How heavily should ethical considerations weigh in allowing or disallowing genetic patents? The concept of 'ordre public' can be useful in offsetting a simple utilitarian view.

Genetically engineered (GE) insects, such as the GE OX513A Aedes aegypti mosquitoes, have been designed to suppress their wild-type populations so as to reduce the transmission of vector-borne diseases in humans. Apart from the ecological and epidemiological uncertainties associated with this approach, such biotechnological approaches may be used by individual governments or the global community of nations to avoid addressing the underlying structural, systemic causes of those infections... We discuss here key ethical questions raised by the use of GE mosquitoes, (...) with the aim of fostering discussion between the public, researchers, policy makers, healthcare organizations, and regulatory agencies at the local, national, and international levels. We affect that goal by outlining a procedural approach to decision-making about the use of the “biotechnology” that goes beyond “community engagement.” The protocol we advocate for entails informed deliberations and decision-making at the community level. It is designed to ensure that the voices of the marginalized and vulnerable groups that would be disproportionately affected by the decision are heard during the community-wide discussions. Moreover, we make the case that the values embedded in the risk assessment should be identified so that the community can make an informed decision about the use of GE insects. In addition, we advocate for the involvement of a variety of actors whose responsibility would be to ensure that the community has the opportunity to make an informed decision based on deliberations about the use of the “biotechnology.”. (shrink)

By exploring whether nanotechnologies have the potential to generate green innovations, we consider the paradox between the negative and positive side-effects that could come with the development of nanotechnologies. Starting from the conceptual framework of green product innovation, the potential green innovation activity of more than 14,000 firms of the nanotech sector is investigated. Using a query-search method, their patenting activity is explored. Results first show that there is an increasing trend toward the creation of fundamental green knowledge by (...) firms involved in nanotechnologies; second, they demonstrate that energy efficiency is the main driver of green knowledge creation in the sector and third they reveal the main characteristics of nanotech firms creating green knowledge. Beyond their contribution to the debate between positive and negative outcomes of nanotechnology developments, these results also enrich the conceptual framework of green product innovation—a key route to achieving sustainability at the same time as growth. (shrink)

The law of patents has long struggled with the status of intent in determining liability for infringement. This struggle has recently been given a sharper edge by the emergence of biotechnological products with the inherent ability of auto-dispersal and regeneration. The question thus is whether a person on whose backyard a patented genetic organism has grown without the active intervention of that person is liable in infringement to the patentee of that organism. This article examines the ramifications of the (...) legal conundrum and argues that on a proper construction of the theories of liability in patent law intent to infringe is necessarily crucial if the nature of the subject matter of the patent makes it unjust and absurd to argue otherwise. (shrink)

The prelims comprise: Introduction The Range of Genetic Material Nonhuman Genetic Material and Life Forms Nonconsequentialist Arguments against Property Rights in Human Genetic Material Conclusion.

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.

Patents for genetic material in theindustrialized North have expandedsignificantly over the past twenty years,playing a crucial role in the currentconfiguration of the agricultural biotechnologyindustries, and raising significant ethicalissues. Patents have been claimed for genes,gene sequences, engineered crop species, andthe technical processes to engineer them. Mostcritics have addressed the human and ecosystemhealth implications of genetically engineeredcrops, but these broad patents raise economicissues as well. The Catholic social teachingtradition offers guidelines for critiquing theeconomic implications of this new patentregime. The Catholic principle (...) of the universaldestination of goods implies that genes, genesequences, and engineered crop varieties areineligible for patent protection, although theprocesses to engineer these should be eligible.Religious leaders are likely to make a moresubstantive contribution to debates aboutagricultural biotechnology by addressing theselife patents than by speculating that geneticengineering is ``playing God.''''. (shrink)

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)

The 2014 Varsity Medical Ethics debate convened upon the motion: “This house believes that genetic information should not be commoditised”. This annual debate between students from the Universities of Oxford and Cambridge, now in its sixth year, provided the starting point for arguments on the subject. The present article brings together and extends many of the arguments put forward during the debate. We explore the circumstances under which genetic material should be considered patentable, the possible effects of this (...) on the research and development of novel therapeutics, and the need for clear guidelines within this rapidly developing field. (shrink)

Ongoing research in the fields of genetics and biotechnology hold the promise of improved diagnosis and treatment of genetic diseases, and potentially the development of individually tailored pharmaceuticals and gene therapies. Difficulty, however, arises in determining how these services are to be evaluated and integrated equitably into public health care systems such as Canada's. The current context is one of increasing fiscal restraint on the part of governments, limited financial resources being dedicated to health care, and rising costs for (...) new health care services and technologies. This has led to increasing public debate in the last few years about how to reform public health care, and whether we should prohibit, permit or perhaps even encourage private purchase of health care services. ;In Canada, some of these concerns have crystallized around the issue of gene patents and commercial genetic testing, in particular as illustrated by the case of Myriad Genetics' patented BRACAnalysis test for hereditary breast and ovarian cancer. While most Canadians who currently access genetic services do so through the public health care system, for those with the means, private purchase is becoming an option. This situation raises serious concerns---about justice in access to health care; about continued access to safe and reliable genetic testing supported by unbiased patient information; and about the broader effects of commercialization for ongoing research and the Canadian public health care system. Commercial genetic testing presents a challenge to health care professionals, policy analysts, and academics concerned with the social, ethical and policy implications of new genetic technologies. Using the Myriad case as an exemplar, tools from moral philosophy, the social sciences, and health policy and law will be brought to bear on the larger issues of how as a society we should regulate commercial research and product development, and more coherently decide which services to cover under public health insurance and which to leave to private purchase. Generally, the thesis is concerned with the question of "how best to bring capital, morality, and knowledge into a productive and ethical relationship". (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)

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)

The rationale of patents on transgenic organisms leads to the startling notion of the human qua infringement. The moral reasons by which we may tenably reject such notion are not conclusive as to human life forms outside the body. A close look at recombinant DNA experimentation reveals ingenious processes, but not entities that the body lacks. Except for artificial genes, the genes of biotechnology are found on chromosomes, albeit nonconsecutively, and their uninterrupted transcripts appear in messenger RNA. An enhanced form (...) of protection for ingenious processes, the human methods patent, is proposed and defended as a replacement for product patents. The proposed patent would pertain to biotechnology manufacturing and genetic intervention in somatic and germ cells. A counterpart could govern nonhuman life forms. It is argued that compulsory licensing protections should be a condition of such patent. Contrary to the conservative assumption that statutory sobriquets suffice, the reckoning of what qualifies as a patentable ingenious process will continue to require systematic scientific guidance. (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)

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)

: he commercialization of biotechnology, especially research and development by transnational pharmaceutical companies, is already excessive and is increasingly dangerous to distributive justice, human rights, and access of marginal populations to basic human goods. Focusing on gene patenting, this article employs the work of Margaret Jane Radin and others to argue that gene patenting ought to be more highly regulated and that it ought to be regulated with international participation and in view of concerns about solidarity and the (...) common good. The mode of argument called for on this issue is more pragmatic than logical, emphasizing persuasion based on evidence about the reality and effects of control of genetic research by profit-driven biotech companies. (shrink)

The biotechnology patent debates have revealed deep moral concerns about basic genetics research, RD and specific biotechnological products, concerns that are seldom taken into consideration in Technology Assessment. In this paper important moral concerns are examined which appear at the various stages of development of a specific genetic product: a predictive genetic test. The purpose is to illustrate the need for a more contextual approach in technology assessment, which integrates the various forms of interaction between bio-technology and society (...) or societal segments. Such an approach will generate greater insight in the moral issues at all stages of a products life-cycle and this will facilitate decision-making on the morality of a specific biotechnological product. (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)

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)

The pursuit of genetic knowledge has such emotional, social, scientific, and financial importance that it has been compared to the divine quest for the Holy Grail, and to the calamity of opening Pandora's Box. Therefore, it comes as no surprise that the recent announcement of a completed blueprint for the human genome has fueled calls for both increased research and increased precautions. This new era, which holds the potential promise of advances in medicine, agriculture and other areas, also requires (...) the careful investigation of a myriad of issues. Those issues such as informed consent, patenting, privacy, and confidentiality, have been explored in at least some detail. Others, such as equity, mutual respect, empowering education, consensus building, and planning for long-term survival, have not been as fully examined, nor have they been as comprehensively integrated into mainstream thinking. To facilitate this, we need to implement an ethical approach that leads us to ask critical questions about the appropriate use of our new tools. (shrink)

Objectives: To determine whether authors of scientific publications in molecular biology declare patents and other potential financial interests.Design: Survey of a 6-month sample of papers related to molecular biology in Nature.Methods: The esp@cenet worldwide patent search engine was used to search for patents applied for by the authors of scientific papers in Nature that were related to molecular biology and genetics, between January and June 2005.Results: Of the 79 papers considered, four had declared that certain authors had competing financial interests. (...) Seven papers in which no financial interests were declared had authors with patent applications that were based on the research in the paper or were closely related to it. Another paper had two authors with connections to biotechnology companies that were not disclosed.Conclusion: Two thirds of the papers in which authors had patent applications or company affiliations that might be considered to be competing financial interests did not disclose them. Failure to disclose such information may have negative implications on the perception of science in society and on its quality if the possible bias is hidden. Journals should make greater efforts to ensure full disclosure, and scientific institutions should consider failure to disclose financial interests as an example of scientific malpractice. Establishing a register of interests for scientists is one way to increase transparency and openness. (shrink)

Eighty percent of (commercial) genetically engineered seeds (GES) are designed only to resist herbicides. Letting farmers use more chemicals, they cut labor costs. But developing nations say GES cause food shortages, unemployment, resistant weeds, and extinction of native cultivars when “volunteers” drift nearby. While GES patents are reasonable, this paper argues many patent policies are not. The paper surveys GE technology, outlines John Locke’s classic account of property rights, and argues that current patent policies must be revised to take account (...) of Lockean ethical constraints. After answering a key objection, it provides concrete suggestions for implementing its ethical conclusions. (shrink)

This chapter contains sections titled: Introduction Values Micro‐organisms and Plants Animals Humans Patents References.

This paper offers a different pragmatic and patent-based approach to concerns regarding the negative effects of genetic-based patenting on advancing scientific research and providing adequate and accessible health care services. At the basis of this approach lies an explication of a mandatory provisional patented paper procedure (PPPA), designed for genetic-based patents and administered by leading scientific journals in the field, while officially acknowledged by the USPTO, and subsequently by other patent offices as well. It is argued that (...) the uniqueness of PPPAs lies in subsequently mitigating the negative ramifications of genetic patents on scientific research and genetic-based health care services, while basing such mitigation on a patents’ advocate viewpoint that neither discards the patent system nor jeopardizes its integrity. (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)

In the immediate future we are likely to witness significant developments in human genetic science. It is therefore of critical importance that Christian ethics engages with the genetics debate, since it affects not just the way we perceive ourselves and the natural world, but also has wider implications for our society. This book considers ethical issues arising out of specific practices in human genetics, including genetic screening, gene patenting, gene therapy, genetic counselling as well as feminist (...) concerns. Genetics and Christian Ethics argues for a particular theo-ethical approach that derives from a modified version of virtue ethics, drawing particularly on a Thomistic understanding of the virtues, especially prudence or practical wisdom and justice. The book demonstrates that a theological voice is highly relevant to contested ethical debates about genetics. (shrink)

The genetic component of variations in human responses to pharmacological agents is called pharmacogenetics while the molecular basis for these variations are most often identified as pharmacogenomics. Pharmacogenomics as a field of scientific endeavor is so new that in the scientific literature the two terms are often used interchangeably. In fact, the search for new drugs at the molecular level start with the identification of variations in DNA sequences whose products produce alterations in the amino acid structure of the (...) active portion of a protein which are then identified with the clinical disorder in question. This process is just the reverse of standard pharmaceutical approaches which begin with exploration of the physiological and potentially the biochemical basis of the specific disorder under study. The completion of the first draft of the human genome in the first months of the new millenium has increased expectations that molecular genetic approaches to drug disovery and development will significantly shorten the time-frame of new drug testing, significantly reduce the level of adverse events and anable the design of drugs to treat those with unique disorders.Based on such rosy expectations and the potential economic opportunities afforded by those who obtain such patents, there has been a rush of patent applications both in the United States and in Europe by private industry and university laboratories conducting genomic research to secure the rights to specific DNA sequences and federal agencies attempting to place the control of such information in the public domaine. This paper will document and discuss from a historic prospective the public policy and bioethical issues associated with the availability of patents for drug development. (shrink)

Developments in biotechnology and genomics have moved the issue of patenting scientific and technological inventions toward the center of interest. In particular, the patentability of genes of plants, animals, or humans and of genetically modified (parts of) living organisms has been discussed, and questioned, from various normative perspectives. This paper aims to contribute to this debate. For this purpose, it first explains a number of relevant aspects of the theory and practice of patenting. The focus is on a (...) special and increasingly significant type of patents, namely product patents. The paper provides three general arguments against the concept and practice of product patenting. The first argument briefly considers the claim that patents are legitimate because they promote socially useful innovation. Against this claim, it is argued that product patents may hamper rather than promote such innovation. The second and main argument concludes that product patents are not adequately based on actual technological inventions, as they should be according to the usual criteria of patentability. The principal moral issue is that product patents tend to reward patentees for inventions they have not really made available. The final argument proposes a method for patenting the heat of the sun. Assuming that granting this patent will be generally considered absurd, the argument exposes a further, fundamental problem of the concept and practice of product patenting. (shrink)

Over the last two decades, the ethical implications of patents for biological materials and processes have been the subject of spirited public debate between the many individuals and groups on which the patent system impacts. Whereas copyright, trade marks, and other species of Intellectual Property Rights (IPR) are widely acceptable, the patent system evokes criticism from many quarters, especially in relation to the legal protection of inventions in the Life Sciences. Some of these criticisms expressed by prestigious public organisations are (...) addressed here from the patent professional standpoint. (shrink)

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)

The introduction of open source in the life sciences is increasingly being suggested as an alternative to patenting. This is an alternative, however, that takes its shape at the intersection of the life sciences and informatics. Numerous examples can be identified wherein open source in the life sciences refers to access, sharing and collaboration as informatic practices. This includes open source as an experimental model and as a more sophisticated approach of genetic engineering. The first section discusses the (...) greater flexibly in regard of patenting and the relationship to the introduction of open source in the life sciences. The main argument is that the ownership of knowledge in the life sciences should be reconsidered in the context of the centrality of DNA in informatic formats. This is illustrated by discussing a range of examples of open source models. The second part focuses on open source in synthetic biology as exemplary for the re-materialization of information into food, energy, medicine and so forth. The paper ends by raising the question whether another kind of alternative might be possible: one that looks at open source as a model for an alternative to the commodification of life that is understood as an attempt to comprehensively remove the restrictions from the usage of DNA in any of its formats. (shrink)

This article contends that the environmental release of genetically engineered (GE) animals with heritable traits that are patented will present a challenge to the efforts of nations and indigenous peoples to engage in self‐determination. The environmental release of such animals has been proposed on the grounds that they could function as public health tools or as solutions to the problem of agricultural insect pests. This article brings into focus two political‐economic‐legal problems that would arise with the environmental release of such (...) organisms. To address those challenges, it is proposed that nations considering the environmental release of GE animals must take into account the underlying circumstances and policy failures that motivate arguments for the use of the modified animals. Moreover, countries must recognize that the UN International Covenant on Civil and Political Rights and the UN International Covenant on Economic, Social and Cultural Rights place on them an obligation to ensure that GE animals with patented heritable traits are not released without the substantive consent of the nations or indigenous peoples that could be affected. (shrink)

: The gene patenting debate, which proved to be a focal point for divergent moral concerns about recent developments in genome research and biotechnology, has revealed that the moral status of DNA is not clear. One of the arguments used to stop undesirable developments was that DNA possesses a unique status, which renders it unfit for patenting. This paper investigates the allegedly unique (moral) status of genetic material and the information it holds from different perspectives. Several properties (...) of DNA prove to be unique. We examine the relevance of these for patentability of genes and conclude that only the unique symbolic meaning of DNA is a relevant factor, which should be taken into account but weighed against other interests involved. (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).

First published in 1998, this volume why and how genetic engineering has emerged as the technology most likely to change our lives, for better or worse, in the opening century of the third millennium. Over twenty international experts, including moral philosophers and social scientists, describe the issues and controversies surrounding modern biotechnology and genetic engineering. They explore ways in which lay individuals and groups can join in an effective and constructive dialogue with scientists and industrialists over the assessment, (...) exploitation and safe management of these new and important technologies. Topics covered include a discussion of the issues surrounding 'Dolly', the cloned sheep, the politics and ethics of the international research programme to sequence the entire human genome, the ethical questions raised by the creation of transgenic farm animals, the morality of genetic experimentation on animals, the controversy surrounding the patenting of genetic material and of the transgenic animals themselves, the ethical implications of engineering animals for transplanting their organs into humans, and the environmental hazards of releasing genetically engineered organisms. (shrink)

Feminism offers three separate but equally important insights about human genetics and the new reproductive technologies. First, feminism is concerned with ways in which these new technologies have the potential to exploit women, particularly in the treatment of their reproductive tissue, while seeming to offer both sexes greater reproductive freedom. This risk has been largely ignored by much bioethics, which has concentrated on choice and autonomy at the expense of justice, giving it little to say about the concept of exploitation. (...) Second, feminist scholars have developed complex and subtle analyses of how women's labour is incorporated into the global bioeconomy in a gendered manner. Although feminist perspectives vary on such issues as surrogate motherhood, they have provided important studies of how women's labour is commodified in the new reproductive technologies. Finally, feminist analysts and activists have been among the leaders in identifying and resisting the threats from commodification and commercialisation in genetic research and patenting, which often affect women disproportionately. In all three areas, feminist writers have drawn specific attention to medical, economic and political impacts on women that had not been adequately considered. (shrink)

The extension of intellectual property rights into the realm of biology has emerged as an increasing focus of controversy in relation to science,2 biodiversity,3 agriculture,4 health,5 development,6 human rights7 and trade.8 This paper presents the results of a review of international trends in activity for patent protection between 1990-2000 and provisional data to 2004 and 2005 from over 70 national patent offices, four regional patent offices and the World Intellectual Property Organisation using the European Patent Office esp@cenet worldwide database.9 The (...) review employed patent publication counts as an indicator of activity for traditional medicines, pharmaceuticals, agriculture, and biotechnology. The research provides insights into the internationalisation of patent activity in multiple areas of biology. The review emphasises the need to combine the further development of quantitative methods with qualitative analysis of the implications of international patent activity in relation to biological and genetic material for science, society and policy. (shrink)

In 1973-1974 Stanley N. Cohen of Stanford and Herbert W. Boyer of the University of California, San Francisco, developed a laboratory process for joining and replicating DNA from different species. In 1974 Stanford and UC applied for a patent on the recombinant DNA process; the U.S. Patent Office granted it in 1980. This essay describes how the patenting procedure was shaped by the concurrent recombinant DNA controversy, tension over the commercialization of academic biology, governmental deliberations over the regulation of (...) genetic engineering research, and national expectations for high technology as a boost to the American economy. The essay concludes with a discussion of the patent as a turning point in the commercialization of molecular biology and a harbinger of the social and ethical issues associated with biotechnology today. (shrink)

. 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 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)

The nature and status of cultural evolution and its connection with biological evolution are controversial in part because of Richard Dawkin’s suggestion that the scientific study of culture should include “memetics,” an analog of genetics in which genes are replaced by “memes”—the hypothetical units of cultural evolution. Memetics takes different forms; I focus on its minimal form, which claims merely that natural selection shapes to some extent the evolution of some aspects of culture. Advocates and critics of memetics disagree about (...) the scientific status of memetics, but they agree that memetics must face the following fundamental problems. Problem 1: Cultural evolution differs too much from biological evolution. Problem 2: Culture is too complex. Problem 3: Memes are too difficult to identify and track. Problem 4: Memetics produces only trivial results. This paper examines these problems in the context of a minimal memetic analysis in one specific context: patented inventions. Technology is a special subset of culture, and patented inventions are a special subset of technology—not least because there is a detailed written record of every patent. I describe four recent empirical results on technological innovation derived from memetic analysis of the patent record. Result 1: Inkjet printing, PCR, and stents are key drivers of technological innovation. Result 2: Patent genealogies are tangled and incestuous. Result 3: Door-opening innovations drive the evolution of technology. Result 4: The evolving content of the drivers of innovation confirms the importance of inkjet printing, PCR, and stents, among other inventions. These results show that minimal memetics can provide a novel and illuminating analysis the evolution of patented technology. Furthermore, this memetic analysis can answer all of the main problems with memetics. Problem 1 can be dismissed because culture and biology can be quite disanalogous, provided that natural selection still operates in both. Problem 2 is a mirage, because memetic analysis of the patented inventions is consistent with the full richness and complexity of the evolution of technology. Problem 3 is easy to solve, because the patent record makes it trivial to identify and track patents and their key traits through lineages. Problem 4 can be fully answered only after memetic analysis becomes widespread, but the results reviewed here shows that minimal memetics does yield scientific results that are nontrivial and interesting. (shrink)

BMJ Editorial -/- Campaigners are calling on policy makers at next week's sixth World Trade Organization ministerial conference in Hong Kong to make trade fairer for and improve the lives and health of the world's poorest people. This broad and important aim may dominate the headlines, but ministers will also be discussing technical issues surrounding international patenting laws. One issue with implications for the development of medical products is the tension between international patenting laws and benefit sharing requirements, (...) which may threaten agreements on protecting biodiversity. If the biodiversity door shuts because of protests in developing countries, pharmaceutical research will be seriously hampered. (shrink)

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 primary theme of this paper is the normative case against ownership of one's genetic information along with the source of that information (usually human tissues samples). The argument presented here against such “upstream” property rights is based primarily on utilitarian grounds. This issue has new salience thanks to the Human Genome Project and “bio-prospecting” initiatives based on the aggregation of genetic information, such as the one being managed by deCODE Genetics in Iceland. The rationale for ownership is (...) twofold: ownership will protect the basic human rights of privacy and autonomy and it will enable the data subjects to share in the tangible benefits of the genetic research. Proponents of this viewpoint often cite the principle of genetic exceptionalism, which asserts that genetic information needs a higher level of protection than other kinds of personal information such as financial data. We argue, however, that the recognition of such ownership rights would lead to inefficiency along with the disutility of genetic discoveries. Biomedical research will be hampered if property rights in genes and genetic material are too extensive. We contend that other mechanisms such as informed consent and strict confidentiality rules can accomplish the same result as a property right without the liabilities of an exclusive entitlement. (shrink)

This paper focuses on the ethical justifiability of patents on Genetically Modified (GM) crops. I argue that there are three distinguishing features of GM crops that make it unethical to grant patents on GM crops, even if we assume that the patent system is in general justified. The first half of the paper critiques David Resnik’s recent arguments in favor of patents on GM crops. Resnik argues that we should take a consequentialist approach to the issue, and that the best (...) way to do so is to apply the Precautionary Principle, and that the Precautionary Principle, in this case, supports patents on GM crops. I argue that his argument in favor of a consequentialist treatment is invalid; his Precautionary Principle in any case appears to be incompatible with consequentialism; and his conception of reasonable precautions is too ill-defined to have any argumentative purchase. In the second half of the paper, I argue against GM crop patents, on three grounds. First, there is insufficient evidence to say whether allowing patents on GM crops will make research go faster than not having patents, whilst there is a good reason to think that, other things being equal, a society that allows patents on GM crops will be less just than one that does not. Second, even assuming that patents on GM crops will increase the pace of GM crop research, there is no social need to do so. Third, patents on GM crops will frequently have ethically unacceptable side effects. (shrink)