Patent Rights to Cloned Human Embryos
Science (Vol. 287, No. 5453)
January 28, 2000; A U.S. company has received two British patents that appear to grant it commercial rights to human embryos created by cloning. The precedent-setting patents, issued last week on the cloning method that produced Dolly the sheep, have sparked protests from groups concerned about the ethics of biotechnology patents, especially those covering human genes or cells.
The British government is "the first government in the world that has issued patent protection on a human being at any stage in development," claims author-activist Jeremy Rifkin of the Foundation on Economic Trends in Washington, D.C. He said he will challenge the patent, arguing that British law forbids giving someone property rights to a human even at the blastocyst stage. The patent, he says, is "breathtaking and profoundly unsettling."
The patent gives California-based Geron Corp. exclusive rights to "a reconstituted animal embryo prepared by transferring the nucleus of a quiescent diploid donor cell into a suitable recipient cell" up to and including the blastocyst stage. That claim includes human embryos, says David Earp, Geron's vice president of intellectual property. Last summer, Geron bought Roslin Bio-med, the commercial arm of the government-funded Roslin Institute outside Edinburgh, Scotland, where Dolly was born in 1996.
The application process was fairly smooth, says attorney Nick Bassil of the London firm Kilburn and Strode, which represented Roslin and Geron. He says the patent office allowed the claim because it is consistent with recommendations from the U.K. Human Fertilisation and Embryology Authority and the Human Genetics Advisory Commission that cloning technology be permitted on human embryos for the development of treatments for disease. The government has imposed a moratorium on any such experiments, however, while an expert advisory group reviews that recommendation. U.K. patent office spokesperson Brian Caswell says European Union directives forbid patents on human cloning, but he suggests that the patent was allowed because it only covers embryos in "the very early stages of development" that would not result in a live birth. "The exercise of any invention would have to be in accordance with the law," he adds.
Geron, a biotechnology company which has also supported much of the work on human embryonic stem cells, hopes to develop so-called "therapeutic cloning" to treat human diseases. The process would involve transferring the nucleus of a patient's skin, muscle, or other cell that has been made "quiescent," or nondividing, to an egg cell to create an embryo. The embryo would be allowed to develop for a few days and then harvested for its stem cells, which would be used to treat the patient.
The patent surprised others in the cloning field, including commercial competitors. Michael West, president and CEO of the Massachusetts-based Advanced Cell Technology, says the claim is "extremely broad." "If Geron is right and its claim is to a human embryo, then to my knowledge it's the first time that anyone has claimed ownership of a human embryo," West says. Advanced Cell Technology received a U.S. patent on nuclear transfer from nonquiescent cells last year, but the patent covers only nonhuman mammalian species. Earp says Geron has received word from the U.S. Patent Office that its claims have been allowed, and he expects the patent in the next few months. However, the U.S. patent office has been reluctant in the past to issue patents covering human material, and the company's U.S. application only covers cloning of nonhuman mammals. Although Earp says Geron also plans to pursue therapeutic cloning in the United States, he says the company "is pursuing a different strategy" to protect its commercial claims.