More on the Weldon amendment to Appropriations bill  and  concerns about
its effects on medical research.

From 11/25 edition of the Chronicle of Higher Education.
Amendment to Spending Bill Would Ban Patents on a 'Human Organism'

By JEFFREY BRAINARD

Washington

Congress is poised to approve legislation that would bar the U.S. Patent
and Trademark Office from issuing a patent on a "human organism,"
including any human embryo created by researchers.

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"Some scientists have worried that the amendment could be interpreted
broadly to prevent the development of stem cells for medical therapies,
but the final measure includes clarifying language to allow such
research.

Some research advocates were satisfied with the clarification, which was
offered on Tuesday. But others continued to worry about the measure's
impact, in part because it was proposed by Rep. Dave Weldon, a Florida
Republican who has backed previous efforts to ban the cloning of human
cells for medical research and has criticized research on embryonic stem
cells.

The research is controversial because scientists must destroy embryos to
derive the cells, which have the potential to treat diseases. Opponents,
including Representative Weldon, regard embryos as human lives.

For now, the proposal is in the form of a amendment to a giant spending
bill to finance several federal agencies in the 2004 fiscal year.
Congress is expected to approve the bill in December or January.

Representative Weldon, who is a physician, has said he does not intend
the measure to prevent research on stem cells. The patent office has
approved patents on stem cells, and its director, James E. Rogan, said
last week that Dr. Weldon's proposal was consistent with the office's
existing policy, which prohibits patents "directed to or encompassing a
human being." Dr. Weldon said he substituted the words "human organism"
for the patent office's "human being" because the former was "more
politically neutral and more precise."

Academic researchers continued to mull the amendment, worrying that it
could have unintended consequences that could hamper medical research
related to embryos and stem cells. The scientists' ability to patent
discoveries can influence whether they work with biotechnology companies
to develop findings from their basic research into therapies for
patients. Colleges stand to receive royalties and license fees from such
work.

Dr. Weldon has argued that Congress should codify the patent office's
existing policy because of advances in medical research, including the
genetic modification of embryos for various research purposes. In
particular, he said he was referring to reports this year that Spanish
researchers had created a hybrid embryo containing some cells from a
human male embryo and other cells from a female embryo, a union they
dubbed a "she-male." (The researchers destroyed the hybrid after it had
grown for six days.)

"We should not allow such researchers to gain financially by granting
them an exclusive right to practice such ghoulish research," Dr. Weldon
said in July.

Absent Congressional support for the patent office's policy, he noted,
courts could overrule it. In 1980, the U.S. Supreme Court struck down a
patent-office policy when it allowed a gene to be patented -- a decision
that has helped fuel a surge of genetic research at colleges.

Lawrence S.B. Goldstein, a professor of cellular and molecular medicine
at the University of California at San Diego, said that he agreed with
Dr. Weldon that human embryos themselves should not be patented. But Dr.
Weldon's amendment was too broad, and the word "organism" is vague, he
said.

"If this is so important," said Mr. Goldstein, "why not write a carefully
crafted bill, with definitions and exclusions" for stem-cell research?
"What Congressman Weldon would find," the professor said, "is that there
would be a lively debate." But because the proposal was offered as an
addition to a spending bill, it did not get a Congressional hearing.

In response to such criticism, the clarification added on Tuesday
contains a reference to Dr. Weldon's July statement that the policy would
not apply to "stem-cell research or patenting genes."

Should Dr. Weldon's amendment pass when Congress takes final action on
the underlying bill, the policy would be in effect for only the 2004
fiscal year, unless it is renewed -- which could provoke another round of
debate. "
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forwarded by:
Francesca Fierro O'Reilly
Managing Director of Education and Advocacy
Parkinson's Action Network
1000 Vermont Avenue, NW, Suite 900
Washington, DC 20005
202-842-4101 phone
202-842-4105 fax
[log in to unmask]
www.parkinsonsaction.org

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