Patents have been issued in the United States for genes and gene sequences since 1980. Patent protection has provided incentives to aggressively probe the genome of humans and non-humans alike in search of profitable applications. Yet it is not clear that patent protection should have been afforded to genes and gene sequences and it is increasingly clear that patent protection, as currently formulated, is not an appropriate means to realize the full benefits of genetic research. As we stand (...) on the threshold on a genetically enhanced future, in which we shall have the power to consciously steer our evolution as a species, we need to carefully consider how to shape the benefits of genetic research and how to recognize and contain its detriments. (shrink)

What accounts for the continued lack of clarity over the legal procedures for the patenting of DNA sequences? The patenting system was built for a "bricks-and-mortar" world rather than an information economy. The fact that genes are both material molecules and informational systems helps explain the difficulty that the patent system is going to continue to have.

Die weltweite Praxis der Vergabe von Patenten auf Gene, die isoliert und von ihren natürlichen Gegebenheiten gereinigt worden sind, wird auf die Behauptung gestützt, dass diese Gene neu, nicht offensichtlich und nützlich sind. Während die Behauptungen von Nicht-Offensichtlichkeit und Nützlichkeit unbestreitbar sind, beruht die Behauptung von Neuheit auf einer rechtlichen Fiktion und enthält einen fundamentalen logischen Fehler. Darüber hinaus stellt das Argument, das diese Fiktion unterstützt, etwas als res nullius dar, was doch tatsächlich res communis ist. Die gängige Praxis sanktioniert (...) demnach eine ungerechtfertigte Aneignung und involviert eine fundamentale Verletzung des Begriffs des Rechtsanspruchs. Im Lichte der entgegenstehenden Gründe kann diese Verletzung auch nicht unter Berufung auf wirtschaftliche Notwendigkeiten gerettet werden. Im Unterschied dazu trifft die hier vorgetragene Kritik nicht Patentansprüche für künstliche Gene oder genetisch modifizierte Lebensformen, die daher anerkannt werden sollten. Mögliche Implikationen im Hinblick auf ein genetisch modifiziertes menschliches Genom werden kurz erörtert. The worldwide practice of granting patents on genes that have been isolated and purified from their natural occurrences is based on the claim that these genes are novel, non-obvious and have utility. While the claims of non-obviousness and utility are indisputable, the claim of novelty rests on a legal fiction and involves a fundamental logical error. Moreover, the argument in support of the fiction portrays as res nullius what in fact is res communis . Current practice therefore constitutes the legal sanction of an unjustified appropriation, and involves a fundamental violation of the notion of entitlement. In light of evidence to the contrary, this violation cannot be saved by an appeal to economic necessity. By contrast, patent claims for artificial genes or genetically modified life-forms are not subject to such a critique and should be granted. Possible implications with respect to a genetically modified human genome are briefly considered. (shrink)

The decade-long debate over ownership of living human materials has recently intensified with the ability of biomedical research to isolate, purify, and use human genes and gene products as therapeutics, factories for the production of therapeutics, and targets for the identification of therapeutic pharmaceuticals. Indeed, advances in genomic research have resulted in the identification of hundreds of thousands of DNA fragments and hundreds of genes. Many within the scientific and business communities believe genes and gene fragments have (...) commercial value and have filed patent applications on the nucleic acid sequences. This commercialization has amplified the discussion surrounding the ethics of patenting genes and the ownership of the human genome. (shrink)

The recent Canadian lawsuit on patent infringement, filed by the Children’s Hospital of Eastern Ontario, has engendered a significant public debate on whether patenting genes should be legal in Canada. In part, this public debate has involved the use of social networking sites, such as Twitter. This case provides an opportunity to examine how Twitter was used in the context of this gene patent controversy.

Human gene patents are patents on human genes that have been removed from human bodies and scientifically isolated and manipulated in a laboratory. The U.S. Patent and Trademark Office (the USPTO) has issued thousands of patents on such genes, and patents have also been granted by the European Patent Office, (the EPO). Legal and moral justification, however, are not identical, and it is possible for a legal decision to be immoral although consistent with legal precedent and procedure. So, (...) it is surprising to learn that some people believe that the legal justification of human gene patents can remove the most serious moral objections to them. Yet, those who are well-versed in patent law often believe that confusion over some quite basic legal and scientific facts accounts for moral objections to such patents and, in particular, for the belief that they justify the ownership of one person by another. Once these confusions are removed, they contend, we will see that there is nothing especially alarming about patents on human genes, and no reason to believe them immoral. -/- Such claims seem especially surprising because the morality of an invention is generally supposed to have little role in decisions about whether or not an invention deserves a patent under U.S. law. Although the European Patent Convention’s article 53 (a) prohibits patenting inventions, the publication or exploitation of which would be contrary to public order or morality, it turns out that this clause rarely justifies withholding a patent from an invention that otherwise meets legal criteria. Thus, although more than 320,000 patents have been granted by the EPO since its creation, this clause has never been used successfully to strike down a claim for a patent. Indeed, Ulrich Schatz explains, “Poisons, explosives, extremely dangerous chemical substances, devices used in nuclear power stations, agro-chemicals, pesticides and many other things which can threaten human life or damage the environment have been patented, despite the existence of the public order and morality bar” in almost all European countries. -/- Indeed, this paper shows, while ethical objections to human gene patents are often controversial, they need not be unreasonable, nor need they depend on mistaken assumptions about patent law. Rather, they may reflect familiar ethical concerns about the dominance of commercial imperatives in modern societies; concerns about the disparities in power and wealth amongst individuals and countries; and concerns about the lack of public discussion, transparency and accountability surrounding significant changes in people’s rights, status and opportunities. Hence, I conclude, ethical concerns cannot be easily dismissed and, indeed, point to the need to think harder about the nature and justification of patent law, itself. (shrink)

The ethics of gene patenting is concerned with whether human genes are the kind of thing that is appropriate for patenting, and whether it is ethical to do so. Is genetic technology a special case compared to other medical technology that have been patented? Much of the debate has revolved around the benefits and harms of allowing gene sequences to be patented. In this paper, I am concerned with a non-consequential consideration: Can someone patent my genes? (...) If genes are the common property of humankind, are genes patentable? I present an objection to the patenting of processes used to manipulate our genes that have the potential to change human nature. Should not all members of the human species have a say regarding genetic engineering that can be used to irreversibly change what makes each one a human? I conclude with an examination of how genetic research may be democratically controlled. (shrink)

Brussen, Kerri Anne A patent provides the exclusive legal right to a person or company to regulate the distribution, manufacture or use of their invention. This paper examines some of the issues surrounding Gene Patents. Although there is a drive to abolish Gene Patents, we argue that refined and clearly defined regulation would continue to support medical research, avoid exploitation, and be of benefit to public health.

I am grateful to Feeney and colleagues for their thoughtful engagement with, and application of, the normative analysis I developed concerning gene patents in Farrelly (2016). Their exploration of...

The patenting of human genes has been the subject of debate for decades. While China has gradually come to play an important role in the global genomics-based testing and treatment market, little is known about Chinese scholars’ perspectives on patent protection for human genes. A content analysis of academic literature was conducted to identify Chinese scholars’ concerns regarding gene patents, including benefits and risks of patenting human genes, attitudes that researchers hold towards gene patenting, (...) and any legal and policy recommendations offered for the gene patent regime in China. 57.2% of articles were written by law professors, but scholars from health sciences, liberal arts, and ethics also participated in discussions on gene patent issues. While discussions of benefits and risks were relatively balanced in the articles, 63.5% of the articles favored gene patenting in general and, of the articles that explored gene patents in the Chinese context, 90.2% supported patent protections for human genes in China. The patentability of human genes was discussed in 33 articles, and 75.8% of these articles reached the conclusion that human genes are patentable. Chinese scholars view the patent regime as an important legal tool to protect the interests of inventors and inventions as well as the genetic resources of China. As such, many scholars support a gene patent system in China. These attitudes towards gene patents remain unchanged following the court ruling in the Myriad case in 2013, but arguments have been raised about the scope of gene patents, in particular that the increasing numbers of gene patents may negatively impact public health in China. (shrink)

One strategy for defenders of gene patenting is to adopt a constructivist interpretation of genetic testing to avoid the I argue that accepting this view (which seems to be the approach of the U.S. Office of Patents and Trademarks) results in an intolerable dilemma for physicians. They must either infringe patents or fail to act on all the medically relevant information they possess (malpractice).

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 10.3 (2000) 265-281 [Access article in PDF] Scope Note 39 Genes, Patents, and Bioethics-Will History Repeat Itself? Susan Cartier Poland Gene patenting--the very notion sounds absurd! How can anyone claim to have invented the genes with which one is born? To make matters worse, genetic makeup precedes birth, meaning the existence of the invention predates the existence of the inventor. So, (...) do we really own our genes, or do they belong to our parents, or our governments, or a Supreme Being? Ownership is only one bioethical issue involved in gene patenting. But before looking at the issues, some essential and basic terms must be understood, namely genes and patents. Genes In his book On the Origin of Species, published in 1859, the biologist Charles Darwin proposed a theory called "natural selection," whereby living things changed over time or evolved through generations due to competition and variation. By experimenting with the garden pea in the 1860s, Gregor Mendel, a monk and accomplished horticulturalist, provided the mechanism of inheritance supporting the natural selection theory of his contemporary Darwin. That mechanism is the gene, or, as Mendel described it, a discrete "factor." The gene has also been defined as "the fundamental unit of heredity" (United States 1987, p. 157). Each individual has two copies of a gene, one from each parent, but that individual passes down to offspring only one of the two copies. Because of Mendel, the gene has become a scientific concept and the basis of a new scientific field: genetics.David C. Page (2000) of the Whitehead Institute for Biomedical Research at the Massachusetts Institute of Technology explained today's terms for genetics structures using an analogy taken from the home. In his view, the cell is a kitchen, the genome is a shelf in the kitchen, the chromosome is a cookbook on the shelf, the gene is a recipe in the cookbook, and a base-pair (either adenine with thymine or guanine with cytosine) is a single letter in the recipe. A protein, the [End Page 265] working molecule blueprinted by a gene, is a dish ready to eat, and an ingredient in the dish is an amino acid, which is a building block of the protein as specified by a string of base-pairs.Colin Tudge (1993), a British science journalist, would disagree with Page's description of the gene as a recipe. A recipe is like a blueprint: both are directions that precede the work. But a gene is not passive according to Tudge; it actively administers the cell's work, and it also responds to cellular events (Aldridge 1996).The current focus of scientific research and funding is on the gene and the completion of the sequencing of all the genes that comprise the human genome, portrayed in the press as a race between the U.S. government's Human Genome Project and the private corporation Celera Genomics. The real action, however, is at the protein level. The gene only holds the information to produce a protein; it is the three-dimensional shaped protein that does the work. In order to produce energy, eliminate waste, and perform other functions specific to a cell or tissue, proteins must bind, thus creating "biological pathways." Proteins bind (or not) and detach as a function of their shapes, which are determined by their precise chemical composition as spelled out in their genetic code. IBM will spend the next five years making one computer, Blue Gene, that will then take an entire year to come up with the chemical map for only one protein (Gillis 2000). It is estimated that there are about 40,000 proteins in the human body.Despite these overwhelming numbers, modern biology has been able to achieve significant results within the Human Genome Project's 15-year time frame, from 1990 to 2005. The genetic map was completed in 1993; the physical map was completed in 1995; and the genetic sequence is expected to be completed in 2002, with 97 to 99 percent completed as of 26 June 2000. This... (shrink)

Since the establishment of the Human Genome Project and the identification of genes in human DNA that play a role in human diseases and disorders, a long, moral and political, battle has began over the extension of IPRs to information contained in human genetic material. According to the Nuffield Council on Bioethics, over the past 20 years, large numbers of human genes have been the subject of thousands of patent applications. This paper examines whether human gene patents can (...) be justified in terms of liberal theories of morality such as natural law, personality development, just reward and social utility. It is argued that human gene patents are in conflict with fundamental principles of liberal morality and justice because they result in "genetic information feudalism". (shrink)

The European Parliament rejected in 1995 the European Commission proposal to harmonize legal protection of biotechnological inventions. Although it did not seem initially the most contentious of the many issues involved in the current legal and ethical debate around biomedicine and genetics, patenting is now focusing bioethics in Europe.

Although the U.S. Patent and Trademark Office (“PTO”) has granted patents on genes for over 20 years, the prudence of gene patenting continues to stir controversy. Some have questioned the ethics of monopolizing a resource that is so fundamental and basic to all living organisms. It has also been argued that patents unfairly restrict the use of genes, impeding both basic and commercial research. For the biotechnology industry, however, gene patents are the currency it uses to protect (...) its investment in research and development, and eventually, the products it brings to market. This paper examines the eligibility of genes for patenting, and considers whether the policy reasons that have led courts to decide that certain categories of subject matter are unpatentable, apply to the realm of genes. Even if this were the case, this does not mean that biotech companies have no way of protecting their inventions. Methods and processes of using the genes do not invoke the same policy considerations, and may provide a more appropriate way of rewarding industry for the narrow discovery of a gene’s specific use. (shrink)

When one examines the emerging debate about genetic patenting, it becomes clear that those who oppose so-called misunderstand genetics or apply inappropriate moral and jurisprudential theory. In this brief essay I examine some arguments against gene patents of the variety, and conclude that patents on methods for detecting the presence of a genetic correlation with disease-related (and other) phenotypes can be appropriate, and that with several precautions the U.S. Patent and Trademark Office should continue granting patent protection to investigators (...) who generate genetic disease diagnostic innovations. (shrink)

The prelims comprise: Introduction Patent Policy prior to the 1980s The Landmark Chakrabarty Decision Public Debate over Chakrabarty The Joint Appeal Inventions or Objects of Nature? Conclusion Notes.

To date, over 5,000 applications have been filed with United States Patent Office for patents on human genes. More than 1,500 of these applications have been granted. Other jurisdictions are experiencing a similar rush to mine and protect genomic gold. This paper argues that although many jurisdictions allow the patenting of human genes, this is ethically indefensible and amounts to an unjustified appropriation of a general human heritage. Economic and legal arguments in favour of patenting are (...) considered and rejected. Reference is made to the Wellcome Trust Consortium's initiative and the Merck Gene Index Project, which place patented genetic information into the public domain. (shrink)

After ten years of debate Directive 98/44/EG on the legal protection of biotechnological inventions was adopted in 1998. This directive takes decisions on some controversial bioethical and legal issues and offers the European biotech industries more space to develop their inventions, but leaves a number of philosophical and moral issues unresolved. This paper distinguishes between different layers in the debate and maps its modes of argumentation. Major philosophical, ethical and conceptual issues are located. It is argued that further analysis of (...) these issues can help resolve further ethical and legal difficulties as regards patenting of human DNA. As the allegedly special status of genetic material remains unclear, the status of (human) DNA and its relation to the human body and personal identity should be further explored. (shrink)

The purpose of the patent system is to provide incentives for the development of new and useful products and processes. Such products and processes are generally referred to as ‘inventions’. Whilst patents have historically been sought and granted for mechanical and chemical inventions only, the biotechnology revolution of the last 30 years has radically changed this by precipitating a mass of patent applications in respect of living and biological matter. Applications of this nature have forced a re-examination by courts and (...) policy makers of traditional understandings of what can be patented. In particular, they have forced consideration of the extent (if any) to which life and nature can be viewed as ‘inventions’ so as to be capable of supporting a patent. In considering this question the central guiding principle has been the distinction, on which all of patent law is said to rest, between man-made inventions on the one hand and discoveries of nature on the other. (shrink)

: This paper discusses the morality of patenting human genes and genetic technologies. After examining arguments on different sides of the issue, the paper concludes that there are, at present, no compelling reasons to prohibit the extension of current patent laws to the realm of human genetics. However, since advances in genetics are likely to have profound social implications, the most prudent course of action demands a continual reexamination of genetics laws and policies in light of ongoing developments (...) in science and technology. (shrink)

In Evangelium vitae, Pope St. John Paul II recognized that scientific progress would bring about new attacks on the dignity of the human person. Since that time, remarkable expansion in our knowledge and understanding of the human genome has brought forth questions of ownership rights via patents on human genes and related technology. This article argues that patenting human genes is incompatible with human dignity as it commodifies that which is priceless. In contrast, granting patents to manipulations (...) of human genes does not violate human dignity so long as it is utilized toward the common good. National Catholic Bioethics Quarterly 15.2 : 265–285. (shrink)

This paper examines the claims that moral objections to the patenting of human genes are misplaced and rest on confusions about what a patent is, or what is patented by a human gene patent. It shows that theese objections rest on too simple a conception of property rights, and the connections betwteen familiar moral objections to private property and moral objections to the patenting of human genes. Above all, the paper claims, objections to HGPs often reflect (...) worries about the lack of democratic oversight, accountability and participation involved in grants of intellectual property. The paper claims that we should take these worries seriously, whether or not we think HGPs immoral. (shrink)

Dr. McGee presents a cogent argument for the patentability of the diagnosis of gene forms that are found to be associated with disease or other phenotypic manifestations. We're convinced he's wrong. An analogy will help explain why.

In March 2010, a United States (U.S.) District Court held that isolated human genes are “products of nature”, and methods of analysis and comparison “abstract mental processes”, for which a U.S. patent cannot validly be granted. Its decision undermined U.S. patent granting practices, and widens the gap between U.S. and European law on what constitutes inherently patentable subject matter (“inventions”), as well as a proportionate patent grant.

. On June 13, 2013, the Supreme Court issued a unanimous decision in Association for Molecular Pathology v. Myriad Genetics, holding that a naturally occurring DNA segment that has merely been “isolated” is not patent eligible, and effectively overturning a longstanding policy that had allowed for patents to be issued on thousands of human genes. Drawing largely on the expert testimony and arguments presented during the court proceedings, this paper provides an overview of the discovery and patenting of (...) the BRCA1 and BRCA2 genes at issue in the case, the impacts of gene patents on biomedical research and innovation and clinical practice, and the legal analysis presented by the plaintiffs throughout the case for how patents issued on genes violate the Patent Act and the U.S. Constitution. Finally, it discusses how the Court’s decision in this case marked an extraordinary victory not only for the plaintiffs directly involved, but more generally for women, patients, researchers, civil liberties, and the future of medicine. (shrink)

This study examines the representations of human gene patents in Chinese newspapers. We conducted a qualitative content analysis of news articles published between 2006 and 2017 to identify the major themes in media coverage, ethical considerations, perceptions of risks and benefits, and attitudes towards the patentability of human genes. The results show that two key ethical concerns were expressed by journalists: that it is morally wrong to own or patent human genes and that gene patents could potentially impede (...) patients’ access to healthcare services. Nonetheless, the press coverage has tended to be largely favorable, rather than opposed to human gene patenting. There were no normative claims that human genes should not be patentable in China, which indicates a generally positive attitude towards patentability in media discourse. Most articles that expressed criticism toward gene patenting discussed challenges in other countries, with significant attention given to the United States Supreme Court’s ruling in the Myriad case that invalidated Myriad Genetics’ patents on the BRCA1 and BRCA2 genes. Overall, the newspapers were uncritical of the Chinese gene patenting regime. News reporting on the issue was highly suggestive of a strong pro-commercialization stance, although some discussions emphasized potential risks over benefits. Our analysis highlights the need for balanced media reporting on human gene patents in China and a top-down approach to engage the public in substantive discussions on the ethical and societal implications of the existing patent regime. (shrink)

This chapter discusses some of the practical consequences of the recent and evolving situation in both science and industry, and forecasts how altering the law might affect each. It considers at least three possibilities: (1) justice demands eradicating patenting genes no matter what the consequences, (2) justice and economic efficiency demand altering the current system to meet both concerns, or (3) the economic effects of altering or eradicating the present system outweigh both the concerns of justice or economic (...) efficiency, and so the status quo should be maintained. The chapter explores each of these possibilities with an eye toward actually proposing rational public policy scenarios that could be adopted. Open Source essentially amounts to the ideal methods of the sciences applied to products in the marketplace. DNA in its natural state is the object of discovery and therefore the domain of science. (shrink)

In 2012, a new and promising gene manipulation technique, CRISPR-Cas9, was announced that seems likely to be a foundational technique in health care and agriculture. However, patents have been granted. As with other technological developments, there are concerns of social justice regarding inequalities in access. Given the technologies’ “foundational” nature and societal impact, it is vital for such concerns to be translated into workable recommendations for policymakers and legislators. Colin Farrelly has proposed a moral justification for the use of patents (...) to speed up the arrival of technology by encouraging innovation and investment. While sympathetic to his argument, this article highlights a number of problems. By examining the role of patents in CRISPR and in two previous foundational technologies, we make some recommendations for realistic and workable guidelines for patenting and licensing. (shrink)

This paper focuses on the question of whether DNA patents help or hinder scientific discovery and innovation. While DNA patents create a wide variety of possible benefits and harms for science and technology, the evidence we have at this point in time supports the conclusion that they will probably promote rather than hamper scientific discovery and innovation. However, since DNA patenting is a relatively recent phenomena and the biotechnology industry is in its infancy, we should continue to gather evidence (...) about the effects of DNA patenting on scientific innovation and discovery as well the economic, social, and legal conditions relating to intellectual property in biotechnology. We should give the free market, the courts, researchers, and patent offices a chance to settle issues related to innovation and discovery, before we seek legislative remedies, since new laws proposed at this point would lack adequate foresight and could do more harm than good. However, we should be open to new laws or regulations on DNA patents if they are required to in order to deal with some of the biases and limitations of the free market. (shrink)

There are a number of ways one could criticize the practice of patenting genes. This chapter argues that computer‐mediated expressions have revealed the false dichotomy in the law of intellectual property and that as new technologies emerge they will continue to pose problems for courts and innovators alike. This is because the range and nature of our expressions is increased with new technologies like computers, nanotechnology, and biotech. Genetic engineering and nanotechnology undermine the distinction between “clearly” patentable inventions (...) and copyrightable works of authorship. Persons carry obligations, rights, moral duties, and are the objects of almost all our ethical and legal considerations. Health care in general has improved to enable us to make more careful predictions about risks and to make choices with greater information. Useful scientific data have emerged from the various “mapping” projects seeking to reveal the intricacies of genomes and phenotypes. (shrink)

En este trabajo nos proponemos analizar los efectos que tienen en la genética y la microbiología la aplicación de las leyes de propiedad intelectual, en su forma de derechos de patentes. A través del estudio de la historia de estas áreas de la biología, argumentamos porque nos parece errónea, desde el punto de vista jurídico y filosófico, la patentabilidad de los genes y genomas que provienen total o parcialmente de la naturaleza. Demostraremos cómo esta práctica legal acarrea una gran (...) cantidad de valores no-epistémicos y concepciones ético-políticas que afectan de lleno a las investigaciones biológicas que forman parte del negocio biotecnológico y generan un desmesurado choque de cosmovisiones con culturas ajenas al sistema liberal-capitalista. (shrink)