research for Diversa,
a San Diego-based biotech firm, said universities
have become very savvy and aggressive about
seeking patents for work done by their scientists.
"I'd say the material transfer agreements we have
are just as onerous as commercial versions. That's
not being negative. UCSD is just as assertive
about its patent rights."
THE FIX
Virtually everyone agrees that the U.S. patent
system needs fixing. Virtually no one agrees on
the scope of those fixes. There is legislation in
Congress that would streamline the process and
remodel it to be more in accord with patent
systems elsewhere in the world. The U.S. Supreme
Court has heard arguments on a potentially
significant case involving two biotech companies
that may or may not substantially reduce the scope
of what's deemed patentable.
A couple of things, though, seem certain.
In Europe, patent policy includes consideration of
"public ordre" or public morality. As a result,
controversial scientific endeavors like human stem
cell research, which are broadly opposed by
Europeans, have been deemed unpatentable.
There is no similar clause in U.S. patent law,
which has already ruled that human stem cells
capable of differentiating into various kinds of
cells (but not whole humans) may be subject to
patent.
Also, whatever happens next, either in new court
decisions or legislation, will not be radical.
There will be no reversal of fortune.
"We're locked into this patent system," said Gold.
"The question of whether genes should be patented
was an issue 26 years ago. It's not practical to
turn back the clock now because the whole system
would have to be reinvented. The cost and
disruption of doing so would be unacceptable."
Any change, Gold predicted, will be slow,
tinkering and evolutionary.
A lot like life itself. |
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