.S. DENIES PATENT FOR A TOO-HUMAN HYBRID

By Rick Weiss
Washington Post
Sunday, February 13, 2005; Page A03

A New York scientist's seven-year effort to win a patent on a
laboratory-conceived creature that is part human and part animal ended in
failure Friday, closing a historic and somewhat ghoulish chapter in American
intellectual-property law.

The U.S. Patent and Trademark Office rejected the claim, saying the hybrid
-- designed for use in medical research but not yet created -- would be too
closely related to a human to be patentable.

Paradoxically, the rejection was a victory of sorts for the inventor, Stuart
Newman of New York Medical College in Valhalla, N.Y. An opponent of patents
on living things, he had no intention of making the creatures. His goal was
to set a legal precedent that would keep others from profiting from any
similar "inventions."

But in an age when science is increasingly melding human and animal
components for research -- already the government has allowed many patents
on "humanized" animals, including a mouse with a human immune system -- the
decision leaves a crucial question unanswered: At what point is something
too human to patent?

Officials said it was not so difficult to make the call this time because
Newman's technique could easily have created something that was much more
person than not. But newer methods are allowing scientists to fine-tune
those percentages, putting the patent office in an awkward position of being
the federal arbiter of what is human.

"I don't think anyone knows in terms of crude percentages how to
differentiate between humans and nonhumans," said John Doll, a deputy
commissioner for patents. Yet neither is the office comfortable with a
"we'll know it when we see it" approach, he added: "It would be very helpful
. . . to have some guidance from Congress or the courts."

The Newman case reveals how far U.S. intellectual-property law has lagged
behind the art and science of biotechnology. The Supreme Court has addressed
the issue of patenting life only once, and that was 25 years ago.

It also raises profound questions about the differences -- and similarities
-- between humans and other animals, and the limits of treating animals as
property.

"The whole privatization of the biological world has to be looked at,"
Newman said, "so we don't suddenly all find ourselves in the position of
saying, 'How did we get here? Everything is owned.' "

Newman's application, filed in 1997, described a technique for combining
human embryo cells with cells from the embryo of a monkey, ape or other
animal to create a blend of the two -- what scientists call a chimera.
That's the Greek term for the mythological creature that had a lion's head,
a goat's body and a serpent's tail.

Others had used similar methods to create a "geep," part goat and part
sheep. But Newman's human-animal chimeras would have greater utility in
medicine, for drug and toxicity testing and perhaps as sources of organs for
transplantation into people.

In collaboration with Jeremy Rifkin, a Washington biotech activist and
president of the Foundation on Economic Trends, he challenged the patent
office: Issue the patent, which would keep others from pursuing such work
for 20 years, or reject it, effectively accomplishing the same thing.

The two had until Friday to appeal the latest rejection, but they decided to
let it pass and declare victory.

For Rifkin, the case was deja vu in reverse. When U.S. scientist Ananda
Chakrabarty applied for the first patent on a living organism -- a
genetically engineered bacterium able to digest oil spills -- the case ended
up in the Supreme Court because the patent office did not want to patent
life forms. That time Rifkin filed the main amicus brief supporting the
patent office.

They lost. In a 5 to 4 decision, the court declared that patents could be
issued on "anything under the sun that is made by man."

The office has obliged, issuing patents on bacteria, yeast and, as of last
fall, 436 animals.

In 1987, the patent office announced it would draw the line with humans, but
it offered no legal rationale or statutory backing.

The paper trail created by the Newman claim offers perhaps the best
explication yet for that ban. One rationale in the documents sent to Newman
is that such a patent would be "inconsistent with the constitutional right
to privacy." After all, the office wrote, a patent allows the owner to
exclude others from making the claimed invention. If a patent were to issue
on a human, it would conflict with one of the Constitution's core privacy
rights -- a person's right to decide whether and when to procreate.

Patents on humans could also conflict with the 13th Amendment's prohibition
against slavery. That is because a patent permits the owner to exclude
others from "using" the invention. Because "use" can mean "employ,"
officials wrote, a patent holder could prevent a person from being employed
by any other -- which "would be tantamount to involuntary servitude."

Finally, the office noted that it is illegal to import products that are
made abroad using processes patented in the United States. To show how that
could cause a problem in a world where people are patentable, it gave an
example in which a person goes overseas and undergoes one of the many
surgical procedures patented by U.S. doctors. Simply by returning to the
United States, the office said, that "surgically altered human being" could
be guilty of patent infringement for illegally importing herself.

Not all those concepts hold water with legal scholars. But the general
position was greatly strengthened two years ago when Rep. David Joseph
Weldon (R-Fla.) added a rider to an appropriations bill -- renewed this year
-- barring patents on humans or human embryos.

Still unresolved by that wording, however, is what is human and what is not.

Last week, patent officials conceded they lack a good way of defining the
"human" that Newman's patent supposedly too closely resembles.

The decision letter to Newman notes that many people have heart valves from
pigs. A patent has even issued on the use of baboon cells in people to aid
in organ transplantation. Those procedures, the letter says, "did not
convert the human patient to a non-human."

Similarly, mice that have up to 1 percent human brain cells in their skulls
are clearly mice, said Stanford University biologist Irving Weissman, one of
the scientists who helped make hybrid rodents.

The tricky part, all agree, is what to do with the middle ground. Weissman
and others, for example, have talked about their desire to make mice whose
brains are made entirely of human brain cells.

Hank Greely, a professor of law and director of Stanford's Center for Law
and the Biosciences, said even those animals would not seem very human to
him. "But a chimp brain with human neurons. . . ."

That's exactly the kind of scenario that makes Rifkin, Newman and others
want a total ban.

"If the U.S. Congress and president are not willing to do this now, then
there is no door that will remain closed to an era of commercial eugenics,"
Rifkin said. "We'll be on our way to that brave new world that Aldous Huxley
warned us about."

Leon Kass, chairman of the President's Council on Bioethics, agreed that
Congress should at least get involved.

"The patent office is not the place for society to make its moral
decisions," Kass said.

Weldon, the Florida representative, said he is interested in providing such
guidance -- and believes the public would favor restrictions.

"There's instant public revulsion when you start talking with the average
person about this stuff." For starters, Weldon said, "I'd like to ban the
creation of human embryos with animal genes in them."

But many scientists fear that Congress is likely to overreact.

"There are chimeras out there that serve very valuable purposes in medical
research, such as mice that make human antibodies," said Michael Werner,
chief of policy for the Biotechnology Industry Organization. "This is
sufficiently technical scientifically that it should be left to scientific
bodies like the National Academy of Sciences to decide."

That organization is now preparing a report, due in April, that will address
scientific and ethical issues relating to human-animal chimeras. And
although it will not probe deeply into intellectual-property issues, it may
at least offer the patent office -- and the nation -- a modicum of the
guidance it craves.

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