It is obvious that every inventor should be rewarded for the intellectual effort, and at the same time be encouraged to successively improve his or her discovery and to work on subsequent innovations. Patents also ensure that patent owners are officially protected against intellectual piracy, but protection of intellectual property may be difficult to accomplish. Nevertheless, it all comes down to this basic question: Does a contradiction exist between medical ethics and the “Medical and Surgical Procedure Patents” system? (...) It may well turn out that medical-procedure patents can have a negative influence on the standard of medical care. Medical-method patents may also interfere with the physician-patient relationship. At present, physicians do not question the usefulness of patent protection for medicines, biotechnology, equipment and devices, but they strongly oppose it for surgical procedures. (shrink)

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

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

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)

Instead of impeding access to essential medicines in developing countries, the essay explores why and how patents can serve as a source of funding for the much needed access to medicine. Instead of a weakening of patents, prolonged protection periods are suggested in circumstances where there is widespread lack of access. The revenues from extended patents are seen as a source of funding for drug donations to the least developed countries.

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)

Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] 304 ALR 1At the heart of some disputes regarding medical treatment is the conceptual difficulty of finding the appropriate legal framework. The diagnosis and treatment of medical conditions are clearly subject to professional standards and thus sit within the negligence framework, but what of those who develop and provide that diagnosis and treatment? Do innovative approaches give rise to a patentable interest and can the intellectual property in a method of treatment (...) be protected under existing patent law? This question was recently addressed by the High Court in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] 304 ALR 1.The technical arguments are clearly set out in the judgment and do not warrant repetition. For present purposes it is sufficient to highlight the central legal question, which was whether a method of medical treatment could be a “manner of manufacture” and therefore patentable.The DecisionThe High Court .. (shrink)

Patent landscaping is the process of finding patents related to a particular topic. It is important for companies, investors, governments, and academics seeking to gauge innovation and assess risk. However, there is no broadly recognized best approach to landscaping. Frequently, patent landscaping is a bespoke human-driven process that relies heavily on complex queries over bibliographic patent databases. In this paper, we present Automated Patent Landscaping, an approach that jointly leverages human domain expertise, heuristics based on patent metadata, and machine (...) learning to generate high-quality patent landscapes with minimal effort. In particular, this paper describes a flexible automated methodology to construct a patent landscape for a topic based on an initial seed set of patents. This approach takes human-selected seed patents that are representative of a topic, such as operating systems, and uses structure inherent in patent data such as references and class codes to “expand” the seed set to a set of “probably-related” patents and anti-seed “probably-unrelated” patents. The expanded set of patents is then pruned with a semi-supervised machine learning model trained on seed and anti-seed patents. This removes patents from the expanded set that are unrelated to the topic and ensures a comprehensive and accurate landscape. (shrink)

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

How heavily should ethical considerations weigh in allowing or disallowing genetic patents? The concept of 'ordre public' can be useful in offsetting a simple utilitarian view.

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)

Though many more patents emerge from industry sources, drug-related patents generated in the non-profit setting appear to have greater importance than patents arising from the commercial sector, which helps demonstrate the value non-profit research institutions can have in driving drug development.

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

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)

Utility patent protection has been granted broadly to living organisms in the United States only in the last quarter century, but in the late nineteenth century, for reasons related to the nationalization of agricultural markets, animal breeders and plant innovators began attempting to devise alternative arrangements to protect intellectual property in their living products. The arrangements had to take into account both the requirements of IP protection and the various ways the organisms could be reproduced. For animals, prior to patentability, (...) the arrangements involved mainly breed associations and registries. Plant innovators tried to achieve returns from their IP through pricing strategies and trademarks. Finding neither adequate, they began to agitate for legislation that would protect their type of IP, an effort that resulted in the passage of the Plant Patent Act of 1930, the first legislation anywhere to extend a type of patent protection to living products. (shrink)

Patents have been issued in the United States for genes and gene sequences since 1980. Patent protection has provided incentives to aggressively probe the genome of humans and non-humans alike in search of profitable applications. Yet it is not clear that patent protection should have been afforded to genes and gene sequences and it is increasingly clear that patent protection, as currently formulated, is not an appropriate means to realize the full benefits of genetic research. As we stand on (...) the threshold on a genetically enhanced future, in which we shall have the power to consciously steer our evolution as a species, we need to carefully consider how to shape the benefits of genetic research and how to recognize and contain its detriments. (shrink)

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)

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)

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

The view of patents as well-defined property rights is as simplistic as it is ubiquitous. This article argues that in newly arising or immature technologies, patents are subject to intrinsic and extrinsic uncertainty that make them very opaque representations of the underlying inventions. The opacity is a result of unsettled legal doctrine and scientific terminology, uncertain commercial and technological prognosis, and leads to considerable ambiguity in property parameters. Patents in immature technologies do not solve Arrow's information paradox (...) of non-rivalrous goods because they do not represent the sharp exclusive right that is central to his thesis. In such cases patents ought to be reclassified in terms of their perceived and actual function as credence goods. The difficulty in discovering the value of these patents necessitates credence verifiers, further increasing the transaction costs of encouraging innovation. The theoretical and empirical implications of credence explored in this article are based primarily on the Anglo-American legal protection of biotechnological inventions, but may be equally relevant to patents in general and patents in other newly arising technologies, in particular. (shrink)

In 2012, a new and promising gene manipulation technique, CRISPR-Cas9, was announced that seems likely to be a foundational technique in health care and agriculture. However, patents have been granted. As with other technological developments, there are concerns of social justice regarding inequalities in access. Given the technologies’ “foundational” nature and societal impact, it is vital for such concerns to be translated into workable recommendations for policymakers and legislators. Colin Farrelly has proposed a moral justification for the use of (...) patents to speed up the arrival of technology by encouraging innovation and investment. While sympathetic to his argument, this article highlights a number of problems. By examining the role of patents in CRISPR and in two previous foundational technologies, we make some recommendations for realistic and workable guidelines for patenting and licensing. (shrink)

Brain Organoids in their current state of development are patentable. Future brain organoids may face some challenges in this regard, which I address in this contribution. Brain organoids unproblematically fulfil the general prerequisites of patentability set forth in Art. 3 (1) EU-Directive 98/44/ec (invention, novelty, inventive step and susceptibility of industrial application). Patentability is excluded if an invention makes use of human embryos or constitutes a stage of the human body in the individual phases of its formation and development. Both (...) do not apply to brain organoids, unless ES-cells are used. Art. 6 (1) EU-Directive 98/44/ec excludes patentability for inventions “the commercial exploitation of which would be contrary to ordre public or morality”. While there is no conceivable scenario, in which the commercial application of current brain organoids violates the ordre public, the same is not necessarily true for future brain organoids. Keeping in mind that a development of consciousness-like abilities in future brain organoids cannot be excluded and that an ability for both physical and psychological suffering has been theorized, both of which are aspects of the ordre public, certain applications of future brain organoids may constitute a violation of the ordre public and therefore lead to an exclusion of patentability. (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)

Respect for and promotion of the human rights of people with HIV/AIDS is now an entrenched component of the global response to HIV. However, as the global HIV epidemic has turned into a global AIDS epidemic, and as the death toll mounts, one area of human rights—the right to health care—has become fiercely contested. In particular, the degree to which patents on medicines impede what the United Nations High Commissioner for Human Rights has described as the “human right” of (...) access to essential medicines is receiving close scrutiny. The controversy generated by a recent article that argues, “in Africa patents and patent law are not a major barrier to treatment access in and of themselves,” is indicative of the intensity of the debate. (shrink)

Respect for and promotion of the human rights of people with HIV/AIDS is now an entrenched component of the global response to HIV. However, as the global HIV epidemic has turned into a global AIDS epidemic, and as the death toll mounts, one area of human rights—the right to health care—has become fiercely contested. In particular, the degree to which patents on medicines impede what the United Nations High Commissioner for Human Rights has described as the “human right” of (...) access to essential medicines is receiving close scrutiny. The controversy generated by a recent article that argues, “in Africa patents and patent law are not a major barrier to treatment access in and of themselves,” is indicative of the intensity of the debate. (shrink)

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

A patent agent is a person with recognised expertise in the field of intellectual property generally and patents specifically. In the UK patent agents form an elite professional community, membership of which is denoted by inclusion on the Register of Patent Agents. The Register exists under statute and is maintained by The Chartered Institute of Patent Attorneys (CIPA), a body empowered by royal charter of which most patent agents are also members.

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 have been issued in the United States for genes and gene sequences since 1980. Patent protection has provided incentives to aggressively probe the genome of humans and non-humans alike in search of profitable applications. Yet it is not clear that patent protection should have been afforded to genes and gene sequences and it is increasingly clear that patent protection, as currently formulated, is not an appropriate means to realize the full benefits of genetic research. As we stand on (...) the threshold on a genetically enhanced future, in which we shall have the power to consciously steer our evolution as a species, we need to carefully consider how to shape the benefits of genetic research and how to recognize and contain its detriments. (shrink)

The ethics of gene patenting is concerned with whether human genes are the kind of thing that is appropriate for patenting, and whether it is ethical to do so. Is genetic technology a special case compared to other medical technology that have been patented? Much of the debate has revolved around the benefits and harms of allowing gene sequences to be patented. In this paper, I am concerned with a non-consequential consideration: Can someone patent my genes? If genes are the (...) common property of humankind, are genes patentable? I present an objection to the patenting of processes used to manipulate our genes that have the potential to change human nature. Should not all members of the human species have a say regarding genetic engineering that can be used to irreversibly change what makes each one a human? I conclude with an examination of how genetic research may be democratically controlled. (shrink)

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

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 systems of patent rights in force in Europe today, both at the level of national law and on the regional level, contain general clauses prohibiting the patenting of inventions whose publication and exploitation would be contrary to “ordre public” or morality. Recent years have brought frequent discussion about limiting the possibility of patent protection for biotechnological inventions for ethical reasons. This is undoubtedly a result of the dynamic development in this field in the last several years. Human genome sequencing, (...) the first successful cloning of mammals, and the progress in human stem cell research present humanity with many new questions of an ethical nature. Directive 98/44 of the European Parliament and of the Council of July 6, 1998, on the Legal Protection of Biotechnological Inventions created a new basis for patent protection in this field of technology. Based on the European experience to now, however, it must be said that patent law is not the right place to legislate the consequences of the morality of an invention. (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)

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)

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)

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

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 decade-long debate over ownership of living human materials has recently intensified with the ability of biomedical research to isolate, purify, and use human genes and gene products as therapeutics, factories for the production of therapeutics, and targets for the identification of therapeutic pharmaceuticals. Indeed, advances in genomic research have resulted in the identification of hundreds of thousands of DNA fragments and hundreds of genes. Many within the scientific and business communities believe genes and gene fragments have commercial value and (...) have filed patent applications on the nucleic acid sequences. This commercialization has amplified the discussion surrounding the ethics of patenting genes and the ownership of the human genome. (shrink)

Brussen, Kerri Anne A patent provides the exclusive legal right to a person or company to regulate the distribution, manufacture or use of their invention. This paper examines some of the issues surrounding Gene Patents. Although there is a drive to abolish Gene Patents, we argue that refined and clearly defined regulation would continue to support medical research, avoid exploitation, and be of benefit to public health.

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)

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)

Antibiotic resistance is a serious public health problem on a global scale. In both developed and developing countries, the unpleasant consequences of the phenomenon are being felt. This paper discusses wild-card patent extensions as a means to incentivize research and development of new antibiotics. The thesis defended in the paper is that the implementation of such patent extensions is an appropriate legislative response to the problem of antibiotic resistance. The general idea of wild-card patent extensions is presented in the first (...) part of the paper. A number of objections to the idea are thereafter discussed and rejected. (shrink)

The biotechnology patent debates have revealed deep moral concerns about basic genetics research, RD and specific biotechnological products, concerns that are seldom taken into consideration in Technology Assessment. In this paper important moral concerns are examined which appear at the various stages of development of a specific genetic product: a predictive genetic test. The purpose is to illustrate the need for a more contextual approach in technology assessment, which integrates the various forms of interaction between bio-technology and society or societal (...) segments. Such an approach will generate greater insight in the moral issues at all stages of a products life-cycle and this will facilitate decision-making on the morality of a specific biotechnological product. (shrink)

Intellectual property law has been interacting with software for over sixty years. Despite this, the law in this area remains confused and uncertain: this is particularly evident in patent law. Focusing on U.S. patent law from the 1960s through to the mid-1970s, this article argues that a key reason for this confusion relates to the particular way that the subject matter was construed. While the early discussions about subject matter eligibility were framed in terms of the question “is software patentable?”, (...) what was really at stake in these debates was the preliminary ontological question: what is software? Building on work that highlights the competing ways that software was construed by different parts of the information technology industry at the time, the article looks at the particular way that the law responded to these competing interpretations and how in so doing it laid the foundation for the confusion that characterizes the area. When engaging with new types of subject matter, patent law has consistently relied on the relevant techno-scientific communities not only to provide the law with a relatively clear understanding of the nature of the subject matter being considered; they have also provided the means to allow the law to describe, demarcate, and identify that new subject matter. The inherently divided nature of the nascent information technology industry meant that this was not possible. As a result, the law was forced to develop its own way of dealing with the would-be subject matter. (shrink)

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

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)