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November|December 2002

huMouseTM

A design for creatures that are half man, half animal has raised fundamental questions about what it means to be human. Two critics of biotechnology want the U.S. Patent Office to answer them.

By Dashka Slater

Dr. Stuart Newman doesn't look like a mad scientist. He is a quiet, thoughtful man who walks with his head leading the way. He's tall, slightly stooped, with deep-set eyes that give him a kind of hangdog look. His sandy brown hair is orderly, his speech is unaccented, and he's not in the habit of rubbing his hands together, bursting into peals of maniacal laughter, and chortling, "With the help of my creature, I will someday rule the world!"

Nonetheless, Newman has invented a monster. In fact, an entire class of monsters. Five years ago, he submitted a patent application to the U.S. Patent and Trademark Office for a chimera, a creature that would be made by melding human and animal embryos. Concoctions included the huMouse, a mixture of man and mouse; the humanzee, a cross between a human and chimpanzee; and blends of human with pig and human with baboon. The chimeras!named after the mythical Greek monster with a goat's body, a lion's head, and a serpent's tail!could potentially be used to study embryonic development, raise organs for transplants, or test new drugs.

The chimeras' real purpose, however, is their shock value. If the notion of human-ape half-breeds rising from the laboratory makes your stomach churn and your mind reel, then the monsters are serving their creator's subversive goals. Newman is both a developmental biologist and a founding member of the Council for Responsible Genetics, one of the nation's oldest biotechnology watchdog groups, and he has been writing and lecturing about the ethical perils of genetic engineering since the late 1970s. Ten years ago, he got a call from the economist, rabble-rouser, and fellow biotech critic Jeremy Rifkin, who asked if Newman could come up with a genetically engineered invention that was technically feasible, scientifically useful, and "so disturbing that it would draw the public's attention to the possibilities of genetically engineering humans." It took a few years for all the pieces to come together; in December 1997, Newman and Rifkin jointly submitted their application to the patent office.

Neither man has any intention of actually making a chimera. Instead, by applying for a patent the pair hopes to prevent anyone else from making one. If the patent office says that human-animals like these blends can't be patented, the decision will block other similar applications. If the chimera application succeeds, then anyone who wants to make one will have to apply to Newman and Rifkin for a license for the 20-year life of the patent. "If we lose, everyone else has to lose," Rifkin says. "If we win, we lock it up."

In five years, the patent office has preliminarily rejected the chimera application three times, but has yet to reach a final decision. If the decision is a rejection, it's certain to be appealed, potentially up to the U.S. Supreme Court. "This will make law, one way or another," Rifkin said. And when the patent application reaches the courts, it will raise questions that extend beyond a ruling by a federal agency into science, ethics, and philosophy. "What is a human being? What is life?" Rifkin asked, rattling off some of the ontological high points. "What is the border between nature and artifice? What is the border between humans and our fellow creatures? What does it mean to be alive? These are incredible issues. The irony is that some 25 years into the biotech revolution, the first agency in this government that has had to really wrestle with the larger philosophical implications has been the U.S. Patent Office."

Assuming you had the materials on hand, Newman says, it would take only a day of laboratory work to create a chimera. The process was first tried by British scientists, who announced in 1984 that they had created the "geep" by blending embryonic materials from a sheep and a goat. Newman's patent application suggests three methods for mixing human and animal embryos. One method would merge an eight-cell human blastula, the structure resulting from a fertilized egg, with a mammalian embryo at the same stage of development. The other two techniques would introduce human embryonic stem cells, which can be harvested from spare embryos created for in vitro fertilization, into an early-stage animal embryo. The cells could be mixed at any ratio from 8:1 to 1:8, so that there would be as many as eight human cells for every one mouse or chimpanzee cell, or as many as eight mouse or chimpanzee cells for every one human cell. The new embryo would then be implanted in the uterus of a pregnant mouse, chimpanzee, or human to gestate until birth.

A chimeric animal would be fundamentally different from a hybrid, which is created by cross-breeding two species. A mule, for instance, has a horse and a donkey for parents and every cell in its body contains both donkey and horse DNA. A chimera, on the other hand, would have four parents!two from each species!since each blastula, embryo, or stem cell is produced by a human-human or animal-animal combination of egg and sperm. And every cell in the chimera's body could be from either one species or the other. The geep, for instance, had an odd, patchy-looking coat because its woolly sheep cells lie cheek-by-jowl with its hairy goat cells.

What a human-animal chimera might look like, and how it would behave, is a mystery. It's not even clear that such a creature could develop past the embryonic stage. But based on the success of the geep, Newman thinks a human-primate chimera has a pretty good chance of developing into a viable creature. "Evolutionarily, sheep and goats diverged at least 12 million years ago," he explained. "But humans and chimpanzees diverged no more than 6 million years ago. So we're closer to chimpanzees and gorillas than sheep and goats are to each other."

Newman, a professor of cell biology and anatomy, sat in his office at the New York Medical College as we talked. It's a small, windowless room lit by a fluorescent light, giving it the stultified, forgotten feel of a dungeon lair. Every surface was stacked with papers, with the exception of a wall heater, which was stacked with empty bottles of champagne. The walls were similarly crammed with books, many of them critiques of science and its mores. One stood out: a tattered copy of Aldous Huxley's 1932 dystopian fantasy Brave New World, which envisions a society in which children are cultivated in a laboratory to preconceived specifications. The scientist observed, "Young people reading Brave New World now don't find that scenario that outrageous."

Newman has been concerned about the political and ethical implications of scientific research since he was a graduate student at the University of Chicago. "I was educated in the 1960s," he explained, "when you had to be blind not to realize that science was connected to larger social questions." Nowhere was that more clear than in his own field of developmental biology, a discipline that used to be known as embryology. Newman's research focuses on the interactions between the genetic and physical factors that stimulate undifferentiated cells to develop into structures like limbs and brains. It's an interest he shares with biotech firms, which are hoping to use embryonic stem cells to grow tissues and organs that can be used for transplants.

But Newman has grave concerns about genetically manipulating human embryos, a technology he believes will lead by a series of ethical baby steps to designer babies ("yuppie eugenics," he calls it) and the creation of human clones.

"I'm pro-choice," he said. "I don't want to valorize the embryo in any way. But I think it's damaging to the human community to get into a mindset where you can produce human embryos for any purpose. Even if it's a useful purpose."

Developed in 1973 by Stanley Cohen and Herbert Boyer, recombinant DNA technology has given researchers the ability to tinker with the building blocks of evolution. The technology is gaining ground at a speed that was unimaginable a few decades ago. Eight years after Cohen and Boyer discovered how to cut and paste genetic information and reproduce the new DNA in bacteria, Chinese scientists cloned the first animal, a carp, and American scientists were creating the first transgenic animals. By 1987, scientists had begun field-testing genetically altered organisms, including a bacterium that made plants resistant to frost. In the next few years, the first genetically engineered food reached the market and a 4-year-old girl with an immune disorder received gene therapy.

There are now transgenic cows that produce therapeutic human proteins in their milk, and transgenic mice that produce human growth hormone in their semen. Last year, the Massachusetts biotech firm Advanced Cell Technology announced that it had successfully cloned human embryos. The frantic pace of innovation!driven in part by a rush by medical researchers, drug companies, and others to claim valuable patents!continues to increase. The patent office granted 7,532 biotechnology patents in 2001, almost as many as it had for the previous ten years combined. "I think this is the tip of the iceberg," said Lori Andrews, a professor at Chicago-Kent College of Law. "I think we'll see patents on human embryos that have been genetically engineered to have blue eyes."

In this environment, the chimera application doesn't seem that radical. "It's not so out of bounds," Newman said. "A couple of years ago you would have heard people say, 'Nobody wants to clone a full-term human being.' But you read in the paper all the time about a couple demanding to clone a deceased child, or a living child, to get tissues or bone marrow.... There are doctors who are supporting this."

Legislation was introduced in the Senate this year by supporters of "therapeutic cloning"!cloning for the purpose of producing a healthy copy of a sick person's tissue or organ for transplantation. It would allow cloned embryos to develop long enough for researchers to harvest stem cells. Scientists and an international protocol say that the development period is no longer than 14 days. But a researcher at Johns Hopkins University has found a more promising type of cell than stem cells. They're called germ cells and they come from the gonads of embryos aborted at eight to nine weeks.

Newman uses the shades of difference between stem and germ cell development to argue for a total ban on cloning. Anything else, he said, will be a blurry line, because once we get used to allowing cloned embryos to develop to 14 days, researchers will promise medical miracles if the embryos are allowed to develop to nine weeks. And so on, step by incremental step, until we're harvesting cells from full-term fetuses.

It's a classic slippery slope argument, and many in the field of bioethics reject it. They say it's possible to draw a firm line, for instance, between "therapeutic cloning" and "reproductive cloning," which would produce cloned people. "Our intention is not to create cloned human beings, but rather to make life-saving therapies for a wide range of human disease conditions, including diabetes, strokes, cancer, AIDS, and neurodegenerative disorders such as Parkinson's and Alzheimer's disease," Robert P. Lanza, ACT's vice president of medical and scientific development, told reporters after announcing the company's cloning success last year.

An odd facet of the bioethical debate is that it seems to bypass traditional left-right boundaries. Newman and Rifkin are identified with the left, but their views on cloning and genetic modification are shared by Leon Kass, the chair of President Bush's Council on Bioethics who also questions in vitro fertilization, euthanasia, and abortion. If there's a neat division in the bioethical community, it's not between liberals and conservatives or even Luddites and technojunkies. The split is between those who believe that the mantra of medical science should be "caution" and those who think it should be "cure."

Newman argues that the precautionary principle embodied in the Hippocratic oath!"first do no harm"!precludes fiddling with the genetic structure of plants, animals, or people. Other bioethicists ask how science can turn its back on a cure for Alzheimer's disease or breast cancer. "You must use the tools available to you to try to reduce human suffering and cure human disease," bioethicist Kenneth Goodman, who sits on ACT's ethical advisory board, has argued.

Clearly the dilemma posed by biotechnology patents is stickier than that raised by a patent on widgets. The question is whether the patent office is the best forum for weighing the pros and cons. "Profound ethical issues are being decided by the patent office, which really has no interest [in deciding] and no capabilities to decide those issues," Andrews said. "The 'bio' in biotechnology is pieces of people and animals and plants. We have profound cultural and religious and other values that have an effect on what we think is appropriate to do to people, plants, and animals."

The U.S. Patent and Trademark Office museum is housed off the lobby of a towering federal building in Arlington, Va. A series of placards give a brief history of the concept of intellectual property, from its enshrinement in Article I of the Constitution ("The Congress shall have Power... To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries") to its elaboration in the Patent Act of 1793, which defined patentable subject matter as "any new and useful art, machine, manufacture, or composition of matter."

Sitting on the first three-man patent board was Thomas Jefferson, an inventor who nonetheless harbored grave doubts about the wisdom of allowing inventors to monopolize their ideas. The board met on the last Saturday of each month and granted only a handful of patents a year.

These days, the office employs 3,500 patent examiners to evaluate some 350,000 patent applications yearly, about 24,000 of which fall into the category of biotechnology. Congress and applicants attacked the office this year, complaining about a backlog of more than 400,000 applications and about examiners' skill level. Both problems relate to the growing technical complexity of what the office does: one recent biotech patent application contained the equivalent of six million pages of data. In their evaluations, patent examiners use four criteria: Is the invention novel? Is it useful? Is it non-obvious? Has the method been completely described and disclosed?

Two glass cases in the museum display some of the working models that the patent office once required inventors to submit along with their applications!shiny brass gizmos with complicated gears, cranks, rollers, and pistons. Each one is tagged with a handwritten label like this: "No. 202,235 WA Clark. Lubricator. Patented April 9, 1878." There is a steam engine, a wool-washing machine, a machine for filling cans, and one for shaping dough into crackers. Looking over these gleaming inventions, it's impossible not to wonder what would happen if the model requirement were still in effect. Would a human-ape chimera have to come slouching toward Washington, carrying the reams of papers required to prove its novelty, utility, non-obviousness, and the feasibility of its creation?

The question of whether inventors can patent living creatures arose in 1972 when a scientist named Ananda Chakrabarty tried to patent a bacterium that he had bestowed with an appetite for petroleum in hope of cleaning up oil spills. The patent office denied the application, saying that Congress didn't intend to grant patents to laboratory-created micro- organisms. Chakrabarty appealed to the Court of Customs and Patent Appeals (then the federal court with expertise in patent law) which ruled that the bacterium's status as a living organism was "without legal significance" with regard to the question of whether it could be patented. The patent office appealed this decision to the Supreme Court, which heard the matter in March 1980. Only a handful of spectators looked on from the gallery. At the time, Rifkin was one of the few people who seemed to understand what was at stake.

An economist with a roving curiosity and the ability to spot emerging social and financial trends!his 16 books include titles on corporate downsizing, the information economy, and hydrogen fuel-cell technology!Rifkin combines a formidable intellect with a Madison Avenue talent for sound bites, superlatives, and sensational creep-show scenarios that's earned him enemies in the biotech world. He has been an anti-technology crusader since 1976, when he and his friend Ted Howard first noted that drug companies were experimenting with recombinant DNA techniques. The pair collaborated on a book entitled Who Should Play God? When the Supreme Court agreed to hear the Chakrabarty case, they filed a friend-of-the-court brief supporting the patent office's position. Allowing any living creature to be patented, they argued, would inexorably lead to the patenting of higher forms of life.

Sitting in a sunny, uncluttered office at his Foundation on Economic Trends in Washington, D.C., Rifkin resembled nothing so much as a cat with a career in advertising. He has small ears that are set high on his head!they give him his feline appearance!a neatly trimmed grey moustache, a bald pate, and brown eyes that droop a bit at the corners. As his thoughts unskeined, his voice was equal parts silk and gravel. "We warned of the life of the planet being reduced to intellectual property and invention without any discussion at all," he recalled. "We said it would be one of the most momentous changes not only in the history of commerce but also in human social life."

In their brief to the Supreme Court, Rifkin and Howard warned that "Scenarios which once appeared far-fetched!the manufacturing of mammals, including human beings, to specification; the creation of super-intelligent beings; the asexual reproduction of organisms through cloning; the advent of genetic surgery designed to alter the heredity of complex organisms!will become science fact, if not tomorrow, then certainly within the lifetimes of the majority of Americans." The court did not heed these predictions. By a 5-4 margin, the justices held that Congress had intended "anything under the sun that is made by man" to be pat-entable, including living organisms.

Writing for the majority, Chief Justice Warren Burger explained that the question before the court was a narrow one!was the organism in question patentable under the statute? The law said patents could be granted to a "manufacture" or a "composition of matter." Did Chakrabarty's bacterium fit one of those categories?

The court said yes. Given that Chakrabarty had created a useful bacterium with "markedly different characteristics from any found in nature," five justices agreed that "his discovery is not nature's handiwork but his own." Which meant it could be patented. Burger dismissed what he called the "gruesome parade of horribles" described by Rifkin and Howard. The case before the court, Burger said, wasn't about whether genetic research was good or bad. "We are without competence to entertain these arguments!either to brush them aside as fantasies generated by fear of the unknown, or to act on them," the chief justice wrote. The court's job, he continued, was to interpret the law as written; the larger ethical questions were a matter for Congress.

The decision delighted the biotech industry, which continues to argue that it needs patent protection to survive. "Patents are the lynchpin for movement forward," explained Lila Feisee, the director for intellectual property at the trade group Biotechnology Industry Organization. "For companies that don't have medicines yet, the patents are their sole product. They use the patents to go to Wall Street. That's how our industry works."

Perhaps because the court limited itself to a relatively narrow question of law rather than larger ones of science and ethics, Chakrabarty didn't make much of a splash. But Rifkin and Howard's predictions turned out to be dead on. In 1987, then-Commissioner of Patents and Trademarks Donald Quigg issued a memo clarifying his interpretation of the law: "The Patent and Trademark Office now considers non-naturally occurring non-human multicellular living organisms, including animals, to be patentable subject matter," he wrote. By 1988, Harvard University researchers had created and patented the Onco-mouse, a laboratory mouse im-planted with a human cancer gene. Before long, there were patented rats, rabbits, fish, sheep, pigs, and cows.

At the same time, the patent office kept one living creature off-limits. "A claim directed to or including within its scope a human being will not be considered to be patentable subject matter," Quigg wrote. The basis for this directive, he said, was the Constitution!presumably the Thirteenth Amendment ban on human slavery, which precludes treating human beings as property. Allowing someone to patent a person, the argument goes, is the same as allowing someone to own one.

But what constitutes a human being? Clearly it takes more than a snippet of human DNA to make a person, but how much more? A human cell? An organ? An embryo? The question gets caught in a philosophical and political thicket. Some, particularly those who oppose abortion, define human life as beginning at conception; others say that it begins when a fetus can survive on its own. Some would use sentience or self-awareness as a litmus test, while others point out that chimpanzees and gorillas are almost certainly far more so than an infant without a brainstem, yet are not considered human.

In the two decades since Chakrabarty, the patent office has granted over 1,000 patents on human genes alone. Another 20,000 biotech applications await review. In the interest of developing tests for diseases as well as potential cures, private companies have claimed ownership of human genes that govern breast cancer, Alzheimer's, and cystic fibrosis.

Sometimes, these patents restrict the ability of other scientists to do research on those genes and related illnesses. The complicated web of ownership has led to an epidemic of patent infringement lawsuits as different companies battle over access to genetic information. It has also led to lawsuits by patients who object to losing ownership of their own genetic material. Families of children with Canavan disease, a degenerative disorder of the central nervous system, are suing the Miami Children's Hospital, which used blood and tissue from Canavan-afflicted children to develop a genetic test for the disease. The resulting patent, the families argue, is hampering other researchers who are trying to find a cure. Similar issues were raised in 1984 after the University of California patented a cell line derived from a patient with a rare form of cancer. When the patient took the hospital to court, arguing that he ought to be able to own the products of his own body, the California Supreme Court ruled that the patent was justified because the process of culturing the cells was "difficult!often considered an art."

The patent office tries to draw similar distinctions. "We are not patenting life," then-Patent Commissioner Bruce Lehman said in 1998. "God, I suppose, has a patent on life. We are patenting technology." Yet the distinction between human life and technology is getting fuzzier by the minute, as researchers transfer human genetic material into animals, animal genes into plants, and potentially even plant genes into humans. "A scientist called me and asked about putting the gene to photosynthesize in human embryos," Andrews said. "I asked my law students, when would human rights click in? If you had half-plant genes, or half-animal genes, would you still be protected by the Constitution? By international human rights treaties? The very boundaries of humanity are being changed by technology." Lori Knowles, an associate for law and bioethics at the Hastings Center, puts the legal dilemma this way: "We have in law essentially just two categories: people and property.... Frozen embryos, animal-human hybrids, all of those things fall somewhere in between."

With only the broad sweep of the Thirteenth Amendment for guidance!and no direction from lawmakers or judges on applying the ban on slavery to patents involving human material!it's not surprising that the patent office seems confused about where to draw the line. "Each application is reviewed on a case-by-case basis," says spokeswoman Brigid Quinn. The Wall Street Journal recently reported that the question of "humanness" is a regular topic of discussion at the patent office. "Patent examiners can attend regular meetings to help them understand which biotechnology inventions are 'human' and which aren't," the Journal reported.

Stepping into the breach left by Congress and the courts, the biotech industry is pushing the boundaries of the patentable as far as it can. Last year, the University of Missouri won patent 6,211,429, which covers a method of producing cloned mammals!a category that includes humans. (A university spokesman later told The Wall Street Journal that the institution opposed human cloning and would use its patent to prevent anyone else from cloning humans.)

Three other patent applications now being weighed by examiners also involve the cloning of animal and human embryos. One is from Ian Wilmut, the British researcher who created Dolly, the first cloned sheep, and is for use on "mammalian embryos," including human ones. Another, from the University of Massachusetts, is for a cloning process that would transplant human tissues from cloned embryos, fetuses, and offspring. None of the researchers is considered a scientific renegade. The goal of their research is to cure genetic diseases, reverse the aging process, and help people needing hearts, livers, and bone marrow.

But, Rifkin asks, at what price? "Even if you take the position that a human being isn't a human being until the first breath, you still have to say that at conception, when the sperm and egg come together, it's a potential human being," he said. "Then the question is, can a company own a potential human being, from conception through gestation to birth, as intellectual property? If that doesn't raise one of the great social issues in history, I don't know what does."

When Rifkin and Newman delivered the application for their chimera patent to the patent office in December 1997, they got the flurry of media reports they'd hoped for. There was coverage in The New York Times and on ABC's World News Tonight, discussion in legal, scientific, and news magazines, and dozens of law review articles. A few commentators mocked Newman and Rifkin for being pseudo-scientific fearmongers pulling a cynical stunt. But most used the application to discuss the murky legal backdrop against which genetic research is taking place.

The patent office has a policy of refusing to comment on pending applications, but in April 1998, then-Commissioner Lehman was moved to break the usual silence. In a written statement, his office invoked an 1817 federal district court decision denying patent protection to inventions that were deemed "injurious to the well being, good policy, or good morals of society." "There will be no patents on monsters, at least not while I'm commissioner," Lehman said in a subsequent interview.

The moral utility doctrine Lehman in-voked is a legal antique. It was coined by Justice Joseph Story in a case considering whether a water-pumping invention was useful enough to merit a patent. In his decision granting the patent, Story mused that "useful" was "in contradistinction to mischievous or immoral," a curious reflection since no one had suggested that the pump was going to be used for nefarious purposes. Despite its digressive origins, the patent office used Story's moral utility doctrine throughout the 19th century to deny patents to gambling machines and inventions used to commit fraud.

Until Lehman resurrected it, the concept had fallen out of favor in modern times. In 1977, for instance, a district court upheld a patent on a radar detector, even though the sole purpose of the invention is to help drivers disobey the speed limit. That's as it should be, argues Patrick Coyne, the intellectual property attorney representing Newman and Rifkin in their dealings with the patent office. "With due respect to Commissioner Lehman's views, I don't agree that the commissioner has some inherent authority to reach out and grab things that he thinks are immoral," the lawyer argues. "That's a very subjective standard, very far-reaching potentially, and it's nowhere in the statute.... As a policy matter, you don't want the patent office, an appointed government agency, deciding what's good or bad for science."

Morality is one of those things, like obscenity, that arbiters have had a hard time defining. "I'm quite certain that when we see one of these, we'll know it," Lehman told The Washington Post in 1998. But Rifkin thinks the patent office is fooling itself. "We say, well, wait a minute, you've already put other human genes into animals and claimed the animal as an invention," he said. "How many genes does it take to make it immoral? One gene? Twenty? A couple cassettes? Three chromosomes? ... They can't create a policy that will deal with this because they don't have the statutory guidance."

No one was surprised when the patent office rejected the chimera application in March 1999. What was surprising was the office's declaration that the chimera failed to meet any of the criteria necessary for patentability. In addition to citing moral grounds, the patent office declared that the chimera violated Quigg's rule because it "embraces a human being." Examiners also found that the application was not different enough from previous inventions to meet the criteria of non-obviousness, yet at the same time was not well documented enough for them to be certain that it could be done at all.

To Patrick Coyne, such a sweeping indictment was suspicious, especially following on the heels of Lehman's no-monsters-on-my-watch remarks. At the same time, Coyne admitted, "It was a well-researched, well-thought-out action. They obviously put a lot of effort into this!much more than you see in a typical case."

It's common enough for a patent application that's eventually approved to be initially rejected. Rifkin and Newman have elected not to share with reporters their application and the patent office's response. (Rifkin says the correspondence is no one else's business; Newman says he doesn't want to jeopardize the application.) So it's hard to judge whether the initial rejection was a short-term setback or a foreshadowing of the outcome, and whether the follow-up submissions that Rifkin and Newman have filed since the first rejection addressed the examiners' more mundane concerns about the invention's patentability.

Some commentators question whether the invention would have any use other than as a sideshow. Because most of the organs harvested from such chimeras would contain an unpredictable mix of human and ape tissues, they would not be much more compatible with the human body than organs taken from pure chimpanzees, notes an article in the Hoover Institution publication Policy Review.

Be that as it may, Coyne argues, his clients' application is as non-obvious and useful as other biotech patents, like those of genes, that aren't fully understood. "To be blunt, the principal reason this case has not been allowed is because of who the applicant is," he said.

Coyne has a neatly trimmed beard, twinkling blue eyes, and an air of ironic amusement. He is not an ideologue but an advocate, and it's an odd facet of this case that the position he's pushing for in many ways contradicts the beliefs of his two clients. Rifkin and Newman may say that it's immoral to privatize the genetic commons, but Coyne will argue that morality is best determined by the market. The idea is to corner the patent office into issuing a clear declaration as to what kinds of life forms may or may not be patented—a declaration that can then be taken up with a higher court. "Whatever [a chimera] is, it's plainly not human," the lawyer said. "But they are nonetheless rejecting it as 'embracing a human being'—whatever that means."

The patent office rejected the chimera application for the third time in August 2000. Rifkin and Newman responded in February 2001 and are still waiting for a final ruling. If the answer is no, the applicants can appeal to the Board of Patent Appeals and Interferences, senior officials from the patent office who sit as administrative law judges in Arlington. The board's decision, in turn, can be appealed to the U.S. Court of Appeals for the Federal Circuit, the court that handles intellectual property appeals. The next and final arbiter is the Supreme Court.

Will the chimera prompt the court to take on the ontological issues it passed up in Chakrabarty? If all goes as Rifkin and Newman hope, the justices will begin to map out the uncharted territory between Justice Burger's ruling in favor of patenting living organisms and the patent office's ban on owning human beings. In doing so, the court presumably would have to face the question that has puzzled the patent office for decades and philosophers for eons: What makes us human? Are we human because of what we do and what we are capable of, or because of something written in our DNA?

Many legal scholars argue that questions of such magnitude should mostly be answered elsewhere. "It would be extremely useful for the Supreme Court to clarify the scope of Chakrabarty," said Knowles of the Hastings Center. "But there should be some policy action. . . . This is an ethics area. And the court does not have the expertise, nor do they have jurisdiction, to bring up all the ethical issues."

On the other hand, the ethical questions raised by the chimera application aren't ones that the other branches of government seem eager to answer. The patent office has made it clear that it resents being "dragged into a controversy which, from our particular perspective, we don't need to be a part of," as Stephen Kunin, deputy assistant commissioner for patent policy, told a legal magazine in 1999.

And Congress, which the agency looks to for guidance, has so far declined to rein in a robust young biotech industry with a habit of making generous campaign contributions. (An attempt to restrict patents on humans failed in the 1980s partly because no one could agree on a definition of "human.") Legislation that would ban the cloning of human embryos has been debated in Congress both this year and last but is stalled in the Senate.

Biotechnology, however, marches ahead, even as scientists, judges, and lawmakers flinch from grappling with its moral implications. That is precisely what worries Rifkin and Newman. Ours is not a culture used to looking at technology through an ethical lens, and when science and philosophy encounter each other, the reaction on both sides is usually silence and discomfort. The discomfort was evident one afternoon in August, when members of a National Research Council committee charged with defining scientific—rather than policy—concerns about animal biotechnology gathered in Washington to answer journalists' questions about a report they'd just issued. The committee was composed of scientists with expertise in animal husbandry, and its chair, a zoology professor from North Carolina State University named John Vandenbergh, spent most of the briefing answering technical questions about the welfare of cloned and transgenic animals and the potential effect of these animals on the environment and on the health of consumers.

At last Michael Fox, then a bioethics scholar at the Humane Society of the United States, came to the microphone. "After you'd finished your in-depth deliberations on the risks, did a consensus on your committee begin to surface that in some way this is a Promethean bargain. . . and that we're in one hell of a pickle right now?" he asked. A few members of the audience giggled uncomfortably. "And how are we going to regulate this? Is this the best evolutionary choice for the human species in relation to the rest of creation on earth? What are we doing? Where are we going? I'm sure you must have spoken about these things when you had your drinks after a hard day's work together."

By the time Fox was done speaking, the giggles had erupted into gales of laughter. It was as if he'd wandered into a meeting of cartographers and questioned the shape of the globe.

"We did not specifically address the issues you are talking about, which are obviously philosophical," Vandenbergh said when the hilarity subsided, adding that he thought the committee agreed that the science of biotechnology had many benefits but probably needed to be regulated. Then he looked beseechingly around the room at the other members of the committee. "Anyone else want to comment on this? No? Okay."

And with that, the discussion was adjourned.


Dashka Slater, a writer in Oakland, Calif., last wrote for Legal Affairs about dog laws.

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