In response to the great crises of the COVID-19 coronavirus, virtually all new technologies protected by patent rights have been used in practice from diagnostics, therapeutic, medical equipment, and vaccine to prevention, tracking, and containment of COVID-19. However, the moral justification of patent rights is questioned when pharmaceutical patents conflict with public health. This paper proposes a revised approach of deciding on how to address the conflicts between business ethics and patent protections and then compares the different mechanisms of clearing (...) patent thickets. Our findings highlight that patent pledges may not only contribute to achieving the maximized substantive justice of the public but also help patent pledgors fulfill procedural justice. The advantages of patent pledges have attracted many patent holders to make public statements during the COVID-19 pandemic. In contrast, the disadvantages of a free license may make patent pledges not sustainable for a long time without the related supporting measures. Our findings will be helpful for policymakers or company managers to make an appropriate decision on rationally utilizing patent portfolios for fighting against public health crises. (shrink)

The EU offers a suitable milieu for the comparison and harmonisation of healthcare across different languages, cultures, and jurisdictions, which could provide improvements in healthcare standards across the bloc. There are specific ethico-legal issues with the use of data in healthcare research that mandate a different approach from other forms of research. The use of healthcare data over a long period of time is similar to the use of tissue in biobanks. There is a low risk to subjects but it (...) is impossible to gain specific informed consent given the future possibilities for research. Large amounts of data on a subject present a finite risk of re-identification. Consequently, there is a balancing act between this risk and retaining sufficient utility of the data. Anonymising methods need to take into account the circumstances of data sharing to enable an appropriate balance in all cases. There are ethical and policy advantages to exceeding the legal requirements and thereby securing the social licence for research. This process would require the examination and comparison of data protection laws across the trading bloc to produce an ethico-legal framework compatible with the requirements of all member states. Seven EU jurisdictions are given consideration in this critique. (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 main question explored by the book is: How can cross-border access to human genetic resources, such as blood or DNA samples, be governed in such a way as to achieve equity for vulnerable populations in developing countries? The book situates the field of genomic and genetic research within global health and research frameworks, describing the concerns that have been raised about the potential unfairness in exchanges during recent decades. Access to and sharing in the benefits of human biological resources (...) are aspects not regulated by any international legal framework such as the Convention on Biological Diversity, which applies only to the exchange of plants, animals and microorganisms, as well as to associated traditional knowledge. Examples of genetic research perceived as exploitative are provided in order to illustrate the legal vacuum concerning the global governance of human genetic resources. The main conclusions drawn from the legal and ethical analysis are: - Benefit sharing is crucial in order to avoid the exploitation of developing countries in human genetic research. - With functioning research ethics committees, undue inducement is less of a concern in genetic research than in other areas of medical research (e.g. clinical trials). - Concerns remain over research involving indigenous populations; accordingly, recommendations are provided. In drawing these conclusions, the book addresses in detail a highly pressing topic in global bioethics and international law. In this regard, it combines bioethical arguments with jurisprudence, in particular with reference to the law of equity and the legal concepts of duress (coercion), unconscionable dealing, and undue inducement. (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)

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)

The first stage of the human embryonic stem(ES) cell research debate revolved aroundfundamental questions, such as whether theresearch should be done at all, what types ofresearch may be done, who should do theresearch, and how the research should befunded. Now that some of these questions arebeing answered, we are beginning to see thenext stage of the debate: the battle forproperty rights relating to human ES cells. The reason why property rights will be a keyissue in this debate is simple and (...) easy tounderstand: it costs a great deal of money todo this research, to develop new products, andto implement therapies; and private companies,researchers, and health professionals requirereturns on investments and reimbursements forgoods and services. This paper considersarguments for and against property rightsrelating to ES cells defends the followingpoints: (1) It should be legal to buy and sellES cells and products. (2) It should be legalto patent ES cells, products, and relatedtechnologies. (3) It should not be legal tobuy, sell, or patent human embryos. (4) Patentson ES cells, products, and related technologiesshould not be excessively broad. (5) Patents onES cells, products, and related technologiesshould be granted only when applicants statedefinite, plausible uses for their inventions. (6) There should be a research exemption in EScell patenting to allow academic scientists toconduct research in regenerative medicine. (7)It may be appropriate to take steps to preventcompanies from using patents in ES cells,products, and related technologies only toblock competitors. (8) As the field ofregenerative medicine continues to develop,societies should revisit issues relating toproperty rights on a continuing basis in orderto develop policies and develop regulations tomaximize the social, medical, economic, andscientific benefits of ES cell research andproduct development. (shrink)

Some fundamental biotechnologies hold unprecedented potential to eradicate many incurable diseases. However, in absence of regulations, the power of patent makes the future use of some important biotechnology in few institution’s hands. The excessive patents restrict researcher access to the fundamental technologies. It generates concerns and complaints of deteriorating the public health and social welfare. Furthermore, intellectual curiosities, funding, respect among colleagues etc., rather than patents, are the real motivations driving a major ground-breaking discoveries in biotechnology. These phenomena reveal that (...) some biotechnology patents are alienated from the purpose of patent system. Therefore, it is necessary to take some approaches to stop over-patenting these fundamental biotechnology inventions. This article proposes a model regulatory framework for controlling biotechnology patent alienating from the purpose of patent system. (shrink)

DNA patents have been being granted since the 1970s. Patents are meant to act as incentives, encouraging innovation and dissemination in biotechnology by granting inventors exclusive economic control of their inventions for a set period of time. Governments in North America and Europe have therefore been using patents as a public policy tool to encourage the invention of health-related biotechnologies since the 1980s and 1990s, respectively. However despite this laudable policy goal, there have also in recent decades been a number (...) of controversies related to patenting in biotechnology. Commentators are concerned that patents may in fact be having a detrimental effect on innovation of and access to health-related products and processes. While empirical evidence that has been collected to date in relation to these concerns remains inconclusive, the debate may be clarified through the articulation of the rights and responsibilities that are at stake. The scope and content of a human right to healthcare are ultimately society-dependent, but its articulation can clarify whether instrumental property rights granted to inventors are interfering with this right in an unacceptable way. Intellectual property rights in health-related biotechnologies cannot be justified from a theoretical perspective, and so more definitive empirical data elucidating the role that patents play in regards to innovation and dissemination of health-related biotechnology is needed. (shrink)

Protection of intellectual property as well as its exploitation for monetary benefit have existed for centuries. However, commercialization of intellectual property had not entered the precincts of academic universities in a significant way until the introduction of the Bayh–Dole Act in the 1980s in the United States. The post–Bayh–Dole era has seen a quantitative increase in patenting activity in universities. This article summarizes the ethical conflicts ushered in by increasing commercialization of academic university research. Activities related to the protection and (...) commercial exploitation of intellectual property have led to changes in academic culture that have given room for debate between the puritans and the modernists. Issues contended by the two groups have been identified, and both sides of the argument are discussed. The key to achieving “responsible commercialization of research” is to balance the Bayh–Dole ethos with the traditional Mertonian norms of academic research. (shrink)

The scientific challenges and ethical controversies facing human embryonic stem cell (hESC) research continue to command attention. The issues posed by patenting hESC technologies have, however, largely failed to penetrate the discourse, much less result in political action. This paper examines U.S. and European patent systems, illustrating discrepancies in the patentability of hESC technologies and identifying potential negative consequences associated with efforts to make available hESC research tools for basic research purposes while at same time strengthening the position of certain (...) patent-holders' rights. Differences between the U.S. and the European contexts may in part explain why the course of hESC research in those jurisdictions ultimately diverges. Nevertheless, questions about whether and how patenting, related agreements, and licensing practices progress and shape the field of hESC research in both the U.S., Europe, and elsewhere must no longer be marginalised. These questions are fundamentally important in determining what benefits are likely to result from hESC research. Assuring these benefits is the moral issue with which patent systems are most intrinsically concerned, and that governments must begin to directly address rather than assume or ignore. (shrink)

În studiul Laviniei Marin, Universitatea şi problema proprietăţii intelectuale, este discutată problema actuală a tipului de universitate pe care îl presupune noua economie a cunoaşterii. Pornind de la interesul pentru cuantificarea performanţelor universităţilor şi stabilirea de ierarhii, autoarea ajunge la unele teme epistemologice privind reportul dintre cunoaşterea teoretică şi cunoaşterea practică şi cel dintre cunoaşterea explicită şi cunoaşterea tacită într-o societate în care însăşi cunoaşterea devine un capital, iar inovarea este modul în care se realizează performanţă.

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)

This paper is a critique of the current US patent system along general consequentialist lines. I present a pro tanto case against it because of its effects on scientific inquiry. The patent system is often thought to be justified because it provides incentives to innovate. I challenge this concern. Economists and legal scholars have spent a good portion of time analyzing particular aspects of the patent system. I here synthesize their work, showing how it amounts to a pro tanto moral (...) case against patents. This is the case even though patents are said to incentivize innovation, its disclosure, and its transfer to interested parties. I explore all of these possibilities, finding them to only weakly support the institution of patent rights. Juxtaposing this weak case for patents along with various problems that patents cause for science, we find a pro tanto case against our current patent system. To my knowledge, no one has tried to synthesize the various concerns I raise, with particular attention to not only the patent’s system purported ability to incentivize innovation, but also to disclose and transfer technology. (shrink)

Open source software production is a successful new innovation model which disproves that only private ownership of intellectual property rights fosters innovations. It is analyzed here under which conditions the open source model may be successful in general. We show that a complex interplay of situational, motivational, and institutional factors have to be taken into account to understand how to manage the ‘tragedy of the commons’ as well as the ‘tragedy of the anticommons’. It is argued that the success of (...) this new innovation model is greatly facilitated by a well balanced portfolio of intrinsic and extrinsic motivation, low costs for contributors and governance mechanisms that do not crowd out intrinsic motivation. (shrink)

Since the 1980s in the US and the 1990s in Europe, patenting and licensing activities by universities have massively increased. This is strongly encouraged by governments throughout the Western world. Many regard academic patenting as essential to achieve ‘knowledge transfer’ from academia to industry. This trend has far-reaching consequences for access to the fruits of academic research and so the question arises whether the current policies are indeed promoting innovation or whether they are instead a symptom of a pro-intellectual property (...) (IP) culture which is blind to adverse effects. Addressing this question requires both empirical analysis (how real is the link between academic patenting and licensing and ‘development’ of academic research by industry?) and normative assessment (which justifications are given for the current policies and to what extent do they threaten important academic values?). After illustrating the major rise of academic patenting and licensing in the US and Europe and commenting on the increasing trend of ‘upstream’ patenting and the focus on exclusive as opposed to non-exclusive licences, this paper will discuss five negative effects of these trends. Subsequently, the question as to why policymakers seem to ignore these adverse effects will be addressed. Finally, a number of proposals for improving university policies will be made. (shrink)

In this paper, we explore the perspectives of expert stakeholders about who owns data in a medical information commons and what rights and interests ought to be recognized when developing a governance structure for an MIC. We then examine the legitimacy of these claims based on legal and ethical analysis and explore an alternative framework for thinking about participants' rights and interests in an MIC.

Evaluation studies of the Bayh-Dole Act are generally concerned with the pace of innovation or the transgressions to the independence of research. While these concerns are important, I propose here to expand the range of public values considered in assessing Bayh-Dole and formulating future reforms. To this end, I first examine the changes in the terms of the Bayh-Dole debate and the drift in its design. Neoliberal ideas have had a definitive influence on U.S. innovation policy for the last thirty (...) years, including legislation to strengthen patent protection. Moreover, the neoliberal policy agenda is articulated and justified in the interest of competitiveness. Rhetorically, this agenda equates competitiveness with economic growth and this with the public interest. Against that backdrop, I use Public Value Failure criteria to show that values such as political equality, transparency, and fairness in the distribution of the benefits of innovation, are worth considering to counter the policy drift of Bayh-Dole. (shrink)

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

Matthew Rimmer, ACIPA, The Australian National University, College of Law, Canberra, ACT, 0200, Australia. Tel.: (02) 61254164; Email: matthew.rimmer{at}anu.edu.au ' + u + '@' + d + ' '//--> Abstract This article considers the significance of the first export of essential medicines under the WTO General Council Decision 2003. In July 2007, Rwanda became the first country to provide a notification under the WTO General Council Decision 2003 of its intent to import a fixed-dose, triple combination HIV/AIDS drug manufactured by (...) the Canadian generic pharmaceutical manufacturer Apotex, Inc. In September 2007, Apotex was granted the first compulsory licence application under Canada's Access to Medicines Regime. This article considers the convoluted and protracted negotiations between the Government of Rwanda, Apotex and three patent holders, GlaxoSmithKline, Boehringer Ingleheim Canada and Shire BioChemical, Inc. It questions the efficiency of this process. This article considers the review of the Jean Chrétien Pledge to Africa Act 2004 (Canada). It is critical of the refusal of the Conservative Government of Canada to make any amendments to the legislation to improve the cost-effective delivery of essential medicines. This article queries the proposed Hong Kong Amendment to the TRIPS Agreement 1994, given the concerns of the Africa Group. It is submitted that it is undesirable to codify the WTO General Council Decision 2003, given its failure to provide a speedy, efficient and cost-effective delivery of essential medicines. CiteULike Connotea Del.icio.us What's this? (shrink)

This paper addresses an apparent dilemma that must be resolved in order to respond ethically to global climate change. The dilemma can be presented as follows. Responding ethically to global climate change requires technological innovation that is accessible to everyone, including inhabitants of the least developed countries. Technological innovation, according to many, requires strong intellectual property protection, but strong intellectual property protection makes it highly unlikely that patent-protected technologies will be accessible to developing countries at affordable prices. Given this, responding (...) ethically to global climate change is highly unlikely. I argue that this apparent dilemma – which I call ‘the patent dilemma in global climate change’ – should be taken seriously. I discuss a number of possibilities for resolving it, and I argue that any acceptable strategy must satisfy the criteria of near-term feasibility and non-paternalism. Finally, I propose a multi-pronged, multi-tiered strategy that meets these conditions. (shrink)

Progress in gene sequencing could make rapid whole genome sequencing of individuals affordable to millions of persons and useful for many purposes in a future era of genomic medicine. Using the idea of $1000 genome as a focus, this article reviews the main technical, ethical, and legal issues that must be resolved to make mass genotyping of individuals cost-effective and ethically acceptable. It presents the case for individual ownership of a person's genome and its information, and shows the implications of (...) that position for rights to informed consent and privacy over sequencing, testing, and disclosing genomic information about identifiable individuals. Legal recognition of a person's right to control his or her genome and the information that it contains is essential for further progress in applying genomic discoveries to human lives. (shrink)

The comprehension of living organisms in all their complexity poses a major challenge to the biological sciences. Recently, systems biology has been proposed as a new candidate in the development of such a comprehension. The main objective of this paper is to address what systems biology is and how it is practised. To this end, the basic tools of a systems biological approach are explored and illustrated. In addition, it is questioned whether systems biology ‘revolutionizes’ molecular biology and ‘transcends’ its (...) assumed reductionism. The strength of this claim appears to depend on how molecular and systems biology are characterised and on how reductionism is interpreted. Doing credit to molecular biology and to methodological reductionism, it is argued that the distinction between molecular and systems biology is gradual rather than sharp. As such, the classical challenge in biology to manage, interpret and integrate biological data into functional wholes is further intensified by systems biology’s use of modelling and bioinformatics, and by its scale enlargement. (shrink)

In Het kapitaal beschreef Karl Marx in uiterst schrille kleuren de voorgeschiedenis van de kapitalistische productiewijze. Het was een langdurig proces dat zich over eeuwen uitstrekte en waarbij kleine boeren op gewelddadige wijze van hun primaire productiemiddel, de grond, werden gescheiden en aldus in 'vrije' loonarbeiders veranderd. De kern van dit proces was de privatisering van de meent of commons, de traditioneel voor gemeenschappelijk gebruik bestemde grond.

This article claims that an ‘enclosure of the commons’ is underway, which reaches far beyond intellectual property, to a point where, through profiling, ‘identity’ has itself become enclosed property that can be owned by another. With a detour through the natures of both money and innovation, this paper looks at the imperative driving ‘intellectual property rights.’ By introducing the notion of biopiracy, it shows how ‘invasion of privacy’ is justified, and ends with “a world of rapacious, state-aided ‘privatization’” of enclosed (...) identity: the ultimate identity theft. (shrink)

Profiling technologies are the facilitating force behind the vision of Ambient Intelligence in which everyday devices are connected and embedded with all kinds of smart characteristics enabling them to take decisions in order to serve our preferences without us being aware of it. These technological practices have considerable impact on the process by which our personhood takes shape and pose threats like discrimination and normalisation. The legal response to these developments should move away from a focus on entitlements to personal (...) data, towards making transparent and controlling the profiling process by which knowledge is produced from these data. The tendency in intellectual property law to commodify information embedded in software and profiles could counteract this shift to transparency and control. These rights obstruct the access and contestation of the design of the code that impacts one’s personhood. This triggers a political discussion about the public nature of this code and forces us to rethink the relations between property, privacy and personhood in the digital age. (shrink)

In order to take ethical considerations of patenting biological material into account, the so-called “ordre public or morality clause” was implemented as Article 6 in the EC directive on the legal protection of biotechnological inventions, 98/44/EC. At first glance, this seems to provide a significant advantage to the European patent system with respect to ethics. The thesis of this paper argues that the ordre public or morality clause does not provide sufficient protection against ethically problematic uses of the patent system (...) within the area of life. On the contrary, there are worrisome obstacles to any effective and comprehensive critical analysis of the ethical aspects of bio-patenting, especially in the field of agriculture. These obstacles can be seen as indirect consequences of the implementation of ethical considerations in form of the ordre public and morality clause in the EC Directive. Therefore, Article 6 of the EC Directive on the legal protection of biotechnological inventions seems to ultimately weaken the position of ethics in the debate concerning bio-patenting because the ordre public and morality clause is usually interpreted in an exclusively bio-ethical way in the sense of an “intrinsic ethics,” which is primarily interested in questions regarding the moral status of particular entities. It is argued that an important cause of this phenomenon is that the decisive reasons against bio-patenting are concerns of social ethics, and not bio-ethics. (shrink)

The dramatic and ongoing changes in the funding of science have stimulated interest in an economics of scientific knowledge, which would investigate the effects of these changes on the scientific enterprise. Hands has previously explored the lessons for such an ESK from the existing precedent of the sociology of scientific knowledge. In particular, he examines the philosophical problems of SSK and those that any ESK in its image would face. This paper explores this argument further by contending that more recent (...) literature in SSK exposes even deeper philosophical problems than those identified by Hands. Meaning finitism has emerged as the philosophical core of SSK. An examination of the profound problems with this position is used to show that an underlying extensionalism is the root of SSK's intractable philosophical difficulties, and to illustrate the entirely different approach of a critical philosophy that is advocated in its place. In this way, the project of an ESK is shown to depend upon a critical philosophy. (shrink)

When we talk about intellectual property, it is often implicitly assumed that we are talking about private intellectual property. However, private property and the idea of private ownership do not exhaust the possibilities for accounts of ownership and of property. There are other ways that ownership can operate, such as common property. A resource is common property if its use is ‘governed by rules whose point is to make them available for use by all or any members of the society.’.

Biotechnology and nanotechnology are both strategic technologies, and the former provides several lessons that could contribute to more successful embedding and integration processes for the latter. This article identifies some of the key questions emerging from the biotechnology experience and summarizes several lessons learned in the context of constructive technology assessment. This approach broadens the range of social considerations relevant to the sustainable development of nanotechnology and emphasizes the need for developing social tools for nanotechnology innovation while the technology is (...) in its early stages of design. (shrink)

In the opening years of the 21st century, it became fashionable to describe the human genome as belonging to the common heritage of humanity. The United Nations, in its Universal Declaration on the Human Genome and Human Rights, now identifies the human genome as part of the common heritage, as does the international Human Genome Organization and the Council of Europe. The common heritage concept has played a prominent role in arguments against patenting the human genome or portions thereof. This (...) essay considers whether the common heritage designation will advance the political and legal goals of its proponents. (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)

Systems biology is the rapidly growing and heavily funded successor science to genomics. Its mission is to integrate extensive bodies of molecular data into a detailed mathematical understanding of all life processes, with an ultimate view to their prediction and control. Despite its high profile and widespread practice, there has so far been almost no bioethical attention paid to systems biology and its potential social consequences. We outline some of systems biology's most important socioethical issues by contrasting the concept of (...) systems as dynamic processes against the common static interpretation of genomes. New issues arise around systems biology's capacities for in silico testing, changing cultural understandings of life, synthetic biology, and commercialization. We advocate an interdisciplinary and interactive approach that integrates social and philosophical analysis and engages closely with the science. Overall, we argue that systems biology socioethics could stimulate new ways of thinking about socioethical studies of life sciences. (shrink)

We introduce the papers in this special issue by providing an overarching perspective on the variety in kinds of commons and the ethical issues stemming from their diversity. Despite a long history of local commons management, recent decades have witnessed a surge of scholarly interest in the concept of “the commons,” including a growing management literature. This swell was impelled especially by Garrett Hardin’s paper of 1968, and the body of work generated by Elinor Ostrom and her colleagues. However, the (...) term itself has come to be used in a variety of ways. To contextualize its ethical dimensions, we map a number of commons-related concepts such as common-pool resources, common property regime, excludability and subtractability, common-pool resource types and commons or “commoning” as a source of production. Following a brief summary of papers in this special issue, the essay concludes with an identification of implications for research, practice and policy. (shrink)

Drawing on a landscape analysis of existing data-sharing initiatives, in-depth interviews with expert stakeholders, and public deliberations with community advisory panels across the U.S., we describe features of the evolving medical information commons. We identify participant-centricity and trustworthiness as the most important features of an MIC and discuss the implications for those seeking to create a sustainable, useful, and widely available collection of linked resources for research and other purposes.

The common discourse on intellectual property rights rests mainly on utilitarian ground, with implications on the question of justice as well as moral significance. It runs like this: Intellectual property rights are to reward the originators for his/her intellectual labour mainly in monetary terms, thereby providing incentives for originators to engage in future innovative labouring. Without such incentives, few, if not none, will engage in creative activities and the whole human community will, thereby, suffer because of reduced inventions. However, such (...) utilitarian argument on piracy as de-motivation may not be necessarily justified. In fact, intellectual property arrangement is one among different institutions concerning how the society may handle new ideas and creative works. In reality, private ownership over one's intellectual product is merely a modern western concept that is being ' advertised' as being normative, which, by itself, is highly debatable. Alarming still, such normative argument assumes both justness and moral dimensions. This article will analyse whether such argument is philosophically sound. (shrink)

This article integrates previously missing components of government quality into the governance-piracy nexus in exploring governance mechanisms by which global obligations for the treatment of IPRs are effectively transmitted from international to the national level in the battle against piracy. It assesses the best governance tools in the fight against piracy and upholding of intellectual property rights (IPRs). The instrumentality of IPR laws (treaties) in tackling piracy through good governance mechanisms is also examined. Findings demonstrate that: (1) while all governance (...) tools under consideration significantly decrease the incidence of piracy, corruption-control is the most effective weapon; (2) but for voice and accountability, political stability and democracy, IPR laws (treaties) are instrumental in tackling piracy through government quality dynamics of rule of law, regulation quality, government effectiveness, corruption-control, and press freedom. Hence, the need for a policy approach most conducive to expanding development is to implement an integrated system of both IPRs and corollary good governance policies. Moreover, our findings support the relevance of good governance measures in developing countries wishing to complement their emerging IPR regimes. (shrink)

With closer interactions between academic and commercial entities the role of the university is expanding to also include knowledge transferIn the biomedical and health sciences , close interactions between academic and commercial entities are now common place. Funds from pharmaceutical and biotechnology companies have helped finance major bioscience projects and research centres, graduate students are receiving training in commercial laboratories, and university scientists are translating their ‘intellectual property’ by patenting their research and launching start-up companies. And this is happening with (...) the blessing of universities, who see the commercialisation of research – and the royalties brought in from ‘technology transfer’ – as part of their new mission.The result is that no longer are universities simply places of higher learning, where academics are dedicated to teaching and research, traditionally the ‘first’ and ‘second’ missions of universities; universities now have a ‘third’ mission, to engage in knowledge transfer. Governments and research-intensive industries , are keen to translate university research into marketable products. Facilitated by policies and laws to protect intellectual property rights and aid commercialisation, universities are transforming into ‘entrepreneurial’ institutions.1 University administrators seek to generate new funding streams, while governments see universities as drivers of technology development and economic growth. In such a climate, it should not be surprising that researchers in many disciplines are facing pressure to collaborate …. (shrink)

The presence of experts holding patents and simultaneously providing policy advice on areas where they hold patents pose several normative questions. Through a comparative study of several IPCC reports, this article documents the scope of this phenomenon and discusses it with respect to a theory of conflict of interest. Seemingly, it is more likely to be patent-holders on issues of infrastructures, industry and transport rather than for single technologies as such. According to insights from studies on conflict of interest, there (...) is an increased risk for bias. The article investigates the possible relations between patenting and conflicts of interest according to theoretical and empirical insights from the relation between science and society. (shrink)

The present is a moment of crisis and transition, both generally and specifically in “knowledge” and its institutions. Acknowledging this elicits the key questions: where are we? Where are we headed? What, if anything, can be done about this? And what can the “economics of science” contribute to this? This paper assumes a “cultural political economy of research & innovation” perspective to explore the current upheaval and transition in the system of academic knowledge production, at the confluence of accelerating commercialisation (...) and the seemingly opposing movement of “open science.” This perspective affords a characterisation of the core of the current crises as a crisis of moral economy; an issue to which a political economy of epistemic authority is in turn crucial. A “remoralizing” of knowledge production is thus a matter of key systemic importance, though it is important to understand such developments in power-strategic, and not explicitly moral, terms. Much of the current moves towards “open science” and “massively open online courses” can also then be seen as self-defeating developments that simply exacerbate the crisis of a viable “economy of science” and in no sense its solution. Their lasting significance, however, is more likely to lie precisely in their effects on the construction of a new moral economy of knowledge production. (shrink)

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