Following the 1980 US Supreme Court decision to allow a patent on a living organism, debate has continued on the moral issues involved in biotechnology patents of many kinds and remains a contentious issue for those opposed to the use of biotechnology in industry and agriculture. Attitudes to patenting in the life sciences, including those of the research scientists themselves, are analysed. The relevance of morality to patent law is discussed here in an international context with particular reference (...) to the law of the European Patent Convention administered by the European Patent Office (EPO). The EPO has been the principal forum for opposition to such patents and the few cases under dispute in the EPO are reviewed, including patents for the onco-mouse, human relaxin gene, and the PGS herbicidally resistant plant (gmo). Morality provisions in the European Parliament and Council Directive 98/44/EC are also summarised. (shrink)

ABSTRACTMore than a third of the world's population has no access to essential drugs. More than half of this group of people live in the poorest regions of Africa and Asia. Several factors determine the accessibility of drugs in developing countries. Hardly any medicines for tropical diseases are being developed, but even existing drugs are often not available to the patients who need them.One of the important determinants of access to drugs is the working of the patent system. This (...) paper first maps out some facts about the global patent regime that has emerged as a consequence of the conclusion of the WTO‐TRIPs Agreement in 1994. Attempts to construct a moral justification of the patent system have been based on three grounds: natural rights, distributive justice, and utilitarian arguments. This paper examines to what extent and on which grounds drug patents can be justified. The final section looks at the so‐called ‘Doha Declaration on the TRIPs Agreement and Public Health’, which was adopted by the WTO Ministerial Conference two years ago, recognising the primacy of public health over the interests of patent proprietors. (shrink)

More than a third of the world's population has no access to essential drugs. More than half of this group of people live in the poorest regions of Africa and Asia. Several factors determine the accessibility of drugs in developing countries. Hardly any medicines for tropical diseases are being developed, but even existing drugs are often not available to the patients who need them.One of the important determinants of access to drugs is the working of the patent system. This (...) paper first maps out some facts about the global patent regime that has emerged as a consequence of the conclusion of the WTO‐TRIPs Agreement in 1994. Attempts to construct a moral justification of the patent system have been based on three grounds: natural rights, distributive justice, and utilitarian arguments. This paper examines to what extent and on which grounds drug patents can be justified. The final section looks at the so‐called ‘Doha Declaration on the TRIPs Agreement and Public Health’, which was adopted by the WTO Ministerial Conference two years ago, recognising the primacy of public health over the interests of patent proprietors. (shrink)

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

Much international debate over access to medicines focuses on whether patent law accords with international human rights law. This article argues that this is the wrong question to ask. Following an analysis of both patent and human rights law, this article suggests that the better approach is to focus on national debates over the best calibration of patent law to achieve national objectives.

Patents and free trade make strange bedfellows. For most of their history, patents have been instruments deployed to resist trade with other countries, not to enhance it. Whether one looks at Venetian laws that punished citizens who practiced local crafts outside the city, the Mercantilist uses to which patents were put in Elizabethan England, or the cartels of the 19th and 20th centuries created on a foundation of interlocking patent rights, patents have had a distinctly protectionist function. It is (...) thus ironic that it is intellectual property rights in general, and patents in particular, that have been held up in recent years as the poster child of much that is wrong with globalization and free trade. Nowhere is this more so than in debates concerning international human rights law and patents, in particular the position that patents violate an international right to health. (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.

Considerable controversy has recently arisen regarding the patenting of medical and surgical processes in the United States. One such patent, viz. for a "chevron" incision used in ophthalmologic surgery, has especially occasioned heated response including a major, condemnatory ethics policy statement from the American Medical Association as well as federal legislation denying patent protection for most uses of a patented medical or surgical procedure. This article identifies and discusses the major legal, ethical and public policy considerations offered by (...) proponents and opponents of such patents. The existing literature divides up into those who favor such patents essentially without qualification, and those who condemn and wish to outlaw them. We advance a compromise position where administrative and legislative action is called for to provide more specific guidelines regarding the patentability of such processes by the Patent and Trademark Office. Our position, in sum, will be that too much is at stake in this complicated area for either the blanket prohibition, or wholesale, uncritical acceptance, of the patenting of medical and surgical processes or techniques. (shrink)

In patent law most of the crucial legal questions such as patentability and infringement are linked to the patent claims. The European Patent Office regards patent claims as a set of independent features which are examined separately in a more or less formal way. The author has found that this approach allows for developing a simple mathematical model which treats patent claim features as logical statements and patent claims as compound statements wherein the individual (...) statements are connected by logical connectives. The proposed mathematical model provides a uniform system for examining various legal questions that are dealt with separately under current case law, moreover, it allows for developing an expert system for resolving complex legal situations and for automating the evaluation of a large number of patent claim variants that is currently not possible. (shrink)

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

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)

The momentum of advances in biology is evident in the history of patents on life forms. As we proceed forward with greater understanding and technological control of developmental biology there will be many new and challenging dilemmas related to patenting of human parts and partial trajectories of human development. These dilemmas are already evident in the current conflict over the moral status of the early human embryo. In this essay, recent evidence from embryological studies is considered and the unbroken continuity (...) of organismal development initiated at fertilization is asserted as clear and reasonable grounds for moral standing. Within this frame of analysis, it is proposed that through a technique of Altered Nuclear Transfer, non-organismal entities might be created from which embryonic stem cells could be morally procured. Criteria for patenting of such non-organismal entities are considered. (shrink)

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

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

A patent is a property granted to any new shape, configuration or arrangement of elements, of any device, tool, instrument, mechanism or other object or part thereof, that allows for a better or different operation, use or manufacture of the object that incorporates it or that provides it with some utility, advantage or technical effect that it did not have before. As a document, a patent really is a title that recognizes the right to exploit the patented invention (...) exclusively, preventing others from making, selling or using it without the consent of the owner. The fact of making a patent is motivated by the fact of promoting creativity, hindering competition in the market as only one person holds the patent, thus protecting the initial investment and fighting against plagiarism. Patents are available to the public for dissemination and general knowledge. It is generally recognized in the specialized literature that patents can be used as an indicator to calculate the results generated by research and development activities, being a very useful indicator to measure various social, economic or technological aspects. For this reason, it is of relevant interest to have tools or systems that allow us to obtain the patents developed in a specific period of time and to carry out analyses of various economic and social factors. These analyses can serve to obtain a social perspective of society’s progress in the technological field, and this is why an analysis of patents is of our interest. This paper proposes a platform specifically designed to obtain knowledge about patents as an indicator of Spanish social, economic or technological aspects. For this purpose, the platform retrieves, analyses and visualizes functionalities that represent data on the landscape of patents obtained from the Spanish Patent and Trademark Office as a particular case of study. (shrink)

This article discusses the emergence of a patenting culture in university science. Patenting culture is examined empirically in the context of the increasing commerciali zation of science, and theoretically within debates over scientific "credibility." The article explores the translation of academic credit into patents, and vice versa, and argues that this process raises new questions for our understanding of scientific recognition and of scientists' networks. In particular, the analysis suggests that scientists must move between two distinct social worlds to (...) manage the rewards that academic and patent cultures carry. (shrink)

Criticisms of patent laws for technological innovations in the United States reveal a multifaceted milieu of problems centered around the protection of short-term economic gain and individual property rights. In this article, we consider this a conflict between current patent laws and the innovation capabilities of organizations. We propose a solution that enables the company to assure its long-term survival in the face of these restrictions. This presumes that the firm will at least maintain its innovation capacities while (...) preserving the company's ethical values and those of its social environment. We offer a theoretical model that is designed to help managers and policymakers reorient their governance strategies for managing the innovation process, using the “ethics of responsibility,” which establishes the link to individual moral values at the beginning of a governance process as well as the consequences of a decision. Our integrated causal model of ethical innovation for patents is presented and implications for global organizations and possible solutions for patent law process failure are offered. (shrink)

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

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)

Regardless of the increased interest in technological innovation in universities, relatively little is known about the technology developed by academic scientists. Long-term analyses of researchers’ technological contribution are notably missing. This paper examines university-based technology in Finland during the period 1900–85. The focus is on the quantity and technological specialization of applications created inside the universities and in the changes that occurred in scientists’ technological output over nine decades. In the long-term analysis several aspects in universities’ technological contribution, which (...) are typically considered a recent phenomenon, turn out to have long historical roots. Thus the empirical evidence provided in the article challenges views emphasising that the world of science has faced a drastic change in recent decades. (shrink)

This article examines the assertion that human embryonic stem cells patents are immoral because they violate human dignity. After analyzing the concept of human dignity and its role in bioethics debates, this article argues that patents on human embryos or totipotent embryonic stem cells violate human dignity, but that patents on pluripotent or multipotent stem cells do not. Since patents on pluripotent or multipotent stem cells may still threaten human dignity by encouraging people to treat embryos as property, patent (...) agencies should carefully monitor and control these patents to ensure that patents are not inadvertently awarded on embryos or totipotent stem cells. (shrink)

Compensation rules for patent infringement greatly affect patent quality, which is closely related to R & D investments. In this study, A duopoly game model was developed to analyze innovative factories’ R&D investment and patent licensing behavior, as well as the strategic choices of potential infringers under different compensation rules for patent infringement. Furthermore, a comparative analysis was conducted to analyze the patent quality under different scenarios, ultimately finalizing an optimal sequence rule for (...) class='Hi'>patent infringement compensation. The results show that patent quality is influenced by the invention height of patent and R&D efficiency, while the amount of patent infringement compensation has a great effect on potential infringement behavior. Patent quality can be effectively improved if the court adopts a proper sequence rule for patent infringement compensation according to the market circumstances. (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)

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

The 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)

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

As universities are increasingly called by their national governments for a more entrepreneurial management of public research results, they started to develop internal structures and policies to take a proactive role in the commercialisation of university research. For the first time, this paper presents a detailed chronicle of how country-level reforms on Intellectual Property Rights were translated into organisation-level mechanisms to regulate university-patenting activity. The analysis is based on the complete list of patent policies issued between 1993 and (...) 2009 by the population of Italian universities. Our evidence suggests that universities first dealt with legislative changes on IPRs by enacting isomorphic behaviours, then by creating a community of practices, and finally by leveraging on such community to influence government reforms on IP-related matters. We discuss our results in the light of institutional theory and public policy. (shrink)

Amazon’s projects for future automation contribute to anxieties about the marginalization of living labor in warehousing. Yet, a systematic analysis of patents owned by Amazon suggests that workers are not about to disappear from the warehouse floor. Many patents portray machines that increase worker surveillance and work rhythms. Others aim at incorporating workers’ activities into machinery to rationalize the labor process in an ever more pervasive form of digital Taylorism. Patents materialize the company’s desire for a technological future in (...) which workers act and sense on behalf of machinery, becoming its living and sensing appendages. In this new relationship, humans extend machinery and its reach. Through the work-in-progress process of reaching increasing levels of automation, Amazon develops new technical foundations that consolidate its power in the digital workplace. (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 (...) class='Hi'>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 nature and status of cultural evolution and its connection with biological evolution are controversial in part because of Richard Dawkin’s suggestion that the scientific study of culture should include “memetics,” an analog of genetics in which genes are replaced by “memes”—the hypothetical units of cultural evolution. Memetics takes different forms; I focus on its minimal form, which claims merely that natural selection shapes to some extent the evolution of some aspects of culture. Advocates and critics of memetics disagree about (...) the scientific status of memetics, but they agree that memetics must face the following fundamental problems. Problem 1: Cultural evolution differs too much from biological evolution. Problem 2: Culture is too complex. Problem 3: Memes are too difficult to identify and track. Problem 4: Memetics produces only trivial results. This paper examines these problems in the context of a minimal memetic analysis in one specific context: patented inventions. Technology is a special subset of culture, and patented inventions are a special subset of technology—not least because there is a detailed written record of every patent. I describe four recent empirical results on technological innovation derived from memetic analysis of the patent record. Result 1: Inkjet printing, PCR, and stents are key drivers of technological innovation. Result 2: Patent genealogies are tangled and incestuous. Result 3: Door-opening innovations drive the evolution of technology. Result 4: The evolving content of the drivers of innovation confirms the importance of inkjet printing, PCR, and stents, among other inventions. These results show that minimal memetics can provide a novel and illuminating analysis the evolution of patented technology. Furthermore, this memetic analysis can answer all of the main problems with memetics. Problem 1 can be dismissed because culture and biology can be quite disanalogous, provided that natural selection still operates in both. Problem 2 is a mirage, because memetic analysis of the patented inventions is consistent with the full richness and complexity of the evolution of technology. Problem 3 is easy to solve, because the patent record makes it trivial to identify and track patents and their key traits through lineages. Problem 4 can be fully answered only after memetic analysis becomes widespread, but the results reviewed here shows that minimal memetics does yield scientific results that are nontrivial and interesting. (shrink)

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

This paper uses John Rawls' theory of justice to defend the patent system against charges that it has an unfair effect on access to medications, from the perspective of national and international justice. The paper argues that the patent system is fair in a national context because it respects intellectual property rights and it benefits the least advantaged members of society by providing incentives for inventors, investors, and entrepreneurs. The paper also argues that the patent system is (...) fair in an international context, provided that developed nations take steps to help disease-stricken countries secure internal justice. Fairness in a national or international context also requires that the patent system should include emergency exceptions to deal with short-term inequities. (shrink)

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

Neodevelopmental patent regimes aim to facilitate local actors’ access to knowledge and also encourage incremental innovations. The case of pharmaceutical patent examination in Brazil illustrates political contradictions between these objectives. Brazil’s patent law includes the Ministry of Health in the examination of pharmaceutical patent applications. Though widely celebrated as a health-oriented policy, the Brazilian experience has become fraught with tensions and subject to decreasing levels of both stability and enforcement. I show how one pillar of the (...) neodevelopmental regime, the array of initiatives to encourage incremental innovations, has fostered the acquisition of innovative capabilities in the Brazilian pharmaceutical sector, and how these new capabilities have altered actors’ policy preferences and thus contributed to the erosion of the coalition in support of the other pillar of the neodevelopmental regime, the health-oriented approach to examining pharmaceutical patents. The analysis of capability-derived preference formation points to an endogenous process of coalitional change. (shrink)

Natural language processing is a critical part of the digital transformation. NLP enables user-friendly interactions between machine and human by making computers understand human languages. Intelligent chatbot is an essential application of NLP to allow understanding of users’ utterance and responding in understandable sentences for specific applications simulating human-to-human conversations and interactions for problem solving or Q&As. This research studies emerging technologies for NLP-enabled intelligent chatbot development using a systematic patent analytic approach. Some intelligent text-mining techniques are applied, including (...) document term frequency analysis for key terminology extractions, clustering method for identifying the subdomains, and Latent Dirichlet Allocation for finding the key topics of patent set. This research utilizes the Derwent Innovation database as the main source for global intelligent chatbot patent retrievals. (shrink)

Is the market civilizing or destructive? The increased salience of science commercialization is forcing scientists to address this question. Benefiting from the sociology of morality literature’s increased attention to specific kinds of morality and engaging with economic sociology’s moral markets literature, we generate competing hypotheses about scientists’ value-driven attitudes toward patenting. The Civilizing Market thesis suggests scientists who prioritize universalism will tend to support patenting. The Destructive Market thesis, by contrast, suggests universalism will be correlated with opposition to patenting. We (...) analyze survey data from biologists and physicists nested within academic organizations, which are nested within the following regions: France, Hong Kong, India, Italy, Taiwan, Turkey, UK, and the USA. Employing multilevel analysis, we find correlational evidence to support the Destructive Market thesis. Universalism is associated with anti-patenting attitudes, suggesting scientists expect patenting to have deleterious effects on science and society. We end with a discussion of this article’s implications for the moral markets literature, sociology of morality and business ethics. (shrink)

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

The 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)

There is an increasing interest in scanning and assessing the science and technology landscape for emerging technologies - such as those based on genomics knowledge - because innovations are beneficial to businesses and nations, and because of the Collingridge dilemma. The latter concerns the uncertainty and manageability of technology in its early development phases versus the more solidified later stages. In this context, the assessment of upcoming scientific and technological (sub)fields or "hot spots" is of interest. In this paper we (...) focus on methods to identify hot spots in pharmacogenomics and nutrigenomics and how this method can contribute to policy strategies. Moreover, the bibliometric results contribute to our understanding of hot spots within these genomics subfields. We answer the following leading research question: What are the main research fields of emerging pharmacogenomics and nutrigenomics technologies and how do these impact policy strategies? First, this paper introduces a novel method for identifying hot spots in emerging technologies. Following this method, pharmacogenomics and nutrigenomics show an above-average growth in patent applications. Patent search also suggests that for pharmacogenomics, countries such as Italy and France, and subfields such as cancer genomics are highly visible. For nutrigenomics, the Netherlands and Austria are important countries, while the dairy subfield proves to be a hot spot. Second, we discuss implications for policy strategies. We argue that it is difficult for policymakers to follow hot spots when they design their policy, because of the inherent tendency to "nurture" winners instead of "picking" fundamental new winners. Policymakers should be aware of this bias and research should address this issue by, for example, complementing the hot spot analysis with more interactive methods. (shrink)

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

In the era of the knowledge economy, the improvement of national innovation systems is playing a significant role in the global entrepreneurship ecosystem. Entrepreneurs are accelerating international intellectual property applications to be competitive. What remains to be explored is the evolution of international intellectual property network in the globe. With the application of social network analysis and intellectual property application database, the global innovation network structure from 2000 to 2019 is explored. Results showed that in the period 2000–2019, the (...) global innovation network has been expanding rapidly from a sparse network to a dense and complex one. Patent application is unevenly distributed in the globe. Countries such as the US, China, and Canada have been the top countries flowing in, while Japan, Korea, EU, and Switzerland have been the main countries flowing out. Global innovation network shows an obvious “core-periphery” pattern. The distribution pattern presents a quadrilateral structure with the four core regions of “US, Japan, EU, and China” as the apex. This analysis contributes to the visualization of the global layout of intellectual property and the evolution trend by analyzing intellectual property application networks. This can provide important experience reference for enterprises to study the global entrepreneurship ecosystem. (shrink)

In a Special Issue of Discourse Studies titled ‘The Epistemics of Epistemics’, contributing authors criticize Heritage’s research on participants’ orientations to, and management of, the distribution of knowledge in conversation. These authors claim that the analytic framework Heritage developed for analyzing epistemic phenomena privileges the analysts’ over the participants’ point of view, and rejects standard methods of conversation analysis ; that and are adopted in developing and defending the use of abstract analytic schemata that offer little purchase on either (...) the specific actions speakers accomplish or the understanding others display of them; and that, by virtue of these deficiencies, claims about the systematic relevance of epistemic phenomena for talk-in-interaction breach long-standing norms regarding the relationship between data analysis and generalizing claims. Using a collection of excerpts bearing on the import of epistemics for action formation and action sequencing, I demonstrate that these claims are patently false and suggest that they reflect the authors’ effort to recast CA as a kind of fundamentalist enterprise. I then consider excerpts from a second collection to illustrate how the form of social organization described by Heritage can be used to explicate other phenomena that depend on systematic alterations to its basic features. In conclusion, I suggest that CA’s success in enhancing our grasp of the organization of talk-in-interaction derives from its unique commitment to both generalization and context specificity, collections and single cases, findings plus a continual openness to the ‘something more’ that each particular case can provide. (shrink)

Two property regimes for software development may be distinguished. Within corporations, on the one hand, a Private Regime obtains which excludes all outsiders from access to a firm's software assets. It is shown how the protective instruments of secrecy and both copyright and patent have been strengthened considerably during the last two decades. On the other, a Public Regime among hackers may be distinguished, initiated by individuals, organizations or firms, in which source code is freely exchanged. It is argued (...) that copyright is put to novel use here: claiming their rights, authors write `open source licenses' that allow public usage of the code, while at the same time regulating the inclusion of users. A `regulated commons' is created. The analysis focuses successively on the most important open source licenses to emerge, the problem of possible incompatibility between them (especially as far as the dominant General Public License is concerned), and the fragmentation into several user communities that may result. (shrink)

Introduction Financial conflicts of interest (fCOI) present well documented risks to the integrity of biomedical research. However, few studies differentiate among fCOI types in their analyses, and those that do tend to use preexisting taxonomies for fCOI identification. Research on fCOI would benefit from an empirically-derived taxonomy of self-reported fCOI and data on fCOI type and payor prevalence.Methods We conducted a content analysis of 6,165 individual self-reported relationships from COI statements distributed across 378 articles indexed with PubMed. Two coders (...) used an iterative coding process to identify and classify individual fCOI types and payors. Inter-rater reliability was κ = 0.935 for fCOI type and κ = 0.884 for payor identification.Results Our analysis identified 21 fCOI types, 9 of which occurred at prevalences greater than 1%. These included research funding (24.8%), speaking fees (20.8%), consulting fees (18.8%), advisory relationships (11%), industry employment (7.6%), unspecified fees (4.8%), travel fees (3.2%), stock holdings (3.1%), and patent ownership (1%). Reported fCOI were held with 1,077 unique payors, 22 of which were present in more than 1% of financial relationships. The ten most common payors included Pfizer (4%), Novartis (3.9%), MSD (3.8%), Bristol Myers Squibb (3.2%), AstraZeneca (3.1%), GSK (3%), Boehringer Ingelheim (2.9%), Roche (2.8%), Eli LIlly (2.5%), and AbbVie (2.4%).Conclusions These results provide novel multi-domain prevalence data on self-reported fCOI and payors in biomedical research. As such, they have the potential to catalyze future research that can assess the differential effects of various types of fCOI. Specifically, the data suggest that comparative analyses of the effects of different fCOI types are needed and that special attention should be paid to the diversity of payor types for research relationships. (shrink)

To reveal the mechanisms of firms’ technological strategic choices between innovation and imitation, an evolutionary game model is proposed from the perspective of the behavioral biases. First, behavioral biases such as reference point dependence, loss aversion, and probability weighting can be defined and modeled based on the prospect theory. Second, according to the firm theory, a Cournot or Stackelberg game modeled with a technology spillover effect and intellectual property protection is applied to portray the interaction between firms. Third, an improved (...) evolutionary game model is provided by incorporating behavioral biases into the framework of the decision-making process. Finally, the simulation analysis of some important factors, such as intellectual property protection, patent fees, innovation risks, decision-making attitudes, and consumers’ price preference on firms’ technological strategic choices, is presented. The corresponding results show that innovation risk is an important factor affecting the technological strategic choices of firms, increasing the intellectual property protection and the patent fee for technology transfer can effectively control the spillover effect of technology, there is a partial U-shaped relationship between the consumers’ price preference and innovation, and the behavioral biases such as reference point dependence, loss aversion, and probability weighting will change the perception of payoff and risk and will eventually induce firms to adopt the innovation strategy. (shrink)