Patented Genes: An Ethical Appraisal

On May 18, 1995, about 200 religious leaders representing 80 faiths gathered in Washington, D.C., to call for a moratorium on the patenting of genes and genetically engineered creatures. In their “Joint Appeal Against Human and Animal Patenting,” the group stated: “We, the undersigned religious leaders, oppose the patenting of human and animal life forms. We are disturbed by the U.S. Patent Office’s recent decision to patent body parts and several genetically engineered animals. We believe that humans and animals are creations of God, not humans, and as such should not be patented as human inventions.”

Religious leaders, such as Ted Peters of the Center for Theology and Natural Sciences, argue that “patent policy should maintain the distinction between discovery and invention, between what already exists in nature and what human ingenuity creates. The intricacies of nature . . . ought not to be patentable.” Remarks such as this worry the biotech industry, which has come to expect as a result of decisions over two decades by the U.S. Patent and Trademark Office (PTO) and by the courts that genes, cells, and multicellular animals are eligible for patent protection. The industry is concerned because religious leaders have considerable influence and because their point of view is consistent with the longtime legal precedent that products of nature are not patentable.

Representatives of the biotech industry argue that their religious critics fail to understand the purpose of patent law. According to the industry view, patents create temporary legal monopolies to encourage useful advances in knowledge; they have no moral or theological implications. As Biotechnology Industry Organization president Carl Feldbaum noted: “A patent on a gene does not confer ownership of that gene to the patent holder. It only provides temporary legal protections against attempts by other parties to commercialize the patent holder’s discovery or invention.” Lisa Raines, vice president of the Genzyme Corporation, summed up the industry view: “The religious leaders don’t understand perhaps what our goals are. Our goals are not to play God; they are to play doctor.”

The differences between the two groups are not irreconcilable. The religious leaders are not opposed to biotechnology, and the industry has no interest in being declared the Creator of life. The path to common ground must begin with an understanding of the two purposes of patent law.

Double vision

Patent law traditionally has served two distinct purposes. First, it secures to inventors what one might call a natural property right to their inventions. “Justice gives every man a title to the product of his honest industry,” wrote John Locke in his Two Treatises on Civil Government. If invention is an example of industry, then patent law recognizes a preexisting moral right of inventors to own the products they devise, just as copyright recognizes a similar moral right of authors. Religious leaders, who believe that God is the author of nature (even if evolution may have entered the divine plan), take umbrage, therefore, when mortals claim to own what was produced by divine intelligence.

Second, patents serve the utilitarian purpose of encouraging technological progress by offering incentives-temporary commercial monopolies-for useful innovations. One could argue, as the biotech industry does, that these temporary monopolies are not intended to recognize individual genius but to encourage investments that are beneficial to society as a whole. Gene patents, if construed solely as temporary commercial monopolies, may make no moral claims about the provenance or authorship of life.

Legal practice in the past has avoided a direct conflict between these two purposes of patent policy-one moral, the other instrumental-in part by regarding products of nature as unpatentable because they are not “novel.” For example, an appeals court in 1928 held that the General Electric Company could not patent pure tungsten but only its method for purifying it, because tungsten is not an invention but a “product of nature.” In 1948, the Supreme Court in Funk Brothers Seed Company v. Kalo Inoculant invalidated a patent on a mixture of bacteria that did not occur together in nature. The Court stated that the mere combination of bacterial strains found separately in nature did not constitute “an invention or discovery within the meaning of the patent statutes.” The Court wrote, “Patents cannot issue for the discovery of the phenomena of nature. . . . [They] are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none.”

The moral and instrumental purposes of patent law came into conflict earlier in this century when plant breeders, such as Luther Burbank, sought to control the commercial rights to the new varieties they produced. If patents served solely an instrumental purpose to encourage by rewarding useful labor and investment, one might say that patents should issue on the products of the breeder’s art. Yet both the PTO and the courts denied patentability to the mere repackaging of genetic material found in nature because, as the Supreme Court said later about a hybridized bacterium, even if it “may have been the product of skill, it certainly was not the product of invention.”

To put this distinction in Aristotelian terms, breeders provided the efficient cause (that is, the tools or labor needed to bring hybrids into being) but not the formal cause (that is, the design or structure of these varieties). Plant breeders could deposit samples of a hybrid with the patent office, but they could not describe the design or plan by which others could construct a plant variety from simpler materials. The patent statute requires, however, applicants to describe the design “in such full, clear, concise and exact terms as to enable any person skilled in the art to which it pertains . . . to make and use the same.” A breeder could do little more to specify the structure of a new variety than to refer to its ancestor plants and to the methods used to produce it. This would represent no advance in plant science; it would tell others only what they already understood.

Confronted with the inapplicability of intellectual property law to new varieties of plants, Congress enacted the Plant Patent Act of 1930 and the Plant Variety Protection Act of 1970, which protect new varieties against unauthorized asexual and sexual reproduction, respectively. Breeders were required to deposit samples in lieu of providing a description of how to make the plant. Congress thus created commercial monopolies that implied nothing about invention and therefore nothing about moral or intellectual property rights. Accordingly, religious leaders had no reason to object to these laws.

The Court changes everything

This legal understanding concerning products of nature lasted until 1980, when the Supreme Court, by a 5-4 majority, decided in Diamond v. Chakrabarty, that Chakrabarty, a biologist, could patent hybridized bacteria because “his discovery is not nature’s handiwork, but his own.” The court did not intend to reverse the long tradition of decisions that held products of nature not to be patentable. The majority opinion reiterated that “a new mineral discovered in the earth or a new plant discovered in the wild is not patentable subject matter.” The majority apparently believed that the microorganisms Chakrabarty wished to patent were not naturally occurring but resulted from “human ingenuity and research.” The plaintiffs’ lawyers failed to disabuse the court of this mistaken impression because they focused on the potential hazards of engineered organisms, a matter (as the Court held) that is irrelevant to their patentability.

Although Chakrabarty’s patent disclosure, in its first sentence, claims that the microorganisms were “developed by the application of genetic engineering techniques,” Chakrabarty had simply cultured different strains of bacteria together in the belief that they would exchange genetic material in a laboratory “soup” just as they do in nature. Chakrabarty himself was amazed at the Court’s decision, since he had used commonplace methods that also occur naturally to exchange genetic material between bacteria. “I simply shuffled genes, changing bacteria that already existed,” Chakrabarty told People magazine. “It’s like teaching your pet cat a few new tricks.”

The Chakrabarty decision emboldened the biotechnology industry to argue that patents should issue on genes, proteins, and other materials that had commercial value. In congressional hearings on the Biotechnology Competitiveness Act (which passed in the Senate in 1988), witnesses testified that the United States was locked in a “global race against time to assure our eminence in biotechnology”; a race in which the PTO had an important role to play.

While Congress was debating the issue, the PTO was already implementing a major change in policy. It began routinely issuing patents on products of nature (or functional equivalents), including genes, gene fragments and sequences, cell lines, human proteins, and other naturally occurring compounds. For example, in 1987, Genetics Institute, Inc., received a patent on human erythropoietin (EPO), a protein consisting of 165 amino acids that stimulate the production of red blood cells. Genetics Institute did not claim in any sense to have invented EPO; it had extracted a tiny amount of the naturally occurring polymer from thousands of gallons of urine. Similarly, Scripps Clinic patented a clotting agent, human factor VIII:C, a sample of which it had extracted from human blood.

Harvard University acquired a patent on glycoprotein 120 antigen (GP120), a naturally occurring protein on the coat of the human immunodeficiency virus. A human T cell antigen receptor has also been patented. Firms have received patents for hundreds of genes and gene fragments; they have applied for patents for thousands more. With few exceptions, the products of nature for which patents issued were not changed, redesigned, or improved to make them more useful. Indeed, the utility of these proteins, genes, and cells typically depends on their functional equivalence with naturally occurring substances. Organisms produced by conventional breeding techniques also now routinely receive conventional patents, even though they may exhibit no more inventive conception or design than those Burbank bred. The distinction between products of skill and of invention, which was once sufficient to keep breeders from obtaining ordinary patents, no longer matters in PTO policy. Invention is no longer required; utility is everything.

The search for common ground

Opponents of patents on genetic materials generally support the progress of biotechnology. At a press conference, religious leaders critical of patenting “the intricacies of nature” emphasized that they did not object to genetic engineering; indeed, they applauded the work of the biotech industry. Bishop Kenneth Carder of the United Meth-odist Church said, ”What we are objecting to is the ownership of the gene, not the pro-cess by which it is used.” In a speech delivered to the Pontifical Acad-emy of Sciences in 1994, Pope John Paul II hailed progress in genetic science and tech-nology. Nevertheless, the Pope said: “We rejoice that numerous researchers have refused to allow discoveries made about the genome to be patented. Since the human body is not an object that can be disposed of at will, the results of research should be made available to the whole scientific community and cannot be the property of a small group.”

Industry representatives and others who support gene patenting may respond to their religious critics in either of two ways. First, they may reply that replicated complementary DNA (cDNA) sequences, transgenic plants and animals, purified proteins, and other products of biotech-nology would not exist without human intervention in nature. Hence they are novel inventions, not identical to God’s creations. Second, industry representatives may claim that the distinction between “invention” and “discovery” is no longer relevant to patent policy, if it ever was. They may concede, then, that genetic materials are products of nature but argue that these discoveries are patentable compositions of matter nonetheless.

Consider the assertion that genes, gene sequences, and living things, if they are at all altered by human agency, are novel organisms and therefore not products of nature. This defense of gene patenting would encounter several difficulties. First, patents have issued on completely unaltered biological materials such as GP120. Second, the differ-ences between the patented and the natural substance, where there are any, are unlikely to affect its utility. Rather, the value or usefulness of the biological product often depends on its functional identity to or equivalence with the natural product and not on any difference that can be ascribed to human design, ingenuity, or invention. Third, the techniques such as cDNA replication and the immortalization of cell lines by which biological material is gathered and reproduced have become routine and obvious. The result of employing these techniques, therefore, might be the product of skill, but not of invention.

Proponents of gene patenting might concede that genes, proteins, and other patented materials are indeed products of nature. They may argue with Carl Feldbaum that this concession is irrelevant, however, because patents “confer commercial rights, not ownership.” From this perspective, which patent lawyers generally endorse, patenting makes no moral claim to invention, design, or authorship but only creates a legal monopoly to serve commercial purposes. Ownership remains with God. Accordingly, gene patents carry no greater moral implications than do the temporary monopolies plant breeders enjoy in the results of their investment and research.

Although this reply may be entirely consistent with current PTO policy, legal and cultural assumptions for centuries have associated patents with invention and therefore with the ownership of intellectual property. These assumptions cannot be dismissed. First, patents confer the three defining incidents of ownership: the right to sell, the right to use, and the right to exclude. If someone produced and used, say, human EPO, it would be a violation of the Genetic Institute patent. But all human beings produce EPO as well as other patented proteins in our bodies. Does this mean we are infringing a patent? Of course not. But why not, when producing and using the same protein outside our bodies does infringe the patent? If a biotech firm patents a naturally occurring chemical compound for pesticidal use, does that mean that indigenous people who have used that chemical for centuries will no longer be allowed to extract and use it? That such questions arise suggests that patents confer real ownership of products of nature, not just abstract commercial rights.

Second, intuitive ties founded in legal and cultural history connect patents with the moral claim to intellectual property. For centuries the PTO followed the Supreme Court in insisting that “a product must be more than new and useful to be patented; it must also satisfy the requirements of invention.” The requirements of invention included a contri-bution to useful knowledge-some display of ingenuity for which the inventor might take credit. By disclosing this new knowledge (rather than keeping it a trade secret), the inventor would contribute to and thus repay the store of knowledge on which he drew. One simply cannot scoff, as industry representatives sometimes do, at a centuries-long tradition of legal and cultural history, enshrined in every relevant Supreme Court decision, that connects intellectual property with moral claims based on contributions to knowledge.

Religious leaders who decry current PTO policy in granting intellectual property rights to products of nature have suggested alternative ways to give the biotech industry the kinds of commercial protections it seeks. Rabbi David Saperstein, director of the Religious Action Center of Reform Judaism in Washington, D.C., has proposed that ways be found “through contract laws and licensing procedures to protect the economic investment that people make . . .” On the industry side, spokespersons have been eager to assure their clerical critics that they do not want to portray themselves as the authors of life. What industry wants, they argue, is not to upstage the Creator but to enjoy a legal regime that protects and encourages investment. Industry is concerned with utility and practical results; religious and other critics are understandably upset by the moral implications of current PTO policy.

It is not hard to see the outlines of a compromise. If Congress enacts a Genetic Patenting Act that removes the “description requirement” for genetic materials, as it has removed this requirement for hybridized plants, patents conferred on these materials may carry no implications about intellectual authorship. Such a statute, explicitly denying that biotech firms have invented or designed products of nature, might base gene patenting wholly on instrumental grounds and thus meet the objections of religious leaders.

A new statutory framework could accommodate all these concerns if it provided the kinds of monopoly commercial rights industry seeks without creating the implication or connotation that industry “invents,” “designs,” or “owns” genes as intellectual property. In other words, some middle ground modeled on the earlier plant protection acts might achieve a broad agreement among the parties now locked in dispute.