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)

This paper is about disposability as a technological concern and about how to trace the related issues through the analysis of patents. It examines how moral and social concerns happened to be embedded in technology, based on the case of disposable feminine hygiene products. The focus is placed on what “disposable” means and on exploring relative notions as well as their dynamic and consequences. To conduct such analysis, the paper proposes to perform a classic and computer-assisted analysis of the (...) patents published by Johnson & Johnson over almost a century. Tracing social and moral concerns in patents challenges the existing literature in law, which tends to envision patents as legal assets deprived of moral considerations. The paper shows how hygiene products addressed women, how these products were made disposable, and how what disposability means evolved, both in the heart of technology and in the wider space of “concerned” markets. (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)

With the aim of understanding current problematizations of embryonic stem cell patenting this article rehearses the history of social entitlements related to reproductive material derived from women seeking care in institutions for reproductive health in Denmark. Our interest lies in the emergence of commercial exchange of material derived from embryos. Such exchange is characterized by contestation of the status of the embryo: is it a person or a commodity? To understand the modus operandi of the exchanges, we first explore how (...) the concepts of personhood and morality, of commodity and ownership tend to be related in the ideal type of capitalist exchange. Historical context then helps us understand the contingency of exchange systems. Historically Danish women have had much less influence on the dissemination of material derived from them than they do today. However, today their entitlements have also found their limits, in particular with respect to commercial transactions. We claim that, ironically, material derived from institutionally mediated reproduction gains unprecedented personhood from confrontation with a capitalist exchange form which potentially designates it as a mere commodity. (shrink)

This article details how patent law works to create discrete, immutable biological ‘objects’. This socio-legal maneuver is necessary to distinguish these artifacts from the unwieldy realm of the natural world. The creation of ‘objects’ also serves the interests of capital, where a stable, unchanging, immutable object goes hand in hand with commodification. Yet this stabilization is incomplete. Pointing to a variety of different examples, this article illustrates how biotech patents do not speak to specific, immutable things. Biotech patents, (...) rather, are better understood as ontologically fluid, which is to say their identity cannot be ‘fixed’ — or, at least, not without undermining the very existence of today’s biotechnology regime. The article concludes by speaking briefly about how this mutability is perpetuating certain inequalities, particularly between holders of various property forms. (shrink)

The hydrogen market in the world today is capable ovule and empirical evidence on activity of patents in fuel cells and hydrogen production is limited so far. Patent applications in zero-emission mobility in the aspect of fuel cells include: DAFC/dmfc&dmfc, PEMFC, SOFC, AFC, PAFC. As for the patents relating to the hydrogen production, they concern low carbon, electrolysis and inorganic. The purpose of the study was to investigate certain aspects of the activity of patents in fuel cells (...) and hydrogen production in the context of passenger car fleet in the Visegrad group (V4) countries and to explore the relationship between patent registrations and GDP per capita in V4. The research area relates to the answer to the question of whether a country’s involvement in zero-emission patent activity (patents in fuel cells and hydrogen production) could contribute to the renewal of the country’s passenger car fleet. The theses were formulated as follows: 1) activity of patents in fuel cells and hydrogen production in the V4 countries doesn’t depend on the car fleet in these countries, 2) the level of GDP per capita in the V4 countries is not followed by the number of patents registrations in hydrogen technology, 3) the highest patent activity in fuel cells and hydrogen production doesn’t mean that the car fleet in these country will be zero-emission in coming years. The method used in this article is a comparative analysis, but also the relationships between patent registrations, GDP per capita and passenger car fleet in V4 are considered. (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)

Just as human embryonic stem cell research has generated controversy about the uses of human embryos for research and therapeutic applications, human embryonic stem cell patents raise fundamental ethical issues. The United States Patent and Trademark Office has granted foundational patents, including a composition of matter (or product) patent to the Wisconsin Alumni Research Foundation (WARF), the University of Wisconsin-Madison’s intellectual property office. In contrast, the European Patent Office rejected the same WARF patent application for ethical reasons. (...) This article assesses the appropriateness of these patents placing the discussion in the context of the deontological and consequentialist ethical issues related to human embryonic stem cell patenting. It advocates for a patent system that explicitly takes ethical factors into account and explores options for new types of intellectual property arrangements consistent with ethical concerns. (shrink)

The production of vaccines for COVID-19 has been far from ideal in terms of meeting world demand, thereby mitigating the infections and deaths caused by the pandemic. Part of the reason production has been inefficient is that those pharmaceutical companies that own the vaccine do not have sufficient productive capacity to meet demand. Resultantly, many have advocated for waiving patent rights to the vaccine so it can be massively produced worldwide. Pharmaceutical companies and their advocates have opposed this waiving of (...) patent rights. In this article, I respond to the arguments that oppose waiving patents and contend that there is a case for temporarily waiving them. Mainly, I present a negative argumentative strategy that upholds the view that patents ought to be waived. However, in light of my arguments, the absence of positive reasons to withhold the patents implies that there are positive views for temporarily waiving them. (shrink)

In May 2011, the Brazilian Ministry of Health announced the distribution of the first batch of locally produced generic tenofovir disoproxil fumarate (TDF) to support its program of universal and free access for the treatment of HIV/AIDS. The inclusion of TDF in the public health program illustrates what has been considered the ‘Brazilian model’ of HIV/AIDS response, as it illustrates the current phase of the Brazilian pharmaceutical economy. Brazil is known for having managed to control the expansion of HIV/AIDS through (...) a unique initiative combining the public health and the industrial production of generics. But, if at first local manufacturers could freely copy ARVs and produce cheaper generic versions that were delivered to the Ministry of Health, since the country started to grant patents on drugs in 1996, the sustainability of this policy has been challenged by the high cost of patented second-line HIV/AIDS treatments. In order to assure continuity of the local production of ARVs, and keep the program of public health alive, Brazilians are now forced to deal with conflicts of drugs' intellectual property rights in order to open the path to generic production. This article aims to describe the experiences surrounding TDF in Brazil and the unprecedented conflicts and challenges it has brought for our different interviewees. Blurring the frontier between the public and the private, the TDF case was driven at the same time by an ethic of drug access and regulation of drug quality, which has inspired Brazilians to intervene and transform the world they live in. (shrink)

The commercialization of academic science has come to be understood as economically desirable for institutions, individual researchers, and the public. Not surprisingly, commercial activity, particularly that which results from patenting, appears to be producing changes in the standards used to evaluate scientists’ performance and contributions. In this context, concerns about a gender gap in patenting activity have arisen and some have argued for the need to encourage women to seek more patents. They believe that because academic advancement is mainly (...) dependent on productivity (Stuart and Ding in American Journal of Sociology 112:97–144, 2006 ; Azoulay et al. in Journal of Economic Behavior & Organization 63:599–623, 2007 ), differences in research output have the power to negatively impact women’s careers. Moreover, in the case of patenting activity, they claim that the gender gap also has the potential to negatively affect society. This is so because scientific and technological advancement and innovation play a crucial role in contemporary societies. Thus, women’s more limited involvement in the commercialization of science and technology can also be detrimental to innovation itself. Nevertheless, calls to encourage women to patent on grounds that such activity is likely to play a significant role in the betterment of both women’s careers and society seem to be based on two problematic assumptions: (1) that the methods to determine women’s productivity in patenting activities are an appropriate way to measure their research efforts and the impact of their work, and (2) that patenting, particularly in academia, benefits society. The purpose of this paper is to call into question these two assumptions. (shrink)

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

A topic of growing importance within philosophy of science is the epistemic implications of the organization of research. This paper identifies a promising approach to social epistemology—nonideal systems design—and uses it to examine one important aspect of the organization of research, namely the system of patenting and licensing and its role in structuring the production and dissemination of knowledge. The primary justification of patenting in science and technology is consequentialist in nature. Patenting should incentivize research and thereby promote the development (...) of knowledge, which in turn facilitates social progress. Some have disputed this argument, maintaining that patenting actually inhibits knowledge production. In this paper, I make a stronger argument; in some areas of research in the US—in particular, research on GM seeds—patents and patent licenses can be, and are in fact being, used to prohibit some research. I discuss three potential solutions to this problem: voluntary agreements, eliminating patents, and a research exemption. I argue against eliminating patents, and I show that while voluntary agreements and a research exemption could be helpful, they do not sufficiently address the problems of access that are discussed here. More extensive changes in the organization of research are necessary. (shrink)

Universities are regarded as key institutions in the knowledge economy. Traditionally, the concept of scientific progress has been linked with an ideal of free and open dissemination of scientific information.At present, however, there is a growing strain to cash in the commercial potential created by academic research, and to regard academic knowledge as targets for opportunities for creating income. The major question is how to reconcile the traditional academic mission of knowledge production and science sharing with the current trend towards (...) knowledge protection and appropriation through patenting. In balancing the sharing and shielding of knowledge, two major sets of measures should be contemplated.A first set of measures aims at safeguarding individual and collective research from the harm patents might have on research practice and scientific conduct, and at cautiously watching potential conflicts of interest. The appointment of an ombudsperson for science, a mandatory system of whistle blowing, a code of conduct, and a set of conflict-of-interest guidelines are explored as helpful instruments in this regard.A second set of tools aims at designing institutional strategies to balance the ethos of sharing and profit maximalisation through patents. Public patents, open access patents, and two-tiered patent license strategies are examined in order to find a new balance in the growing conflict between private and public knowledge with which contemporary universities are faced. (shrink)

The framers of the U.S. Constitution believed that intellectual property rights were crucial to scientific advancement. Yet, the framers also recognized the need to balance innovation, privatization, and public use. The courts’ expansion of patent protection for biotechnology innovations in the last 30 years raises the question whether the patent system effectively balances these concerns. While the question is not new, only through a thorough and thoughtful examination of these issues can the current system be evaluated. It is then a (...) policy decision for Congress if any change is necessary. (shrink)

The rising cost of the opioid antagonist and overdose reversal agent naloxone is an urgent public health problem. The recent and dramatic price increase of Evzio, a naloxone auto-injector produced by Kaléo, shows how pharmaceutical manufacturers entering the naloxone marketplace rely on market exclusivity guaranteed by the patent system to charge prices at what the market can bear, which can restrict access to life-saving medication. We argue that 28 U.S.C. § 1498, a section of the federal code that allows the (...) government to use patent-protected products for its own purposes in exchange for reasonable compensation, could be used to procure generic naloxone auto-injectors, or at least bring Kaléo to the negotiating table. Precedent exists for the use of § 1498 to procure pharmaceuticals, and it could give meaning to the federal government's recent declaration of a public health emergency around the opioid epidemic, discourage new market entrants from charging exorbitant prices, and yield important public health benefits. (shrink)

The patent system appears to make three ontological assumptions often associated with scientific realism: there is a natural world that is independent of human knowledge and technology; invented products can be unobservable things; and invented products have causal powers. Although a straightforward reading of patent laws implies these ontological commitments, it is not at all clear that what the patent system has to say about the world has any bearing on issues of scientific realism. While realists might embrace the patent (...) system’s apparent ontology as providing additional support for their view, anti-realists could propose an alternative interpretation of patent law that does not involve realist ontological commitments. Thus, questions about the patent system’s ontology depend on whether one takes patent laws at face value or defends an interpretation of patent law motivated by philosophical theory. Philosophers of science should pay attention to the practice of patenting, even if they ultimately reject the patent system’s apparent ontology and offer an alternative interpretation. (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)

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

The filing of patent applications by universities remains a debatable issue in Europe more than 25 years after the Bayh Dole Act in the U.S.A. The European Commission and several national governments are currently exerting pressure on universities to take a more active part in the innovation process.The importance of university research as a source of technology is increasing in the knowledge economy, which is characterized by open innovation. The funding of research may eventually be at stake. Patent applications are (...) essential instruments in the knowledge-transfer process. They enable universities to reconcile their mission of disseminating knowledge with a direct participation in innovation. They contribute to the development of new products, to the funding of more collaborative research with industry, and to the creation of new companies.This article offers guidelines for making the filing of patent applications by universities consistent or even synergistic with their other missions. Yet, despite all these considerations, the propensity of European universities to file patent applications is 5 times lower than in the U.S.A., which is also reflected in the other knowledge-transfer indicators.This article suggests two reasons for this lower propensity: the mindset of the mostly independent European universities based on the Humboldt model and the much less attractive European patent system for universities. (shrink)

The attitudes of physicians and drug manufacturers in the US toward patenting pharmaceuticals changed dramatically from the mid-nineteenth century to the mid-twentieth. Formerly, physicians and reputable manufacturers argued that pharmaceutical patents prioritized profit over the advancement of medical science. Reputable manufactures refused to patent their goods and most physicians shunned patented products. However, moving into the early twentieth century, physicians and drug manufacturers grew increasingly comfortable with the idea of pharmaceutical patents. In 1912, for example, the American Medical (...) Association dropped the prohibition on physicians holding medical patents. Shifts in wider patenting cultures therefore transformed the ethical sensibilities of physicians. (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 decade-long debate over ownership of living human materials has recently intensified with the ability of biomedical research to isolate, purify, and use human genes and gene products as therapeutics, factories for the production of therapeutics, and targets for the identification of therapeutic pharmaceuticals. Indeed, advances in genomic research have resulted in the identification of hundreds of thousands of DNA fragments and hundreds of genes. Many within the scientific and business communities believe genes and gene fragments have commercial value and (...) have filed patent applications on the nucleic acid sequences. This commercialization has amplified the discussion surrounding the ethics of patenting genes and the ownership of the human genome. (shrink)

The International Bill of Rights enshrines a right to health, which includes a right to access essential medicines. This right frequently appears to conflict with the intellectual property regime that governs pharmaceutical patents. However, there is also a human right that protects creative works, including scientific productions. Does this right support intellectual property protections, even when they may negatively affect health? -/- This article examines the recent attempt by the Committee on Economic, Social and Cultural Rights to resolve this (...) issue and argues that it fails. This is problematic because it means defenders of the present patent regime can continue using human rights documents to support their position. I offer a new framework for resolving the problem by examining the values that underlie human rights. (shrink)

The commercialization of academic science has come to be understood as economically desirable for institutions, individual researchers, and the public. Not surprisingly, commercial activity, particularly that which results from patenting, appears to be producing changes in the standards used to evaluate scientists’ performance and contributions. In this context, concerns about a gender gap in patenting activity have arisen and some have argued for the need to encourage women to seek more patents. They believe that because academic advancement is mainly (...) dependent on productivity (Stuart and Ding in American Journal of Sociology 112:97–144, 2006; Azoulay et al. in Journal of Economic Behavior & Organization 63:599–623, 2007), differences in research output have the power to negatively impact women’s careers. Moreover, in the case of patenting activity, they claim that the gender gap also has the potential to negatively affect society. This is so because scientific and technological advancement and innovation play a crucial role in contemporary societies. Thus, women’s more limited involvement in the commercialization of science and technology can also be detrimental to innovation itself. Nevertheless, calls to encourage women to patent on grounds that such activity is likely to play a significant role in the betterment of both women’s careers and society seem to be based on two problematic assumptions: (1) that the methods to determine women’s productivity in patenting activities are an appropriate way to measure their research efforts and the impact of their work, and (2) that patenting, particularly in academia, benefits society. The purpose of this paper is to call into question these two assumptions. (shrink)

In the past, for universities, the suggestion that they rather than other, commercial, actors should seek to control and profit from the results of research was hardly entertained at all, not least as in many cases these institutions jealously guarded their relative unconnectedness from the market.However, two political economic shifts have transformed this situation and the previous benign neglect of intellectual property in universities is unlikely to continue. On the commercial side, the increased share of value-added in many products has (...) focussed corporate managers on the issue of the ownership and exploitation of knowledge and information.On the other side, universities have themselves have been suffering varying, and in some cases quite extensive, pressure as regards their publicly funded budgets. Thus, in many developed and developing countries, encouraged by their own governments, and in the case of developing countries by international financial institutions, many universities have started to examine new ways of capitalising on their activities through market activities. This has led to many universities finding themselves torn between a norm of scientific community and the requirements to utilise their research-related resources as sources of income.This article explores this issues and concludes that the university’s most obvious competitive advantage is in the provision of publicly available knowledge and research; to become too like the corporate sector is to invite conversion into commercial actors. We already have quite enough commercial actors in the global information society; our attention must be focussed on maintaining and even expanding the realm of the public research institution by building on the many centuries of success universities have enjoyed in providing social goods. (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)

Explanations of productivity differences between men and women in science tend to focus on the academic sector and the individual level. This article examines how variation in organizational logic affects sex differences in scientists' commercial productivity, as measured by patenting. Using detailed data from a sample of academic and industrial life scientists working in the United States, the authors present multivariate regression models of scientific patenting. The data show that controlling for education- and career-history variables, women are less likely to (...) patent than men. However, in biotechnology firms—industrial settings characterized by flatter, more flexible, network-based organizational structures— women scientists are more likely to become patent-holding inventors than in more hierarchically arranged organizational settings in industry or academia. The authors discuss how the organization of scientists'work settings may influence enduring disparities between men and women in science and the implications of these findings for future work. (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)

It is generally recognised that public health problems in the developing world are dire and that the rest of the world has a moral commitment to provide assistance. Yet many of the world’s poor are unable to access essential pharmaceuticals simply because products that are under patent are too expensive and cheaper generics are not available. One of the proposed solutions to this problem is to allow domestic manufacture of generic products in response to public health crises. However, this solution (...) will provide no assistance in countries that lack the capacity to manufacture pharmaceuticals. This article discusses the extensive international negotiations occurring during the last couple of years that seek to provide an appropriate balance between access rights and patent rights. (shrink)

The genome is one of the primordial elements of the human being and is responsible for human identity and its transmission to descendants. The gene as such ought not be appropriated or owned by man. However, any sufficiently complete description of a gene should be capable of being protected as intellectual property. Furthermore, all utilisations of a gene or its elements that permit development of processes or new products should be patentable. Ethics, in the sense of moral action, should come (...) into play from the very first stages of research into the human genome. Protection of intellectual and industrial property is of purely legal concern and need not provoke ethical consideration. By contrast, the use of the results of, and in particular the commercialisation of products deriving from, research into the human genome, ought to be subjected to ethical consideration and control. Considering the economic and societal stakes of such research, ethical analysis ought to be at an international level if mistakes and unforeseen risks of conflict are to be avoided. (shrink)

In June 2020, Gilead agreed to provide the USA with 500 000 doses of remdesivir—an antiviral drug which at that time was percieved to show promise in reducing the recovery time for patients with COVID-19. This quantity represented Gilead’s then full production capacity for July and 90% of its capacity for August and September. Similar deals are evident around access to proposed vaccines for COVID-19, and such deals are only likely to increase. These attempts to secure preferential access to medicines (...) and vaccines, so-called vaccine/treatment nationalism, jeopardise supplies of life-saving treatments and vaccines available elsewhere, and jeopardise global equitable distribution of such vaccines/treatments more generally. Much of the focus to date has been on States’ role in negotiating such deals. However, such developments also demonstrate the power patent holders have in controlling access to life-saving healthcare, determining who obtains access first and at what price. This article argues that the extent of control currently given to patent holders for COVID-19 must be questioned. This article demonstrates that patents have significant implications for healthcare acting as private governance tools over patented inventions. It is only by greater probing of patent holders’ role in delivering access to medicines, diagnostics and vaccines for COVID-19 that equitable global equitable access can be achieved. (shrink)

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)

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

The notion of economic violence has long been recognized in the work of Johan Galtung and others. The work of Thomas Pogge and the field of global justice have addressed the impact of economic disparities between the Global North and the Global South, and their impact on human well-being, and social and economic development more broadly. Patents, publication in scholarly journals, academic collaborations, access to academic journals, and so forth do not on their face seem to be closely tied (...) to indicators of human well-being. However, disparities in knowledge production, including access to academic resources and publication venues, are tied directly or indirectly to infrastructure, food security, health and mortality rates, employment, and gender equity. (shrink)

A well-developed perspective in the study of urban systems is that cities are complex systems that manifest as networks of interdependent economic units. These units might be occupations, industries, labor skills, patent technologies, etc. Much research has focused on describing the nature of these networks, quantifying their links, and suggesting applications for policymakers. In this paper, we examine the US skill network, focusing on the relationship between network centrality and economic performance. Here, nodes are represented by individual labor skills, and (...) edge weights are derived from the colocation pattern of skill pairs among 384 US metropolitan statistical areas. The centrality of skills, using three centrality measures, is then aggregated to the occupational and metropolitan level. We find that occupations with higher skill centrality are associated with greater annual salaries, and metropolitan areas with higher skill centrality have higher productivity rates. Overall, these results suggest that the application of traditional network metrics to this view of cities as complex networks can offer new insights into the dynamics of regional economies. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and (...) informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

This paper argues that regulatory agencies have a responsibility to further the public interest when they determine the conditions under which new technological products may be commercialized. As a case study, this paper analyzes the US 9th Circuit Court’s ruling on the efforts of the US Environmental Protection Agency to regulate an herbicide meant for use with seed that are genetically modified to be tolerant of the chemical. Using that case, it is argued that when regulatory agencies evaluate new technological (...) products, they have an obligation to draw on data, analyses, and evaluations from a variety of credible epistemic sources, and not rely solely or even primarily on the technology developer. Otherwise, they create conditions for their own domination and that of the polity by the technology developer. Moreover, in the interest of advancing the public interest, regulatory agencies must evaluate new technologies in a substantively and procedurally unbiased manner. (shrink)

New research and a government investigation have shed light on an anticompetitive practice called “Product Hopping” and specifically how it was employed in the case of the multiple sclerosis treatment glatiramer acetate beginning in 2014, which cost payers billions of dollars. We examine this case as well as a separate, impending instance of product hopping.

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and (...) informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

This paper discusses the economic, legal, moral, and political difficulties in developing drugs for the developing world. It argues that large, global pharmaceutical companies have social responsibilities to the developing world, and that they may exercise these responsibilities by investing in research and development related to diseases that affect developing nations, offering discounts on drug prices, and initiating drug giveaways. However, these social responsibilities are not absolute requirements and may be balanced against other obligations and commitments in light of economic, (...) social, legal, political, and other conditions. How a company decides to exercise its social responsibilities to the developing world depends on the prospects for a reasonable profit and the prospects for a productive business environment. Developing nations can either help or hinder the pharmaceutical industry’s efforts to exercise social responsibility through various policies and practices. To insure that companies can make a reasonable profit, developing nations should honor pharmaceutical product patents and adhere to international intellectual property treaties, such as the Trade‐Related Aspects of Intellectual Property Rights agreement. To insure the companies have a good business environment, developing nations should try to promote the rule of law, ethical business practices, stable currencies, reliable banking systems, free and open markets, democracy, and other conditions conducive to business. Overall, this paper advocates for reciprocity and cooperation between pharmaceutical companies and developing nations to address the problem of developing drugs for the developing world. In pursuing this cooperative approach, developing nations may use a variety of other techniques to encourage pharmaceutical companies to act responsibly, such as subsidizing pharmaceutical research, helping to design and implement research protocols, providing a guaranteed market, and bulk buying. (shrink)

Globalized in 1995 through the TRIPs Agreement, humanity’s dominant mechanism for encouraging innovations involves 20-year product patents, whose monopoly features enable innovators to reap large markups or licensing fees from early users. Exclusive reliance on this reward mechanism in the pharmaceutical sector is morally problematic for two main reasons. First, it imposes a great burden on poor people who cannot afford to buy patented treatments at monopoly prices and whose specific health problems are therefore neglected by pharmacological research. (...) Second, it discourages pharmaceutical firms from fighting diseases at the population level with the aim of slashing their incidence. These problems can be alleviated by establishing a supplementary alternative reward mechanism that would enable pharmaceutical innovators to exchange their monopoly privileges on a patented product for impact rewards based on the actual health gains achieved with this product. As such, an international Health Impact Fund (HIF) would create powerful new incentives to rapidly develop remedies against diseases concentrated among the poor, provide such remedies with ample care at very low prices, and deploy them strategically to contain, suppress, and ideally eradicate the target disease. By promoting innovations and their diffusion together, the HIF would greatly enlarge the benefits, and thereby also the cost-effectiveness, of the pharmaceutical sector, especially in favor of the world’s poor. (shrink)

This article argues that considerations about the role and predictability of intellectual innovation make the protection of intellectual property morally obligatory even when it greatly reduces short-term welfare. Since the provision of good new ideas is the only productive input not subject to decreasing marginal productivity, welfarist considerations require that no impediment to its maximal provision be erected and the potentially substantial welfare losses imposed by a patent system be mitigated by taxation of other sources of wealth and income. Key (...) Words: patent system • welfarism • decreasing marginal productivity. (shrink)

Recent rulings from the US Supreme Court seem to have effectively narrowed the trend toward allowing patents on artificially produced natural products. All objects must have a structural quality and a genetic quality, and if both are the result of some human intention and meet the other criteria of patent (new, useful, and nonobvious) then they may be patentable. There are millions of natural phenomena that are duplicated by man. Products and processes are mutually exclusive categories. No product (...) is a process, and vice versa. This much, the patent law gets right. All objects are either products (continuants) or processes (occurants). There are two types of each: man‐made and natural, for the purposes of intellectual property law. Any discovery of a law or phenomenon of nature involves some degree of intention, some exercise of consciousness and directedness. (shrink)

Les informaticiens, qui sont les premiers à avoir travaillé à la conception du libre accès, ne s’en sont pas nécessairement saisis pour leurs propres pratiques de publication scientifique, privilégiant longtemps les échanges interindividuels. La question de l’accès ouvert se pose pour leurs productions de manière différente selon qu’il s’agit de conception de logiciels ou de publication de texte, de recherche industrielle ou publique, de secteurs brevetables, de données ouvertes ou non.Computer scientists, who were the first to work on open access (...) design, have not necessarily been its most fervent users in their own scientific publication practice, since they have long given preference to interpersonal exchanges. Concerning their output, the question of open access arises in different terms, depending on whether the context is software design, text publishing, industrial public research, patentable sectors, or open or restricted access data. (shrink)

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

The productivity gains generated by innovation are the root cause of long-term economic growth. In this paper, two empirical hypotheses are proposed to clarify our view: the trade turnover of technology market and intellectual property protection are important factors to stimulate innovation; The main channel of communication is through the increase of research staff and R&D funds. The empirical research result show that: The greater the technology trade volume, the greater the incentive to regional innovation activities, the greater the number (...) of regional patents; About the intellectual property protection, The higher the protection intensity is, the greater the incentive is to regional innovation activities and the greater the number of regional patents. Different from relevant researches, this paper discusses the decisive role of market activity and legal environment on regional innovation behavior from the perspective of technology trade and patent protection, and emphasizes the theoretical significance of market and legal system from a more general perspective. (shrink)

Gene patenting has captured the headlines for the past four years, thanks in large part to the lawsuit the American Civil Liberties Union and the Public Patent Foundation brought against Myriad Genetics for the patents on the breast cancer genes, BRCA 1 and 2. Despite their recent celebrity, human gene patents have been granted by the United States Patent and Trademark Office for over thirty years. The commodification of the human body is not all that recent: one might (...) be tempted to argue that gene patenting is the inevitable next step in the com-modification of natural processes and products. Edward Yoxen dates the origins of the technological capitalization of life back to the 1920s.. (shrink)