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Ethics is not the only touchy area for stem-cell research
A patent fight is also possible.
A California company holds rights to technology some say
belongs in the public domain.
By Paul Jacobs
KNIGHT RIDDER NEWS SERVICE

SAN JOSE, Calif. - A storm is brewing over ownership rights
to the promising but controversial technology behind
embryonic stem-cell research, which got a boost Thursday
when President Bush cleared the way for limited federal
funding of the research.

Geron Corp., a small but aggressive biotechnology company
in Menlo Park, Calif., appears to hold the dominant position
by virtue of a patent licensing agreement with the University
of Wisconsin. That is where in 1998 a team of scientists led
by James A. Thomson first excised cells from discarded
early-stage embryos in a way that keeps the cells alive
and multiplying almost indefinitely.

Scientists hope those stem cells can be coaxed into forming
tissues to treat a host of intractable human disorders,
including spinal-cord injury, Parkinson's disease, heart
disease, and diabetes. Critics have questioned the ethics
of destroying embryos even for such a laudable purpose.
The looming patent disputes could become as contentious
as the ethical debate.

In addition to the Wisconsin scientists, several companies
and academic research centers have produced embryonic
stem cells and are questioning the scope of the patents held
by the Wisconsin Alumni Research Foundation, the
university's patenting arm.

"The platform technology of embryonic stem cells really does
belong in the public domain," said Martin F. Pera, an associate
professor at Australia's Monash University, who worked with
colleagues in Israel and Singapore to produce embryonic stem
cells just a few months after the Wisconsin researchers did so
in the United States. "As I understand what an invention is,
this discovery is not an invention."

But that is not the view of the U.S. Patent and Trademark
Office, which issued two far-ranging patents covering the
stem-cell technology to the Wisconsin foundation. Patent
applications in Europe and other parts of the world are
pending.

The foundation and Geron, which paid for most of the
human-cell-line work at Wisconsin, argue that others
who develop commercial uses of embryonic stem cells
will probably be infringing the Wisconsin patents and will
have to come to the university to negotiate rights.


But the company has not taken anyone to court for
infringing any of the patents that it holds or licenses
from others, said Geron's chief financial officer,
David L. Greenwood. "We can't police the marketplace
all the time from day one," Greenwood said. "It's
prohibitively expensive to do that."

Moreover, Greenwood argues that it is in the company's
interest, as well as society's, to make the technology
widely available to scientists. "We can't pursue every
good idea, and that is why we are big proponents of getting
these materials into people's hands."

The Wisconsin foundation has set up the WiCell Research
Institute to do just that by making any one of its five
human stem-cell lines - each derived from an individual
embryo - available to academic researchers for $5,000,
an amount intended to cover the institute's costs.
About 30 research centers have acquired cells; 100 applications
are under review. A number of biotech companies could be
affected by the President's decision on federal funding,
even if they are not themselves working with embryonic
stem cells. On Thursday, share prices of many of the
companies soared in anticipation of a favorable outcome.
Geron stock, for example, climbed 16 percent to close at $14.94.
Yesterday, those stocks fell, however. Analysts said the
technology was too far from being commercial to be a good
investment bet. Geron's stock fell 99 cents to $13.95. Shares
of Stemcells, a company that aims to create cell-based
treatments of diseases of the central nervous system, liver
and pancreas, fell $1.61 to finish at $4.84.

Embryonic stem cells are wonderfully versatile, retaining the
ability of the embryo to form all of the more than 200 cell
types in the human body, although they cannot form
a complete human being.

The stem cells are derived from a four- or five-day-old embryo,
which contains about 250 cells arranged into a tiny, hollow
sphere surrounding a smaller clump of cells. The Wisconsin
Alumni Research Foundation holds the embryonic stem-cell
patents. Geron has an exclusive license on six "cell lineages" -
six types of cells that can be generated by the stem cells.
And it has an option to pick up a similar exclusive license
on any of the other 200 or more cell types by a certain date,
which neither the company nor the university foundation
will reveal.

SOURCE: The Philadelphia Inquirer
http://inq.philly.com/content/inquirer/2001/08/11/business/PATENT11.htm

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