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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.
The global food system exhibits dizzying complexity, with interaction among social, economic, biological, and technological factors. Opposition to the first generation of plants and animals transformed through rDNA-enabled gene transfer (so-called GMOs) has been a signature episode in resistance to the forces of industrialization and globalization in the food system. Yet agricultural scientists continue to tout gene technology as an essential component in meeting future global food needs. An ethical analysis of the debate over gene technologies reveals the details that matter. On the one hand, alternative regimes for institutionalizing gene technology (through regulation, trade policy, and intellectual property law) could mitigate injustices suffered by politically marginalized and economically disadvantaged actors in the food system, especially smallholding farmers in less industrialized economies. On the other hand, GMO opposition has been singularly effective in mobilizing citizens of affluent countries against policies and practices that lie at the heart of these same injustices. As part of the roundtable, “Ethics and the Future of the Global Food System,” this essay argues that charting a middle course that realizes the benefits of gene technology while blocking its use in the perpetration of unjust harms may require a more detailed grasp of intricacies in the food system than even motivated bystanders are willing to develop.
Rivulidae comprises a family of fish largely distributed in Brazil that includes 201 species, of which 125 are considered endangered. This fact emphasizes the need for development of conservation strategies including studies on genetics and reproduction. In this paper, we describe aspects of biology and reproduction of the rivuliid species Hypsolebias sertanejo. We outline the reproductive behaviour of this species under laboratory conditions, analyze ploidy status by flow cytometry, describe reproductive behaviour and performance and test dry and wet incubation of eggs. Although H. sertanejo showed well known patterns of reproductive behaviour, we verified many peculiarities inherent to its reproductive biology. As expected, most individuals were diploid (87.71%), however 14.29% were considered mosaics. Although no sterility was observed within mosaics, infertility of these fish was not fully evaluated. Hatching rate of the eggs collected was very low following both dry and wet incubation (5.04 and 3.79%, respectively). These results provide interesting information regarding the reproductive success of this species, and suggest that chromosomal abnormalities described may reduce the survival of H. sertanejo under natural conditions, limiting the perpetuation of this species, and emphasizing the need for more preservation efforts, including artificial propagation and gene banking.
In the chapter “The Biotechnology Sector – Therapeutics”, the author covers a wide range of topics summarizing the significant role that the formation and growth of the biotechnology sector has played in the entire biopharmaceutical industry. The chapter begins with a bit of history, from the earliest days of how genetic engineering gave birth to this sector, and takes the reader through an overview of biotechnology as it exists today and how the growing innovation in science over the years has been able to both drive the sector and have a tremendous impact on healthcare overall. There is a particular focus on describing various types of innovation which have played a huge role in driving product development in the broader biopharmaceutical industry. Later in the chapter, there is a focus on many of the business aspects of the sector, as drug development in biotechnology requires enormous amounts of capital for success. The author outlines many of the key issues related to different business and financing models that we see across the sector, in addition to the unique management issues in small biotechnology companies. There is significant description and explanation of the symbiotic relationship between the larger pharmaceutical companies and smaller biotechnology start-ups with a focus on how they help each other to bring transformative medicines to patients. The chapter concludes with a discussion about international and regulatory aspects impacting the sector. Overall the author tells the story of the birth and growth of this exciting sector, and its impact on patients and drug development over the last forty years, well substantiated with current data to build the case for how biotechnology today plays a major role in driving one of the most important and exciting technological industries of our time.
Product innovation is the central strategic challenge in the healthcare value chain. Companies in each of the sectors covered in this volume – pharmaceuticals, biotechnology, medical devices, and information technology – compete largely on their rate of innovation and the innovativeness of the new products they make. Start-up companies live and die based on their ability to develop new products and therapies that meet needs not satisfied by larger incumbents. This chapter examines the similarities and differences across these sectors, the commonalities they all face in the innovation process, the basis for the imperative to develop new technologies, and the common challenges facing firms in these sectors. Finally, the chapter explains why everyone studying the healthcare industry needs to know more about these technology-based sectors and their impact upon the rest of the healthcare industry and the economy.
Through a long history of co-evolution, multicellular organisms form a complex of host cells plus many associated microorganism species. Consisting of algae, bacteria, archaea, fungi, protists and viruses, and collectively referred to as the microbiome, these microorganisms contribute to a range of important functions in their hosts, from nutrition, to behaviour and disease susceptibility. In this book, a diverse and international group of active researchers outline how multicellular organisms have become reliant on their microbiomes to function, and explore this vital interdependence across the breadth of soil, plant, animal and human hosts. They draw parallels and contrasts across hosts in different environments, and discuss how this invisible microbial ecosystem influences everything from the food we eat, to our health, to the correct functioning of ecosystems we depend on. This insightful read also pertinently encourages students and researchers in microbial ecology, ecology, and microbiology to consider how this interdependence may be key to mitigating environmental changes and developing microbial biotechnology to improve life on Earth.
This chapter advances the argument that religious and ethical reasoning have a role to play in policy debates about patent law, and also in some patent law cases. We begin at the most general level, by arguing that in democratic, pluralist societies, moral and religious argument have a legitimate contribution to make to public discourse tout court. We then make a case for the relevance of religious and moral deliberation for patent law in particular, given that inventions and new technologies that seek patent protection sometimes have significant repercussions for wider society, and patent protection is a way of encouraging and supporting their development. We also consider ways in which religion and ethics might be said to count as relevant evidence not only in patent policy debates, but also in patent proceedings. We address this against the background of the ‘politics of knowledge’ that has arisen in Europe and the United States, and include reference to the explicit immorality exclusion found in European patent legal systems. Given that the interpretation and application of the immorality exclusion has been controversial with lawyers, we finally propose an alternative, potentially more fruitful approach to the exclusion, treating it as a ‘policy lever’.
The chapter discusses the relationship between patent governance, ethics, and democracy, referring to limits in patent law set in democratic decisions by the EU legislator in the EU Biotech Directive. The ordre public clauses in Articles 5 and 6 attempt to "upstream" ethics and anticipatory impact assessment in biotechnology patent law. However, the interpretation of these clauses, especially for inventions concerning human embryonic stem cells, gametes, parthenotes, and genome editing (CRISPR-Cas) techniques, has ignited intense policy debates. Granting practices and case law of the European Patent Office (EPO) and its Boards of Appeal have circumvented some of these legal restrictions, and thus pose challenges for transparency and accountability norms in patent practice. Case law of the Court of Justice of the European Union (CJEU) and empirical analyses of patent application and granting practices are scrutinised. The chapter states that interpretation of legal statutes must not be narrowly literal but must also include the history and purpose of the Biotech Directive and the socio-technical and economic implications of its application. This requires that the EPO and the European Commission act transparently and account for their application of the legal rules as set by the European legislator and interpreted by the CJEU.
Intraspecific and interspecific cloning via somatic cell nuclear transfer (iSCNT) is a biotechnique with great possibilities for wild mammals because it allows the maintenance of biodiversity by recovering species, nuclear reprogramming for the production of pluripotency-induced cells, and studies related to embryonic development. Nevertheless, many areas in cloning, especially those associated with wild mammals, are still in question because of the difficulty in obtaining cytoplasmic donor cells (or cytoplasts). Conversely, donor cell nuclei (or karyoplasts) are widely obtained from the skin of living or post-mortem individuals and often maintained in somatic cell banks. Moreover, the creation of karyoplast–cytoplast complexes by fusion followed by activation and embryo development is one of the most difficult steps that requires further clarification to avoid genetic failures. Although difficult, cloning different species, such as wild carnivores and ungulates, can be successful via iSCNT with embryo development and the birth of offspring. Thus, novel research in the area that contributes to the conservation of biodiversity and knowledge of the physiology of species continues. The present review presents the failures and successes that occurred with the application of the technique in wild mammals, with the goal of helping future work on cloning via iSCNT.
In 1989, Edgar Woolard began his tenure as chief executive of the chemical giant DuPont by calling for a new “corporate environmentalism.” DuPont has changed dramatically since then to become more environmentally sustainable, but the company still has a poor record in some areas. The sustainability push also had mixed financial consequences. Though eco-efficiencies saved DuPont billions of dollars, the effort to create more sustainable engines of corporate growth failed to meet Wall Street expectations. The DuPont story offers important insights into the difficulties of greening an established industrial enterprise.
The number of people able to end Earth's technical civilization has heretofore been small. Emerging dual-use technologies, such as biotechnology, may give similar power to thousands or millions of individuals. To quantitatively investigate the ramifications of such a marked shift on the survival of both terrestrial and extraterrestrial technical civilizations, this paper presents a two-parameter model for civilizational lifespans, i.e. the quantity L in Drake's equation for the number of communicating extraterrestrial civilizations. One parameter characterizes the population lethality of a civilization's biotechnology and the other characterizes the civilization's psychosociology. L is demonstrated to be less than the inverse of the product of these two parameters. Using empiric data from PubMed to inform the biotechnology parameter, the model predicts human civilization's median survival time as decades to centuries, even with optimistic psychosociological parameter values, thereby positioning biotechnology as a proximate threat to human civilization. For an ensemble of civilizations having some median calculated survival time, the model predicts that, after 80 times that duration, only one in 1024 civilizations will survive – a tempo and degree of winnowing compatible with Hanson's ‘Great Filter.’ Thus, assuming that civilizations universally develop advanced biotechnology, before they become vigorous interstellar colonizers, the model provides a resolution to the Fermi paradox.
Antarctica is one of the most suitable locations for the bioprospecting of psychrotrophic fungi, which play a key role in the nutrient cycle and organic material mineralization in cold environments. These actions mainly take place via the production of several cold-active extracellular enzymes. The aim of this study was to investigate the diversity of filamentous fungi from King George Island (25 De Mayo Island), Antarctica and their ability to produce extracellular hydrolytic enzymes at low temperatures. A total of 51 fungal isolates were obtained from 31 samples. Twelve genera were identified, with seven among the Ascomycota (Cadophora, Helotiales, Monographella, Oidodendron, Penicillium, Phialocephala, Phialophora, Phoma and Pseudogymnoascus), one Basidiomycota (Irpex) and two Mucoromycota (Mortierella and Mucor). Monographella lycopodina and Mucor zonatus, not previously reported in Antarctica, were identified. Nine isolates could not be identified to genus level and may represent novel species. Most of the studied fungi were psychrotrophic (76.5%). Nevertheless, only five isolates were able to grow at 35°C, 15°C being the optimal growth temperature for 65% of the fungal isolates. Results from enzyme production at low temperature revealed that the Antarctic environment contains metabolically diverse fungi, which represent potential tools for biotechnological applications in cold regions.
Nearly two decades into the 21st century, we revisit the topic of changes in the US agricultural system. We focus on trends in structure, technology and policy, and on the increasing influence of consumer preferences on this system, particularly for organic agriculture and local and regional foods. We examine technological innovations in the 21st century, including biotechnology, precision agriculture and indoor farming. Within overall trends toward consolidation, we identify an increasing number of vegetable farms and greenhouse operations, accompanied by a decrease in average size of those operations. We note the shift away from price support toward greater reliance on risk management in farm policy, and also track the impact of food movement trends on recent farm bills. While farm bill policies continue to focus on conventional field crop agriculture, some trends—expanded crop insurance, conservation program support and spending on federal data collection, research and community-based grants, for example—have begun to incorporate the growing movement toward organic, local and regional food systems into the mainstream of US agricultural production and policy.
U.S. agriculture has seen a rapid adoption of biotechnology over the last two decades. This study investigates how biotechnology has affected U.S. farm input demand and agricultural productivity. The analysis relies on data at the national level and at the state level for selected states in the Corn Belt. It evaluates the rate of technological change and price elasticities of demand for agricultural inputs over time. The study documents the evolving biases in technological change in agriculture. It finds evidence that farm input demands have become more price inelastic.
This article identifies a major transformation in India's approach to strategic technology development from an earlier Commission model, epitomized by atomic energy, that seeks the enhancement of sovereign power, to a Mission model, epitomized by telecommunications, directed toward the furthering of biopolitical power. It compares five strategic industries in India—atomic energy, space, electronics, biotechnology and telecommunications—and shows that no single factor is responsible for technological success or failure. Outcomes depend on the strength of political networks, the structure and maturity of the industry, the extent of bureaucratic resistance, and the technological strategy adopted. This finding contests the widely held perspective that success in strategic technology development is the product of the extraordinary efforts of a single individual, a technology “czar,” and explains the persistence of this narrative by highlighting the role of technoscience in mediating a highly ambivalent relation between the Indian middle class and the state.
In 2015, we published an article entitled “The Medicalization of Love,” in which we argued that both good and bad consequences could be expected to follow from love’s medicalization, depending on how the process unfolded. A flurry of commentaries followed; here we offer some preliminary thoughts in reply to the more substantial of the criticisms that were raised. We focus in particular on the nature of love itself as well as the role it plays (or should play) in our lives; we also touch on a number of practical issues concerning the likely effects of any plausible “real-life” love drugs and conclude with a call for careful regulation.
Weeds are a significant problem in crop production and their management in
modern agriculture is crucial to avoid yield losses and ensure food
security. Intensive agricultural practices, changing climate, and natural
disasters affect weed dynamics and that requires a change in weed management
protocols. The existing manual control options are no longer viable because
of labor shortages; chemical control options are limited by ecodegradation,
health hazards, and development of herbicide resistance in weeds. We are
therefore reviewing some potential nonconventional weed management
strategies for modern agriculture that are viable, feasible, and efficient.
Improvement in tillage regimes has long been identified as an impressive
weed-control measure. Harvest weed seed control and seed predation have been
shown as potential tools for reducing weed emergence and seed bank reserves.
Development in the field of allelopathy for weed management has led to new
techniques for weed control. The remarkable role of biotechnological
advancements in developing herbicide-resistant crops, bioherbicides, and
harnessing the allelopathic potential of crops is also worth mentioning in a
modern weed management program. Thermal weed management has also been
observed as a useful technique, especially under conservation agriculture
systems. Last, precision weed management has been elaborated with sufficient
details. The role of remote sensing, modeling, and robotics as an integral
part of precision weed management has been highlighted in a realistic
manner. All these strategies are viable for today's agriculture; however,
site-specific selection and the use of right combinations will be the key to
success. No single strategy is perfect, and therefore an integrated approach
may provide better results. Future research is needed to explore the
potential of these strategies and to optimize them on technological and
cultural bases. The adoption of such methods may improve the efficiency of
cropping systems under sustainable and conservation practices.
This article reviews biotechnology legislation in the 50 states for 11 policy areas spanning 1990–2010, an era of immense growth in biotechnology, genetic knowledge, and significant policy development. Policies regarding health insurance, life insurance, long-term care insurance, DNA data bank collection, biotech research protection, biotech promotion and support, employment discrimination, genetic counselor licensing, human cloning, and genetic privacy each represent major policy responses arising from biotechnology and coinciding with key areas of state regulation (insurance, criminal justice, economic development, labor law, health and safety, privacy, and property rights). This analysis seeks to answer three questions regarding biotechnology legislation at the state level: who is acting (policy adoption), when is policy adopted (policy timing), and what is policy doing (policy content). Theoretical concerns examine state ideology (conservative or liberal), policy type (economic or moral), and the role of external events (federal law, news events, etc.) on state policy adoption. Findings suggest ideological patterns in adoption, timing, and content of biotech policy. Findings also suggest economic policies tend to be more uniform in content than moral policies, and findings also document a clear link between federal policy development, external events, and state policy response.