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US denies patent for part-human hybrid

Scientist aimed to prevent others' use

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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