The Right to Patent a Human Being: Fact, Fiction, or Future Possibility?
Regular analysis of new patents by the International Center for Technology Assessment (ICTA) recently yielded a disturbing discovery. Patent US 6,211,429, was granted to the University of Missouri on April 3, 2001 by the United States Patent and Trademark Office (PTO). The patent, which was issued on a process for animal cloning, was written so broadly that it appears to include human cloning and products of cloning in its protection. As the ICTA wrote in the announcement of its discovery:
The description of the patent places the public on notice that "the present invention encompasses the living, cloned products produced by each of the methods described herein" (column 7, lines 5-7). Patentees have the right until April 3, 2003, to present such product claims. However, even in the absence of such a claim broadening, the patent owners now have rights over the product, i.e., any cloned human embryo or person born under the process, via operation of the statute 35 U.S.C. 271(g) [Process Patent Amendments Act of 1988], which extended process claims to cover materially unaltered products of patented processes.1
Theoretically, the patent could extend to include embryos, fetuses, and children resulting from using the particular patented cloning method. The application even specifically includes the use of "human oocytes" (eggs) in the list of mammalian eggs that may be used in the cloning process.2. The University shares control of the patent with BioTransplant, Inc., a biotech company in Massachusetts.
Patenting of Biological Life Forms
A patent gives the holder exclusive rights to benefit from his or her innovation for twenty years. Some things, like products of nature and physical laws, are not patentable, and others, such as plant hybrids, are. Until the late 20th century, biological life forms could not be patented. In 1980 the United States Supreme Court ruled by a razor-thin margin that a genetically engineered bacterium capable of dissolving oil spills was patentable.3. Just seven years ago, the PTO issued a policy statement that non-naturally occurring, non-human multi-cellular living organisms could be patented. Within a year the "Harvard Mouse" genetically engineered to be highly susceptible to cancer met the new criteria and was patented. The PTO has previously had a policy of denying patents on humans or human embryos because they institute a form of slavery in violation of the 13th Amendment. That policy seems to have changed.
The Ethical Issues
The ethical issues relating to cloning are far from settled in the United States. An issue of such importance should not be settled by a federal agency nor left to the conscience of a university or biotech company. We should all be involved in the process to determine the limits of this new technology.
When a university spokesman was asked about the controversy, he said, "This [patent] gives us control of this particular technology so we will know that this technology will not be used in humans."4
That may be, but the patent leaves the University, not the public, as the gatekeeper. How long can we realistically expect this type of cloning to be forestalled in humans when the twin pressures of institutional pride (to be the first to successfully clone a human embryo or person) and the need to increase its funding base (by licensing the process to biotech companies) are always weighing heavily?
There are abundant ethical arguments against human cloning. Some are particularly relevant to the patenting issue described here. The prevailing apparent ethical perspective of the biotechnology industry, is a utilitarian free-enterprise approach--propped up by claims of academic freedom and unconstrained medical research. Cloning advocates allege near-miraculous benefits from the new technical wonder of cloning; mainly revolutionary therapies to treat a host of maladies from Parkinson's disease to diabetes to arthritis. Embryonic stem cells from clones, being a genetic match to the patient receiving the cells, are believed to be immune to problems of tissue rejection normally associated with stem cells from non-genetically identical embryos.
However, the only way to obtain the embryonic stem cells is to extract them from the cloned embryo, destroying the embryo in the process. Some deny that this is the destruction of an individual human being since it is a microscopic ball of cells smaller than the "head of a pin" that has not been implanted in a mother's womb. Orrin Hatch has made his famous statement that he believes "life begins in a mother's womb, not in a refrigerator." But other utilitarian proponents of this research argue that even if it is a human life, the research should go forward because there is just too much hope that cures will be found for people suffering today. The greatest good is seen as helping people who are conscious and able to communicate with us at the expense of nascent human life.
The other side of this ethical debate is the position that argues that all human life, regardless of age or status in life, should be accorded human rights and dignity. From a Christian perspective, this value comes from all human life being created in the image of God. But should those who do not share these convictions be concerned if only some human life is protected and accorded dignity? Absolutely. If some human life can be used for the benefit of others, defined out of the protected status we all should enjoy, then we are all vulnerable to exploitation. Once the principle of universal human rights and dignity is broken, the weak will always risk suffering at the hands of the powerful. It is a situation that we all should want to avoid.
Public Policy Issues
The patent grant by the PTO may be due to lack of scientific expertise, bureaucratic oversight (there is only one reference to human oocytes in a 16-page application), PTO determination that human cloning is not covered by the patent, or outright approval of the process's potential for human cloning. What is true is that there is no clearly spelled out, comprehensive public policy on human cloning addressing the ethical issues at stake. Federal laws, regulations, state legislation, and administrative actions (such as patent grants) are debated and decided in a piecemeal manner.
Whether this human cloning process patent was granted with full knowledge or inadvertence, it points out the need for a consistent, enforceable public policy. Neither patent attorneys nor the PTO should be responsible for prohibiting or limiting human cloning efforts in this way. Patent applications are often written in terms that cover the waterfront, to prevent infringement by competitors. Competing claims are left to the determination of federal judges. In the case of human cloning, that offers little comfort to those of us who believe we need a real public debate. Judges are not supposed to create public policy in a vacuum, but rather to interpret laws that have been through the public debate process. In the absence of such clear-cut legal parameters, judges often must make law. Our public policy is then determined by whether the case is decided by a judge sympathetic to life-affirming moral concerns or one who prefers the utilitarian calculus, finding the claims of embryos in petri dishes outweighed by the forces of the multi-billion dollar biomedical industrial complex. Neither the patent office nor the courts should make the initial determination of whether a human cloning process is legally patentable. A public policy issue of this gravity--and few are of greater importance to the human race--should be resolved by Congress.
What would an ethical public policy entail? At the least, it should recognize the following principles:
- Every human being, however conceived or created, is unique and deserving of protection. From a religious perspective, humans are different from animals and above all animals, because humans, alone, are created in the image of God.
- Every human being has the right to individual autonomy, i.e., that his or her bodily integrity must not be invaded or compromised by others.
- No person or entity has the right to enslave, own, or control any human being, regardless of stage of biological development.
- Any organism that is genetically human is a human being.
- A cloned embryo is distinct and separate from the person donating the genetic material, and therefore is a unique being protected in law.
- No person or institution has the right to control or profit from any process designed to clone a human being.
The debate over legislation to ban cloning of human beings should resolve what aspects, if any, of this technology ought to be patentable. The current lack of a coherent public policy is a quagmire that must be addressed promptly, firmly, and ethically.
1"Executive Summary of Patent Watch Project's Discovery of the First U.S. Patent for Reproductive Human Cloning" (accessed May 23, 2002); available from http://cloninginformation.org/info/icta-patent_summary.htm; Internet.
2 Perhaps the intent was to cover nuclear transfer of non-human mammalian material into a human egg. If so, this raises the question of how much human DNA is required to make a "human"? Mitochondrial human DNA in the egg will be part of the cloned embryo.
3Diamond v. Chakrabarty, 447 U.S. 330 (1980).
1 Andrew Pollack, "Debate on Human Cloning Turns to Patents" (accessed 18 May 2002); available from http://www.nytimes.com/2002/05/17/science/17CLON.html; Internet.