Patents and Patients: Human Gene Patenting and Jewish Legal Ethics

Byron L. Sherwin, Rabbi, Ph.D.

In 1964, the eminent Jewish theologian, Abraham Joshua Heschel, delivered an address entitled, “The Patient as a Person,” at the annual convention of the American Medical Association. Today’s religious bioethicist must not only deal with the patient as a person, but also with the prospect of the patient as a patent. The following deals with the patenting of human genes from the perspective of Jewish legal ethics.

Jewish Genes

“If you often feel tired, it could be anemia. If you’re Jewish, it could be Gaucher Disease. . . . Gaucher Disease . . . is the most common genetic disease affecting Jews of Eastern and Central European descent. Approximately one out of every 14 carries the Gaucher gene—it is far more prevalent than Tay-Sachs. And it is not gender or age specific.” This is from an advertisement in a leading American Jewish magazine. It serves to remind American Jews of their particular pre-disposition toward a wide variety of genetic diseases.

“Ashkenazi Jewish families are needed to help scientists understand the biological basis for schizophrenia and bipolar disorder,” reads a 1999 advertisement placed by the Department of Psychiatry at Johns Hopkins University. Just fill in another disease or medical condition, such as breast cancer, colitis, lactose intolerance, etc., and then fill in the name of another university, hospital or laboratory, and you can find similar advertisements published regularly in a wide variety of newspapers, magazines and journals. As Matt Ridley succinctly put it in his popular book, Genome, “Jewish people retained their genetic integrity . . . . As a result the Ashkenazim in particular are a favourite people for genetic studies.”

American Jewry, particularly those of European or “Ashkenazic” heritage (i.e., over 90 percent of American Jewry), provides an ideal population group for geneticists to study in order to identify certain genetic mutations and disease-causing genes. As the Johns Hopkins ad puts it, “Due to a long history of marriage within the faith, which extends back thousands of years, the Jewish community has emerged from a limited number of ancestors and has a similar genetic makeup. This allows researchers to more easily perform genetic studies and locate disease-carrying genes.” Over the course of history, certain diseases have been popularly identified with Jews. For example, in nineteenth-century colloquial German, diabetes was known as the Judenkrankeit, the Jewish disease.

Perhaps more than any other American sub-population, American Jews have been studied for genetic diseases and disorders and have undergone extensive genetic screening. As a result, genetic research during the past few decades has expanded the list of diseases toward which American Jews are more predisposed than other segments of the American population. These include Tay-Sachs, Gaucher, Canavan Disease, breast cancer, colorectal cancer and Chron’s Disease. Regretfully and inevitably, “genetic profiling” leads to stigmatization, not only in terms of how Jews may view themselves, but also in how others view them. In certain quarters, Jews of Ashkenazic origin are known as the “carriers” of bundles of horrible diseases. Despite legal prohibitions against discrimination on the basis of genetic information, such stigmatization can affect employment opportunities and eligibility for health insurance.

As the primary victims of eugenics during the Nazi regime, Jews tend to have a visceral opposition to genetics research, especially when they are its subjects. There remains an omnipresent apprehension that the eugenics policies and practices that characterized American social and public policy in the early twentieth-century and the subsequent eugenic policies and practices of Nazi Germany, may once again raise their ugly heads in new forms as government or corporate sponsored policy and practice. On the other hand, most American Jews recognize the many benefits that genetics holds forth for humankind in general and for themselves in particular. For example, because of efforts encouraging genetic screening for “Jewish” diseases like Tay-Sachs and cystic fibrosis, the number of children born to parents who have been screened has precipitously declined, and in certain segments of the Jewish community has been virtually eliminated. Nonetheless, opposition to genetic testing persists, largely because of the effects that social stigmatization and damage to one’s self-image might have upon a potential carrier of such genetic diseases. There is also a reticence to perform genetic testing for diseases for which no cure or treatment yet exists. Why test for a predisposition for a disease that might not develop, especially if it leads to asymptomatic preventative measures like surgery or abortion?

American Jews have many reasons both to support as well as to oppose developments in genetics. They have reasons to endorse the patenting of human genes because of the potential benefits it holds forth for health care, and, they have reasons to oppose it, including the fact that it raises the specter of genetic discrimination and evokes memories of the demonic eugenic social policies of Nazi Germany during the Holocaust. Indeed, references to the Holocaust have been evoked by some of the most articulate opponents of the patenting of human tissues and human genes. For example, the eminent biologist, Erwin Chagroff, has discussed the sometimes predatory and exploitative practices of the biotech and pharmaceutical industries to secure monopolistic patents on human genes and tissues as “an Auschwitz in which valuable enzymes, hormones, and so on will be extracted instead of gold teeth.” For similar reasons, members of groups with a common gene pool, such as various indigenous peoples, are apprehensive about participating in genetic research. They fear being commercially exploited by governments and corporations. They, therefore, refuse to participate in genetic research.

Patents, Pastors, and Public-Policy

In May 1995, in a rare expression of unanimity, 180 American religious leaders denounced the moral propriety of the patenting of human genes, some comparing it to slavery. Indeed, since the inception of bioengineering in the 1970s, religious leaders have consistently expressed their concern about the moral and public-policy implications of unfolding developments in biotechnology. For example, in 1980, shortly after the U.S. Supreme Court in a 5 to 4 decision in the case of Diamond v. Chakrabarty (which, for the first time allowed for the granting of a patent on a bioengineered living entity, i.e., a bacterium), 16 leaders of the American Protestant, Catholic and Jewish communities wrote to then President Jimmy Carter articulating their dismay at the Court’s decision. These religious leaders claimed that the Court’s ruling was unduly narrow, focusing only on the legal issue of whether a particular entity created through recombinant DNA technology is patentable. What the Court, neglected in their view, were the implications of its decision with regard to broad public-policy issues and moral concerns. The questions raised by the new technologies, in their view, were not simply a matter of interpreting existing patent law, but “moral, ethical and religious questions. They deal with the fundamental nature of human life and the dignity and worth of the individual human being. . . . the issue goes far beyond patents.” Yet, precisely because patent law was the arena in which the Court had made its far reaching decision, these religious leaders called for a reexamination of U.S. patent law: “With the Supreme Court decision allowing patents on new forms of life—a purpose that could not have been imagined when patent laws were written—it is obvious that these laws must be reexamined. . . . Given all the responsibility to God and to our fellow human beings, do we have the right to let experimentation of new life forms move ahead without public regulation?.... We also intend to ask appropriate Congressional committees to begin immediately a process of revising our patent laws looking to revisions that are necessary to deal with the new questions related to the patenting of life forms.” Indeed, in Chakrabarty, the Court had stated that “Congress, not the courts, must define the limits of patentability. . . Congress is free to amend patent statute so as to exclude from patent protection organisms produced by genetic engineering.”

President Carter appointed the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research to address these and related issues. In 1982, the Commission issued their findings in Splicing Life. Though the Commission dealt extensively with the ethical and public policy issues related to the creation of new life forms through genetic engineering, it did not address the issue of patents.

Both since, and as a result of, the U.S. Supreme Court decision in Chakrabarty, biotechnology and genetics rapidly expanded. It seems that this exponential growth of biotechnology and genetics has led to an expansion of the scope of patentable entities, including human DNA, by the U.S. Courts, the Congress, and the Patents and Trademarks Office (PTO). Consequently, the ethical and public policy implications of continuing scientific, technological and legal developments in biotechnology and genetics, including the patenting of human DNA, is of on-going concern to American religious groups, including American Jewry. For the most part, spokespersons for American religious groups have opposed the patenting of human DNA. However, as has been noted, American Jewry remains conflicted about developments in genetics. Consequently, Jews may be found both among the strongest advocates for and among the most vocal opponent against developments in genetics, including the patenting of human DNA. Such conflicts among American Jews reflect features of the current public policy debate about the patenting of human DNA.

In recent debates about the nature, scope and goals of U.S. patent law, advocates of patenting human tissue and genes often focus on the actual and potential health-care benefits that derive from patents and therefore maintain that DNA patenting is ultimately in the public good. Opponents often point out the dangers of subordinating the rights of individuals to the furthering of medical science and technology. They focus on the dangers of the commodification and exploitation of patients in the pursuit - not only of scientific progress, but also of individual and corporate pecuniary greed. Advocates of human gene patents maintain that patent protections are necessary to provide incentives to develop products that will improve human health care, that without patent protection advances in genetically-based health care would be stifled. By protecting their patented property, opponents of human gene patenting maintain, patent holders actually stifle the development of improved and more cost-effective genetic diagnostics and therapeutics.

Advocates of human gene patenting defend interpretations of U.S. patent law that broaden its initial scope to include a wide variety of entities such as bioengineered bacteria, plants, animals, human tissue and human genes. Opponents of human gene patenting argue that the decision in Chakrabarty opened the door to offering patent protections for entities, including human genes, that go far beyond the law’s initial intentions, and that the present scope of U.S. patent law should be limited, either by means such as court action or legislation.

The debate over the patenting of human genes relates not only to religious, ethical and public policy concerns, but also to how U.S. patent law is interpreted. Unfortunately, religious spokespersons often articulate positions about human gene patenting without a prior grasp of biotechnology or of U.S. patent law and tend to articulate a “theologically underdeveloped” position on ethical issues emerging because of developments in biotechnology. The purpose of what follows is to present a position on human gene patenting that derives from the legal ethics of Judaism. However, before turning to Jewish legal ethics, some fundamental features of American patent law that will prove relevant to the following presentation and analysis of the issue of human gene patenting should be noted.

U.S. Patent Law: Some Fundamentals

The primal “sacred” document of American law is the U.S. Constitution. In its initial textual version (i.e., the 1787 Constitution, before it was amended to include the Bill of Rights), the only right explicitly mentioned relates to patents. Known as the Copyright and Patent Provision, Article 1, Section 8 (Powers of Congress) states: “Congress shall have the Power to.... provide for the...general welfare of the United States.... to promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.” Here, Congress is not described as bestowing this right, but only as having the power to secure it, presumably as part of its responsibility to provide for the “general welfare of the United States.” Yet, if this right is not bestowed by Congress, what then is its origin?

According to the U.S. Code (U.S.C.), “patents shall have the attributes of personal property,” i.e., patents are a type of property right. Undoubtedly, the framers of the Constitution were influenced by John Locke’s views of property rights. According to Locke, states are formed as a compact, contract or covenant between individuals and their government. The task of government is not to create, but to protect, enforce and interpret the natural rights of its individual citizens, and to adjudicate disputes when a conflict of rights occurs between individuals. For Locke, such natural rights pre-exist the state. Primary among them are the rights to life, liberty and individual property which have been instilled in nature by God. According to Locke, God created the world, desiring the human species to use and to enjoy it. The natural world has been given to all human beings in common. However, through their labor, individuals can acquire private property rights. In Locke’s words, “Whatsoever, then he [i.e., man] removes out of the state that nature has provided and left in it, he hath mixed his labor with, and joined to it something that is his own, and thereby makes it his property.” Apparently, following Locke’s view, the Constitution empowers the government to protect the property rights of investors who have “mixed” labor with nature to create something new. Though protected by the government, patent rights are a variety of property rights, ultimately bestowed by the Creator upon human creatures.

Besides Locke, the framers of the Constitution were influenced by a view of science that emerged in the seventeenth and eighteenth centuries. Until then, science focused primarily on knowing what nature is. But, as science rooted in Aristotelian categories waned, scientific investigations became increasingly concerned with how nature “works.” Seventeenth-century philosophers like Francis Bacon and Rene Descartes saw science not only as scientia (knowledge), but as a tool for improving the human condition. By discerning how nature worked, nature could be employed in the “relief of man’s estate” (Bacon). Influenced by this view, the new American republic became the first nation to embrace scientific and technological invention as a means to providing for the “general welfare.” The Copyright and Patent Provision of the Constitution articulated a national commitment to improve the human condition through scientific and technological progress. The patent laws of 1790, enacted by the first Congress, and composed mostly by Thomas Jefferson, promoted scientific and technological development in the public interest. To be sure, a further goal of these laws was to provide an incentive to stimulate rapid, continuous and substantial industrial and economic growth in the new republic.

For many years, it was generally assumed that natural living entities such as minerals, bacteria, plants and animals, could not be patented. Yet, beginning with the 1930 Plant Patent Act, the scope of patentable entities began to expand when patent protection was afforded to certain “new” asexually reproduced plants. The 1970 Plant Variety Plant Protection Act went further by authorizing patent protection for certain sexually reproduced plants. Later on, patent protection was extended to organisms such as bioengineered bacteria and animals. As has been noted, Diamond v. Chakrabarty is the key case that opened the door for expanding the scope of patented entities that eventually led to the patenting of DNA, including human genes.

According to the Court in Chakrabarty, “a live human-made microorganism is patentable subject matter under statute providing for issues of patent to a person who invents or discovers ‘any’ new and useful ‘manufacture’ or ‘composition of matter.’” In this case, a bacterium not previously found in nature was created by genetic engineering with the property of being able to break down crude oil. As a “new” bio-organism capable of “eating oil slicks” and treating pollution, it was deemed “new,” “useful” and “human made” (i.e., manufactured). According to the Court, patentable materials “include anything under the sun made by man.” In this 5 to 4 decision, the Court seems to have set new precedent, overturning and expanding the decisions of earlier courts and legislation.

The Chakrabarty decision immeasurably helped to stimulate the rapid expansion and development of the biotech industry, especially in the United States. Further stimulation was provided in 1987 when the PTO applied Chakrabarty as a precedent and began to issue patents on various types of bioengineered plants and animals. Congressional legislation weighed in by permitting universities to be granted patents directly, to license patent rights, and even to collect licensing fees for discoveries and products developed with federal funds. As a consequence, a “university-industrial complex” of patent-controlling academic institutions and commercial corporations was established. PTO began to issue patents on human tissue, human DNA, human genes and diagnostic genetic tests. In The Regents of the University of California v. Eli Lilly and Co. (decided 1997), a court ruled that DNA sequences (“a description of the DNA itself”) were required in patent applications for DNA, including human DNA. As genomics became more dependent upon computer science, it is relevant to note that the expansion of patent laws to include computer software programs, including the algorithms used in them (despite the exclusion from patent law of laws of nature and scientific formulae), has had an impact on the process of the patenting of human DNA, since DNA sequences, that are later patented, are often first detected by computer analysis of various information in DNA data banks.

Despite the protections of the Thirteenth Amendment (1865) that forbids a human being from becoming the property of another human being, either in whole or in part, some perceive the expansion of the scope of the patent laws to include the patenting of human DNA as a potential source for the erosion of this constitutional prohibition. They see the patenting of human genes as a way of owning not only parts of human beings, but parts of the collective identity of the human species as represented by the human genome. Since the genome is characteristic of all living beings, ownership of parts of the genome would also constitute ownership of parts of nature. This has been referred to as the “privatization” of nature, and has been considered to be a violation both of the spirit and the letter of patent law which does not extend to natural entities. In this regard, some invoke the argument of the “slippery-slope,” maintaining that the patenting of human genes, of bioengineered animals and plants with human genes and of human stem-cells, could ultimately lead to the private or corporate ownership of parts of human beings. It is feared that soon bioengineered human embryos and fetuses, that will eventually become human adults, will be patented. In response to this apprehension, a bill was introduced into the U.S. Congress in 2003 to prevent the patenting of human organisms, including embryos and fetuses “at any stage of development.”

Patents and Jewish Legal Ethics

At the outset, a critical distinction must be made between two possible meanings of “Jewish ethics”: the ethics of Jews and the ethics of Judaism. The ethics of Jews is related to empirically based examination, usually employing sociological methods, of the attitudes and behavioral patterns of Jews regarding ethical issues. The ethics of Judaism relates to a textually based examination of how the constitutive sacred and significant texts of Jewish theological, ethical and legal religious tradition have dealt with or might deal with an issue of ethics, law and/or public policy. What follows is informed by the legal ethics of Judaism, rather than the ethics of Jews.

Secondly, it must be acknowledged that Jewish legal ethics presupposes jurisprudential categories and employs a vocabulary of legal discourse that often varies from those found in Anglo-American law. For example, Anglo-American law is a rights-based system. American law is primarily concerned with rights, resolving conflicts of rights, and dealing with the infringement of rights. As has been noted, patents are a form of property-right, and issues in patent law usually relate to the nature and scope of that right, alleged conflicts relating to that right, and the disposition of claims that that right has been infringed. Further, in Anglo-American legal tradition, there is a propensity to distinguish between law and morality, often relegating ethical behavior to the private realm, unencumbered by social or legal regulation, as long as the chosen actions do not impinge on the right of others. Legal action is often required when a conflict of rights occurs. In American law, ethical issues usually come to the fore only if they can be couched in the language of rights. As will become increasingly apparent below, Jewish law is not a rights-based, but an obligation-based legal system where law and morality are intertwined. In American law, the primary question is: what are my rights? In Jewish law, the primary question is: what are my obligations, i.e., what am I obligated to do, permitted to do, or prohibited from doing, in a specific situation? At first blush, it would seem that issues relating to patent-property rights would have little resonance in Judaism’s legal-ethical tradition. Indeed, there is no notion of patent property rights in Jewish legal discourse as Rabbi Dr. Isaac Herzog—the first Chief-Rabbi of Israel, established in his definitive 1936 work, The Main Institutions of Jewish Law. Furthermore, today most patents on human genes are held by corporations, and Jewish law has never integrated the concept of an “artificial person,” such as a corporation, into its vocabulary of civil law. Furthermore, in Jewish law, entities that are not visible to the naked eye usually have no legal status. Since genes are not visible to the naked eye, they would have no legal status. Consequently, they cannot be patented, since patenting them which would give them legal status. In this view, like genes, Chakrabarty’s bioengineered microscopic bio-organisms, would have no status in Jewish law and could not therefore be considered as being protected by a property right.

Yet, despite the absence of patent law in Jewish legal discourse, and despite the fact that genes seem to have no legal status in Jewish law, Jewish legal ethics can nonetheless effectively address many of the ethical and legal issues that characterize the public policy debate about the patenting of human genes. For Jewish legal ethics, more significant than the patenting of genes per se, are the ethical, social, medical and public policy consequences of so doing. In considering such issues, one would be drawn to query: How might a Beth Din, a Jewish legal court, adjudicate cases relating to the patenting of human DNA, and how would its findings differ from the findings in these cases by American courts? A case in point is Moore v. The Regents of the University of California.

Moore at the Beth Din

Though the Moore case, decided by the Supreme Court of California in 1990, does not directly involve the patenting of human genes, it is significant to our discussion because it draws attention to many of the issues reflected in the public policy debate over the patenting of human genes, including the patenting of human DNA. First, a review of the Moore case would be in order.

In the late 1970s, John Moore was diagnosed with and treated for a form of leukemia at UCLA Medical Center. In the course of his treatments, extensive amounts of blood, bone marrow and bodily tissue were withdrawn from his body. Without his knowledge, these substances were used by his physicians and others for research purposes aimed at developing future medical treatments for other human beings. Also concealed from him was the expectation of his physician and his physician’s colleagues of benefiting financially from the products of their research with his cells. His physician used his privileged relationship with Moore for exclusive access to substances from Moore’s body. The extraction of these substances was not always related to Moore’s treatment but rather to his physician’s research activities.

Based upon the research of Moore’s physician’s group, a patent on the cell line developed from Moore’s cells was applied for and granted in 1984. Moore’s rare cell line would subsequently be used to produce certain pharmaceuticals. Moore’s physician and his colleagues, together with the UCLA Medical Center (the owners of the patent), sold rights for the commercial development of pharmaceuticals derived from Moore’s cell line for a seven figure amount. It had already been estimated that the sale of such pharmaceuticals would bring a multi-billion dollar yield within seven years. When Moore learned of all this, he brought suit for malpractice and property theft, among other things. He argued that he deserved some part of the funds generated by his own bodily substances, especially those taken for research, and not for therapeutic purposes related to his treatment, and without his knowledge of their eventual use. The Supreme Court of California majority decision went against Moore on the property issue.

In itself, the Moore case is an anomaly. It is rare to have a single individual whose cells would have nearly as high potential market value as those extracted from Moore. Usually, many, many samples would have to be obtained even to determine whether a certain DNA sequence has any potential therapeutic and commercial value. A DNA date base might have great value, but DNA from an individual usually does not. Consequently, a case of an individual like John Moore is unlikely to occur with any frequency. Nonetheless, the issues raised in Moore and the precedents it (now cited in subsequent cases) established, get to the heart of many of the public policy and ethical issues, that relate to the patenting of human DNA, including human genes. Let us now see what some of these issues are and how a Beth Din might deal with them.

What is Being Patented?

At the crux of the public policy debate over human gene patenting is the issue of what precisely is being patented when patent protection is extended to human DNA. Two positions, one in favor of human DNA and gene patenting and one against, drive the public policy debate. For example, a position, usually held by opponents of human gene patenting, is that human genes per se are being patented. Since patent law prohibits the patenting of natural entities and laws of nature, and since human genes are natural entities and genomics (including DNA sequences) expresses itself in biological formulae, human genes should not be patentable entities. In this view, the patentability of human genes is a perversion of patent law and poses a danger to human health and well-being. From this perspective, judicial and legislative intervention to exclude human genes from the already too expansive scope of patentable materials should be made. Nonetheless, many opponents of human gene patenting do not take issue with the patenting of “products” of genetic research, such as genetic testing kits.

Advocates of the patenting of human genes often take the position that human gene patenting does not entail the patenting of the actual genes or DNA of any individual, but rather genetic information relevant to the development of diagnostics and therapeutics. In this view, what is patented are not genes per se, but improved (e.g., “isolated,” “purified”) genes that (although they might be virtually identical to those found in a human person) have been altered by biotechnology. From this perspective, since genes in their natural state are not being patented, patenting these materials should be permitted, and in fact, patenting them has been permitted both by the courts and by the PTO. This view also claims that neither genes nor human body parts are not being patented, but rather specific “chemical compounds,” i.e., nucleic acid that is produced using genetic information.

The position taken by the majority in Moore, in effect, endorsed the views of the advocates of human DNA and gene patenting. The majority decision maintained that finding for Moore would lead to the “hinder[ing] of research by restricting access to the necessary raw materials.” The justices also asserted that the “patented cell line is both factually and legally distinct from the cells taken from Moore’s body,” and that the cell line is patentable because, having been “cultured,” it is “the product of human ingenuity.” Similarly, the argument for the patenting of human genes, accepted by PTO and the courts, is that once genes have been “isolated” and “purified,” they are considered “made by man,” and therefore patentable. (“Isolated” means the separation of DNA from its natural state. “Purified” means excluded from the way the particular DNA naturally occurs. Though this means that “isolated” and “purified” DNA is not identical to DNA in its natural state, it can nonetheless also be quite similar or almost identical to DNA in its natural state.) Furthermore, many advocates of DNA patenting claim that since a human gene patent provides protection for “isolated” or “purified” DNA, it is not a patent on material that is actually found in a human body, that a gene patent provides protection for a chemical compound made through the use of genetic information, but does not give rights over a gene as it is found in any human person’s chromosomes. They further claim that a human gene patent relates to information on a DNA sequence which is a patent on genetic information and not upon human genes themselves. In other words, natural entities in their natural setting, whether it be a mouse or a gene, are not patentable, as they are part of nature. However, once human labor is “mixed” with nature (as Locke put it), the “isolated” or “purified” entity—no matter how close to its natural state it may be, becomes patentable if it meets the other requirements of patent law. The legal foundation for all of this is ultimately the decision in Chakrabarty which held that all “man made” entities that meet the requirements of patent law can be patented. In the case of the patenting of Moore’s DNA in particular, and on the issue of the patenting of human DNA and genes, what might a Beth Din say?

A variety of religious and non-religious traditions oppose gene patenting because they oppose most forms of genetic engineering and methods of reproductive biotechnology, considering them to be unnatural, immoral, “playing God,” etc. Jewish tradition, however, endorses most purposeful and potential beneficial forms of genetic engineering, especially those connected with improving the quality of human life, health, and well-being, i.e., of promoting the public good. In this, Judaism would agree with those seventeenth and eighteenth century scientists (e.g., Descartes and Bacon) who considered science and technology as having the potential to improve the state of the human condition. In this regard, the biblical phrase that God created the world in order “to be made” (bara la-asot) (Genesis 2:3) is taken to mean that God arrested the process of creation as the first Sabbath began and left it to human beings to complete the work God began. Consequently, as the sixteenth- century sage, Rabbi Judah Loew of Prague put it, “Everything God created requires [human] repair (tikkun) and completion (hashlamah).” The human mission is to act as God’s “partner in the work of creation,” to develop and improve upon the raw materials of creation bestowed by God. As this sage put it, “Human beings bring to fruition things that were not previously found in nature; nonetheless, since these activities occur through nature, it is as if it entered the world to be created.” In other words, such forms of human creativity are imitative of nature, and cannot be considered outside the natural order. Not unnatural, they extend nature by bringing its potentialities into actuality. As Shakespeare puts it:

This is an art
Which does mend Nature
Change it rather; but
The art itself is Nature

Rather than “playing God,” such activities fulfill the divine mandate to imitate the ways of God. From this perspective, human beings are not only part of nature, but they can be agents for creating and extending nature as well. In this view, natural entities—though altered through human effort, would still be considered as “natural” entities, i.e., as if they “entered the world to be created.” A bioengineered soybean would still be a soybean, an isolated or purified human gene would still be a human gene. Consequently, a Jewish religious court would disagree with the U.S. Supreme Court’s slim majority decision in Chakrabarty, and with the majority decision in Moore. A Beth Din would maintain that a specific bioengineered bacterium made from existing bacteria and the cell line made from Moore’s cells, even though they did not exist in nature previously, remain “natural” entities. (Ironically, those religious leaders who describe some of the processes and products of bioengineering as being “unnatural” and who therefore oppose gene patenting on that basis, actually play in the hands of their ideological opponents. By considering such entities “unnatural,” they affirm the premise of the advocates of gene patenting that such entities are no longer “natural,” and hence are patentable materials.)

The fundamental issue here is whether human genes, even mutated, “isolated” or “purified” human genes are “natural,” i.e., part of nature. Generally speaking, genes and genetic sequences have been treated by the courts and PTO not as human body-parts or as human tissue, but much like other chemical compositions that are patentable. However, Jewish legal ethics would take the position that as either natural entities or as “extensions of nature,” human DNA and human genes are part of nature, not “man-made,” not merely a chemical, and therefore ineligible to become patented entities protected by a property right.

Property Rights

Moore’s attempt to recapture some of the financial benefits obtained by his physicians, The University of California and the Sandoz Pharmaceutical Company from the tissue, blood, cells, etc., that he claimed were deceitfully taken from his body, rested on his assertion that he had a property-right in those extra-corporeal materials. The majority opinion stated that Moore had no property rights in those materials once he surrendered them to his physician. Citing precedent and common practice, the majority opinion stated that a patient is presumed to surrender control and ownership of his cells once they are excised for medical tests. That some materials, were extracted under false pretenses did not sway the court from its position that Moore had divested himself of his property rights in those materials once they were extracted from his body.

At issue in this case was not whether a person has a property right in either the whole or part of his or her body. This was assumed by the court. The court reaffirmed a tradition rooted in John Locke that with regard to a person’s own body, everyone “has a property in his own person.” In contrast, like other religious traditions, Judaism maintains that everything in the world, including our own bodies, belongs to God, and not to our own person. (Ironically, some Christian religious leaders have opposed gene patenting on the grounds that God owns the human body, while some legal scholars oppose human gene patenting on the opposite grounds, i.e., that each person owns his or her body, including excised tissue and genetic materials.)

In what sense is the body considered to be God’s property? One prominent theological idea is that God mandated human beings to be the stewards or trustees of nature, including one’s own body. In this view, the body is a gift, although a temporary and a conditional gift, that must be cared for. In the Middle Ages, the human stewardship of divine possessions was known in Jewish ethical literature as the “doctrine of deposit.” In this view, God deposits His possessions with human beings as a trust. If the human trustee manages God’s “deposit” properly, then God’s property is well used. If not, the human trustee is liable for misappropriation of funds, even for robbery. Put another way, we hold God’s property on deposit, as if we were God’s “bankers.” Similarly, we could claim that in terms of extra-corporeal body parts, we are depositors and those who excise our blood, cells and DNA are like bankers, accepting these entities not as their property but as the property of those who placed them on deposit. Misusing these deposits is tantamount to robbery, especially, if as in the case of Moore, deception is employed regarding their use. In this regard, it is relevant to note that places where blood and tissue are stored are often called “banks.” What we place in a bank does not become the property of the bank. It might also be suggested that a person’s excised tissues, cells and body parts, and DNA, including his or her genes, especially if they have actual or potential financial value, may also be considered as a kind of bailment.

From this perspective, the blood, tissue and cells discussed in Moore might be considered to have the status of bailments. The patient in such cases would be God’s bailee, and the physicians who extracted these materials, would be considered sub-bailees of God, or bailees of the patient in so far as his or her DNA is concerned. In contrast to British law, according to Jewish law a bailee who meddles with a deposited article without the bailor’s authority or permission, or who deceives a bailor, is considered guilty of theft. Applied to the Moore case, Moore’s physicians would be guilty of the misuse of a bailment, of deception, and consequently of theft. In this view, unlike the majority decision in Moore, Moore would be entitled to a share of the profits obtained by the plaintiffs from the patenting of his cell line and from the pharmaceuticals developed from them. Even if Moore’s cells were surrendered as a gift, he might still retain an interest in their disposition. According to Jewish law, a donor of a gift may make a gift conditional on certain terms, failing which the gift would be void. Moore had asked his physicians whether his cells had any potential value, and his physicians knowingly deceived him. Apparently, his gift was conditional upon the representation that his cells had no commercial value. Consequently, his “gift” would be void, and he would retain an interest in his cells. Furthermore, as already as has been noted, the extraction of Moore’s tissues under false pretenses would be construed as robbery, according to Jewish law.

Moore also alleged “unjust enrichment” on the part of the defendants. Here, too, Moore’s claim would be upheld, for according to the Talmud, “it is forbidden for a person to benefit [without authorization] from something owned by another.” In addition, in the Moore case and in the subsequent Greenberg case, “conversion” was also alleged. This allegation was denied by the court in both cases. However, Jewish law would uphold this allegation. For example, according to the medieval Jewish legal codes, a bailee who, without the bailor’s consent, overtly converts an object to his own use or who denies the ownership of the bailor, is thereby stealing.

There is a debate in the Talmud that extends to post-Talmudic literature on the question of the disposition of stolen property that is improved by the robber. This issue would relate to the Moore case because the cells taken from his body were “improved” for commercial purposes. One view is that the robber must give compensation for his improvements. Another view is that improvement does not transfer title, but that the robber is entitled to be compensated for his labor in improving the item. In this view, Moore would have retained title to his cells after excision and would be entitled to funds made from the “improvements” of his cell line. However, the defendants in the Moore case, i.e., the patent holders and licensees, could then sue Moore - rather than him suing them - for a part of the profits Moore received because of the products made from his cells!

There seems to be an asymmetry in contemporary common practice in the development of genetic tests and therapies from donated human tissue. Patients (like Moore) are expected to surrender their potentially commercially valuable bodily tissues and blood for free, i.e., as a contribution or a gift, while others are presumed to be permitted to utilize these “raw materials” in the pursuit of substantial financial gain. This arrangement seems to be inequitable. If human cells can be used by scientists to secure pecuniary gain through patents, why can they not provide financial compensation for the person from whom they were extracted? Though the sale of non-replenishable organs, i.e., a heart, is prohibited by Jewish and American law, the sale of replenishable body parts, such as blood and hair is not prohibited.

Originally, it seems, individuals tacitly surrendered ownership of their excised extra-corporeal body parts, i.e., during a haircut or a medical test, because of the presumption that these entities had little or no fiscal value. However, because of recent developments in genetics, this can no longer be assumed. For example, with the advent of reproductive cloning, DNA from a celebrity or from a very wealthy individual might have substantial commercial value.

There is ancient precedent in Jewish law for considering excised extra-corporeal bodily tissue as having monetary value. For example, according the Talmudic law, to betroth a wife, a man must offer something of value. One of the many examples offered by the Talmud is the hair of a Nazirite. Such hair was considered to be especially valuable and was a desired commodity that could be exchanged for cash. For this reason, and for those noted above, Jewish law - unlike the majority view in Moore, might assert that Moore is entitled to some of the profits made from the replenishable materials that were taken from his body, especially those that were taken under false pretenses. Obviously, Moore’s cells, unbeknown to him, had great financial value to others.

One could argue that replenishable tissues such a blood, hair, etc. not only could but should be relinquished by individuals if such entities could help save the lives or preserve the health of others. Jewish law might consider it obligatory for a person to do so, e.g., to give blood to help save a life. Such an obligation would not apply, however, to irreplaceable body parts, such as limbs and certain vital organs, for according to Jewish law, one is not permitted to injure oneself or to place oneself in mortal danger, even to save an imperiled person. However, a person is obliged to take reasonable risks and to expend funds to save an imperiled person, which might include an individual actually or potentially afflicted with a chronic or life-threatening disease. Yet, such body parts need not be relinquished for free, especially if they have potential value to commercial entrepreneurs.

Consider, in this regard, how Jewish law deals with the issue of either donated or “sold” human eggs. The major issue here is not primarily one of property rights, but religious commandments and obligations. For example, in cases in which an ovum provided by one woman is fertilized and implanted in the womb of a second woman who gives birth to a child, modern rabbinic decisors (a legal decisionmaker in case law) have discussed the question of who is the mother of the child, i.e., the issue of maternal identity. According to the Ten Commandments, a child is obliged to honor his or her father and mother. In cases such as this, the issue of who is the mother, and therefore the parent whom the child is obliged to honor, becomes relevant. Where the ovum is taken from a non-Jew, the religious identity and status of the child needs to be determined (especially since in Jewish law, religious identity derives from the mother). According to some Jewish legal decisors the birth-mother is the mother. However, religious conversion of the child is required by some in any case, presumably recognizing some maternal interest on the part of the egg donor. Further, according to some decisors, the child would have two mothers - each deserving of honor from the child. Consequently, whether or not the ovum provider donated or sold her ovum to others, she would still have a maternal relationship to the child. Parting with her ovum, does not make the ovum the property of someone else. She retains an interest in the ovum and a relationship to the child born from it.

The notion that a person maintains a relationship with his or her excised tissue is also prominent in many folklore traditions, including Jewish folklore. For this reason, Jewish religious practice requires amputated limbs to be buried with a deceased person. Hair, nails and other replenishable body parts that are excised are not usually handed over to others. In circumcision, which would certainly be viewed as a medical procedure as well as a religious ritual, many Jewish traditions consider it obligatory to retain the foreskin and not surrender it to others. In this view, a barber, a manicurist, a ritual circumciser, would have no right to excised bodily tissue. Here, too, according to Jewish legal ethics, Moore would have an interest in his excised cells and the products made from them, contrary to the ruling of the California Supreme Court. Consequently, individuals would maintain an interest in products made from their excised DNA unless it was freely given as a gift and without any subterfuge on the part of either party, patents not withstanding.

An individual’s DNA is an integral aspect of a person’s identity. For example, the results of diagnostic genetic tests can readily alter an individual’s sense of self-identity and his or her sense of identity vis-à-vis others (e.g., a potential spouse). In Moore’s case, his cell-line was unusually distinct. As Moore himself said in testimony before a committee of scientists in 1996, “I am known as Patent #4,438,032. Some of you may be familiar with pieces of me in your laboratories.” One could claim that the expropriation of Moore’s bodily tissue under false pretenses could be construed under American law not only as a violation of his Fourth Amendment protections against unreasonable search and seizure, but also as a violation of his right to privacy, and perhaps as an example of “identity theft.”

It has been estimated that some ten million Americans were the victims of identity theft in 2003. A 2004 Congressional bill establishes penalties for the crime of identity theft related to theft, terrorism or other reasons. This law refers to a person who “knowingly transfers, possesses, or uses, without lawful authority, a means of identification of another person.” Though this law makes no mention of identity theft related to genetic information, extending the provisions of this or a subsequent law to the appropriation of a person’s genetic information which is a crucial aspect of one’s identity, especially if “unjust enrichment” occurs and/or if it is acquired without one’s consent, could be construed to be a variety of identity theft. From this perspective, the position of the plaintiffs in cases such as Moore and Greenberg would have been immeasurably strengthened. A person’s DNA or genes—even if “isolated” or “purified,” could be considered to be protected under legislation related to identity theft.

In Sharon v. Levi (1980), which was decided by the Israeli Supreme Court, it was stated that “The right not to suffer bodily invasion is one of the basic rights of the individual in Israel, and constitutes part of the human right to personal liberty.” In Military Court of Appeals v. Vaknin (1988), precedents from Jewish religious law regarding the duty to protect the privacy of an individual are cited. For example, in Jewish law, all conveyance of personal information is automatically considered confidential unless permission to disclose it is explicitly and freely given and without subterfuge on the part of the party seeking the information. Such information cannot be conveyed to a third party. It would be reasonable to apply these laws to Moore and to find the defendants liable for violating Moore’s privacy. In addition, those who maintain that gene patenting is not the patenting of genes but of information about genes, might be restrained from patenting information about DNA sequences and other genetic information by invoking privacy and identity theft considerations. Consequently, under American, Israeli and Jewish religious law, Moore might justly claim a violation of his privacy and identity theft by the plaintiffs in Moore.

Doctor-Patient Relations

The majority opinion in Moore did concede that Moore’s physician breached his fiduciary duty to Moore because he failed to disclose his financial interest in Moore’s cells. However, from a theological perspective the more fundamental issue here is the violation of the covenantal relationship between patient and physician which, among other things, is characterized by trust. True, Moore’s serious disease was effectively treated, but his physician irreparably damaged the physician-patient relationship by the way in which he treated Moore. Once Moore learned that his physician was reputed to have said at a dinner party, “John Moore is my gold mine,” the doctor-patient relationship could not be sustained thereafter.

Jewish tradition considers the physician to be a partner of God, an agent of God in the art of healing. Jewish legal ethics relates the obligation to heal to the religious obligation to save and to preserve human life and health. According to a medieval Jewish legal code, “The Torah gave permission to the physician to heal; moreover, it is a religious obligation, and it is included in the obligation to save life.” Other laws might be set aside to save life and to preserve health. This obligation is almost absolute. The issue here is not the rights of scientists and physicians, nor is it the right to health care. Rather, the issue is how those who have the training and ability to heal, exercise their obligation to heal.

Despite his high opinion of medical practice, the thirteenth-century Jewish philosopher, Joseph ibn Falaquera observed, “While the purpose of this [i.e., the medical] profession should be the healing of sickness, some doctors’ only goal is profit and large fees.” In making this observation, Falaquera is commenting upon the enigmatic Talmudic adage, “the best of physicians goes to hell.” In other words, even physicians competent in the healing arts, but who are primarily driven by pecuniary greed, deserve to go to hell. Though according to Jewish law, a physician is protected from liability when competent medical care happens to result in the harm or death of a patient, a physician is not protected from liability when deceiving a patient or when making pecuniary gain a major goal of his or her professional relationship with a patient. Applied to Moore, these observations would find Moore’s physician legally and morally culpable of breaching his fiduciary relationship. They would also be applicable to those who focus more on patents than patients in the “genetic gold rush.” In this regard, it is interesting to note that Leviticus 19:16 has often been translated as “You shall not go up and down as a tale-bearer among your people; neither shall you stand idly by the blood of your neighbor.” This verse has often been applied to the obligation to protect another’s privacy by not revealing confidential information and to the obligation of the physician to render medical care to an imperiled party. However, an alternative translation, based on academic study of the verse would be especially applicable to cases such as Moore, i.e., cases in which a person’s tissue and blood are deceitfully used for pecuniary gain: “Do not deal basely with your countrymen. Do not profit by the blood of your fellow.”

According to Jewish law, a person should not be compensated for observing a religious commandment or fulfilling a religious obligation, e.g., no one would expect payment for praying or observing the Sabbath. As has been noted, Jewish law considers the practice of medicine to be in fulfillment of the religious obligation to save and to preserve life and heath (pikuah nefesh). Some medieval Jewish legal decisors also link the delivery of medical services to the biblical obligation to love one’s neighbor as oneself (Leviticus 19:16). Others link it to the commandment not to stand idly by the blood of one’s neighbor (Leviticus 19:16, which is invoked by the Talmud to require one to aid an imperiled individuals, in this case, an individual imperiled by illness). Still others relate medical care to the biblical injunction requiring one to return lost property to its owner (Deuteronomy 22:2), i.e., the return of health to the patient. Precisely because the professional duties of a physician are considered to be in fulfillment of various biblically-based religious commandments, and because a person is not compensated financially for the observance of God’s commandments, the question of whether a physician is entitled to financial compensation for his professional activities, is raised in Jewish legal sources, beginning with the Talmud. A similar question is raised with regard to the religious obligation to study and to teach the Torah, i.e., are scholars, teachers, rabbis, entitled to compensation for their professional activities?

In Jewish labor law, physicians are often placed in the same category as teachers, since physicians and teachers both practice a profession deemed to be in fulfillment of a divine commandment. According to legal opinion, a competent worker contracted to perform a certain task cannot be dismissed if a more competent worker presents himself, i.e., the contract with the initial worker must be honored. However, if a competent physician or teacher is contracted and a more competent one presents himself, the initial physician or teacher may be dismissed and the more competent one hired. The reason given is that unlike other workers and professionals, a less competent teacher or physician might cause more longstanding damage to the student or patient than a more competent one. Here, the obligation to the student or patient trumps the labor-rights of the health-care professional or teacher.

Although some Jewish legal decisors considered it inappropriate to pay a physician or a teacher because his work fulfills a religious commandment, the dominant view in Jewish law is that a physician and a teacher are entitled to charge a fee. Indeed, a popular proverb recorded in the Talmud states that “A physician who charges nothing is worth nothing.” Though Jewish law identifies specific situations in which physicians should occasionally offer their services gratis - such as providing medical care to an indigent patient, it acknowledges the propriety of paying physicians for rendering professional services.

With regard to the issue of compensating a professional for fulfilling duties he or she is obligated to perform under religious mandate, Jewish law created a legal fiction called “spent time” (bittul zeman). Scholars, teachers and physicians were entitled to compensation, not for their knowledge or their professional skills (because both are exercised in fulfillment of a religious commandment), but for the value of the time they expended which, if otherwise employed, could have produced income. In a case in which the physician acts as an educator, either of his patient or his medical student, the physician cannot be compensated for sharing his knowledge, but only for the value of his expended time.

Both medieval codes and responsa (i.e., case law) address the issue of the appropriate costs of medical care and the sale of pharmaceuticals. A case in point, reported in various medieval sources, involves a desperately ill person who agrees to pay an exorbitant amount both for doctor’s fees as well as for pharmaceuticals to treat his illness. Is such a contract binding? According to the fourteenth-century legal authority, Rabbi Yom Tov ibn Asevelli (known by the acronym “Ritba”), the patient is not required to honor his agreement, and because of his obligation to heal, the physician and the dispenser of drugs is only entitled to a fair fee for the use of his time and the costs of his drugs. Of course, as will be noted below, in certain circumstances, such as a public health emergency, exceptions can be made, and the physician might be obligated to treat patients for free.

Fair-Trade

Following Locke’s contractual theory of government, the patent laws considered patents to be part of the social contract between the individual and the government. The government protected the rights of inventors for a specific period of time while inventors were obliged to make the nature of their inventions public. In exchange for publishing the details related to their invention, the inventor was granted the monopoly right to exclude others from producing or using the invention for a period of time, (initially 17 years) currently 20 years. It is precisely during this period of patent protection when most profits are to be made. In this way, private gain and private property intertwined with the public good. As James Madison observed in this regard, “The public good fully coincides in both cases [i.e., patents and copyrights] with the claims of individuals.” Though patent law protects the interests of the patent holder, the U.S. Supreme Court has endorsed “the proposition that in granting patent rights, the public must not be deprived of any rights that it theretofore freely enjoyed.” Furthermore, patent property rights are “negative” in the sense that they only grant monopolistic rights to the patent holder that prevents others from using the patented item or process.

Most advocates of human gene patenting would agree with Madison. For example, advocates of human gene and DNA patenting, including the majority of justices in Moore, claim that human DNA patenting serves the common good because it protects the rights of those who aim at developing new diagnostic tests as well as treatments and cures for a variety of diseases and medical conditions, and by so doing patents stimulate and encourage such medical treatments that might not be otherwise developed. However, many opponents of human gene patenting would disagree with Madison and would identify an endemic conflict in the patent laws between the rights of patent holders and the interests of the “public good.” What would a Beth Din have to say about these issues?

Like patent law, Jewish law contains the notion of granting a temporary monopoly over property. Already in biblical law, there was the institution of the Jubilee Year regarding real-estate. A Jubilee Year was declared each 50 years, i.e., land could only be possessed for a maximum of 50 years (Leviticus 25:9-15). In each Jubilee Year, the land reverted back to its original owner. For example, real estate sold in the 30th year of the Jubilee cycle could not be possessed for a period exceeding 20 years. During the period in which a person had title to a parcel of real-estate, the “owner” of the “land patent” would enjoy monopoly rights over the land, and would be entitled to any products or profits he or she could accrue from it. The premise of the Jubilee Year is that the land, i.e., nature, belongs to God and cannot become the permanent possession of any individual. For Jewish law, the primary issue insofar as the granting of such licenses for monopolistic use of property for a limited period of time is concerned, is not the scope of property rights, but the potential conflict between the public good and the protection of the economic interests of the holders of the temporary monopoly over the entity in question.

As has been noted, patent-property is a right stated in the Constitution. American law is a rights-based system of jurisprudence whereas Jewish law is an obligation-based system of jurisprudence. In the Lockean-Jeffersonian view, divinely endowed rights are central. In Jewish theology, ethics and law, divinely commanded obligations are central. Consequently, with regard to patents, Jewish law would not focus on the property rights of the patent holder or patent licensee, but rather on his or her obligations. Those obligations, include serving the common good, including the physical health and well-being of the citizenry.

Commercial competition is not proscribed by Jewish law. For example, the Talmud states that “a person may open a shop next to another shop . . . . and the latter [shop-owner] cannot object, because he can say: I do what I like in my property and you do what you want in yours.” Nonetheless, certain restraints were placed on free competition. One example, noted by the Talmud, is a case in which a fisherman discovers a fishing hole where fish are plentiful. According to some of the medieval commentators, the fisherman also developed a process as well as built a new contraption for catching the fish. In such a case, a second fisherman is prohibited from fishing in that place. In this Talmudic case, which is utilized during the Middle Ages as a precedent for justifying monopolistic restraint of trade in certain instances, entrepreneurs can exclude others from using certain inventions based upon their R&D.; From this case, one could justify affording patent holders who have equitable and justly acquired human DNA and altered it by scientific research and labor, a temporary monopolistic restraint against it being utilized by others. For Jewish law, such legal protections would not derive from a property-right or because the product is “man made,” but as a consideration for their investment of labor and capital, because of an appropriate expectation of recouping expenses and of making a profit as a result of this investment of labor and capital, and because such individuals can claim against potential patent infringers, “You are interfering with my livelihood.”

Issues such as whether new organisms created through bioengineering (see Chakrabarty) or whether human DNA and DNA sequences can be patented (as determined by the PTO) flow from a collision between existing patent laws and newly developed science and technology. A similar situation is found in Jewish case law, i.e., responsa, beginning in the sixteenth-century, in response to issues raised by the introduction of the then new technology of printing books with movable type.

In Judaism, no human activity is more highly valued than studying sacred and significant works of Jewish religious tradition. Since ancient times, such study (Talmud Torah) has been considered the fulfillment of a divine commandment of the highest priority, a divinely mandated lifelong endeavor for scholars and laypersons alike. Since study provided access to God, God’s word, God’s will, and the cumulative wisdom of tradition on how to live one’s life, it was considered to be in the “public good.”

The advent of printing made sacred literature much more accessible and economical than it previously had been. However, publishers were inevitably concerned with protecting their capital and labor investments in the works that they printed. Jewish legal decisors were concerned that granting publishers monopoly rights over the publication of certain works, might drive up costs, thereby limiting accessibility to these works and restraining the study of sacred texts. On the other hand, Jewish legal decisors were simultaneously concerned that not granting publishers such monopoly rights would discourage printers from publishing such works, thereby preventing accessibility to the study of these sacred texts. The conflict here is between the desire to protect the property rights of the publishers and the goal of furthering the study of sacred Jewish literature that was deemed to be in the public good and conducive to the “spiritual health” of the public.

A case in point occurred in 1550. Rabbi Meir Katzenellenbogen of Padua, Italy, had entered into a partnership with a prominent Italian publisher, and had invested a large sum of money to print an improved edition of Maimonides’ large and comprehensive twelfth-century code of Jewish law, the Mishneh Torah. This edition contained Katenellenbogen’s extensive explanatory glosses to the text of Maimonides’ work. Shortly after the work was published, another publisher reprinted the Katzenellenbogen edition and set an extremely low retail price for the work, allegedly to spite Katzenellenbogen for refusing to enter into partnership with him to publish the initial edition of that work. The brisk sales of the cheaper rival edition caused Katzenellenbogen great fiscal hardship. The case came before Rabbi Moses Isserles, chief rabbi of Krakow, Poland, one of his generation’s greatest Jewish legal authorities. Isserles placed a ban of excommunication upon anyone buying the rival edition until the first edition sold out, after which that edition would enter the public domain and become “generic.”

In similar cases, bans on reprinting various works were established for a specific period of time, e.g., 10 years, or until the initial edition sold out, thereby hopefully preventing a loss to the publisher and helping to assure a profit. Anyone violating the protections afforded a publisher was liable for infringement. In their rulings in such cases, Jewish legal decisors identified a precedent in the biblical prohibition against “moving a neighbor’s landmark” (hasagat gevul) (Deuteronomy 19:14). This was interpreted by the Talmud as referring to the unlawful encroachment upon another’s source of livelihood. The medieval Jewish legal codes considered such encroachments as a form of stealing.

Though in some of these cases, some attention was paid to the copyright interests of the author, in most it was either ignored or relegated to a secondary concern. In self-published works, there was a greater concern with the author’s investment in printing the work than in his labor in writing it. In the view of many of the decisors, Torah-learning was God’s gift to human beings. Since the goal was to benefit the community through the dissemination of sacred learning, authors were considered to have no intellectual property rights in their work. Applying the ancient dictum that “the law of the land is the law” (dina d’malkhuta dina), some legal decisors claimed that local civil copyright and patent laws should be applied to such cases, not as a matter of Jewish law, but in compliance with local, civil legal requirements. As noted, various legal decisors, however, considered the publisher’s legal protections as deriving from the biblical precedent of “not moving a neighbor’s landmark,” as interpreted by post-biblical Jewish law. In their view, it would be inappropriate to apply secular civil law to an issue of Jewish law.

Before relating this presentation of Jewish law on intellectual property to the patenting of human genes under American law, an additional issue should be noted. With the inception of printing, ancient Jewish religious texts such as the Talmud, that were unquestionably in the “public domain” were published. Because of their religious significance, rabbinic decisors were anxious for them to be accessible. Nonetheless, editions of the Talmud were protected from being reprinted because of the size of the work and the vast outlay of cash needed to print them. However, if another edition of the Talmud was printed with commentaries not found in the earlier protected edition, decisors encouraged the publication of the other edition since they wanted as many commentaries available as possible and were apprehensive that if only the commentaries of the earlier protected edition were available, it might hamper the progress of learning.

As the preceding indicates, though Jewish legal discourse has no concept of patent rights and little concern with copyright protection of an author’s work, it does contain a mechanism for protecting the products of labor and fiscal investment which, similar to U.S. patent law, grants a monopoly for a term of time and enjoins others from producing the protected property. In the Katzenellenbogen case, for example, Katenellenbogen’s commentaries and improvements upon the published text are not considered by the legal decisor, Rabbi Moses Isserles. Only protecting Katzenellenbogen’s investment is considered. Furthermore, like U.S. patent law, Jewish law recognizes the value of furthering the public welfare and encouraging the progress of knowledge. Like American patent law, Jewish law attempts to negotiate a position that mediates between public welfare and protection of financial investment and the expectation of profit. For Jewish law, the issue would not be whether “improved” genes are patentable or not, whether they are “natural” or not, but how to protect the investment of the producers of the product; in this case, diagnostics and therapeutics. Consequently, similar to U.S. patent law, Jewish law would grant a monopoly for a limited duration of time, with the hope that after initial investment has been recouped and a reasonable profit has been made, the product could pass into the public domain, becoming both readily accessible and cheaper to purchase.

In Jewish law, a reasonable profit is usually defined as a maximum of one-sixth over cost. Considering the costs of developing pharmaceuticals, and offsetting costs of pharmaceuticals that do not achieve FDA approval, those direct costs are enormous. It has been estimated that the development of a new drug currently entails direct costs of between $500 and $800 million. However, not to be calculated in direct costs are costs absorbed by government-subvented research support. Jewish law would accept a relevant distinction between basic and applied research. In the United States, much of the basic research in genomics is financially supported by the federal government, e.g., the sequencing and publication of the human genome. Since taxpayers, in a sense, are investors in such basic research, it would be unjust to expect them to pay twice for their share of a product that they helped to finance through their tax dollars. Consequently, the taxpayers’ share of the total costs of the development of a genetically-based diagnostic or pharmaceutical would be taken into consideration when that product is priced for market sale. Furthermore, the actual costs to those who develop the diagnostic or therapeutic would be carefully monitored to be sure that the “books” have not been “padded.” Yet, as in the case adjudicated by Isserles and in similar cases, actual costs of improving a “raw material” through research, development and labor, may be legitimately recouped with an equitable profit. What is advocated here is something akin to the Canadian governmental practice of setting guidelines for the pricing of pharmaceuticals at the manufacturer’s level. Something like the National Institute of Health’s imposition of a “reasonable pricing clause” on diagnostics and drugs developed from government-funded research would also be in order.

In Jewish law, when intellectual property protection ends its term, the product enters the public domain. Prices then inevitably decline and accessibility rises. Though in the short run Torah-learning might be temporarily restrained, in the long run it is not. Similarly, U.S. patent law may temporarily hamper accessibility and affordability of diagnostics and therapeutics, but in the long run the public good would be served. In this view, monopolistic patent protection is defensible, according to Jewish law. Yet, there are restrictions. Again, here, Jewish law would invoke the obligation to heal and to preserve life and health as a justification for restricting monopolistic commercial endeavors in certain circumstances.

Some examples in which patent rights would be vacated by Jewish law already have been given, e.g., in cases of fraud, deception and unjust enrichment, as in the Moore case. For reasons stated above, Jewish law would vacate patent rights to “man-made” entities that are “extensions of nature,” such as “purified” and “isolated” human DNA, but it would uphold the legal protections aimed at recouping investments and securing a profit. Also, for reasons stated above, Jewish law would restrict the ever-expanding scope of patents that commenced with the decision in Chakrabarty. This would include not only human DNA, but also the copyright-like patenting of DNA sequences, many of which are not even “man-made” but are extrapolated from large data banks by computers. Furthermore, Jewish law would prohibit misleading advertisements of “brand name” pharmaceuticals and diagnostics once a generic was available because of the expiration of the terms of a patent. Jewish law might also consider certain inducements, such as gifts to physicians from pharmaceutical companies, to be a form of bribery, that might compromise the best interests of the patient. Using overstatements, deception and “scare-tactics” in advertising to encourage use of certain diagnostics would also be discouraged.

Limiting Patent Rights

Patent law restricts others from making, using or selling the patented item and products derived from it. In American patent law, a patent applicant must demonstrate the utility of the process or entity to be patented, but need not do anything with it once it is patented. One possible reason for so doing would be to preclude a potential competitor from developing either a similar or improved product. Another reason might be based upon a cost-benefit analysis demonstrating that it would not be cost-effective to develop a product based upon the patent, e.g., if the potential market was either too small or too poor to make production or sale of the product economically profitable. However, in European forms of patent law, the holder of a patent is obliged to do something with it. In circumstances in which a patent holder refuses to do something with a patent that could lead to a life-saving or health-maintaining product, nations - including the United States, reserve the right to intervene. For example, in the case of a national health-emergency, the holder of a patent can be compelled to license the held patent for a price deemed equitable by the courts. Certain exemptions and waivers also have been sought for providing much needed available patented drugs in poor nations, i.e., pharmaceuticals that are used to treat HIV-positive and AIDS patients in impoverished African nations.

The Jewish legal codes condemn as a possible murderer, the health-care professional who withholds his or her expertise from a person who could benefit from it. Consequently, Jewish law would not permit the patent holder of a diagnostic test or pharmaceutical, developed from a patented gene or any other entity, to be withheld from the market. In such a case, Jewish law would require the compulsory licensing of that product and/or the licensing of others to develop such a test or drug at a fair price determined by a court. A case in point is the massive distribution of polio vaccine in the 1950s when there was the fear of the outbreak of a polio epidemic among American youth. In this regard, it is relevant to note that Jonas Salk did not patent his polio vaccine. He observed at the time, “Is it possible to patent the sun?” In other words, the vaccine was, in his view, an extension of nature, i.e., a natural substance, and therefore unpatentable. One might speculate that if the polio vaccine were created today, its use might not be publicly accessible, its patent might be held by a profit-driven corporation, and its costs might be prohibitive thereby making it unavailable to many. Intervention might have been necessary to compel its being licensed at a reasonable cost for public use. Indeed, widespread use at a reduced fee might realize the same or greater revenues than more restricted licensing at a higher fee.

American law can utilize trust-busting and other legal remedies to restrain monopolies on certain commodities that charge exorbitant prices. Similarly, Jewish law established precedents for enforcing price controls on certain commodities, such as commodities needed to sustain life (such as food) and commodities required to fulfill certain religious obligations. As was noted above, diagnostic genetically-based tests and pharmaceuticals can be considered necessary to sustain and to preserve life and health. Furthermore, in Jewish law, not only is the practice of medicine a religious obligation for those qualified, but the preservation and care of one’s health—a corollary of the idea that the human body is entrusted by God into our care for its stewardship, is also a religious obligation that each person is enjoined to try to fulfill. Therefore, obstacles that prevent an individual from fulfilling the obligation to seek available health-care, should be reduced. Efforts aimed at making pharmaceuticals economically available and accessible to those who need and seek them would be an example of this.

Various exemptions to patent infringement would be endorsed by Jewish law as being consistent with the mandate to heal and to serve the public good. A case in point occurred in Poland-Lithuania in the early seventeenth-century and was adjudicated by Rabbi Joel Sirkes, one of the greatest Jewish legal scholars of his time and place. In this case, a local Jewish community received a monopoly over selling kosher wine to Jews by the civil authorities. The community (Kehilla) then sold the license to a number of individual wine merchants. When the community realized that this arrangement was not for the public good, presumably because the wine merchants had not made the wine economically accessible to those who needed it (either for drinking or for ritual purposes), the community rescinded the license. The merchants claimed that the action of the community contravened civil law and infringed upon their economic entitlements (hasagat gevul - “moving landmarks”). Sirkes ruled in favor of the community. He found the civil practice of granting such monopolies harmful to the public good and ordered the community to grant (i.e., to sell) licenses to many merchants rather than few, thereby encouraging competition, providing more people with a livelihood, and making the product more accessible to the public. Applied to human DNA patenting, this decision would suggest that monopolies offered by such patents may not always prove to be in the public good, and that such licenses should be issued with the public good in mind, encouraging competition and the equitable pricing of licensed products.

The 1996 Ganske-Frist congressional legislation bars enforcement of any medical procedure patents against its infringers. This legislation recognized that enforcement of patents granted on medical and surgical procedures was having a deleterious effect on patient care. Some are advocating expanding the scope of Ganske-Frist to include certain genetic diagnostic and therapeutic products. This would be acceptable according to Jewish law under the mandate to heal.

A further example is the exclusion of non-commercial research from exposure to patent infringement. Though such an exclusion presently exists “on the books,” it is difficult to actually apply. Even researchers with no commercial goals are apprehensive about exposing themselves to enormously expensive patent infringement litigation that few individuals could afford. The development (largely as an outcome of the Dole-Bayh Bill) of an “academic-industrial complex” has made pure research, i.e., completely detached from commercial interests, difficult to locate or to define. Indeed, a federal court judge has opined that exemptions for pure research can be justified in very few if any actual cases.

There is little doubt that the patenting of DNA and bioengineered entities has immeasurably stimulated the growth of the biotech industry and the potential for the development of genetically based diagnostics and therapeutics. However, there is a growing body of evidence to the effect that the continuous broadening of the scope of such patents has, in effect, actually inhibited the further development of such diagnostics and therapeutics. For example, increasing numbers of physicians and scientists report that DNA patents and licenses substantially restrict research aimed at improving diagnostic tests, performing such tests, and developing improved pharmaceuticals. For instance, in 1999, the American College of Medical Genetics claimed that the following “limit the accessibility of competitively priced genetic testing service and hinder the development of national programs for quality assurance”: “monopolistic licensing that limits a genetic test to a single laboratory, royalty-based licensing agreements with exorbitant up-front fees and per-test fees, and licensing agreements that seek proportions of reimbursement for testing services.” In another instance, a certain American corporation patented a particular genetic test and was both charging exorbitant prices for it (over $2,000) and restricting others from using it without excessive licensing fees. This was especially problematic since most of the basic research for the development of the test already had been done by government-funded research. Meanwhile, a European laboratory developed an improved test (i.e., that tested for additional mutations) for half of the price. Under the terms of the patent, the development of the more sophisticated test and the more economic cost to laboratories and patients were not made available.

In introducing a bill to Congress to “carve out limited exemptions to the applicability of gene patents,” Congresswoman Lynn Rivers stated that “evidence is mounting that the patenting of human genes is both inhibiting important biomedical research and interfering with patient care.” Aware of both the growing opposition in Europe and “the popular view in this country” opposing gene patents as well as “the biotechnology industry’s strenuous assertion that gene patents are essential to genetic and medical intervention,” rather than challenging the viability or legality of gene patents, the congresswoman advocated legislation aimed at “minimizing some of the negative impact of patents on the practice of medicine,” and at broadening “the availability and usefulness of gene-based diagnostics in the overall health care system, while allowing essential medical progress to continue unabated.” She maintains that “owning a profitable genetic test may indeed drive some early innovation, but monopolistic control of a genetic test will ultimately stifle innovation.”

The bill introduced by Congresswoman Rivers attempts to address some of the endemic conflicts noted above that are embedded in U.S. Patent law. The bill recommends exemptions from patent-rights infringement, i.e., research (for non-commercial purposes) and diagnostic use (i.e., exempting genetic diagnostic tests from patent infringement remedies which builds on the Ganske-Frist bill), as well as information disclosure (requiring quicker publication of genomic sequence information contained in a patent application when federal funds have been expended in the development of the patented item). In summarizing her intention for introducing the bill, Rivers notes the need to re-evaluate the entire enterprise of human gene patenting to be sure that patents serve the public good and to “ensure that the fantastic advances in medical genetics are fully harnessed for the benefit not just of patent holders, but also of the general public.” From what already has been stated, these goals would be consistent with the teaching of Jewish legal ethics.

As was noted, various responses on the publication of sacred and significant Jewish texts seek to protect the investment of the publishers, even when texts in the “public domain” are printed in an “improved” form, i.e., with certain commentaries or glosses on the original text. However, that granting of a monopoly does not offer a broad scope of protection. It does not, for example, restrain others from publishing another edition of the original text with other commentaries or glosses. Otherwise, Talmudic learning and research would be inhibited. Put another way, even “improved” editions of entities from their natural state cannot be granted broad monopolistic protection if they inhibit free research. Applied to genetic patenting, this would mean that no patenting infringement would occur when the granting of monopoly rights inhibit research aimed at serving the public good.

Conclusion and Summary

1. Jewish legal ethics has no notion of patents. It also has never integrated the notion of an “artificial person,” such as a corporation, into its understanding of the nature and the function of a legal person. This is not simply because Jewish law derives from ancient and medieval precedents, but because Jewish legal ethics does not accept the philosophical and jurisprudential presuppositions underlying the laws of patents or corporations. Consequently, Jewish legal ethics would not accept the propriety of the patenting of human genes, especially by corporate entities.

2. Since the 1980 U.S. Supreme Court decision in Diamond v. Chakrabarty, the scope of entities and processes eligible for patent protection has been enormously expanded to include certain types of “artificially” created entities, including living beings, human DNA and human genes. U.S. courts have consistently ruled that such entities are “man-made” and consequently not part of nature, and hence eligible for patent-protection. Jewish theological, ethical and legal tradition would consider many such entities to be “extensions of nature,” and therefore “natural,” and hence excluded from patent protection under the longstanding understanding of U.S. patent law until Chakrabarty.

Though beyond the parameters of this study, one may note that U.S. court decisions have moved in opposite directions insofar as patent law and corporate law are concerned. In patent law, the courts have defined as “artificial” and “man-made” entities that might be considered part of nature, i.e., “natural,” or as “extensions of nature.” These include bioengineered plants, animals and human DNA. In corporate law, where corporations are “artificial persons,” features of “natural persons” have been granted to corporations by the courts, e.g., granting corporations constitutional rights characteristic of “natural persons,” thereby obfuscating longstanding distinctions between the legal status of artificial and natural persons. This began with the Supreme Court granting corporations the rights of natural persons under the 14th amendment. So, while patent law has defined natural entities as being artificial, corporate law has treated artificial persons as natural. Neither trend bodes well for the protection of the rights of U.S. citizens.

The “privatization of nature,” including the human genome poses a danger to human dignity, to the public good and to advances in human health care. A concentration of ownership of genetic entities by a relatively small number of corporate entities would reinforce Justice Brandeis’ fear of the corporation becoming a “Frankenstein monster.” Only here, ironically, an “artificial person,” i.e., a corporation, would have property rights in “natural persons,” i.e., human beings. To prevent a small number of corporate patent holders from controlling an entire market, antitrust and other relevant laws restraining untoward corporate power should be applied.

3. Judaism considers healing to be a divine mandate. It therefore encourages and endorses new technologies aimed at improving life and health, including most forms of bioengineering and genomics. However, Jewish teachings would advocate the promotion of beneficial goals of biotechnology without the ethical and legal costs and perplexities engendered by patent law. Indeed, many new and marvelous products have been created, manufactured and marketed without patents. In continuing to serve the public good, some alternative to the patent process that furthers human well-being yet protects the investment and labor of the pharmaceutical industry needs to be identified and endorsed.

4. Though Jewish law has no notion either of patent-property-rights or of corporations, it does endorse free competitive commercial enterprise by individuals and by commercial partnerships. Consequently, Jewish law recognizes the need to protect the investments of labor (including R&D;) and of capital in such enterprises, as well as the expectation of realizing an equitable profit. Therefore, Jewish law accepts the propriety of granting a temporary monopoly to those who engage in such enterprises, especially when they aim at improving human health and serving the public good. To be considered, in addition, are the implications of not granting protection to those who develop effective diagnostics and therapeutics, especially if such denial obstructs the development of such diagnostics and therapeutics. Indeed, new products would become more readily accessible and economical after patent protections expire. The development of such new pharmaceuticals can obviate the need for costly and dangerous surgeries to treat various medical conditions.

5. Jewish law recognizes the endemic conflict between the expectation of return on investment and profit and serving the public good, as embodied in U.S. patent law. In addressing this conflict, Jewish law has established precedents for trying to further the public good while protecting expectations of recouping investment and realizing a profit. Though Jewish law recognizes the legitimate expectation of financial reward for medical research and practice, it considers the exercise of pecuniary greed to be both ethically inappropriate and legally criminal. It therefore would restrain and limit exorbitant fees and profits. In Jewish law, a maximum of one-sixth over investment costs is usually considered to be an equitable profit, especially on “basic commodities” related to life and health.

6. Human body parts, especially regenerative ones, can be surrendered by human beings for medical research, such as for certain, transplants, for medical research, and for the diagnosis of disease. In such cases, an individual retains a relationship to and an interest in their disposition. Acts of misuse or deception on the part of a physician or scientist in the use of such body parts, would be a criminal act, i.e., stealing. The “donor” is entitled to compensation both for their appropriate and inappropriate retrieval and use.

7. Precisely because Jewish legal ethics endorses the divine mandate to heal, it would prohibit the withholding or inaccessibility of medical diagnostics or therapeutics by those who own relevant patents or have developed such diagnostics or therapeutics. In such cases, Jewish law would enforce the compulsory licensing of such diagnostics or therapeutics with the provision of equitable compensation decided on an individual basis by the courts.

8. Jewish law identifies circumstances in which monopolistic property rights can be set aside or restricted for the public good. Precisely because of the mandate to heal, Jewish law would limit the scope and nature of U.S. patent protections when they restrict or unnecessarily inhibit the development of research aimed at furthering the public good, such as the development of new diagnostics and therapeutics or of improved diagnostics and therapeutics related to the potential improvements of human health and well-being. Though Jewish legal ethics has no explicit notion of patents, it would, as a matter of public policy, endorse the various legal remedies of the courts and of legislators - consistent with its own legal-ethical teachings - to limit, in certain cases, the scope of patent protection, and to exclude certain actions aimed at the public good from exposure to patent infringement.

9. In itself, the claim that the patenting of human genes inevitably and in all cases leads to the “commodification,” “exploitation,” or “ownership” of human beings or to the denial of human dignity is neither logically, nor legally compelling, despite its considerable emotional and rhetorical appeal. This approach, however, is useful in alerting us to the need to limit the scope of U.S. patent law when patent law potentially or actually inhibits the development of diagnostics or therapeutics that can enhance human life or health; or, when patent law leads to the exploitation of human beings.

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