US denies patent for part-human hybrid

[Guest guest]

" Bea Bernhausen " <beabernhausen

 

Fri, 4 Mar 2005 20:45:53 -0800 (PST)

 

US denies patent for part-human hybrid

 

 

 

 

 

http://www.boston.com/news/nation/washington/articles/2005/02/13/us_denies_paten\

t_for_part_human_hybrid?pg=full

 

US denies patent for part-human hybrid

Scientist aimed to prevent others' use

 

By Rick Weiss, Washington Post | February 13, 2005

 

WASHINGTON -- 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 US intellectual property law.

 

The US 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. He said his goal was to set a legal precedent that

would keep others from profiting from similar " inventions. "

 

But in an age in which 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. But the office also is not 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, " he said.

 

The Newman case indicates how far US intellectual property law has

lagged behind 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, Newman 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 déjà vu in reverse. When US 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. Rifkin had 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 at 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 be issued on a human, it would conflict

with one of the core privacy rights in the Constitution-- a person's

right to decide whether and when to procreate.

 

Patents on humans also could 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 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 in which people are patentable,

it gave an example in which a man goes overseas and undergoes one of

the many surgical procedures patented by US doctors. Simply by

returning to America, the office said, that " surgically altered human "

could be guilty of patent infringement for illegally importing himself.

 

Not all those concepts hold water with legal scholars. But the general

position was greatly strengthened two years ago when Representative

David Joseph Weldon, Republican of Florida, added a rider to an

appropriations bill -- renewed this year -- barring patents on humans

or human embryos. Unresolved by that wording, however, is what is

human and what is not. 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 been 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 nonhuman. "

 

Similarly, mice that contain 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

produce mice whose brains are composed entirely of human cells.

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