Patently Provoking a Debate

Nearly 10 years ago, a friend called Stuart Newman with an intriguing challenge: Could he think up a new form of life that would be scientifically useful and possible to patent--yet so disturbing that the public would recoil?

And so Newman, a New York medical school professor, proposed a “humouse,” a part-human, part-mouse creature that could be made with existing lab techniques and would help companies test for the toxic effects of new drugs. He even typed up a fake press release claiming a trademark for the “humouse” name.

Newman’s proposal was far more than a whimsical exercise. Today, the U.S. Patent and Trademark Office is in the final stages of deciding whether he can patent his idea. Win or lose, the result could be exactly what the humouse was designed to accomplish: prodding Congress and the courts to place new limits on manipulating and patenting human life.

For the patent office, the humouse raises some awkward issues. For 22 years, the office has granted patents on a wide array of living organisms and elements of life. Human genes have been patented. So have human cells. Patents have gone to animals made with bits of human DNA so scientists can study cancer and other diseases.

But the patent office has drawn a line at claims on human embryos and human beings themselves, saying that Congress, which writes the patent laws, excluded them from the range of things that can be patented. Although Congress has never spoken directly on the subject, the patent office says it infers the ban on these patents from such doctrines as the 13th Amendment ban of slavery.

Some patent experts doubt that this stance is legally sound. Now the humouse is forcing the patent office to defend its position. And in five years of sparring over Newman’s application, the office appears to concede that it has little or no legal authority to stop what would clearly be a controversial development: the patenting of human embryos.

The case will probably wind up in the courts, which could decide whether patent rights to human life--and to new methods of making human life--can be owned and controlled by private hands.

Novel Plan for Raising Moral Objections

Newman has never made a humouse and says he probably never would. In fact, he and his patent partner, technology critic Jeremy Rifkin, have deep moral objections to manipulating human life and oppose patenting any living organisms. They believe that federal law does not sufficiently limit scientific work with human embryos and human life, and their humouse is intended to change just that.

Patent law does not require them to make a humouse, but they must show it can be done. Newman says he could take an embryo from one species, either man or mouse, and inject it with embryonic cells from the other species. The result would be an animal with cells from both species scattered throughout and working cooperatively. A similar technique was used in the early 1980s to make a sheep-goat hybrid, dubbed a “geep,” though no one is known to have tried a similar cross-species mix with humans.

“There really is no boundary on what you can do with human life. There’s no natural stopping point,” Newman said. “That troubles me. I think it will ultimately lead to genetically engineered human beings made for sale.”

Making the humouse would be legal under federal law, as long as no taxpayer money was used and certain administrative rules were followed.

By asking for a patent on the very thing they find unethical, Newman and Rifkin believe they will provoke tighter limits on what can be made and patented. If the patent office awards them a patent on something widely considered monstrous, Congress could be pressured to draw new laws on patenting life. And if the office rejects their patent, Newman and Rifkin would gain standing to appeal in the federal courts.

They are happy to go to court. A judge’s denial of a humouse patent would probably bar patents on all human-animal hybrids and possibly on human embryos. And even if they win a patent in court, they expect a public outcry that also could force Congress to act.

So far, patent examiners have denied the humouse patent on grounds that it “embraces a human being” and human beings cannot be patented. But how, Newman and Rifkin ask, does the patent office know that a human-animal combination is human?

“This is the first test of what constitutes a human being in the age of biotechnology,” Rifkin said. “When we can engineer life, answering these questions becomes an angst-laden struggle.”

Experts See Important Implications

Patent experts say the humouse case could be important for three reasons.

First, no court has ruled on whether human embryos can be patented, or whether a mix of human and animal material remains, in a legal sense, human. This lack of legal clarity is becoming more important as scientists push to understand embryos and the medically promising stem cells that grow inside them.

A Massachusetts company, Advanced Cell Technology Inc., is trying to produce and patent human stem cells made by merging human DNA with cow eggs, creating a human-cow embryo. A Chinese scientist is working with human-rabbit combinations. Cow and rabbit eggs are far cheaper than human eggs, and producing stem cells with them could prove more inexpensive and efficient.

Second, the patent office has allowed thousands of claims on genes, cells and animals over the last two decades. By raising the question of what can be patented, Newman and Rifkin hope to undermine some of those patents.

Finally, the patent dispute is part of a political struggle to define the legal and moral status of the human embryo. President Bush has barred federal funding for experiments that destroy embryos for their stem cells, and he has devoted two speeches to arguing that embryo destruction is unethical in research. Within weeks, the Senate is expected to vote on whether it should be legal to create human embryos through cloning.

Still, cloning and stem cell research are legal today. Congress has not said embryos are so privileged that they deserve protection from privately funded researchers.

Yet the patent office argues that human embryos are equivalent to human beings, which puts them beyond the reach of patent claims. “No question, they’re in a very strange status,” said George Annas, a bioethicist at Boston University. “They’re not the same as mouse embryos, but we haven’t really decided how different they are.”

“There is tremendous symbolism here,” said R. Alta Charo, professor of law and medical ethics at the University of Wisconsin Law School. “Patents stand for the idea that somebody invented something. For those who are religious, it smacks of hubris to say that human beings were invented. They were invented by God.”

1980 Case Allows Patents for Organisms

At one time, the patent office believed living organisms could not be patented. That put the office in accord with people such as Newman, a developmental biologist at New York Medical College in Valhalla, N.Y. He believes that patents on life are an “incursion of private property and private ownership into the realm of nature, into what should be common property.”

But the patent office was forced to change its policy in 1980 after it turned down a patent application from General Electric for a bacterium that had been genetically engineered to “eat” oil spills.

General Electric appealed to the Supreme Court, in a case called Diamond vs. Chakrabarty. Only one “friend of the court” brief was filed arguing that life should not be patented. It was written by Jeremy Rifkin and his colleagues.

The Supreme Court, however, said in a 5-4 ruling that Congress had authorized patents on “anything under the sun that is made by man.” And because the GE microorganism was man-made and not naturally occurring, the court ruled that it qualified for a patent.

It was the first Supreme Court ruling to endorse patents on living organisms. Eventually, the patent office began issuing patents on a barnyard of more complex animals --genetically engineered mice, pigs and cows. Rifkin thought this went far beyond the authority laid out by the court.

“I wanted to revisit the question of what is legally patentable and what is not,” said Rifkin, president of the Foundation on Economic Trends in Washington. “But you can’t bring litigation against the patent office. They have utter discretion, and you can’t challenge them from the outside. The only way to be a player is to apply for a patent.”

And so Rifkin called Newman to ask what invention might make their case best--and bring as much publicity as possible along the way.

After considering the humouse, Newman and Rifkin later broadened their idea to include human combinations with chimpanzees, baboons and other animals. They filed a patent application in 1997, with Newman as inventor and Rifkin as a co-owner.

In 1999, two years after receiving the humouse application, the patent office issued a preliminary rejection. Patent examiner Deborah Crouch said the human-animal hybrid “embraces a human being”--and so did not qualify for a patent.

When Newman and Rifkin pressed the office to identify a law that bars human embryo patents, a second examiner, Deborah Clark, wrote that patents on embryos and human beings would clash with the 13th Amendment’s ban on slavery.

A patent is good for 20 years and allows the holder to prevent anyone else from using an invention. Because of this, Clark wrote, “the patented human being could conceivably be excluded by the patentee from ‘using’ himself, i.e. self-employment, an absurdity that reinforces the conclusion that Congress did not intend to allow patenting of human beings.”

In addition, a patent conveys the right to bar anyone else from making the patented invention. If that invention were a human being or viable embryo, Clark argued, the patent holder could stop that person from copying himself--in other words, from reproducing.

Some patent lawyers question these arguments. Roe vs. Wade, after all, holds that embryos at their earliest stages are not constitutionally protected as human beings, suggesting that the patent office should not equate embryos with people. And the 13th Amendment argument is “just nonsense,” Charo said, because a person, once born, has all the rights of citizenship, including the right to a work life free of patent restrictions.

What in the Mix Makes It a Human?

But even if the patent office had the power to bar patents on human embryos, Newman and Rifkin said in written responses, how did the office classify a human-animal hybrid as human?

Clark pointed to the hypothetical case of a person who received a pig heart. This would mix two species, but the result was clearly human, she said.

But Rifkin and Newman argue that their creatures, composed of cells from two species scattered throughout, are wholly different from a human.

In the patent office’s most recent rejection notice, in August 2000, Clark included a passage that Rifkin, Newman and others took as a clear indication that the office has no authority to reject claims on human embryos.

Congress has not spoken directly to embryo patents, and neither has the Supreme Court, the patent examiner wrote. “In the absence of clear legislative intent and guidance from the courts,” she added, “it is incumbent on the office to proceed cautiously.”

“She’s conceding that they don’t have explicit authority to reject this application as ‘embracing a human being,’” said Patrick Coyne, the lawyer for Newman and Rifkin. But the office is rejecting the application anyway “so the issue can be decided in court,” he said. “To just give it to us would open the floodgates to these kinds of patents.” The patent office would not comment.

Patent examiners told Newman and Rifkin to expect a final rejection of their application more than a year ago, but instead the office sent it to a “quality review” process, which usually take two weeks.

Rejection Could Preclude New Products

For the biotechnology industry, the humouse case is serious business. Without strong patent protections, the industry says, investors will not risk money to develop new products. And Rifkin and Newman aim to narrow the scope of what elements of life can be patented.

Rifkin and Newman claim that denying their patent throws many existing patents into question. They ask how the patent office can reject a mouse-animal hybrid because of its human qualities while not also rejecting all-human stem cells, which come from embryos and can grow into any part of the body.

One of the most sensitive questions is whether patents can cover human embryos that have been engineered to carry certain traits. Although the Biotechnology Industry Assn. says it does not support the patenting of human embryos, pressure may grow from individual biotech companies.

“If you had a system where the embryo could be used to generate cells for therapeutic use, then there could be a compelling reason to want a patent,” said Elizabeth Howard, a patent lawyer in Palo Alto with the firm Orrick, Herrington & Sutcliffe.

In particular, Howard said, scientists will try to modify human embryos to produce stem cells that can be transplanted into patients without resulting in tissue rejection, a common problem in transplants today.

Scientists say they also want to create human embryos to study disease. Many people carry genes that raise their risk of breast cancer, colon cancer, Alzheimer’s disease and other ailments. Through cloning, scientists could take a cell from one of these people and use it to create an embryo that also would have the disease genes. Stem cells from that embryo could offer clues to mechanisms of the disease.

Some scientists consider this work so promising that they have cited it in asking Congress not to outlaw human cloning in medical research.

But some people fear that researchers will not only want to make embryos and stem cells this way but also patent them. With so many disease genes to study, companies could eventually ask for separate patents on each type of embryo they created. Companies already patent and sell mice, rats and other animals that have been engineered to model various human diseases.

Opponents of human cloning, in fact, have run radio advertisements that play up the prospect of embryo patents, in an attempt to persuade the Senate to outlaw the technique.

“It hearkens back to slavery,” said Douglas Johnson, legislative director of the National Right to Life Council, which sponsored the ads. “You would have biotechnology companies owning a class of members of the species Homo sapiens and selling them because of particular genetic traits that are deemed useful in drug testing or experimentation.”

Ultimately, Congress may have to decide what life forms are proper material for patenting. The Supreme Court invited such an action in its Chakrabarty ruling 22 years ago, noting that lawmakers “may choose to craft a statute specifically designed for such living things.”

“Both the majority and minority probably thought Congress would have to say something after that decision, but Congress hasn’t said a thing,” said Annas, the Boston University bioethicist. “It’s Congress’ job to say what the limits are of patent law, and it’s time for Congress to do that.”

But resolving the question would require a compromise between lawmakers who consider embryos equivalent to humans and those who hope to use them to make stem cells and tissues for patients.

“We as a society are ambivalent about the moral status of the embryo,” said Arthur L. Caplan, a bioethicist at the University of Pennsylvania. “That’s why this has been going on for a long time, and why no one wants to try to sort it out.”