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)

Those objecting to human DNA patenting frequently do so on the grounds that the practice violates or threatens human dignity. For example, from 1993 to 1994, more than thirty organizations representing indigenous peoples approved formal declarations objecting to the National Institutes of Health's bid to patent viral DNA taken from subjects in Papua New Guinea and the Solomon Islands. Although these were not patents on human DNA, the organizations argued that the patents could harm and exploit indigenous peoples (...) and violate their cultural values. NIH eventually dropped one of its patent applications.On May 18, 1995, 180 religious leaders, led by biotechnology critic Jeremy Rifkin, held a press conference objecting to DNA patenting in Washington, D.C. In their “Joint Appeal against Human and Animal Patenting,” these leaders decried any attempt to patent nature. Some of the more outspoken members of the Joint Appeal likened DNA patenting to slavery, while others objected to treating human beings as marketable commodities. In his recent book, The Biotech Century, Rifkin rehashed the objections to DNA patenting voiced by members of the Joint Appeal. (shrink)

A clear, introductory overview of the issues surrounding gene patenting.

This book is devoted to showing that with the single exception of patents on people's whole genomes, DNA patents are morally permissible. Resnik begins with three useful background chapters: one on recent controversies over DNA patents in the United States and abroad; another on the basic science of DNA, as well as research and product development related to DNA; and another, especially useful, chapter on the legal nature of patents and intellectual property. The focus of moral (...) evaluation is patents as they are set out in American law. These give their holders a right to exclude others from producing, using, or commercializing the patented item for twenty years. Items that can be patented include products, processes, and improvements thereof. However, a patentable item must issue from human ingenuity (as opposed to nature); this rules out laws of nature, natural phenomena, and naturally occurring living things and chemical compounds. Of course, in its natural form, DNA is not a product of human nature and therefore not a candidate for patenting. However, since 1980 American law has deemed it patentable in isolated and purified form (in this form, Resnik reports, up to 95% of the sequences in the artificial sequence are in the natural sequence). Turning to ethical issues, Resnik argues for the permissibility of both the general practice of patents, as well as patents on DNA. The general practice is morally defensible because patents produce public benefits, protect private rights of ownership, and strike a reasonable balance in doing so. The public benefits include, in the near term, scientific, medical and agricultural discoveries and innovations; the central long-term benefit is the lower prices that come after the patent has expired and the patented item is publicly disclosed for others to market. Patents help to bring about all of these benefits by providing a legally protected twenty-year monopoly, thus functioning as powerful economic incentives. They thereby also protect private rights of ownership; but even here the public good is not overlooked, since patent-based monopolies are constrained in various ways to protect the public good (e.g.. (shrink)

Whether, and to what degree, do patents granted on human genes cast a shadow of uncertainty over genomics and its applications? Will owners of patents on individual genes or clusters of genes sue those performing whole-genome analyses on human samples for patent infringement? These are related questions that have haunted molecular diagnostics companies and services, coloring scientific, clinical, and business decisions. Can the profusion of whole-genome analysis methods proceed without fear of patent infringement liability?Whole-genome sequencing is proceeding apace. (...) Academic centers have been performing whole-genome and -exome sequencing in research for at least five years, and academic clinical laboratories with national reach have been doing sequencing for clinical applications for almost as long. Companies have also been offering WGS and WES as a clinical service for a few years now. So far as we know, no one has been sued for infringement of “gene patents” for performing WGS. (shrink)

The scientific advances described in earlier chapters have inevitably triggered a response in the world of business and economics, and in this chapter I consider the recent activities of the American company, Celera Genomics, which aims to obtain patent rights for aspects of the human genome. This brings into question whether life, indeed human life, should belong to anyone or anybody. It raises, too, the further question as to how this new information will be used.

Edwin Southern developed a blotting technique for DNA in 1973, thereby creating a staple of molecular biology laboratory procedures still used after several decades. It became a seminal technology for studying the structure of DNA. The story of the creation and dissemination of this technology, which was not patented and was freely distributed throughout the scientific community, stands as a case study in open science. The Southern blot was developed at a time when attitudes about commercial intrusion into health research (...) were beginning to change and the practical value of molecular genetics was becoming apparent to industry. Interest from industry in fundamental molecular biological techniques meant that scientists began to think about commercial uses of their work even in otherwise "basic" research. The unpatented Southern blot is contrasted with later patented technologies, particularly microarray methods, which were created in the same environment by many of the same people, but which followed significant changes to UK policies encouraging commercialization of academic research and a norm shift friendlier to such commercialization within academic molecular biology. Professor Southern's personal experience illuminates how the technologies evolved, and his views provide insight into how scientists' attitudes about commercialization have changed. (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)

DNA possesses a double nature: it is both an analog chemical compound and a digital carrier of information. By distinguishing these two aspects, this paper aims to reevaluate the legally and politically influential idea that the human genome forms part of the common heritage of mankind, an idea which is thought to conflict with the practice of patenting DNA. The paper explores the lines of reasoning that lead to the common heritage idea, articulates and motivates what emerges as the most (...) viable version of it, and assesses the extent to which this version conflicts with gene-patenting practices as exemplified by the U.S. regime. It concludes that the genome is best thought of as a repository of information to which humanity has a fiduciary relationship, and that on this view, the perceived conflict with gene-patenting largely dissolves. (shrink)

For nearly two decades, nonengineered human DNA was patented without challenge. The US Supreme Court recently agreed that many of those patents do not fit accurately into any currently accepted scheme of intellectual property protection. One should consider: whether DNA fits into other forms of property protection (land, moveables, chattels, etc.); whether DNA warrants a new and unique form of property protection, or whether DNA belongs to the class of objects generally considered to be as “the commons.” Current schemes (...) of patent protection for genes are entirely new, unwarranted by precedent, and utterly aberrant in applying the law of patent. Nonetheless, it bears examining how intellectual property schemes might serve as guidance for new forms of intellectual property protection for genes, if indeed those genes fit into classical dimensions of intellectual property. Private ownership of property has emerged as the dominant legal institution covering modes of possession. (shrink)

This paper discusses the genesis of human DNA patents and the legal confusion and ramifications that ensued. Beginning in the mid-1970s with policymakers and lawmakers in the United States, confronted with an economy impacted by an oil crisis, inflation, growing and persistent unemployment and the fledgling biotechnology industry, this paper tracks the development of the practice until its banning in the US Supreme Court in June 2013. The paper raises serious questions regarding the relevance of a patent system—a system (...) that, as the patenting of naturally occurring biological materials demonstrates, is so easily manipulated through the use of legal contrivances. The paper outlines that potential future manipulation poses as a significant threat to the national economy and security of the United States if history is allowed to repeat itself in the context of biological materials. (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)

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.

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)

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)

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)

Besides its use in basic research, the DNA:RNA hybridization technique has helped the development of genetic engineering: it is instrumental in the isolation of specific genes that can be inserted into foreign cells, thus modifying their genetic information. Plants, animals, and microorganisms can now be altered to yield improved crops, pest-resistant plants, and a cheaper source of important proteins or drugs. The social relevance of genetic engineering received official sanction in 1980 when the U.S. Supreme Court ruled that genetically modified (...) organisms can be patented. In this article I have tried to describe the discovery of the DNA:RNA hybridization technique as the successful outcome of years of intelligent and patient research in many laboratories, of inductive and deductive processes in the minds of many biologists. The synthesis that led to the final result and to the early development of the technique was made possible by the coming together of two brilliant scientists, Sol Spiegelman and Benjamin Hall. (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)

Patents on biotech products have a scope that goes well beyond what is covered by the most widely applied ethical justifications of intellectual property. Neither natural rights theory from Locke, nor public interest theory of IP rights justifies the wide scope of legal protection. The article takes human genes as an example, focusing on the component that is not invented but persists as unaltered gene information even in the synthetically produced complementary DNA, the cDNA. It is argued that patent (...) on cDNA holds this information captive, or illegitimately appropriates it in limiting other researchers and inventors’ opportunity to explore new functions and uses based on this non-invented information. A tighter connection between legal IP protection and the use description stated in the patent claim is suggested. By binding protection to the product’s foreseeable functions and use, instead of the product itself and all future uses of it, legitimacy of biotech product patents is restored. (shrink)

The existing literature on the development of recombinant DNA technology and genetic engineering tends to focus on Stanley Cohen and Herbert Boyer's recombinant DNA cloning technology and its commercialization starting in the mid-1970s. Historians of science, however, have pointedly noted that experimental procedures for making recombinant DNA molecules were initially developed by Stanford biochemist Paul Berg and his colleagues, Peter Lobban and A. Dale Kaiser in the early 1970s. This paper, recognizing the uneasy disjuncture between scientific authorship and legal invention (...) in the history of recombinant DNA technology, investigates the development of recombinant DNA technology in its full scientific context. I do so by focusing on Stanford biochemist Berg's research on the genetic regulation of higher organisms. As I hope to demonstrate, Berg's new venture reflected a mass migration of biomedical researchers as they shifted from studying prokaryotic organisms like bacteria to studying eukaryotic organisms like mammalian and human cells. It was out of this boundary crossing from prokaryotic to eukaryotic systems through virus model systems that recombinant DNA technology and other significant new research techniques and agendas emerged. Indeed, in their attempt to reconstitute 'life' as a research technology, Stanford biochemists' recombinant DNA research recast genes as a sequence that could be rewritten thorough biochemical operations. The last part of this paper shifts focus from recombinant DNA technology's academic origins to its transformation into a genetic engineering technology by examining the wide range of experimental hybridizations which occurred as techniques and knowledge circulated between Stanford biochemists and the Bay Area's experimentalists. Situating their interchange in a dense research network based at Stanford's biochemistry department, this paper helps to revise the canonized history of genetic engineering's origins that emerged during the patenting of Cohen-Boyer's recombinant DNA cloning procedures. (shrink)

The U.S. patent office has granted patents on segments of human DNA to several biotechnology companies, enabling them to control the development of DNA-related "products." While it is recognized that expanded knowledge of DNA codes is extremely important in helping to overcome genetic diseases, such knowledge can easily also be used to redefine genetically the human person. Much wisdom is needed for such an endeavor. This paper suggests that the market should not have control of this important knowledge because (...) it is incapable of exercising such wisdom, specifically because of the salient traits that govern the market. Those traits are: expediency, efficiency, the need for quantifiable results, and impersonality. The very structures of the market necessarily lead to a deterministic and reductionist view of the human person and overlook important issues of distributive justice. (shrink)

Thirteen years ago, commenting on the treatment of the human body and its cell lines as patentable commodities, Mary Taylor Danforth wrote:Research with human cells that results in significant economic gain for the researcher and no gain for the patient offends the traditional mores of our society in a manner impossible to quantify Such research tends to treat the human body as a commodity — a means to a profitable end. The dignity and sanctity with which we regard the human (...) whole, body as well as mind and soul, are absent when we allow researchers to further their own interests without the patient's participation by using a patient's cells as the basis for a marketable product.In his insightful article, David Resnik would have us travel further down the path of allowing the patenting of DNA in order to advance scientific research and the welfare of humankind. Dr. Resnik suggests that that the acquisition of such proprietary rights in DNA research must proceed cautiously. (shrink)

Thirteen years ago, commenting on the treatment of the human body and its cell lines as patentable commodities, Mary Taylor Danforth wrote:Research with human cells that results in significant economic gain for the researcher and no gain for the patient offends the traditional mores of our society in a manner impossible to quantify Such research tends to treat the human body as a commodity — a means to a profitable end. The dignity and sanctity with which we regard the human (...) whole, body as well as mind and soul, are absent when we allow researchers to further their own interests without the patient's participation by using a patient's cells as the basis for a marketable product.In his insightful article, David Resnik would have us travel further down the path of allowing the patenting of DNA in order to advance scientific research and the welfare of humankind. Dr. Resnik suggests that that the acquisition of such proprietary rights in DNA research must proceed cautiously. (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)

The existing literature on the development of recombinant DNA technology and genetic engineering tends to focus on Stanley Cohen and Herbert Boyer's recombinant DNA cloning technology and its commercialization starting in the mid-1970s. Historians of science, however, have pointedly noted that experimental procedures for making recombinant DNA molecules were initially developed by Stanford biochemist Paul Berg and his colleagues, Peter Lobban and A. Dale Kaiser in the early 1970s. This paper, recognizing the uneasy disjuncture between scientific authorship and legal invention (...) in the history of recombinant DNA technology, investigates the development of recombinant DNA technology in its full scientific context. I do so by focusing on Stanford biochemist Berg's research on the genetic regulation of higher organisms. As I hope to demonstrate, Berg's new venture reflected a mass migration of biomedical researchers as they shifted from studying prokaryotic organisms like bacteria to studying eukaryotic organisms like mammalian and human cells. It was out of this boundary crossing from prokaryotic to eukaryotic systems through virus model systems that recombinant DNA technology and other significant new research techniques and agendas emerged. Indeed, in their attempt to reconstitute 'life' as a research technology, Stanford biochemists' recombinant DNA research recast genes as a sequence that could be rewritten thorough biochemical operations. The last part of this paper shifts focus from recombinant DNA technology's academic origins to its transformation into a genetic engineering technology by examining the wide range of experimental hybridizations which occurred as techniques and knowledge circulated between Stanford biochemists and the Bay Area's experimentalists. Situating their interchange in a dense research network based at Stanford's biochemistry department, this paper helps to revise the canonized history of genetic engineering's origins that emerged during the patenting of Cohen-Boyer's recombinant DNA cloning procedures. (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)

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)

There was a time, in the late 1970s and 1980s, when great feats were expected of recombinant DNA biotechnology, some verging on the miraculous. According to both business enthusiasts and sober analysts like the U.S. Congressional Office of Technology Assessment, the new techniques of gene splicing would not only lift the drug industry out of its deep scientific and economic rut (characterized by long-declining introduction rates of genuinely novel medicines), but rejuvenate the American manufacturing sector (Chase 1979; Chemical Week 1987; (...) OTA 1984). Once freed by policy interventions to promote academic-industry collaboration, such as the 1980 Bayh-Dole Act, lifesaving drugs locked up in ivory towers would .. (shrink)

Intellectual property in biotechnology invention provides important incentives for research and development leading to advances in genetic tests and treatments. However, there have been numerous concerns raised regarding the negative effect patents on gene sequences and their practical applications may have on clinical research and the availability of new medical tests and procedures. One concern is that licensing policies attempting to capture for the benefit of the licensor valuable rights to downstream research results and products may increase the financial (...) risks and cliniinish potential payoffs of — and therefore motivation for — performing downstream research and development. In addition, very broad patent claims allowed by the U.S. Patent and Trademark Office, the sheer growth in patents claiming genetic sequences, and threats of overlapping patents create a veritable minefield for researchers in both academia and industry. The concern is that research may be stifled because of the high cost and hassle of negotiating access. (shrink)

Intellectual property in biotechnology invention provides important incentives for research and development leading to advances in genetic tests and treatments. However, there have been numerous concerns raised regarding the negative effect patents on gene sequences and their practical applications may have on clinical research and the availability of new medical tests and procedures. One concern is that licensing policies attempting to capture for the benefit of the licensor valuable rights to downstream research results and products may increase the financial (...) risks and cliniinish potential payoffs of — and therefore motivation for — performing downstream research and development. In addition, very broad patent claims allowed by the U.S. Patent and Trademark Office, the sheer growth in patents claiming genetic sequences, and threats of overlapping patents create a veritable minefield for researchers in both academia and industry. The concern is that research may be stifled because of the high cost and hassle of negotiating access. (shrink)

The properties of DNA -- DNA as universal property -- DNA as intellectual property -- DNA as national property -- DNA as personal property -- DNA as academic property -- DNA as taxable propety.

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)

Opposition to `ownership' of cells and tissues often depends on arguments about the special or sacred nature of human bodies and other living things. Such arguments are not very helpful in dealing with the patenting of DNA fragments. Two arguments undergird support for patenting: the notion that an author has a `right' to an invention resulting from his/her labor, and the utilitarian argument that patents are needed to support medical inventiveness. The labor theory of ownership rights is subject to (...) critique, though it may still have enduring value. The more important argument is that deriving from the common good. If patents on DNA are supported on the basis of their contributions to the common good, then they can also be limited based on considerations of the common good. (shrink)

The purpose of this analysis is to widen and clarify the debate which arose during the last years around granting patents (and other ownership rights) upon different methods and mechanisms of manipulating and engineering life. In doing so, I draw a limited, prima facie argument against many sorts of entitlements or granting rights to those capable of manipulating life at its core level. The general tendency nowadays is to put pressure on the institutional setting in order to accept and (...) promote the manipulation of life as a novel discovery and invention, i.e. to grant patents. I will argue why this is not only socially risky, but also morally doubtful. (shrink)

This paper applies aspects of Hugo Grotius's theologically informed theory of property to contemporary issues concerning access to the human DNA sequence and patenting practices. It argues that Christians who contribute to public debate in these areas might beneficially employ some of the concepts with which he worked--notably "common right," the "right of necessity," and "use right." In the seventeenth century, wars were fought over trading rights and access to the sea. In the twenty-first century, information and intellectual property are (...) the issues of the day. Grotius's writings serve to correct the overemphasis in modern liberalism on individual rights, and have practical application to the debate concerning the reduction of the human genome to the status of private property. (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 chapter contains sections titled: The Current Conundrum The Objects of Our Study The Legal Framework So Far Special Challenges of DNA Property and Parts Autonomy, Individuality, and Personhood Economics and the Marketplace for Genes Ethics and Method An Outline for the Investigation The Challenge Ahead.

The Bermuda Principles for DNA sequence data sharing are an enduring legacy of the Human Genome Project. They were adopted by the HGP at a strategy meeting in Bermuda in February of 1996 and implemented in formal policies by early 1998, mandating daily release of HGP-funded DNA sequences into the public domain. The idea of daily sharing, we argue, emanated directly from strategies for large, goal-directed molecular biology projects first tested within the “community” of C. elegans researchers, and were introduced (...) and defended for the HGP by the nematode biologists John Sulston and Robert Waterston. In the C. elegans community, and subsequently in the HGP, daily sharing served the pragmatic goals of quality control and project coordination. Yet in the HGP human genome, we also argue, the Bermuda Principles addressed concerns about gene patents impeding scientific advancement, and were aspirational and flexible in implementation and justification. They endured as an archetype for how rapid data sharing could be realized and rationalized, and permitted adaptation to the needs of various scientific communities. Yet in addition to the support of Sulston and Waterston, their adoption also depended on the clout of administrators at the US National Institutes of Health and the UK nonprofit charity the Wellcome Trust, which together funded 90% of the HGP human sequencing effort. The other nations wishing to remain in the HGP consortium had to accommodate to the Bermuda Principles, requiring exceptions from incompatible existing or pending data access policies for publicly funded research in Germany, Japan, and France. We begin this story in 1963, with the biologist Sydney Brenner’s proposal for a nematode research program at the Laboratory of Molecular Biology at the University of Cambridge. We continue through 2003, with the completion of the HGP human reference genome, and conclude with observations about policy and the historiography of molecular biology. (shrink)

This chapter contains sections titled: The Evolution of the Institutions of Science The Big Business of Biotech, and the Cornucopia of the HGP The Marketplace of Genes Open Source and Free Markets Open Source in Biology National Regulation of Gene Markets DNA Wants to be Free.

ABSTRACT Monoclonal antibodies played a key role in the development of the biotechnology industry of the 1980s and 1990s. Investments in the sector and commercial returns have rivaled those of recombinant DNA technologies. Although the monoclonal antibody technology was first developed in Britain, the first patents were taken out by American scientists. During the first Thatcher government in Britain, blame for the missed opportunity fell on the scientists involved as well as on the National Research and Development Corporation, which (...) had been put in place after World War II to avoid a repeat of the penicillin story, when patent rights were not sought. Instead of apportioning the blame, this essay suggests that despite past experiences and despite the new channels that were in place, Britain was not in a “patent culture” in the 1970s. It traces the long and painful process that made a commercial attitude among publicly funded British research scientists and in a civil service institution like the Medical Research Council both possible and desirable. In this process the meaning of the term “public science” also changed dramatically. (shrink)

Ethics in scientific research has never been more important. Recent controversies over the integrity of data in federally funded science, the manipulation and distortion of privately sponsored research, cloning, stem cell research, and the patenting of DNA and cell lines, illustrate the need for a more thorough education in ethics for researchers at all levels. Now in its second edition, Responsible Conduct of Research provides an introduction to many of the social, ethical, and legal issues facing scientists today. The fully (...) updated volume includes three brand new chapters and additional cases for discussion, as well as analysis of the latest issues and problems in research ethics. Featuring chapters that treat such topics as ethical decision-making, research misconduct, and intellectual property, this new edition will be an indispensable resource for students and teachers, academics and industry professionals alike. (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)

Opposition to `ownership' of cells and tissues often depends on arguments about the special or sacred nature of human bodies and other living things. Such arguments are not very helpful in dealing with the patenting of DNA fragments. Two arguments undergird support for patenting: the notion that an author has a `right' to an invention resulting from his/her labor, and the utilitarian argument that patents are needed to support medical inventiveness. The labor theory of ownership rights is subject to (...) critique, though it may still have enduring value. The more important argument is that deriving from the common good. If patents on DNA are supported on the basis of their contributions to the common good, then they can also be limited based on considerations of the common good. (shrink)