From Eugenics to Patents: Genetics, Law, and Human Rights

Authors


Corresponding author: Daniel J. Kevles, Department of History, 201 Hall of Graduate Studies, Yale University, 320 York Street, New Haven, Connecticut 06520–8324. Tel: 203 432 1365; Fax: 203 436 4624; E-mail: daniel.kevles@yale.edu

About a decade ago, President William Clinton said that the next half century will be the age of biology, and, that the engine of that age is genetics. Partly because of the Human Genome Project, scientists have been producing a torrent of information and claims about the role of genes in human disease, capacities, and behaviour. The new knowledge is bringing about a revolution in the diagnosis of diseases and disorders. It is also predicted to yield a powerful arsenal of therapies and cures—and possibly an ability to improve people genetically. According to some, it may also fulfil the longstanding dream of the eugenics movement, which flourished during the first-third or so of the last century.

In a number of ways, the eugenics movement trampled on human rights as we understand them. It has no more powerful association than with the Nazis. In Germany during the Hitler years, the eugenics movement prompted the sterilisation of several hundred thousand people and helped lead to anti-Semitic programmes of euthanasia and ultimately, of course, to the death camps. But in fact after the turn of the century, eugenics movements, including demands for sterilisation of the unfit, blossomed in the United States, Canada, Britain, and Scandinavia, not to mention elsewhere in Continental Europe and parts of Latin America and Asia. Eugenics was thus not unique to the Nazis. It could—and did—happen everywhere.1

Modern eugenics was rooted in the social Darwinism of the late 19th century, with all its metaphors of fitness, competition, and rationalisations of inequality. Indeed, its pioneering advocate was Francis Galton, a cousin of Charles Darwin and an accomplished scientist in his own right. He gave the word “eugenics” its currency and programmatic definition—promoting the ideal of improving the human race by, as he put it, getting rid of the “undesirables,” multiplying the “desirables” (Galton, 1883: pp. 24–25).2 Eugenics began to flourish after the rediscovery, in 1900, of Mendel's theory that the biological makeup of organisms is determined by certain “factors,” later identified with genes. The application of Mendelism to human beings reinforced the idea that we are determined almost entirely by what the German scientist August Weissmann had called our “germ plasm.”

Eugenics is often dismissed as a crank movement energised by pseudoscience, but we need to bear in mind that science is in any day what scientists do and defend. Eugenics fell squarely in the mainstream of scientific and popular culture. Its doctrines were articulated by physicians, especially those who worked with people suffering from mental diseases and disorders, and a variety of social scientists, notably psychologists, as well as biologists, especially those who were pursuing the new discipline of genetics. Eugenic science was bolstered by the research that poured out of institutes for the study of eugenics or “race biology” that were established in a number of countries, including Denmark, Sweden, and Germany. Galton himself had led the way, establishing the Galton Laboratory for National Eugenics, at University College London, in 1906, and in his will endowing the Galton Professorship of Eugenics, whose first occupant was the statistician and biometrician Karl Pearson (Kevles, 1995). In the United States, in 1909, a philanthropist funded the creation of a Eugenics Record Office at the Station for Experimental Evolution at Cold Spring Harbor, on Long Island, in the United States (Allen, 1986).3

Eugenics had its own scientific journals, including the Journal of Heredity in the United States and the Annals of Eugenics, which was established in 1925 and edited at the Galton Laboratory.4 Eugenics was also widely popularised in books, lectures, and articles in magazines and newspapers to the educated public of the day. It became a commonplace, to quote a Mendelian-minded chart at a eugenics exhibit in Kansas, that “unfit human traits such as feeblemindedness, epilepsy, criminality, insanity, alcoholism, pauperism, and many others run in families and are inherited in exactly the same way as colour in guinea pigs” (Kevles, 1995: p. 62). Experts insisted that “feebleminded” people—to use the broad-brush term then commonly applied to persons believed to be mentally retarded—were responsible for a wide range of social problems and were proliferating at a rate that threatened social resources and stability. Such people were identified in part by the IQ tests that psychologists had developed for the American army during World War I. Feebleminded women were held to be driven by a heedless sexuality, the product of biologically grounded flaws in their moral character that led them to prostitution and illegitimacy.

Such doctrines make eugenics sound to our ears like a socially conservative movement. Indeed, in part it did draw significant support from social conservatives concerned to prevent the proliferation of lower-income groups and save on the cost of caring for them. But much of eugenics belonged to the wave of progressive social reform that swept through Western Europe and North America during the early decades of the century. For progressives, eugenics was a branch of the drive for social improvement or perfection that many reformers of the day thought might be achieved through the deployment of science to good social ends such as clean cities, greater temperance, child welfare, and public health. In the American Deep South, for example, eugenics was introduced in the manner of the campaigns against hookworm, tuberculosis, and venereal disease—by reformist missionaries from the North, particularly activists from national organisations for mental health and care of the feebleminded. They found a responsive audience among Southerners worried about Caucasian “degenerates,” in the words of a white Louisiana physician, who threatened what they thought of as their own separate race with physical, mental, and moral “decay” (Larson, 1995: p. 2).

“Race,” to use the common contemporary term, was a minor subtext in Scandinavian and British eugenics, but it played a major part in the American and Canadian versions of the creed. North American eugenicists were particularly disturbed by the immigrants from Eastern and Southern Europe who had been flooding into their countries since the late 19th century. They took them to be not only racially different from but inferior to the Anglo-Saxon majority, partly because they were disproportionately represented among the criminals, prostitutes, slum dwellers, and feebleminded in many cities. Eugenic reasoning in the United States had it that if immigrant deficiencies were hereditary and Eastern European immigrants outreproduced natives of Anglo stock, then inevitably the quality of the American population would decline.

The progressives and the conservatives found common ground not only in attributing phenomena such as crime, slums, prostitution, and alcoholism primarily to biology but also in believing that biology might be used to eliminate these discordances of modern urban, industrial society. Eugenicists on both sides of the Atlantic argued for a two-pronged programme that would increase the frequency of socially good genes in the population and decrease that of bad genes. One prong comprised “positive” eugenics, which meant manipulating human heredity and/or breeding to produce superior people. The other was “negative” eugenics, which meant improving the quality of the human race by eliminating or excluding biologically inferior people from the population.

In Britain between the wars, positive eugenic thinking led to proposals for family allowances that would be proportional to income. Such proposals failed, largely on the grounds that they sought to turn into public policy the doctrine: Unto those who have it shall be given, a doctrine lacking persuasiveness in most sectors of society. In the United States, it fostered so-called “Fitter Family” competitions, a standard feature at a number of state fairs that were held in their “human stock” sections. At the 1924 Kansas Free Fair, winning families were awarded a Governor's Fitter Family Trophy. Families could compete in three categories: small, average, and large. Individuals could also compete, and those judged to be “Grade A” received a medal that portrayed two diaphanously garbed parents, their arms outstretched towards their (presumably) eugenically meritorious infant. It is hard to know what made these families and individuals stand out as fit, but some evidence is supplied by the fact that all entrants had to take an IQ test—and the Wasserman test for syphilis (Kevles, 1995).

Much more was urged for negative eugenics, notably the passage of eugenic sterilisation laws. In the United States by the late 1920s, such laws had been enacted in two dozen American states, largely in the Middle Atlantic region, the Midwest, and in California, the champion. Similar measures were passed in Canada, in the provinces of British Columbia and Alberta. These laws struck especially hard against lower-income and minority groups. California, which as of 1930 had sterilised more people than all the other states of the union combined, sterilised blacks and foreign immigrants at nearly twice the rate as their presence in the general population (McLaren, 1990; Reilly, 1991; Kevles, 1998; Kline, 2001).

The sterilisation laws rode roughshod over private human rights, holding them subordinate to an allegedly greater public good. Such reasoning figured explicitly in the U.S. Supreme Court's ruling, in 1927, in the case of Buck v. Bell (1927). The case had come to the Court as a constitutional test of Virginia's eugenic sterilisation law. Bell was the superintendent of the Virginia Colony for the Feebleminded, where Carrie Buck was an inmate and was judged suitable for sterilisation. Carrie had originally come to the attention of the Virginia authorities because she had given birth to an illegitimate daughter, Vivian (Kevles, 1995).5

Carrie had been living with a foster family. Research in recent years has revealed that she was the victim of a rape by the son in the house. That fact was evidently unknown to the authorities. What they did know was that Carrie, by their standards, was socially immoral and delinquent, and that by reason of her behaviour and the results of an IQ test, she was feebleminded, a typical member, it was said by one of the experts in the case, of the region's poor white trash. The judgement in support of her sterilisation was made because her feeblemindedness had been determined to be hereditary. Her mother, Emma, had also done poorly when tested for IQ and was shiftless to boot. Her daughter Vivian, observed by a nurse at the age of eight months, was diagnosed as feebleminded, too, because the nurse found that she had an odd look about her. Feeblemindedness was thus concluded to be hereditary in the Buck line and sterilising Carrie would help halt its further transmission (Lombardo, 2008).

The Supreme Court ruled by eight to one to uphold the constitutionality of Virginia's eugenic sterilisation law. The majority opinion was rendered by the highly respected jurist, Justice Oliver Wendell Holmes. His text reveals how progressives like himself thought about the reproductive rights of people like Carrie Buck in relationship to the welfare of the larger society:

We have seen more than once that the public welfare may call upon the best citizens for their lives. It would be strange if it could not call upon those who already sap the strength of the State for these lesser sacrifices, often not felt to be such by those concerned, in order to prevent our being swamped with incompetence. It is better for all the world, if instead of waiting to execute degenerate offspring for crime, or to let them starve for their imbecility, society can prevent those who are manifestly unfit from continuing their kind. The principle that sustains compulsory vaccination is broad enough to cover cutting the Fallopian tubes … . Three generations of imbeciles are enough (Buck v. Bell, 1927).

The next year, the province of Alberta, in Canada, passed a eugenic sterilisation law. During a long and bitter debate, the premier defended the measure by seemingly taking a leaf from Holmes’ book, insisting that “the argument of freedom or right of the individual can no longer hold good where the welfare of the state and society is concerned” (Kevles, 1998).

The concern for reducing the frequency of bad genes in the population was partly economic. At the Sesquicentennial Exposition in Philadelphia, in 1926, the American Eugenics Society exhibit included a board that, in the manner of the population counters of a later day, revealed with flashing lights that every 15 seconds a hundred dollars of your money went for the care of persons with bad heredity, that every 48 seconds a mentally deficient person was born in the United States, and that only every seven and a half minutes did the United States enjoy the birth of “a high-grade person … who will have ability to do creative work and be fit for leadership” (Kevles, 1995: pp. 62–63).

Sterilisation rates climbed with the onset of the world-wide economic depression in 1929. In parts of Canada and the Deep South and throughout Scandinavia, it acquired broad support, not primarily on eugenic grounds, though some hereditarian-minded mental health professionals continued to urge it for that purpose, but on economic ones, raising the prospect of reducing the cost of institutional care and of poor relief. In this intensified drive for sterilisation, individual human rights were once again held to be subordinate to some greater social—but especially in this era, economic—good. In Scandinavia, sterilisation was broadly endorsed by Social Democrats as part of the scientifically oriented planning of the new welfare state (Broberg & Roll-Hansen, 1996). On such foundations among others, sterilisation programmes continued in several American states and Alberta as well as in Scandinavia well into the 1970s.

In Germany, a sterilisation law had been in the works before Hitler came to power in 1933. It had been advocated by the country's race hygienists, as German eugenicists were known, who, like their counterparts elsewhere, had long contended that socially deviant behaviour such as criminality and prostitution originated less in social conditions than in “the blood.” They had regularly praised American policies, research, and writings and incorporated accounts of them into their works. In Mein Kampf, Hitler himself praised the state sterilisation laws in the United States and the national immigration restriction act (Kühl, 1994). Hitler's cabinet promulgated a Eugenic Sterilisation Law in 1933. It went far beyond American statutes in that it was compulsory with respect to all people, institutionalised or not, who suffered from allegedly hereditary disabilities such as blindness, severe alcohol addiction, and physical deformities that seriously interfered with locomotion or were greatly offensive. After January 1, 1934, when the law went into effect, physicians were to report all “unfit” persons carrying the designated afflictions to hundreds of Hereditary Health Courts established to adjudicate the German procreational future. Within three years, German authorities had sterilised some 225,000 people, almost 10 times the number so treated in the previous 30 years in America (Proctor, 1998).

However, during the interwar years, eugenic doctrines were increasingly criticised for their science, their class and racial bias, and their violations of human rights. It was shown that many mental disabilities have nothing to do with genes, that those which do are often complicated rather than simple products of them, and that most human behaviours, including the deviant variety, are shaped by environment at least as much as by biological heredity, if they are fashioned by genes at all.

All along many people on both sides of the Atlantic had expressed ethical reservations about sterilisation and were squeamish about forcibly subjecting people to the knife. Attempts to authorise eugenic sterilisation in Britain had reached their high-water mark in the debates over the Mental Deficiency Act in 1913; they failed not least because of powerful objections from civil libertarians insistent upon defending individual human rights. More than a third of the American states declined to pass sterilisation laws, and so did the Eastern provinces of Canada. Most of the American states that did pass such laws declined to enforce them, and British Columbia's law was enforced very little.

The opposition varied in composition, drawing from scientifically dubious mental health professionals and civil libertarians, some of whom warned that compulsory sterilisation constituted a Hitler-like suppression of private reproductive rights. In Alabama, for example, attempts to pass a sterilisation law in the mid 1930s prompted Governor Bibb Graves to declare: “The great rank and file of the country people of Alabama do not want this law; they do not want Alabama, as they term it, Hitlerized” (Larson, 1995: p. 146).

Sterilisation was also vigorously resisted by Roman Catholics, partly because it was contrary to Church doctrine, partly because a very high fraction of recent immigrants to the United States were Catholics and thus disproportionately placed in jeopardy of the knife. For many people before World War II, individual human rights mattered far more than those sanctioned by the era's science, law, and perception of social needs. Eugenics also became malodorous precisely because of its connection to Hitler's regime, especially after World War II, when its complicity in the Nazi death camps was revealed.

These revelations strengthened the moral objections to eugenics and sterilisation, and so did the increasing worldwide discussion of human rights, a foundation for which was the Universal Declaration of Human Rights that the General Assembly of the United Nations adopted and proclaimed in 1948. In 1954, Lionel Penrose, the Galton Professor at the time, changed the name of the Annals of Eugenics to the Annals of Human Genetics, and in 1961 he persuaded University College, London to rename his chair as the Galton Professorship of Human Genetics (Kevles, 1995). Beginning in the 1960s, the movement for women's rights and reproductive freedom has further transformed moral sensibilities about eugenics.

Still, even today, the shadow of eugenics hangs over the torrential advance of human genetics, including the human genome project. Some observers have wondered whether new genetic knowledge would be deployed by the state for positive eugenics, for attempts to engineer new Einsteins, Mozarts, or athletes like Michael Jordan (it must be pointed out that the genomic prognosticators rarely mention brilliantly talented women—for example, Marie Curie—in their pantheon of super people). Some commentators fear that the state will seek to foster or enhance a variety of highly valued human qualities or characteristics (Gould, 1985). Other commentators have warned that the genome project will more likely spark a revival of negative eugenics—state programmes of intervention in reproductive behaviour so as to discourage the transmission of “bad” genes in the population, if only to reduce the burden of medical costs. In 1988, China's Gansu Province adopted a eugenic law that would—so the authorities said—improve “population quality” by banning the marriages of mentally retarded people unless they first submit to sterilisation. Since then, such laws have been adopted in other provinces and have been endorsed by the leadership of the People's Republic. The official newspaper Peasants Daily explained, in the vein of Justice Holmes, “Idiots give birth to idiots” (Kristof, 1991).

But a publicly mandated eugenics seems unlikely in the West, especially in the United States, with its strong commitment to civil liberties. Reproductive freedom is much more easily curtailed in dictatorial governments than in democratic ones. State-mandated eugenics profits from authoritarianism; indeed, almost requires it. The institutions of political democracy may not have been robust enough to resist altogether the violations of civil liberties characteristic of the early eugenics movement, but they did contest them effectively in many places, including, recall, in Britain. Many American states declined to pass sterilisation laws, and where they were enacted, they were often unenforced.

What makes today's political democracies unlikely to embrace eugenics is that they contain powerful antieugenic constituencies. Awareness of the barbarities and cruelties of state-sponsored eugenics in the past has tended to set most geneticists and the public at large against such programmes. Geneticists today know better than their early-20th-century predecessors that ideas concerning what is “good for the gene pool” are highly problematic. Then, too, handicapped or diseased persons are politically empowered, as are minority groups, to a degree that they were not in the early 20th century. They may not be sufficiently empowered to counter all quasi-eugenic threats to themselves, but they are politically positioned, with allies in the media, the medical profession, and the Roman Catholic Church, to block or at least to hinder eugenic proposals that might affect them.

But a publicly mandated eugenics is not the only type of eugenics we may see. The emergence of the biotechnology industry has established strong economic incentives to encourage consumers to pursue a kind of “homemade eugenics,” to use the insightful term of the analyst Robert Wright—“individual families deciding what kinds of kids they want to have” (Wright, 1990: p. 27). Perhaps paradoxically, their right to reproductive freedom would assist them in such endeavours. And, they might also be encouraged by scientists. The lure of biologically improving the human race, having tantalised brilliant scientists in the past, could equally seduce them in the future, even though the expression of the imperatives may differ in language and sophistication. Objective, socially unprejudiced knowledge is not ipso facto inconsistent with eugenic goals of some type. Such knowledge may, indeed, assist in seeking them, especially in the consumer-oriented, commercially driven enterprise of contemporary biomedicine (Hodgson, 1989).

Indeed, the near-term human-rights challenges of human genomics lie neither in private forays in human genetic improvement nor in some state-mandated programme of eugenics. They reside in the grit of what human genomics and proteomics is producing in abundance: genetic information and technology. They centre on the control, diffusion, and use of that information and technology within the context of a market economy, including the increasing privatisation of the genome and its protein products.

The torrent of new human genetic information has already begun to pose challenges across a broad spectrum of socioeconomic values and practices. It has been rightly emphasised that employers and medical or life insurers may seek to learn the genetic profiles of, respectively, prospective employees or clients. Employers might wish to identify workers likely to contract disorders that allegedly affect job performance while both employers and insurers might wish to identify people likely to fall victim to diseases that result in costly medical or disability payouts. Whatever the purpose, such genetic identification would brand people with what an American union official has called a life-long “genetic scarlet letter” or what some Europeans term a “genetic passport” (European Parliament, Committee on Energy, Research, and Technology, 1989–91: pp. 25–26).

Human genomics is in large part a branch of genetic medicine, and the issues of human rights it raises must inevitably be understood in the context of the equity of the health delivery system as a whole. If genetic diagnostics, therapies, and cures are not equitably available to all, then, in the vein of the eugenic proposals between the wars for family allowances proportionate to income, the marvellous and growing arsenal of knowledge and technology will only compound current social inequities. And, if genetic enhancement of, say, children becomes a technical reality, then those better-off in talent and resources will only grow more advantaged.

In recent years, the patenting of human genes, a salient feature of the commercialisation of biomedicine, has raised a new challenge to human rights.6 What is wrong with patenting human genes? Nothing, many say, adding that much is right with it because it encourages investment and innovation in genomics. One might add that property rights—which are what a patent embodies—are a type of human right; and patents are partly grounded in the theory of natural rights that people have a right to the fruits of their labours, intellectual as well as otherwise.

But the patenting of human genes is at the least problematic because the practice entails costs to both the enterprise of research and the delivery of medical services (Andrews, 2002). In contemporary academic research, the expectation of patentability discourages open discussion of technical detail during the critical R&D phase before patent filing. Then, too, patented genes are research tools, and such tools, according to a decision by a federal court in 2002, in the case of Madey v. Duke University, are controlled by the patent holder, who may restrict and charge for their use because research even in its most abstract form is part of the “legitimate business” of the university and is not exempt from threats of patent infringement suits (Madey v. Duke University, 2002; Committee on Intellectual Property Rights in Genomic and Protein Research and Innovation, Board on Science, Technology, and Economic Policy, Committee on Science, Technology, and Law, Policy, and Global Affairs, National Research Council, 2005: p. 23). In 1999, a survey of 74 clinical labs revealed that a quarter of them had abandoned a clinical test they had developed because of pending patents and almost half had decided not to develop a clinical test because of the patent (Cassier, 2002).

In the medical service area, gene patent holders have tended to insist that only they can conduct diagnostic tests using their gene. The practice threatens, among other consequences, to concentrate expertise in only a few institutional centres; to fragment molecular medical services; to elevate the prices consumers pay for diagnostic tests; and to make doctors vulnerable for infringement suits. It also flies in the face of sound medical practice in that patent holders can deny patients access to second and independent diagnostic opinions.

Such threats are not merely hypothetical, as is evident from Myriad Genetics’ management of BRCA1 and BRCA2, the two genes known to dispose women to breast cancer. Myriad is a biotechnology firm in Salt Lake City, Utah. For various reasons, by the end of the 1990s, it held monopoly control through patents and exclusive licenses over the DNA sequence of both BRCA1 and BRCA2. Myriad demands that all commercial testing for the two genes be done in its lab. It will not license the test to anyone, with the result that a woman diagnosed positively by Myriad cannot obtain a second opinion from an independent laboratory (Committee on Intellectual Property Rights in Genomic and Protein Research and Innovation, Board on Science, Technology, and Economic Policy, Committee on Science, Technology, and Law, Policy, and Global Affairs, National Research Council, 2005; Cassier, 2002).

Myriad has enforced its patent rights against various universities, a hitherto exceptional practice. In 1999, for example, it notified Arupa Ganguly, of the University of Pennsylvania clinical genetics lab that she was infringing the Myriad patents because she had independently developed a test to screen for mutations in the BRCA genes and, to cover her clinical costs, was charging her patients a fee to undergo the test. Myriad advised the university to halt Ganguly's activities or risk suit. To meet criticism from academic researchers, Myriad negotiated an agreement with NIH in 2000 whereby NIH-funded researchers would be charged $1200 per test instead of the usual $2580 so long as the purpose was research. In exchange, Myriad would have access to resulting research data (Committee on Intellectual Property Rights in Genomic and Protein Research and Innovation, Board on Science, Technology, and Economic Policy, Committee on Science, Technology, and Law, Policy, and Global Affairs, National Research Council, 2005).

Resistance to the BRCA patents has been high in Europe and gathering force in the United States. The European Patent Office (EPO) granted Myriad Genetics three BRCA1 patents in 2001, but according to Gert Matthijs, head of the Centre for Human Genetics at the University of Leuven, in Belgium, no European clinic has since paid royalties for BRCA1-related diagnostics (Abbot, 2008). Many scientists and clinicians objected to the patents on varying general grounds—that it was unethical to grant patents on a human gene, especially one for disease; that the patent was unwarranted in any case because a gene is a product of nature and because obtaining the sequence was obvious.

The objections led not only to defiance of Myriad's patent rights in the laboratory and the clinic but also to legal challenges to the patent. In Europe in 2004, a technical legal argument won the day. This was that the patent had been improperly granted because Myriad had submitted an incorrect sequence when it first filed for the patent, in 1994. A board in the EPO revoked the patent on BRCA1, holding that a perfect sequence is required to make a full diagnosis. In the face of the mounting opposition to the BRCA1 patents, Myriad transferred ownership of them to the University of Utah in November 2004 (Abbot, 2008).

However, on November 19, 2008, the EPO's highest board of appeals countermanded the 2004 decision after the patent owners said that they would reduce the scope of the patent to cover only frame-shift mutations—that is, the deletion or insertion of one or two nucleotides so that the gene generates the wrong series of amino acids. These frame-shift mutations represent only about 60% of the mutations associated with breast and ovarian cancer, and the board held that an exact sequence of the gene is not required to detect them (Abbot, 2008).

In principle, the ruling meant that the University of Utah had gained the right to collect royalties on the tests that tens of thousands of women in Europe were undergoing every year. The royalties are potentially very substantial. In the United States, Myriad now charges more than $3000 for a full analysis of both BRCA1 and BRCA2 and $460 for a single mutation test. In Europe, the test for both genes can come to as much as $1900. However, it seems likely that scientists and clinicians in Europe will continue to defy Myriad's property rights. Dominique Stoppa-Lyonnet, a clinical geneticist at the Curie Institute in Paris, expressed disappointment at the EPO's ruling, having fought Myriad's patents for seven years. She declared, “We will wait to see what royalties the University of Utah might demand of us, but [the ruling] won't stop us testing the gene in France” (Abbot, 2008: p. 556).

Myriad's rights in the patent for BRCA2 are also under challenge. A broad patent on the gene has been granted in Europe to a consortium that is partly owned by the charity Cancer Research UK, in Britain. One of the inventors behind the patent explains that the charity obtained the patent “to defend the gene against other patent approaches,” adding, “We offer free licensing to any reputable laboratory who wants to use it” (Abbot, 2008: p. 556).

In the United States, Myriad's management of its BRCA patents prompted action by the American Civil Liberties Union (ACLU) and the Public Patent Foundation, an advocacy group associated with the Benjamin Cardozo Law School, in New York. In a lawsuit filed on May 12, 2009, the two organisations jointly challenged not only the BRCA patents but the legitimacy of all human gene patents. They were joined in their complaint by several women with breast cancer or at risk for it, scientists and clinicians, and leading biomedical organisations, including the American College of Medical Genetics and the Association for Molecular Pathology (whose name has been appropriated for the shorthand title of the case: Association for Molecular Pathology, et al. v. the U.S. Patent and Trademark Office, et al.) (ACLU, 2009).

The arguments in the complaint centred on broad issues in American Constitutional law and patent law rather than on the kind of technical points advanced against the BRCA1 patent in Europe. The Constitutional argument invoked the First Amendment's right to free speech. It held essentially that Myriad's BRCA patents violated the right by prohibiting anyone—say, a physician—from communicating to a patient the information and its medical significance gleaned from a test for one of the genes unless Myriad had granted the physician a license. The argument was problematic, something of a legal stretch. More promising were the elements of the complaint based in patent law. To cite one of the most important, the ACLU brief contended that the patents on BRCA1 and BRCA2 violate the prohibitions against the grant of patents on products of nature, which is a longstanding doctrine of patent law. According to Myriad Genetics, what made the two genes patentable was that they had been isolated from their natural state in the body and were thus no longer natural products. They were akin to a purified chemical molecule and merited a patent as such.7 According to the ACLU brief, this was in error. The sequence of cancer-disposing base pairs in the extracted gene was identical to that in the natural gene. It encoded a specific type of information whether it was in the body or removed from it. It thus remained a product of nature and was unpatentable (ACLU et al., 2009).

Judge Robert Sweet, presiding over the federal district court in which the case had been brought, agreed. On March 29, 2010 he struck down the two patents, explaining:

The resolution of these motions is based upon long recognized principles of molecular biology and genetics: DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature. It is concluded that DNA's existence in an ‘isolated’ form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed to ‘isolated DNA’ containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter under 35 U.S.C. § 101 [the section in the U.S. Code that is the foundation stone of the nation's patent law]. (Association for Molecular Pathology, et al. v. the U.S. Patent and Trademark Office, et al., 2010)

Judge Sweet declined to address the Constitutional issues raised in the ACLU brief. In this he followed standard practice in the U.S. courts, which holds that if a case can be decided satisfactorily on statutory grounds the ruling should not reach to Constitutional doctrines. Nor did he rule on the broad question raised in the brief of whether human genes as such are unpatentable, evidently because he thought it sufficient to rule only on Myriad's BRCA patents. Still, the legal reasoning in the decision, particularly the product-of-nature doctrine, by implication throws all patents on human genes into question.

Myriad Genetics has appealed Judge Sweet's ruling, and the case may ultimately reach the U.S. Supreme Court. However, it is decided there, it would likely be another legal landmark in the annals of human genetics. Buck v. Bell, the prior landmark, subordinated individual reproductive rights to a scientifically fallacious notion of the greater public good. It has never been directly overturned, but a long string of court decisions and legislative statutes has nullified it. Nowadays, the greater public good is equated with the protection of individual reproductive rights. The principle that sustains compulsory vaccination is no longer broad enough to cover cutting the Fallopian tubes or most other types of state interference with human reproduction.

The rapid translation of molecular genetics into biomedicine has revived some of the old issues inherent in eugenics, reminding us of the importance of safeguarding individual human rights, reproductive and otherwise, when establishing biomedical policies and practices. But the translation into the arena of biotechnology and the health care delivery system has called forth new issues of rights in conflict. They are boldly presented in the American Molecular Pathology case, which pits human medical rights against commercial property rights amid the rapidly expanding knowledge of genes implicated in human disease and the biotechnology industry's drive to privatise the human genome.

Footnotes

  • 1

    For accounts of various national eugenics movements, see Daniel J. Kevles, In the Name of Eugenics: Genetics and the Uses of Human Heredity (Cambridge, MA: Harvard University Press, 1995); Robert Proctor, Racial Hygiene: Medicine Under the Nazis (Cambridge: Harvard University Press, 1988); Mark B. Adams, ed., The Well-Born Science: Eugenics in Germany, France, Brazil, and Russia (New York: Oxford University Press, 1990); Nancy L. Stepan, The Hour of Eugenics: Race, Gender, and Nation in Latin America (Ithaca: Cornell University Press, 1991); and Diane B. Paul, Controlling Human Heredity, 1865 to the Present (Amherst, New York: Humanity Books, 1995). For a fuller discussion of some of the issues raised in this essay, see: Daniel J. Kevles, “Eugenics, the Genome, and Human Rights,”Medicine Studies, I (No. 2, 2009), pp. 85–93, parts of which are reproduced here.

  • 2

    The most recent biography of Galton is Nicholas Wright Gillham, A Life of Sir Francis Galton: From African Exploration to the Birth of Eugenics (New York: Oxford University Press, 2001).

  • 3

    The philanthropist was Mrs. E. H. Harriman, the widow of the railroad magnate, whose daughter was working as an intern at the Office.

  • 4

    See Kenneth M. Weiss and Brian W. Lambert, “When the Time is Ripe,” in this volume.

  • 5

    For the full story of the case see Paul Lombardo, Three Generations, No Imbeciles: Eugenics, the Supreme Court, and Buck v. Bell (Baltimore: Johns Hopkins University Press, 2008).

  • 6

    On the issue of human gene patenting, see Daniel J. Kevles, “Genes, Disease, and Patents: Cash and Community in Biomedicine,” in Caroline Hannaway, ed., Biomedicine in the Twentieth Century: Practices, Policies, and Politics (Amsterdam: IOS Press, 2008), pp. 203–216; Maurice Cassier, “Private Property, Collective Property, and Public Property in the Age of Genomics,”International Social Science Journal, 171 (2002), pp. 88–90; Committee on Intellectual Property Rights in Genomic and Protein Research and Innovation, Board on Science, Technology, and Economic Policy, Committee on Science, Technology, and Law, Policy, and Global Affairs, National Research Council, Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health (Washington, DC: The National Academies Press, 2005), p. 52; Lori Andrews, “Genes and Patent Policy: Rethinking Intellectual Property Rights,”Nature Reviews Genetics, 3 (Oct. 2002), 803–806; Lori Andrews and Jordan Paradise, “Genetic Sequence Patents: Historical Justification and Current Impacts,” in Jean-Paul Gaudilliere, Daniel J. Kevles, and Hans-Joerg Rheinberger, eds., Living Properties: Making Knowledge and Controlling Ownership in the History of Biology (Berlin: Max Planck Institute for History of Science, 2009), pp. 137–164.

  • 7

    Mark Skolnick, of the University of Utah who had founded Myriad Genetics, has long contested the idea that DNA is information, insists that it is a chemical and must be treated as such for patent purposes. He has said, “If you discover a new molecule, whether it's a pharmaceutical or a paint or a dye or a gene, it's a new molecule, you should be protected; … genetic patents really follow the model that's been set up in organic chemistry” (Cassier, 2002: p. 88).

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