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)

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)

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)

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)

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)

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)

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.

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 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)

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

This paper 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)

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)

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)

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)

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)

The 2011 Varsity Medical Debate, between Oxford and Cambridge Universities, brought students and faculty together to discuss the waiving of patents for antiretroviral therapies in the developing world. With an estimated 29.5 million infected by Human Immunodeficiency Virus (HIV) in low- and middle-income countries and only 5.3 million of those being treated, the effective and equitable distribution of anti-retroviral therapy (ART) is an issue of great importance. The debate centred around three areas of contention. Firstly, there was disagreement about whether (...) patents were the real barrier to the access of anti-retroviral therapy in the developing world. Secondly, there were differing views on the effectiveness of a patent pool. Thirdly, concerns were raised over the impact of waiving patents on research to produce new and better anti retro-viral drugs. (shrink)

The term “patent” is an abbreviation of “letters patent”, the open form of document historically issued by the Crown for the purpose of conferring a right or privilege or otherwise communicating the royal will. In contemporary law it denotes the species of intellectual property that is granted as an inducement for the creation and disclosure of novel, inventive and industrially applicable inventions. In the UK that property is conferred under the Patents Act 1977, or with similar effect the European Patent (...) Convention (EPC), and comprises the exclusive right to use and sell a protected invention for up to 20 years. A protected invention may be any subject matter having technical character; a definition derived from the Act’s express exclusion from patentability of (among other things) discoveries, scientific theories, business methods and computer programs “as such”. Also excluded are surgical, therapeutic and diagnostic methods (for lack of industrial applicability), and inventions the commercial exploitation of which would be contrary to public policy or morality. In these and other respects the Patents Act follows the EPC, which it was the explicit purpose of that Act to implement. Patents are territorial, and are thus only valid and infringed in their country of issue. For a UK inventor to obtain protection outside the UK s/he must therefore obtain a patent from that country, either directly by applying under its laws, or if it is a party to the EPC or other intergovernmental agreement, indirectly by applying under that agreement. Inventors seeking protection for an invention in more than one country will often do so by means of the Patent Cooperation Treaty. (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 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)

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.

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)

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)

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)

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)

“No one has advanced a just and logical reason why reward for service to the public should be extended to the inventor of a mechanical toy and denied to the genius whose patience, foresight, and effort have given a valuable new [discovery] to mankind” . The law around the world permits the granting of patents for drugs, medical devices, and cosmetic treatment of the human body. At the same time, patentability for a method of treatment of the same body is (...) denied in some countries on various public policy grounds. Is there any logical justification for this distinction? Are methods of medical treatment not as vital to the health or even to the life of a patient as drugs or medical devices? Why is a cosmetic result patentable and a curative result not? (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)

Concerns have been voiced about the ethical implications of patenting practices in the field of biotechnology. Some of these have also been incorporated into regulation, such as the European Commission Directive 98/44 on the legal protection of biotechnological inventions. However, the incorporation of ethically based restrictions into patent legislation has not had the effect of satisfying all concerns. In this article, we will systematically compare the richness of ethical concerns surrounding biotech patenting, with the limited scope of ethical concerns actually (...) addressed in the patent system. As sources of our analyses we will use literature and document studies and a survey with important stakeholders and experts related to Norwegian patenting in the aquacultural biotechnology sector. We will structure the analyses with an ethical matrix, developed for this purpose. Showing the misalignment of the discussions within and outside the patent system, we suggest that an important reason for the ethical controversy still surrounding patenting is that ethical questions keep being framed in a narrow way within the system. Until a richer set of ethical considerations is addressed head-on within the patent system, the patent system will continue to evoke academic and interest group criticism, potentially contributing to a legitimacy crisis of the whole system. (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.

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)

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

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 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)

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

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

How do we inhabit technology? This theme for a conference on the way in which technology (apparently mobile, rootless, individualistic) at once surrounds us and becomes part of our very bodies (becomes `inhabited', with connotations of identity, community, locality) prompts reflections from Melanesia. If the concept of technology inhabits anything, it most emphatically inhabits our ways of speaking about ourselves, reifying many different projects as the extensions of one - an enchantment with creativity. The same language imagines `nature' existing apart (...) from human creations. It is clear that the life of these old Euro-American divisions is not over yet. Intellectual property protocols, notably patenting, foster the divide between `technology' and `nature' while presaging its collapse. This article points to some alternatives, incidentally offering a candidate for `habitation' that has nothing to do with community or locality. (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)

This article focuses primarily on to what extent novel beings, and particularly, beings which display something akin to human consciousness or agency would be (or should be) patentable under current European patent law. Patents grant the patent holder a right to exclude others from using the patented invention for the period of patent grant (usually 20 years). This allows the patent holder to control how that invention can or cannot be used by others downstream, granting patent holders a governance like (...) function over the patented technology for the duration of the patent. Accordingly, the potential for patentability of novel beings gives rise to a myriad of ethical issues including: to what extent is it appropriate for patent holders to retain and exercise patents over “novel beings”; how issues of “agency” displayed by any “novel beings” would fit within the current patent framework, if at all; and to what extent existing exclusions from patentability might exclude patents on “novel beings” or whether changes within patent law may be needed if patents in relation to “novel beings” are deemed ethically problematic. This article focuses on such issues, and in doing so, also sheds light on the role of ethical issues within the patenting of advanced biotechnologies more generally. (shrink)

The European Parliament rejected in 1995 the European Commission proposal to harmonize legal protection of biotechnological inventions. Although it did not seem initially the most contentious of the many issues involved in the current legal and ethical debate around biomedicine and genetics, patenting is now focusing bioethics in Europe.

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.

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)

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

The rationale of patents on transgenic organisms leads to the startling notion of the human qua infringement. The moral reasons by which we may tenably reject such notion are not conclusive as to human life forms outside the body. A close look at recombinant DNA experimentation reveals ingenious processes, but not entities that the body lacks. Except for artificial genes, the genes of biotechnology are found on chromosomes, albeit nonconsecutively, and their uninterrupted transcripts appear in messenger RNA. An enhanced form (...) of protection for ingenious processes, the human methods patent, is proposed and defended as a replacement for product patents. The proposed patent would pertain to biotechnology manufacturing and genetic intervention in somatic and germ cells. A counterpart could govern nonhuman life forms. It is argued that compulsory licensing protections should be a condition of such patent. Contrary to the conservative assumption that statutory sobriquets suffice, the reckoning of what qualifies as a patentable ingenious process will continue to require systematic scientific guidance. (shrink)

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)

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

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)