Winter, 2002
By Stuart A. Newman, PhD
Professor of Cell Biology and Anatomy
New York Medical College, Valhalla, NY
Listening to Congressional debate last July on H.R. 1644, the Human Cloning Prohibition Act of 2001, 1 many people were surprised to learn that the United States has no Federal laws prohibiting manipulation of human embryos chemically or genetically, or the bringing to term of any such embryo. This situation, which is out of line with that in Europe, Japan and a growing number of countries throughout
the world, was on my mind in 1997 when, with the help of the social critic Jeremy Rifkin, president of the Foundation on Economic Trends in Washington, D.C., I decided to apply for a patent on embryos and animals containing human along with nonhuman cells - so-called "chimeras."
I had no intention of producing such creatures, nor does US patent law require that an actual prototype for an invention be supplied, only that feasibility be demonstrated, as well as novelty and utility. But ever since the 1980 Supreme Court decision in Diamond v. Chakrabarty, 2 it has been legal in the United States to obtain a patent on living organisms and their descendants. Moreover, Congress has drawn no line that would preclude a preterm human embryo, if appropriately modified, from being patented. Nor has it indicated how many human genes or cells an animal would have to contain before it could not be patented by virtue of the Constitutional protections pertaining to members of the human community. While a decision as to patentability by the US Patent and Trademark Office (PTO) would not control whether or not it would be legal to produce human-animal chimeras, or other types of biologically manipulated humans, we considered that applying for a chimera patent would raise these issues before the public and the legal system in a particularly dramatic fashion.
In the legal process that ultimately led to the Chakrabarty decision, an appeals court overruled the PTO's original rejection of the General Electric Corporation's application for a patent on oil-eating bacteria in an opinion that stated, absurdly, that bacteria are "more akin to inanimate chemical compositions ... [than] to horses and honeybees and raspberries and roses." Within a few years, however, the Chakrabarty decision had served as a precedent for the issuing of patents on mice, pigs and cows, some containing introduced human genes, as well as on naturally occurring human bone-marrow cells.
As a research scientist in the field of embryonic development who has been concerned that the fruits of this work not be used to society's detriment, I acted on Rifkin's suggestion to invent something that was useful but also so disquieting that it would alert the public to the consequences of unrestricted technological development in this area. The proposed human-animal chimera, whose production would depend on techniques developed in the 1980s that led to the actual generation of "geeps" - animals that were part-goat and part-sheep 3,4 - could contain anything from a minuscule proportion to a majority of human cells. Like the geep, a human-chimp chimera would have recognizable resemblances to both originating species, perhaps stronger and hairier than a human, with mental qualities of both person and ape.
The proposed applications of this invention included the use of partly human embryos to test drugs and chemicals for toxicity, and the use of partly human animals as sources of transplantable organs for human patients. It is clear from such examples that biotechnology is capable of producing items that, while legal and eminently useful, could nonetheless conflict with other cultural values, and would therefore be considered immoral and undesirable by many people.
Scientists can make such things, but would they? If so, would anyone market them and would physicians and the public accept their use? At the time our original filing was announced in early 1998, advocates of the patenting of organisms, including the scientist who patented the first mammal (the "Oncomouse," a research animal that developed cancer at 40 times the normal rate) criticized us for scaremongering. They accused us of presenting monstrous concoctions that no responsible scientist would contemplate producing or patenting. Since then, though, the Massachusetts biotechnology company, Advanced Cell Technology, has obtained a patent on a technique for creating cloned embryos produced from human cell nuclei and cow eggs. And the Geron Corporation of California, which holds licenses on patents for human embryo stem cells, has acquired the Scottish company that holds the patents on the cloning techniques that produced Dolly the sheep.
Indeed, the driving force behind the Congressional Human Cloning Prohibition Act, mentioned above, was concern about the desire of Geron and a number of university-based researchers, as well as patient advocate groups, to produce cloned human embryos to serve as sources of donor-matched human embryo stem cells. Such embryos would be both laboratory materials and potential children for anyone reckless enough to ignore the disastrous biological results of animal cloning experiments. The latter scenario has advocates in the scientific and medical communities, some of whom were afforded the prestigious forum of the National Academy of Sciences this past August. Because H.R. 1644 intended to block the possibility of full-term cloning by prohibiting the production of cloned embryos, it was supported by commentators across the political spectrum, including some prominent abortion rights advocates, and was passed with a bipartisan majority. (It is due to come before the Senate in early 2002). Among the scientific societies and their allies in Congress, however, this position was a minority one.
These developments suggest that, in the absence of binding restrictions - which would represent a societal agreement not to cross certain troubling lines- the public could quickly accommodate itself to fabricated humans and nearhumans, organisms that previously existed only in the realm of speculative fiction. With commercial interests continually touting the benefits of such "breakthroughs," the production of quasi-humans for research or therapy, using our technique or different ones, cannot be too far behind.
As it attempted with the Chakrabarty patent application, the PTO rejected our chimera patent in its initial reviews. Of course, the major difference between the Chakrabarty case and ours is that the PTO no longer opposes patents on organisms. Instead, it would like to draw a line between obviously troublesome inventions of the sort we propose and other life forms they have allowed to be patented, such as human bone-marrow cells and pigs containing human genes. Given the common evolutionary heritage and biological continuity of all organisms on Earth - we share more than 98 percent of our DNA sequence with chimpanzees, for example - this may be an impossible task. Ultimately, the patentability of part-human organisms may have to be resolved by the courts or Congress. But concealed within the patent issue is the deeper one of how far we as a society will go in permitting technology to blur the lines between human and non-human, person and artifact. 5,6
Footnotes
1 Congressional Record: July 31, 2001 (House) Pages H4916-H4945.
http://energycommerce.house.gov/107/action/107-41.pdf
2 206 U.S.P.Q. 193.
3 Fehilly C B, Willadsen S M, Tucker E M. Interspecific chimaerism between sheep and goat. Nature 1984;307:634-6.
4 Meinecke-Tillmann S, Meinecke B. Experimental chimaeras-removal of reproductive barrier between sheep and goat. Nature 1984;307:637-8.
5 Magnani TA. The patentability of human-animal chimeras. Berkeley Tech Law Journal 1999;14:443-60.
6 Lee K. The Natural and the Artefactual. Lanham, MD: Lexington Books, 1999.
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