For 16 years, the U.S. Patent and Trademark Office has refused to issue patents on human beings at any stage of development, including the human embryo. But an attempt by Congress to put that policy into law has provoked a sharp, though largely hidden, debate.
With no public hearings and little discussion, the House approved an amendment in July barring patent claims on the "human organism."
Biotechnology companies and patient advocates say they agree that no patents should be issued on human embryos, but they contend that the House language is overly broad. They call it a back-door attempt to shut down research on medical treatments using stem cells that come from human embryos.
"Our companies are not interested in getting a patent on an embryo
Anti-abortion groups and other critics say the industry aims to kill the amendment because, in fact, it wants the right to patent certain embryos. This, they say, would be an immoral commercialization of human life.
"The biotechnology industry wishes to patent human embryos and collect fees for each copy sold," said Douglas Johnson, legislative director of the National Right to Life Committee, a leading opponent of research using human embryos.
He said the industry wants to create human embryos with certain genetic traits -- such as the genes associated with cancer or other diseases -- and use the embryos for genetic research, to test new drugs and for other purposes.
"That's where this is heading, and I think that's way over the line in terms of exploiting human life for commercial gain," said Rep. Dave Weldon (R-Fla.), sponsor of the amendment. "I think it's morally and ethically reprehensible."
Sen. Sam Brownback (R-Kan.), a vocal opponent of human cloning and embryonic stem cell research, said the House amendment had "a reasonable chance" of becoming law. "This would say that a human is a person, not a piece of property that you can patent," he said.
On a voice vote, the House attached the amendment to legislation that funds the departments of Commerce, Justice and State. The Senate has not voted on its version of that bill, which does not include the patent amendment.
If the bill emerges from the Senate without the amendment, House and Senate negotiators will decide its fate when they reconcile the two versions of the legislation.
For years, the patent office had declined to issue patents on any living organisms.
But in 1980, the Supreme Court forced the office to award a patent on a bacterium that had been genetically engineered to "eat" oil spills. In a 5-4 ruling, the court said that Congress had authorized patents on "anything under the sun that is made by man." Because the bacterium had been modified by scientists and was not found in nature, it qualified for a patent, the court said.
That opened the door to patents on a variety of genetically modified animals, as well as on human genes and human cells. But the law was murky on whether human embryos could be patented.
The lack of clarity has become more important in recent years as scientists developed cloning and other techniques for creating embryos, in some cases to study the medical uses of embryonic stem cells or to better understand the biological mechanisms behind the earliest stages of life.
In 1987, the patent office announced that it would reject any patent claim "including within its scope a human being." Patent examiners have turned down embryo patents unless the claims cover only non-human embryos.
Still, many legal experts have said that the office has been on shaky legal ground in rejecting claims on human embryos. The patent office has suggested that legislation might be needed to make sure its position is not overturned by the courts, as in the 1980 bacterium case.
"Given the uncertain outcome of legal challenges to the exclusion of humans from patent-eligible subject matter, legislation may be required to ensure their exclusion," Karen Hauda, a patent examiner, told the President's Council on Bioethics last year.
Patents grant the holder the exclusive right to make and sell an invention for 20 years, giving investors assurance that competitors cannot copy the innovations they spent money to create.
He said the Weldon legislation, because it covers claims on the "human organism," might threaten patent protection for human stem cells, human tissues, animals that have been given human genes and other biological materials that scientists are studying in an attempt to cure disease.
"This amendment appears to be a 'back-door' approach of getting the U.S. to surrender its leadership in the development of life-saving cures using stem cell research, somatic cell nuclear transfer, and other technologies," said Michael Manganiello, board president of the Coalition for the Advancement of Medical Research. "Somatic cell nuclear transfer" is a technical term for cloning.
Weldon dismissed the idea that his amendment would affect patents on genes, stem cells or anything other than human beings, embryos and fetuses. He said he used the term "human organism" because it covered the human being in all stages of development.
Werner said the biotechnology industry group supports the current patent office policy. At the same time, he acknowledged that the law might allow patents on human embryos that have been genetically modified, even if the patent office refused to grant them, because these embryos could be said to have been "made by man," similar to the genetic alterations in the 1980 bacterium case.
But he said the industry group opposed any effort to write a firm ban on embryo patents into law.