You do not have to be a religious zealot or a scientific Luddite to oppose the patenting of animal and human organisms and genes. In fact, as John Fletcher, ethicist at the University of Virginia, has said, "You don't have to be religious to realize that there ought to be a debate about patenting." It is true, however, that moral and theological concerns are at the heart of the debate.
We should be clear at the outset that we applaud and rejoice in many of the existing and potential uses of the new genetics. The treatment and cure of more than four thousand genetically linked illnesses are prima facie grounds for celebrating and endorsing some genetic technologies. Cures for diseases such as cystic fibrosis, breast cancer, Duchenne's muscular dystrophy, and colon cancer certainly merit both praise and the expenditure of significant financial resources.
At the same time, genetic technology is not an unmixed blessing. The potential abuses of genetic technology warrant our careful and considered attention. Linkages between genetic screening and abortion, testing and discrimination, and the supposedly positive and negative aspects of the discredited pseudo-discipline of eugenics represent important subjects meriting wider public discussion. No less important are the implications of patenting human genes and genetically engineered animals. Unfortunately, due to the rapid expansion of the technology, we do not have the luxury of discussing these issues in a leisurely manner or one at a time. The breathtaking pace of technological advancement requires that the cultural discourse and the public policy with respect to genetics must develop simultaneously.
Unfortunately, some policies have been enacted imprudently. Consequently, some policy decisions in these areas will have to be replaced with policies that reflect more careful and mature moral examination, however embarrassing or disconcerting that may be. Bad decisions make bad policy and should not be defended just because they have been made.
In Diamond v. Chakrabarty (1980), the Supreme Court ruled in a five-to- four vote that a genetically engineered microbe could be patented. Less than a decade later, in April 1988, the first animal patent was issued to Harvard University for the so-called "oncomouse." The patented mouse was genetically engineered to contain a cancer gene making it useful in human cancer research. E. I. du Pont de Nemours & Company was granted exclusive licensure "to practice the patent." According to the now defunded Office of Technology Assessment (OTA), the patent specifically covers "a transgenic nonhuman eukaryotic animal (preferably a rodent such as a mouse) whose germ cells and somatic cells contain an activated oncogene sequence introduced into the animal." That is to say, the patent was granted not only on a mouse and its progeny, but on any mammal that has cancer genes inserted into its genome at an embryonic stage. The mouse now reportedly sells for about fifty dollars.
While whole human beings have not been patented yet, human genetic material is routinely patented. In July 1990, the California Supreme Court ruled that a patient whose diseased spleen had been used to produce patented cell lines had no right to the millions of dollars potentially resulting from the sale of pharmaceutical products derived from his spleen. By September 4, 1993, the National Institutes of Health had filed for patents on 6,122 gene fragments. Although patenting of "gene fragments of unknown biological function" is presently disallowed, who knows what the future holds? Most of this territory is uncharted. Boston University Professor of Health Law George Annas has asked, "Since cloned human embryos are not persons protected by the Constitution and theoretically at least could be as 'immortal' as cloned cell lines, could a particularly 'novel' and 'useful' human embryo be patented, cloned, and sold?" Our candid presupposition is that both humans and animals are more than the sum of their genetic code. In our view, genetic patenting of Homo sapiens is, however, a separate issue in some respects from patenting other organisms. Both are problematic, but for slightly different reasons.
Opposition to patenting human beings and their genetic parts is grounded in the unique nature of Homo sapiens. Human beings, alone among living organisms, bear the imago Dei. "So God created man in His own image, in the image of God He created him" (Genesis 1:27). Human life is therefore sacred and possesses unique value derived from the Creator. Thus, as Philip Edgcumbe Hughes has said, "It is the image of God in which man was created, rather, which pervades his existence in its totality and is the cause of his transcendence over the rest of God's creation." The distinction between human life and animal life, as well as the prohibition against the unjustifiable taking of human life, is foundational to Jewish and Christian anthropology.
Human beings are pre-owned. We belong to the sovereign Creator. We are, therefore, not to be killed without adequate justification (e.g., in self-defense) nor are we, or our body parts, to be bought and sold in the marketplace. Yet the patenting of human genetic material attempts to wrest ownership from God and commodifies human biological materials and, potentially, human beings themselves. Admittedly, a single human gene or a cell line is not a human being; but a human gene or cell line is undeniably human and warrants different treatment than all nonhuman genes or cell lines. The image of God pervades human life in all of its parts. Furthermore, the right to own one part of a human being is ceteris paribus the right to own all the parts of a human being. This right must not be transferred from the Creator to the creature. Imagine a society in which patented human cells, cell lines, and tissues are bought and sold in the scientific marketplace. If such a scenario seems impossible to conceive, consider that Nobel laureate Kary Mullis has bought the rights to extract a part of Elvis Presley's DNA from a lock of the rock idol's hair using a "genetic amplification" technique that Mullis himself invented. Mullis intends to make millions of copies of Presley's genes, according to a September 1995 Washington Post article, "and preserve these minuscule globs inside artificial gemstones, to be made into a line of necklaces, earrings, and other collectables." While Mullis' good sense may be questionable, the commodification of human genes is not inconceivable with only a naturalistic anthropology to guide genetic science.
We argue that the current status of U.S. patent law is incapable of dealing with the potential abuse of human genetic materials. When the framers of the Constitution established congressional power "to promote the progress of science and the useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries," it was impossible to envisage the patenting of human genetic materials. Even in 1952, when Congress passed the Patent Act, intending patentable subject matter to include "anything under the sun that is made by man," it is unlikely that they foresaw human "biopatents." We, therefore, conclude that human genetic materials should not be patentable matter.
We further maintain that a moratorium should be placed on animal patenting on slightly different grounds. In the case of animal patents, social justice issues rise to the fore. Animals, like human beings, are pre-owned entities. Every part of God's creation is owned by the Sovereign. Most Jews and Christians would, however, interpret the mandate of Genesis 1:28 to permit animal ownership. "God blessed them and said to them, 'Be fruitful and increase in number; fill the earth, and subdue it. Rule over the fish of the sea and the birds of the air and over every living creature that moves on the ground.'" Responsible stewardship of the created order is not only allowed, it is imperative.
Under U.S. patent law, patentable subject matter is defined as "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof." Rebecca S. Eisenberg, Professor of Law at the University of Michigan, observes that "although products of nature may not be patented as such, patents have been issued on such products in human-altered form." This is exceedingly troublesome in our view. Oncomice are, in fact, human-altered forms, but are they really "compositions of matter"? Do they truly constitute an "improvement thereof"?
Philosopher Ned Hettinger has rightly said, "There is a substantial disanalogy between these biopatents and the traditional subject matter of patents. Edison really did invent the light bulb. The Wright brothers created a flying machine. But Harvard did not invent or create the oncomouse. Biotechnicians alter, modify, assist, and manipulate nature. They are not inventors of novel organisms or genes that could be appropriate objects for patents."
In truth, the patent on the Harvard mouse constitutes a monopoly on an entire subclass of animal. Again, according to the OTA report, "The actual patent coverage is broad, embracing virtually any species of 'transgenic nonhuman mammal all of whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal, or an ancestor of said mammal, at an embryonic stage.'" Since there are about forty known cancer-causing genes, the patent covers an indordinately wide variety of potentially patentable mammalian life.
While animal ownership per se is morally acceptable, patenting animals represents an abuse of the notion of ownership, and more importantly, of ownership rights. Patents presently protect the ownership rights of the patent holder. Changes in U.S. patent law were recently made under a new set of international trade rules, the General Agreement on Tariffs and Trade. After June 8, 1995, "the term of a patent begins on the date of issue and ends twenty years from the original filing date," according to an article appearing in the Scientist. Since animals are patentable, biotech companies, universities, or individuals may monopolize entire species or subclasses of animals and, as in the Chakrabarty decision, bacteria, for twenty years. In his superb discussion on this subject in Toward a More Natural Science, Leon Kass opines, "It is one thing to own a mule; it is another to own mule. Admittedly, bacteria are far away from mules. But the principles are invoked, the reasoning, and the stance toward nature go all the way to mules, and beyond."
Bernard Rollin, professor of philosophy, physiology, and biophysics at Colorado State University, maintains that "the Patent Office rushed in where angels fear to tread.... The issuing of patents begs these questions or ignores them. It was a bureaucratic decision made in a value-free context (or value-ignoring context) by an agency that has notoriously avoided engaging the ethical and social issues raised by inventions like switchblades, assault rifles, shock collars, and devices for sadomasochists, and agency of that judges applications only by the formal criteria of novelty, usefulness, and nonobviousness. It disavows concern with issues of safety; danger to humans, animals, or environment; or welfare of animals. The decision is, as it were, a punch line without a joke, an ending without a story. The decision to patent or not to patent should follow in the wake of a democratic social examination of the concerns discussed here, and in the wake of establishing a democratic regulatory mechanism for all aspects of genetic engineering of animals.
The explosions of our capabilities without a concomitant expansion of ethical reflection demands that we resist the temptation to apply unthinkingly every technology the day it is conceived. We need careful investigation of alternatives to human and animal patenting. A blind frenzy of patenting is far more dangerous than a strict prohibition. We need to strive for and cultivate measured judgments and restraint with respect to the new genetics.
Recognizing that a moratorium on patenting genes may put some potential treatments and cures for genetically linked illnesses at risk, we advise that Congress and other policy-making bodies encourage the kind of democratic social examination and cultural discourse about biopatents for which Bernard Rollin calls.
There are, of course, social justice issues beyond these to be explored with respect to biopatents. The fact that on May 18, 1995 some 180 leaders from diverse religious perspectives gathered together to call for a moratorium on patenting is evidence that wider and deeper discussion must take place between science, law, and religion.