[Ip-health] Andrew Pollack: Debate on Human Cloning Turns to Patents

[James Love]

http://www.nytimes.com/2002/05/17/science/17CLON.htm
    Debate on Human Cloning Turns to Patents

*By ANDREW POLLACK*

[T] he University of Missouri has received a patent that some lawyers
say could cover human cloning, potentially violating a longstanding
taboo against the patenting of humans.

The patent covers a way of turning unfertilized eggs into embryos, and
the production of cloned mammals using that technique. But unlike some
other patents on animal cloning, this one does not specifically exclude
human from the definition of mammals; indeed, it specifically mentions
the use of human eggs.

Those opposed to cloning and to patenting living things say the patent
is a further sign that human life is being turned into a commodity.

"It is horrendous that we would define all of human life as biological
machines that can be cloned, manufactured and patented," said Andrew
Kimbrell, executive director of the International Center for Technology
Assessment, a Washington group that has long opposed patenting of living
things and also wants to ban all human cloning.

The patent was issued in April 2001, but attracted no attention until
Mr. Kimbrell's group ran across it recently.

Senator Sam Brownback, the Kansas Republican who has been a leading
opponent of human cloning, said he intended to introduce a bill to
prohibit patents on human beings and human embryos, which he said were
"akin to slavery."

"I think the patent office will appreciate having that clarity, given
the applications that are coming into the patent office," Mr. Brownback
said.

That bill would be separate from a bill the senator is already
sponsoring that would prohibit all human cloning. The Senate is debating
how extensively to ban human cloning, but none of the bills it is
considering deal with the patent issues.

The patent also illustrates the tricky legal and ethical issues the
United States Patent and Trademark Office is confronting as scientists
race to develop cloning and to grow human tissues to treat disease. Mr.
Kimbrell said he had found a few other patents that had been applied for
but not granted that might cover human cloning.

The United States has been more liberal than most other countries in
granting patents on living things, ever since a Supreme Court decision
in 1980 that allowed the patenting of a microbe genetically engineered
to consume oil spills. There are patents on complete animals, like a
mouse genetically engineered to be prone to cancer. There are patents on
human genes and human cells. The University of Wisconsin has a patent on
human embryonic stem cells, which are cells taken from human embryos
that have the ability to turn into any other type of tissue.

But the patent office has drawn the line on patenting of humans or human
embryos themselves, saying it would not be constitutional. Many experts
say this is because such patents would violate the 13th Amendment ban on
slavery. Brigid Quinn, a spokeswoman for the patent office, said the
agency was not using the 13th Amendment argument anymore but was not
granting patents on humans because it had not received any guidance from
Congress or the courts saying it should do so.

The result has been that many patents that conceivably could cover
humans -- like on cloning animals or on genetically engineering animals
to produce drugs in their milk -- specifically exclude humans.

A spokesman for the University of Missouri, Christian Basi, said it
believed its patent covered human cloning because it applied to all
mammals. The university has licensed the patent to BioTransplant , a
Massachusetts biotechnology company that is working on creating pigs
that can be used as human organ donors. But the license, Mr. Basi said,
covers only the use in pigs.

"We have absolutely no interest in using this to research humans and we
will not license this technology to anyone for use in humans," Mr. Basi
said, suggesting that the patent could actually help stop human cloning.
"This gives us control of this particular technology so we will know
that this technology will not be used in humans."

Ms. Quinn said the patent office did not comment on individual patents
but had not changed its policy of not issuing patents "drawn to humans."

Randall S. Prather, a professor of reproductive technology at Missouri
whose work was the basis for the patent, said the mention of human eggs
"was put there by the attorneys and they wanted to cover all mammals."

Charles Cohen, who wrote the patent when he was a lawyer at a St. Louis
law firm, declined to comment.

Some lawyers who have looked at the patent, No. 6,211,429, say it is not
clear that it covers human cloning and that interpreting patents
requires careful analysis of the patent's history. That the patent
office did not appear to have problems with it could be a sign that the
agency believes that the patent does not cover humans.

"You'd have to go through line by line, word by word," said Gerald P.
Dodson, a lawyer with Morrison & Foerster in Palo Alto, Calif., who read
the patent and said he could not reach an immediate conclusion.

Mr. Dodson and others noted that the specifications and examples of how
the patent could be used dealt with pigs and cows.

Even if the patent does cover human cloning, some lawyers say, it would
be a stretch to say it covers humans themselves, although the abstract
of the patent says it covers the "cloned products."

But even a patent on the process of cloning humans could give the patent
holder some rights over people, some lawyers said. Conceivably, for
instance, the university could bar people created overseas by its
cloning process from entering the country.

"It definitely is a patent for cloning a human, and under the laws we
have right now, it might actually cover the human," said Richard
Warburg, a patent lawyer at Foley & Lardner in San Diego who represents
Infigen, an animal cloning company.

Dr. Rochelle Seide, a New York patent lawyer who heads the biotechnology
practice at the law firm of Baker & Botts, said the lack of the nonhuman
disclaimer in the Missouri patent was surprising.

"Looking at it," Ms. Seide said, "I can see where people who are against
cloning would have a big problem with it."

Advanced Cell Technology, a company that wants to clone human embryos to
obtain stem cells for disease treatments, licensed a patent from the
University of Massachusetts on its method of cloning. But the patent is
on only nonhuman embryos produced by the process, though it does seem to
cover human cells.

It might be difficult to draw the line on what constitutes a human.
George J. Annas, professor of health law at Boston University School of
Public Health, said it was unclear whether the antislavery amendment
would be a basis for denying patents on human embryos because courts, in
cases like those involving custody of frozen embryos, have said an
embryo is not a person.





-- 
James Love
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