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Patents Revealed on Cloned Mammals, Including Humans
By Jonathan King

The commercial interests behind the increased pressure to support reproductive cloning and related technologies are becoming increasingly clear. In April, 2002, the public interest watchdog group Patent Watch reported that U.S. Patent No. 6,211,429, was granted on April 3, 2001, covering human reproductive cloning and any "products" created by that process, theoretically including embryos, fetuses, and children. The patent was granted to the University of Missouri, but Massachusetts biotech company Biotransplant Inc. shares a financial interest in the patent. Biotransplant is focused on the production of replacement organs and tissues, presently derived from pigs.

Patent Watch also uncovered three pending patents being considered by the US Patent and Trademark Office that represent patent claims for cloned human embryos and fetuses. These are, as reported by Patent Watch:

-- Patent application serial number 09/816,971, assigned to Geron Corporation, which claims a "reconstituted animal embryo" described as having "its main use in . . . mammalian embryos, particularly ruminant, human, or primate embryos;"

--Patent application serial number 09/755,204, assigned to the University of Connecticut, claiming any "animal" embryo made by a cloning process; and

-- Patent application serial number 09/828,876, assigned to the University of Massachusetts and exclusively licensed to Advanced Cell Technology, claiming a mammalian "fetus obtained according to" a particularly specified cloning process. This patent application specifically contemplates the use of human tissues derived from cloned human embryos, fetuses, and children, for transplantation purposes.

In the debates over life patents, proponents have often claimed that such patents were primarily for processes, rather than the entities themselves. The language of these cloning patents, however, makes clear that they are intended to cover the products. In the case of a human embryo, the patents imply that they would be corporate property, and certainly corporate commodities for sale.

When the Supreme Court allowed the patenting of a genetically modified microorganism in 1980, by a narrow 5:4 majority, a process of transforming living organisms into commercial property was launched. Congress could have clarified the patent laws to exclude living creatures or their parts, but declined to do so. Though there have been a flurry of bills trying to address cloning, no current Congressional bills halt the patenting of the process or its products. "This is not a slippery slope, rather this is an ethical and legal free fall," stated Patent Watch’s Executive Director Andrew Kimbrell, commenting on the Missouri patent.

The egregious nature of these cloning patents is finally forcing Congress to address the dangers of life patents. Representative Lynn Rivers of Michigan began the process by introducing legislation this winter that attempts to prevent gene patents from constraining research. Senator Sam Brownback, Republican of Kansas, is planning to introduce stronger legislation to ban human cloning in the context of the 13th amendment, which prohibits slavery. Brownback is the author of one of the currently pending bills limiting human cloning. The commercial interest that lies behind human cloning technology, in the name of protecting biomedical research, will be pushing very hard in the coming months to limit the range of such legislation.

Our view at the Council for Responsible Genetics is to exclude all living creatures, and their cells, genes, and organs, from the patent process. The breakneck pace of biomedical technology is bringing the patent issue into public view with respect to human tissues. We support strong, unambiguous legislation that excludes human embryos or stem cells from the patent process. This would restrain blatant commercialization. However, clearly we also need legislation to prevent the variety of forms of exploitation of human reproductive capacity that are being proposed. These are likely to emerge as full-fledged political battles in the Congress over the next year.

Jonathan King, PhD, is Professor of Molecular Biology at the Massachusetts Institute of Technology where he directs the Biology Electron Microscope Facility. Dr. King is a CRG board member and Chair of CRG’s No Patents on Life Committee.