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)

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

In this presentation, principles of ethics are confronted with the desire of the inventor to make a profit. To this end the presentation is focused on patent protection. Patents should guarantee the return of an inventor’s investment and profit and, on the other side, ensure availability — by patent disclosure — of the invention for the society when the patent terminates. Recent patent applications made by inventors are infringing this principle and societies are paying an unexpected (...) price for these practices. Patent claims are too broad and disclosures too poor. Extreme examples will be discussed. (shrink)

There has been some concern m recent years that economic interests in the biotechnology area could, particularly through patenting, have a constricting influence on scientific research. Despite this concern, there have been no studies of this phenomenon beyond isolated cases. In this article we examine the evolution of the biomedical field of hybridoma/monoclonal antibody research with detailed examples of the three types of patent claims that have emerged there—basic claims, claims on application techniques, and claims on specific antibodies. We (...) analyze the impact of these claims and their legal histories on the free flow of scientific information and, the activity of scientific researchers. We conclude that such patent claims present severe restrictions for both, not only in the monoclonal area but in general, amounting to a subtle but significant shift in the political economy of science and technology. (shrink)

On June 18, 2023, the U.S. Supreme Court in the matter of Amgen, Inc. et al. v. Sanofi, et al.1 unanimously upheld the 2021 decision of the U.S. Court of Appeals for the Federal Circuit,2 striking down as overbroad Amgen’s patent claim to an entire functional genus of monoclonal antibodies. Amgen’s patent claims were not limited to antibody structure or antibody amino acid sequences. This is significant because Amgen’s patent claims did have amino acid sequences, but (...) they were directed to the epitope. (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 moral acceptability of intellectual property rights is often assessed by comparing them to central instances of rights to material property. Critics of intellectual ownership claim to have found significant differences. One of the dissimilarities pertains to the extent of the control intellectual property rights bestow on their holders over the material property of others. The main idea of the criticism of intellectual ownership built around that dissimilarity is that, in light of the comparison with material property rights, the (...) power is excessive. In this article, I assess this objection to intellectual property rights in connection with patents and copyrights. I maintain that it is implausible. (shrink)

The Patent Cooperation Treaty (PCT) is an international treaty that was concluded in 1970 as a special agreement under the 1883 Paris Convention for the Protection of Industrial Property. It establishes an international system for the filing and examination of patent applications and the conduct of “prior art” (technical literature) searches that is administered by a network of national and regional patent offices acting as Receiving Offices, International Searching Authorities and/or International Preliminary Examining Authorities. Its specific purpose (...) is to help inventors obtain a patent for the same invention in two or more PCT countries by allowing them to assert their claim internationally have it subjected to preliminary assessment before committing to one or more local applications. It thus reduces the risk of wasted expenditure by enabling an applicant to postpone the decision to pursue an application to grant until confident of its success. By creating a series of pre-grant procedures with recognised validity in each of the PCT’s nearly 140 countries, it also provides a basis for the harmonisation of patentability standards and facilitates the move toward the creation of an international patent. (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)

The research was conducted using the Advanced search function of the European Patent Office esp@cenet “worldwide” database. In making the dataset available in an open access journal our aim is to encourage greater research and data sharing on intellectual property and biodiversity. On that basis the sole condition of use is attribution of authorship. Excel files are available from the authors upon request.

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 10.3 (2000) 265-281 [Access article in PDF] Scope Note 39 Genes, Patents, and Bioethics-Will History Repeat Itself? Susan Cartier Poland Gene patenting--the very notion sounds absurd! How can anyone claim to have invented the genes with which one is born? To make matters worse, genetic makeup precedes birth, meaning the existence of the invention predates the existence of the inventor. So, do we (...) really own our genes, or do they belong to our parents, or our governments, or a Supreme Being? Ownership is only one bioethical issue involved in gene patenting. But before looking at the issues, some essential and basic terms must be understood, namely genes and patents. Genes In his book On the Origin of Species, published in 1859, the biologist Charles Darwin proposed a theory called "natural selection," whereby living things changed over time or evolved through generations due to competition and variation. By experimenting with the garden pea in the 1860s, Gregor Mendel, a monk and accomplished horticulturalist, provided the mechanism of inheritance supporting the natural selection theory of his contemporary Darwin. That mechanism is the gene, or, as Mendel described it, a discrete "factor." The gene has also been defined as "the fundamental unit of heredity" (United States 1987, p. 157). Each individual has two copies of a gene, one from each parent, but that individual passes down to offspring only one of the two copies. Because of Mendel, the gene has become a scientific concept and the basis of a new scientific field: genetics.David C. Page (2000) of the Whitehead Institute for Biomedical Research at the Massachusetts Institute of Technology explained today's terms for genetics structures using an analogy taken from the home. In his view, the cell is a kitchen, the genome is a shelf in the kitchen, the chromosome is a cookbook on the shelf, the gene is a recipe in the cookbook, and a base-pair (either adenine with thymine or guanine with cytosine) is a single letter in the recipe. A protein, the [End Page 265] working molecule blueprinted by a gene, is a dish ready to eat, and an ingredient in the dish is an amino acid, which is a building block of the protein as specified by a string of base-pairs.Colin Tudge (1993), a British science journalist, would disagree with Page's description of the gene as a recipe. A recipe is like a blueprint: both are directions that precede the work. But a gene is not passive according to Tudge; it actively administers the cell's work, and it also responds to cellular events (Aldridge 1996).The current focus of scientific research and funding is on the gene and the completion of the sequencing of all the genes that comprise the human genome, portrayed in the press as a race between the U.S. government's Human Genome Project and the private corporation Celera Genomics. The real action, however, is at the protein level. The gene only holds the information to produce a protein; it is the three-dimensional shaped protein that does the work. In order to produce energy, eliminate waste, and perform other functions specific to a cell or tissue, proteins must bind, thus creating "biological pathways." Proteins bind (or not) and detach as a function of their shapes, which are determined by their precise chemical composition as spelled out in their genetic code. IBM will spend the next five years making one computer, Blue Gene, that will then take an entire year to come up with the chemical map for only one protein (Gillis 2000). It is estimated that there are about 40,000 proteins in the human body.Despite these overwhelming numbers, modern biology has been able to achieve significant results within the Human Genome Project's 15-year time frame, from 1990 to 2005. The genetic map was completed in 1993; the physical map was completed in 1995; and the genetic sequence is expected to be completed in 2002, with 97 to 99 percent completed as of 26 June 2000. This... (shrink)

This paper examines the claims that moral objections to the patenting of human genes are misplaced and rest on confusions about what a patent is, or what is patented by a human gene patent. It shows that theese objections rest on too simple a conception of property rights, and the connections betwteen familiar moral objections to private property and moral objections to the patenting of human genes. Above all, the paper claims, objections to HGPs often reflect worries about (...) the lack of democratic oversight, accountability and participation involved in grants of intellectual property. The paper claims that we should take these worries seriously, whether or not we think HGPs immoral. (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)

Human gene patents are patents on human genes that have been removed from human bodies and scientifically isolated and manipulated in a laboratory. The U.S. Patent and Trademark Office (the USPTO) has issued thousands of patents on such genes, and patents have also been granted by the European Patent Office, (the EPO). Legal and moral justification, however, are not identical, and it is possible for a legal decision to be immoral although consistent with legal precedent and procedure. So, (...) it is surprising to learn that some people believe that the legal justification of human gene patents can remove the most serious moral objections to them. Yet, those who are well-versed in patent law often believe that confusion over some quite basic legal and scientific facts accounts for moral objections to such patents and, in particular, for the belief that they justify the ownership of one person by another. Once these confusions are removed, they contend, we will see that there is nothing especially alarming about patents on human genes, and no reason to believe them immoral. -/- Such claims seem especially surprising because the morality of an invention is generally supposed to have little role in decisions about whether or not an invention deserves a patent under U.S. law. Although the European Patent Convention’s article 53 (a) prohibits patenting inventions, the publication or exploitation of which would be contrary to public order or morality, it turns out that this clause rarely justifies withholding a patent from an invention that otherwise meets legal criteria. Thus, although more than 320,000 patents have been granted by the EPO since its creation, this clause has never been used successfully to strike down a claim for a patent. Indeed, Ulrich Schatz explains, “Poisons, explosives, extremely dangerous chemical substances, devices used in nuclear power stations, agro-chemicals, pesticides and many other things which can threaten human life or damage the environment have been patented, despite the existence of the public order and morality bar” in almost all European countries. -/- Indeed, this paper shows, while ethical objections to human gene patents are often controversial, they need not be unreasonable, nor need they depend on mistaken assumptions about patent law. Rather, they may reflect familiar ethical concerns about the dominance of commercial imperatives in modern societies; concerns about the disparities in power and wealth amongst individuals and countries; and concerns about the lack of public discussion, transparency and accountability surrounding significant changes in people’s rights, status and opportunities. Hence, I conclude, ethical concerns cannot be easily dismissed and, indeed, point to the need to think harder about the nature and justification of patent law, itself. (shrink)

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

Drugs are much more expensive whilst they are subject to patent protection than once patents expire: patented drugs make up only 20% of NHS drugs prescriptions, but consume 80% of the total NHS drugs bill. This article argues that, given the relatively uncontroversial assumption that we should save the greater number in cases where all are equally deserving and we cannot save both groups, it is more difficult than is usually thought to justify why publicly funded healthcare systems should (...) pay for patented treatments. The claim to medical treatment of those who will be sick with a given condition once the patent runs out is just as strong as those who are sick with it now, but we will be able to treat more people with the same unit of resource in the future. Hence, when resource constraints entail that both cannot be funded, publicly funded healthcare systems ought to wait until patents expire before approving drugs for general use in the publicly funded system. (shrink)

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

This paper discusses the semiotic dimension of patent interpretation. Patent documents are at the same time disclosure of information and a granting of rights. The claim section expresses the granted rights. In this paper, we view the claims as signs that express the granted rights. The semantics to interpret the signs is given by the all-elements rule, as pragmatics. The description and drawings sections of the patent document provide metapragmatics in the form of lexicon and syntax (...) to help the understanding the claims as signs that express the granted rights. This semiotic approach for patent interpretation has important practical consequences to the correct structuring of a patent document. We highlight this contribution through an instance of a patent application in which a claim includes examples of use. Examples are not allowed in the claim text, as examples do not describe the invention, but consist of metapragmatics to better understand the invention. In this way, examples consist of metapragmatics and belong to the description section of the patent, which has the goal to facilitate the understanding of claims. In the patent application used to highlight our semiotics approach for patent interpretation, the examples initially presented in the claims were rephrased in the final granted patent, significantly reducing the scope of the claim. (shrink)

Thus far, the philosophical study of patenting has primarily focused on sociopolitical, legal, and ethical issues, such as the moral justifiability of patenting living organisms or the nature of (intellectual) property. In addition, however, the theory and practice of patenting entails many important problems that can be fruitfully studied from the perspective of the philosophy of science and technology. The principal aim of this article is to substantiate the latter claim. For this purpose, I first provide a concise review (...) of the main features of the theory and practice of the patenting of scientific and technological inventions. Second, I discuss several philosophical issues implied by these features and explore the possible contributions of the philosophy of science and technology to the clarification, or resolution, of these issues. The seven features discussed are: patents as commercial monopolies on scientific and technological inventions, the contrast between natural and non-natural subject matter, the distinction between inventions and discoveries, the reproducibility of inventions, the question of the sameness of two inventions, the distinction between the invented and the protected object, and the contrast between material objects versus concepts and theories. The article concludes with some observations on the problems and prospects of the philosophical study of the theory and practice of patenting scientific and technological inventions. (shrink)

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

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)

Die weltweite Praxis der Vergabe von Patenten auf Gene, die isoliert und von ihren natürlichen Gegebenheiten gereinigt worden sind, wird auf die Behauptung gestützt, dass diese Gene neu, nicht offensichtlich und nützlich sind. Während die Behauptungen von Nicht-Offensichtlichkeit und Nützlichkeit unbestreitbar sind, beruht die Behauptung von Neuheit auf einer rechtlichen Fiktion und enthält einen fundamentalen logischen Fehler. Darüber hinaus stellt das Argument, das diese Fiktion unterstützt, etwas als res nullius dar, was doch tatsächlich res communis ist. Die gängige Praxis sanktioniert (...) demnach eine ungerechtfertigte Aneignung und involviert eine fundamentale Verletzung des Begriffs des Rechtsanspruchs. Im Lichte der entgegenstehenden Gründe kann diese Verletzung auch nicht unter Berufung auf wirtschaftliche Notwendigkeiten gerettet werden. Im Unterschied dazu trifft die hier vorgetragene Kritik nicht Patentansprüche für künstliche Gene oder genetisch modifizierte Lebensformen, die daher anerkannt werden sollten. Mögliche Implikationen im Hinblick auf ein genetisch modifiziertes menschliches Genom werden kurz erörtert. The worldwide practice of granting patents on genes that have been isolated and purified from their natural occurrences is based on the claim that these genes are novel, non-obvious and have utility. While the claims of non-obviousness and utility are indisputable, the claim of novelty rests on a legal fiction and involves a fundamental logical error. Moreover, the argument in support of the fiction portrays as res nullius what in fact is res communis . Current practice therefore constitutes the legal sanction of an unjustified appropriation, and involves a fundamental violation of the notion of entitlement. In light of evidence to the contrary, this violation cannot be saved by an appeal to economic necessity. By contrast, patent claims for artificial genes or genetically modified life-forms are not subject to such a critique and should be granted. Possible implications with respect to a genetically modified human genome are briefly considered. (shrink)

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

Patents recognize economic right and are important for both individual and social economic benefit. Nonetheless, mere economic right does not eliminate the requirement for moral assessment when adjudicating intellectual property claims, especially in the case of claims associated with applications of biomedical technology [e.g., somatic cell nuclear transfer methods]. This is so for applications for patent in the case of live-born animal clones, as governed in the setting of the judicial system of the USA. Here recent federal court decisions (...) in the USA are reviewed, and the ethical ambiguities of this judicial review are engaged in light of the current prohibitions on human reproductive cloning. It is concluded that the legal proscription of patents on animal clones bodes well for human accountability to present and future generations in the event of human reproductive cloning. (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)

ArgumentRecent studies of patents have argued that the very materiality and techniques of legal media, such as the written patent document, are vital for the legal construction of a patentable invention. Developing the centrality placed on patent documents further, it becomes important to understand how these documents are ordered and mobilized. Patent classification answers the necessity of making the virtual nature of textual claims practicable by linking written inscription to bureaucracy. Here, the epistemological organization of documents overlaps (...) with the grid of patent administration. How are scientific inventions represented in such a process? If we examine the process of creating a new patent category within the International Patent Classification (IPC), it becomes clear that disagreements about the substance of the novel inventive subject matter have been resolved by computer simulations of patent documents in draft classifications. The practical needs of patent examiners were the most important concerns in the making of a new category. Such a lack of epistemological mediation between the scientific and legal identities of an invention depicts a legal understanding that science is already inside patent law. From an internal legal perspective, the self-referential introduction of the new patent category may make practical sense; however it becomes problematic from a technological and scientific standpoint as the remit of the patent classification also affects other social contexts and practices. (shrink)

In the mid-1990s, the company Human Genome Sciences submitted three potentially revolutionary patent applications to the US Patent and Trademark Office, each of which claimed the entire genome sequence of a microorganism. The patent examiners, however, objected to these applications, and after negotiation they were eventually re-written to resemble more traditional gene patents. In this paper, which is based on a study of the patent examination files, we examine the reasons why these patent applications were (...) unsuccessful in their original form. We show that with respect to utility and novelty, the patent attorney’s case built on an understanding of the genome as a computer-related invention. The patent examiners did not object to the patenting of complete genome sequences as computer-related inventions on moral grounds or in terms of the distinction between a discovery and an invention. Instead, their objections were based on classification, rules and procedure. Rather than patent examiners having a notion of a genome that should not be patented, the notion of a ‘genome’, and the ways in which it may be different from a ‘gene’, played no role in these debates. We discuss the consequences of our findings for patenting in the biosciences. (shrink)

The scope and type of property rights recognized over the effectiveness of antibiotics have a direct effect on how those claiming ownership engage in the exploitation and stewardship of this scarce resource. We examine the different property claims and rights the four major interest groups are asserting on antibiotics: (i) the inventors, (ii) those demanding that the resource be treated like any other transferable commodity, (iii) those advocating usage restrictions based on good stewardship principles and (iv) those considering the resource (...) as common heritage of humankind. (shrink)

As we have seen in the cases of Serbia and Israel, collectives can be mobilised to perpetrate grave wrongs on the basis of patently ideological claims about the harms they have suffered. This article seeks a theoretical understanding of this troubling phenomenon. It does so, first, by contrasting mobilisation based on vicarious victimhood with revenge. The groups in question do not exhibit the contact with reality and clear sense of agency that are prerequisites for revenge. However, these evasions of agency (...) and reality are not specific to group identities centred on victimhood. Second, therefore, the article considers the attractions of such an identity and how it reinforces groups’ tendencies to myth-making and irresponsibility. Among its more harmful effects, it obscures the realities of state power and forecloses meaningful accountability to those outside the group. It also sets in train a vicious circle, whereby the group discovers perverse incentives to harm others – and to harm itself. Yet these harms only reinforce the group’s self-anointed status as victim: as always done by, never doing to. (shrink)

Private property forms the bedrock of the business/society relationship in a market economy. In one way or another most societies limitwhat people can claim as property as well as theextent of claims they can make regarding it. In the international arena today intellectual property rights are a focal point of debate. Many developing countries do not recognize the monopoly claims of patents and copyrights asserted by business as legitimate. This paper reviews contemporary areas of dispute and then presents the (...) tasks facing the construction of a fair intellectual property rights regime. (shrink)

Historians of science and technology and STS practitioners have always taken intellectual property very seriously but, with some notable exceptions, they have typically refrained from looking “into” it. There is mounting evidence, however, that they can open up the black box of IP as effectively as they have done for the technosciences, enriching their discipline while making significant contributions to legal studies. One approach is to look at the technologies through which patent law construes its object – the invention (...) – in specific settings and periods by examining procedures, classifications, archives, models, repositories, patent specifications (in both their linguistic and pictorial dimensions), and the highly specialized language of patent claims. More ambitiously, we could treat intellectual property as a technology itself. Patent law does not evolve either by merely articulating its doctrine in response to technological developments. The line between what does and does not count as invention may be redrawn with the emergence of new objects and technologies, but is not determined by them. It is this constructive feature of the law that we are trying to capture with the notion of law as technology. We hope that thinking about the technologies of the law and the law as technology will bring into question what we mean by both “technology” and “law”. (shrink)

Hello readers! Hope everyone is fine especially in this season where we often are prone to attacks of cold or flu. The holiday season is at our threshold, and we wish everyone to be in the best of health and happiness.This issue of the BJB is very interesting with topics stretching from Non Communicable Diseases to the ethical issues related to the habitation of the planet Mars, and proves how forward looking are our readers and authors.Mohammad Rashedul Islam et al (...) discuss the application of the SARA method in a district in Bangladesh. The method is based on the principle of Service Availability and Readiness Assessment of WHO. The study in a district in Bangladesh found that about 62% of all the facilities were ready to provide general services like basic amenities with basic equipment, standard precautions for infection prevention, diagnostic capacity and essential medicines. However in case of Non-Communicable Diseases (NCD), only 40% of the health facilities had chronic respiratory disease and cardiovascular diseases diagnosis/management and only 32% had availability of diabetes diagnosis/management. Therefore, service availability and readiness of the health facilities to provide NCD related health services were not satisfactory. The authors emphasize that SARA which is a tool to monitor facilities to be ready for provision of services including NCD, should be used by all clinic managers.The very scientific and forward looking article titled “SCNT Method and the Application for Patent Eligibility on Cloned Animals” by Norman K. Swazo reviews US federal court decisions regarding applications for patent in the case of live-born animal clones. A decision issued from the United States Court of Appeals for the Federal Circuit established an earlier decision of the Patent Trial and Appeal Board that live-born animals cloned by the somatic cell nuclear transfer method (SCNT) like cattle, sheep, pigs, and goats are not patentable, so a scientist using the method is not eligible for a patent claim on the animals. The author feels that this decision has ethical implications related to the moral status of cloned animals. The author argues whether the end product of a SCNT (somatic cell nuclear transfer) application is same as an invention or only a revelation of nature at the cellular level. The author quotes Article 11 of Universal Declaration on the Human Genome and Human Rights UNDHGR “Practices which are contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted.” He concludes that the judicial assessments in the USA deciding on the question of patenting of animal clones provide important barriers to human reproductive cloning research, safeguarding moral and legal commitment to human dignity. The article on Ethics in Public Health Research and Clinical Research by Muhammad Waseem Khanet al discusses on the need to continue to focus on ethical values in conducting any research. Tha authors stress the importance, either in public health research or clinical research, of the need to recognize an ethical standard that respects individual’s autonomy and community’s wellbeing. This can be achieved through collective collaboration for the protection of individual’s autonomy, dignity and wellbeing. Research ethics is a fundamental criterion to be complied with throughout a research study. The very interesting article on Planetary Protection for Mars: Time for Reconsideration by Svetoslav Alexandrov looks into the ethical questions beyond mother earth but which could be affected by people from our planet. In this manuscript the author discusses the ethics of the protection of hypothetical organisms on Mars in terms of planned manned space missions and subsequent colonization. The author discusses the possible problems related to a process called terraformation where the planet is converted to make it suitable for Earth life. He argues that terraformation will change the whole condition of the planet. The author quotes Carl Sagan, of The Planetary Society: “If there is life, then I believe we should do nothing to disturb that life. Mars then, belongs to the Martians, even if they are microbes”. I think we all agree with this brilliant recommendation.The article ‘We Still Need to Improve Our Research Writing Ethics’ by Sheikh Arslan Sehgal looks into the value of maintaining professional integrity of research work. Particularly with issues like plagiarism, ethics, authorship and data fabrication. He argues that the scientific community must obey the scientific ethical norms and rules. He feels that ethical problems must be resolved for the advancement of research in countries including Pakistan. The author recommends teaching students the international, institutional and professional standards regarding research and authorship issue. Thus from the beginning researchers will know the key components of ethics in conducting research and the end product will be research work of quality and acceptability.Dear Readers, we look forward to your articles, commentaries, observations on different issues which touch our lives and will help in broadening our knowledge and understanding of Bioethics. (shrink)

The biotechnology industry's intellectual property claims contribute to a subtle but not insignificant encroachment of commodification within health care. Drawing on the conceptual framework of Margaret Jane Radin, I argue that patent claims on human biological materials may commodify that with which our personhood and individuality is intertwined but that such commodification is broad and incomplete. Patents on nonhuman biological organisms contribute to a more materialistic understanding of them but do not significantly change our relationship to them. The systemic (...) effects of biotechnology's commodification within health care are various and may compromise the goal of good health. The morally problematic aspects of patent claims entail certain obligations to inhibit commodification from becoming more egregious, but on balance, those aspects are currently insufficient to justify denying the benefits the patent system promotes. (shrink)

The ArgumentAlbert Einstein had more than a passing and trivial involvement with patents and inventions. The historian seeking to fathom Einstein's thought processes would be ill-advised to pass lightly over his years at the Swiss Federal Patent office (1902–1909) and to consider his professional advice-giving about patents and his patenting of his inventions as merely peripheral to his core concerns and cognitive style. Years of reading patents and visualizing the machines, devices, and electromagnetic phenomena described in them is a (...) formative experience. A number of inventors besides Einstein enhanced their power of visualization from reading and writing patent claims. It is reasonable to conclude that the Patent Office years honed his remarkable gift for visually conceptualizing systematic artifactual relationships that he used in articulating theory. (shrink)

On June 13, 2013, the Supreme Court placed its imprimatur on a principle that has been gathering force within patent law for several decades: human beings constitute unpatentable subject matter. In Association for Molecular Pathology v. Myriad Genetics, Inc., the court answered the question it had posed itself–“Are human genes patentable?”–decisively in the negative. This legal result was predictable, given a careful reading of the entrails of judicial decisions, congressional bills, executive branch pronouncements, and decisions in other countries about (...) patents claiming human‐related inventions, all of which have echoed the spirit of the Thirteenth Amendment by proscribing property rights‐including intellectual property rights‐in human beings. To understand how patent law has evolved toward this result, one may trace the legal treatment of patents claiming human embryonic stem cells, chemical products of human physiology, human thought, and now, human genes. Woven together, these strands of evidence led inexorably toward the ultimate rejection of human gene patents by the Supreme Court. (shrink)

Legal scholars and philosophers have long been engaged in what has been called 'the pursuit of the holy grail of property' - the secret of the internal structure of property in law. Attempts to capture the idea of property have encountered two fundamental problems. First, it has been notoriously difficult to advance beyond the observation that property involves 'ownership' of 'things', with the incidents of ownership and the list of things owned an essentially descriptive task. Second, it is difficult to (...) explain the wildly inconsistent power that property rights - even when identified - seem to enjoy.In this book, Professor Underkuffler advances our understanding of what property is, as an idea, and the power that claimed property rights should have against competing public interests. There is, she argues, a deeper analytical structure of the idea of property that we can uncover, and - as a result of that discovery - deeper reasons that we can find for property's variable power. It is not a random or unprincipled event that property generally protects in cases involving land titles or patent claims, and fails to protect in cases involving environmental regulation or redistributive taxation. She argues that these results are driven - indeed, predetermined - by the nature of property, as an idea, and the conflicts of that idea with competing public interests. The implications of this book are far-reaching. It explains and justifies - on new grounds - why some property claims are traditionally powerful in law, and others not. It suggests how property rights in controversial or emerging areas should be treated, such as those involving the body as property, personal information as property, cultural property, and state redistributive claims. Finally, it establishes why the protection of property is, in fact, necessarily different from freedom of speech, freedom of religion, due process of law, and other rights - necessitating its different treatment, and lesser protection, as a constitutional right. (shrink)

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

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

In the United States, a longstanding legal rule exists against patenting natural phenomena. The Supreme Court recently had an opportunity to help define the boundaries and clarify the implications of this “natural phenomenon doctrine” in Laboratory Corporation of America v. Metabolite Labs., dismissed as improvidently granted. This article argues that the natural phenomenon doctrine renders both the patent claim at issue in LabCorp, and the patents that directly or indirectly claim biological correlations between genotypes and medical phenotypes, (...) invalid or unenforceable under U.S. patent law. (shrink)

In most traditions, the law is founded upon some extralegal view of morality. There are only a handful of cases prior to the 1970s that involved patenting nonhuman organisms. John Moore made several claims, but the one of most interest to us here was a claim for conversion, which means the unlawful use of another person's property for the enrichment of the person using the thing unlawfully. The cell line produced from Moore's spleen cells was eventually patented by the (...) defendants. The potential market for products relating to that patent was estimated to be roughly $3 billion US dollars. The move from patenting hybridized plants, to genetically altered microorganisms, to human tissues and genes reflected the epitome of the fabled slippery slope. There is clearly a gap between our intuitions about the relations between our individual genomes, our identities, perceptions of privacy and personal autonomy, and the law. (shrink)

It is sometimes claimed that conciliatory views on disagreement ultimately lead to either global or widespread scepticism. This is deemed to be a serious problem for conciliationism either because scepticism of either kind is a patently untenable stance or because it poses a serious threat to our intellectual and social lives. In this paper, I first argue that the alleged untenability of both types of scepticism is far from being obvious and should therefore be established rather than taken for granted, (...) and then that those who reject them because of the threat they pose surprisingly confuse pragmatic reasons with epistemic reasons. (shrink)

Garrath Williams claims that truly responsible people must possess a “capacity … to respond [appropriately] to normative demands” (2008:462). However, there are people whom we would normally praise for their responsibility despite the fact that they do not yet possess such a capacity (e.g. consistently well-behaved young children), and others who have such capacity but who are still patently irresponsible (e.g. some badly-behaved adults). Thus, I argue that to qualify for the accolade “a responsible person” one need not possess such (...) a capacity, but only to be earnestly willing to do the right thing and to have a history that testifies to this willingness. Although we may have good reasons to prefer to have such a capacity ourselves, and to associate ourselves with others who have it, at a conceptual level I do not think that such considerations support the claim that having this capacity is a necessary condition of being a responsible person in the virtue sense. (shrink)

Dallas Willard makes the claim that spiritual formation “refers to the Spirit-driven process of forming the inner world of the human self in such a way that it becomes like the inner being of Christ himself.”1 Can this claim be substantiated and stand up to close scrutiny, or is Dallas Willard selecting an idea of his own fancy and making this the cornerstone of his understanding of spiritual formation? How can this claim be tested and anchored? In (...) this article we will seek to answer these questions by looking at the Apostle Paul in his function as spiritual director. Although it is patently anachronistic to speak of Paul as spiritual director, can we legitimately understand him in this role? We will propose a generative understanding of spiritual direction and then proceed to examine the Apostle Paul and his aims based on that generative understanding. We will also argue that at the core of Paul's functioning as a spiritual director lies a strong appeal to examine and imitate his life and character and to follow his ways. This appeal by Paul for others to imitate him is anchored in Paul's own imitation of Christ himself. Paul's call to imitation thus provides a window into discovering how Paul understood his role as spiritual director and also provides us the means to discern his goals in spiritual direction. (shrink)

It is widely asserted that we are now living in a post-truth society. What that means, this book argues, is that the contemporary global world is thoroughly infested not only with trickster figures but an entire and operational trickster logic; or, that we now live in a Trickster Land - an argument advanced by the claim that in modernity liminality has become permanent; or that modern life is patently absurd. The first part of the book presents a series of (...) 'guides' to this condition, in the form of key thinkers and writers who can help us understand and navigate our Trickster Land. Such guides include Hermann Broch, Lewis Hyde, Roberto Calasso, Michel Serres, Sándor Márai, Colin Thubron, and Albert Camus. The second part goes on to discuss five main regions of Trickster Land: art, thought, the economy, politics, and society. This last, central chapter of the book contrasts trickster logic with the basic, foundational logic of social life, presented as gift-giving by Marcel Mauss and as sociability by Georg Simmel, and which is expressed here, combining Heraclitus and Plato with the Gospel of John, by three basic terms of ancient Greek culture, as arkhé charis logos: meaningful social life originally and in its essence is animated by the power of kind benevolence. This volume will appeal to scholars of social theory, anthropology and sociology with interests in political thought and contemporary culture. (shrink)

Since intelligent design (ID) advocates claimed the ubiquitous mouse trap as an example of systems that cannot have evolved, mouse trap history is doubly relevant to studying material culture. On the one hand, debunking ID claims about mouse traps and, by implication, also about other irreducibly complex systems has a high educational value. On the other hand, a case study of mouse trap history may contribute insights to the academic discussion about material culture evolution. Michael Behe argued that mouse traps (...) cannot trap mice with any part missing; therefore, they cannot have a precursor with one part less, therefore, cannot have a continuous history, and therefore, cannot have evolved. The patented and seminal precursor of current flat snap traps, however, had one part less, because spring and striker were formed of one wire. Secondly, historical records that reach back into the Bronze Age suggest that its history continued for a very long time. Thirdly, all prerequisites for evolution (variation, transmission, and selection) abound in mouse trap populations. Hence, Behe’s triple-jump conclusion about mouse traps is false each step. There is no, in principle, impossibility for mouse traps to evolve. An evolutionary account of mouse trap history also has academic merits beyond its educational value. Three important conclusions can be drawn: (1) reticulate phylogenies of artifact systems may be resolvable as overlapping, but branching, phylogenies of parts; (2) homologous ideas may be realized by analogous material, that is, phylogenies of information do not necessarily coincide with those of material parts; (3) recombination of parts between different artifact systems increases the cumulative nature of cultural evolution. (shrink)

I have sketched the well-known distinction between facts and evidence not to defend or attack it , but rather as a preface to a key episode in the history of the conceptual categories of fact and evidence. My question is neither, “Do neutral facts exist?” nor “How does evidence prove or disprove?” but rather, “How did our current conceptions of neutral facts and enlisted evidence, and the distinction between them, come to be?” How did evidence come to be incompatible with (...) intention, and is it possible to imagine a kind of evidence that is intention-laden?It is my claim that partial answers to these questions lie buried in the sixteenth- and seventeenth-century literature on prodigies and miracles. I shall argue that during this period prodigies briefly became the prototype for a new kind of scientific fact, and that miracles briefly exemplified a form of evidence patent to the senses and crucially dependent on intention. Both conceptions diverge sharply not only from current notions of facts and evidence, but also from medieval views on the nature of prodigies and miracles. Prodigies were originally closely akin to portent, divine signs revealing God’s will and things to come; miracles were more intimately associated with the private experience of grace than with the public evidence of the senses. Prodigies were transformed from signs into nonsignifying facts, and miracles into compelling evidence, as part of more sweeping changes in natural philosophy and theology in the mid-seventeenth century. Lorraine Daston is professor of history of science at the University of Göttingen, Federal Republic of Germany. She is the author of Classical Probability in the Enlightenment and is currently at work on a history of scientific objectivity. (shrink)