US Patent Law Can’t Cope With Human Clones

Adam L. Penenberg
Wired.com, 2.27.97

IMMEDIATELY AFTER DR. IAN WILMUT, AN EMBRYYOLOGIST at the Roslin Institute in Edinburgh, Scotland, announced last weekend that he and his research team had successfully cloned an adult sheep, people around the world began speculating on a matter closer to home: the cloning of humans.

Although Wilmut’s experiments have focused on manufacturing animals for medical research, it’s a sure bet that in the near future, someone somewhere will clone a human being. Many countries, including England, have laws on the books banning human clones, but the United States does not. In fact, US law actually encourages the patenting of life forms: The US Patent and Trademark Office has not only approved patents on human cells, cell lines, viruses, genes, animals, and numerous altered plants and microorganisms, but also awarded the National Institutes of Health a patent on the cell line of an indigenous Papua New Guinea man.
This patent first, ask questions later policy raises thorny legal and rights issues: Would human clones be patentable by the cloner, or would the clones retain intellectual property rights over their genetic material? Since they would be a product of replication rather than procreation, would they be considered humans, covered by all existing laws? And what about human-animal hybrids?

Dr. Lee Silver, a biologist at Princeton University, said that American law is not up to the task of deciding. “In the US, there are no federal laws on reproductive technologies, only state laws. If some states outlawed human cloning but others kept it legal, then anyone with the money could clone him or herself. And if every state banned human cloning, people would just go offshore to do it.”

The Supreme Court faced life for the first time in 1980. The case was Diamond v. Chakrabarty, and the court, by the slimmest of majorities, ruled that an oil-munching microbe, indeed “anything under the sun that is made by man,” could be patented. The US Patent Office applied this ruling to the patenting of plants in 1985, and two years later, expanded the statute to cover all animals, including human stem cells, cell lines, viruses, embryos, and fetuses.

Since the 13th Amendment to the Constitution prohibits slavery, the court found that human beings could not be patented. But the court did not address the most chilling question: How much of a person could you patent before the 13th Amendment kicks in?

“If you can patent human cells, which you can under US law, then could you patent human organs?” asks Joseph Mendelson, legal director for the International Center for Technology Assessment. “Right now, the answer would have to be yes. And if organs, why not a hand? Could you clone and patent a line of embryos predisposed to cancer or HIV for research?”

As the pace of scientific discovery outstrips the law’s ability to cope, these are questions whose day has arrived. Since animals intermingled with human genes could be patented, would human-animal hybrids also be patentable? Could someone patent and enslave an entire race of human-animal hybrids not protected by the 13th Amendment? Is it possible a weapons contractor could count on patent protection to market an army of disposable human clones so long as the clones were genetically altered in some, perhaps tiny, way?

Unless American patent law is revised, the answer, says Mendelson, is yes. All the Patent Office requires for a successful application is for an “invention” to be novel, have utility, and not be a product of nature. Although DNA is obviously a product of nature, the law says it isn’t after you isolate and clone it.

As for Dolly, the cloned sheep, it’s not clear whether she could be patented in this country since she is identical to a preexisting sheep. Alter her genes in some small way, however, and she could be.

“US patent law is based on one size fits all,” said Rebecca Eisenberg, a University of Michigan Law professor and expert on patent law. “In Europe, there is a tradition of asking moral and ethical questions about what can and should be patented. In the US, this is outside the concerns of the patent system, the mission of which is to promote technological progress. Any ban on life forms patents would have to come from Congress, and I don’t see that happening since they are so pro-business.”

Copyright 1997 Adam L. Penenberg (penenberg.com)