Patents, Ethics and Stem Cell Research : The Case of hESC Innovation in Australia, Europe and the United States

Embryonic stem cells offer potentially a ground-breaking insight into health and diseases and are said to offer hope in discovering cures for many ailments unimaginable few years ago. Human embryonic stem cells are undifferentiated, immature cells that possess an amazing ability to develop into almost any body cell such as heart muscle, bone, nerve and blood cells and possibly even organs in due course. This remarkable feature, enabling embryonic stem cells to proliferate indefinitely in vitro (in a test tube), has branded them as a so-called miracle cure . Their potential use in clinical applications provides hope to many sufferers of debilitating and fatal medical conditions. However, the emergence of stem cell research has resulted in intense debates about its promises and dangers. On the one hand, advocates hail its potential, ranging from alleviating and even curing fatal and debilitating diseases such as Parkinson s, diabetes, heart ailments and so forth. On the other hand, opponents decry its dangers, drawing attention to the inherent risks of human embryo destruction, cloning for research purposes and reproductive cloning eventually. Lately, however, the policy battles surrounding human embryonic stem cell innovation have shifted from being a controversial research to scuffles within intellectual property rights. In fact, the ability to obtain patents represents a pivotal factor in the economic success or failure of this new biotechnology. Although, stem cell patents tend to more or less satisfy the standard patentability requirements, they also raise serious ethical and moral questions about the meaning of the exclusions on ethical or moral grounds as found in European and to an extent American and Australian patent laws. At present there is a sort of a calamity over human embryonic stem cell patents in Europe and to an extent in Australia and the United States. This in turn has created a sense of urgency to engage all relevant parties in the discourse on how best to approach patenting of this new form of scientific innovation. In essence, this should become a highly favoured patenting priority. To the contrary, stem cell innovation and its reliance on patent protection risk turmoil, uncertainty, confusion and even a halt on not only stem cell research but also further emerging biotechnology research and development. The patent system is premised upon the fundamental principle of balance which ought to ensure that the temporary monopoly awarded to the inventor equals that of the social benefit provided by the disclosure of the invention. Ensuring and maintaining this balance within the patent system when patenting human embryonic stem cells is of crucial contemporary relevance. Yet, the patenting of human embryonic stem cells raises some fundamental moral, social and legal questions. Overall, the present approach of patenting human embryonic stem cell related inventions is unsatisfactory and ineffective. This draws attention to a specific question which provides for a conceptual framework for this work. That question is the following: how can the investigated patent offices successfully deal with patentability of human embryonic stem cells? This in turn points at the thorny issue of application of the morality clause in this field. In particular, the interpretation of the exclusions on ethical or moral grounds as found in Australian, American and European legislative and judicial precedents. The Thesis seeks to compare laws and legal practices surrounding patentability of human embryonic stem cells in Australia and the United States with that of Europe. By using Europe as the primary case study for lessons and guidance, the central goal of the Thesis then becomes the determination of the type of solutions available to Europe with prospects to apply such to Australia and the United States. The Dissertation purports to define the ethical implications that arise with patenting human embryonic stem cells and intends to offer resolutions to the key ethical dilemmas surrounding patentability of human embryonic stem cells and other morally controversial biotechnology inventions. In particular, the Thesis goal is to propose a functional framework that may be used as a benchmark for an informed discussion on the solution to resolving ethical and legal tensions that come with patentability of human embryonic stem cells in Australian, American and European patent worlds. Key research questions that arise from these objectives and which continuously thread throughout the monograph are: 1. How do common law countries such as Australia and the United States approach and deal with patentability of human embryonic stem cells in their jurisdictions? These practices are then compared to the situation in Europe as represented by the United Kingdom (first two chapters), the Court of Justice of the European Union and the European Patent Office decisions (Chapter 3 onwards) in order to obtain a full picture of the present patenting procedures on the European soil. 2. How are ethical and moral considerations taken into account at patent offices investigated when assessing patentability of human embryonic stem cell related inventions? In order to assess this part, the Thesis evaluates how ethical issues that arise with patent applications are dealt with by: a) Legislative history of the modern patent system from its inception in 15th Century England to present day patent laws. b) Australian, American and European patent offices presently and in the past, including other relevant legal precedents on the subject matter. c) Normative ethical theories. d) The notion of human dignity used as the lowest common denominator for the interpretation of the European morality clause. 3. Given the existence of the morality clause in form of Article 6(1) of the Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions which corresponds to Article 53(a) European Patent Convention, a special emphasis is put on Europe as a guiding principle for Australia and the United States. Any room for improvement of the European morality clause and Europe s current manner of evaluating ethical tensions surrounding human embryonic stem cell inventions is examined. 4. A summary of options (as represented by Australia, the United States and Europe) available as a basis for the optimal examination procedure of human embryonic stem cell inventions is depicted, whereas the best of such alternatives is deduced in order to create a benchmark framework. This framework is then utilised on and promoted as a tool to assist Europe (as represented by the European Patent Office) in examining human embryonic stem cell patent applications. This method suggests a possibility of implementing an institution solution. 5. Ultimately, a question of whether such reformed European patent system can be used as a founding stone for a potential patent reform in Australia and the United States when examining human embryonic stem cells or other morally controversial inventions is surveyed. The author wishes to emphasise that the guiding thought while carrying out this work is to convey the significance of identifying, analysing and clarifying the ethical tensions surrounding patenting human embryonic stem cells and ultimately present a solution that adequately assesses patentability of human embryonic stem cell inventions and related biotechnologies. In answering the key questions above, the Thesis strives to contribute to the broader stem cell debate about how and to which extent ethical and social positions should be integrated into the patenting procedure in pluralistic and morally divided democracies of Europe and subsequently Australia and the United States.

Bridging East and West : The Establishment of the International Institute for Applied Systems Analysis (IIASA) in the United States Foreign Policy of Bridge Building, 1964-1972.

The dissertation examines the foreign policies of the United States through the prism of science and technology. In the focal point of scrutiny is the policy establishing the International Institute for Applied Systems Analysis (IIASA) and the development of the multilateral part of bridge building in American foreign policy during the 1960s and early 1970s. After a long and arduous negotiation process, the institute was finally established by twelve national member organizations from the following countries: Bulgaria, Canada, Czechoslovakia, Federal Republic of Germany (FRG), France, German Democratic Republic (GDR), Great Britain, Italy, Japan, Poland, Soviet Union and United States; a few years later Sweden, Finland and the Netherlands also joined. It is said that the goal of the institute was to bring together researchers from East and West to solve pertinent problems caused by the modernization process experienced in industrialized world. It originates from President Lyndon B. Johnson s bridge building policies that were launched in 1964, and was set in a well-contested and crowded domain of other international organizations of environmental and social planning. Since the distinct need for yet another organization was not evident, the process of negotiations in this multinational environment enlightens the foreign policy ambitions of the United States on the road to the Cold War détente. The study places this project within its political era, and juxtaposes it with other international organizations, especially that of the OECD, ECE and NATO. Conventionally, Lyndon Johnson s bridge building policies have been seen as a means to normalize its international relations bilaterally with different East European countries, and the multilateral dimension of the policy has been ignored. This is why IIASA s establishment process in this multilateral environment brings forth new information on US foreign policy goals, the means to achieve these goals, as well as its relations to other advanced industrialized societies before the time of détente, during the 1960s and early 1970s. Furthermore, the substance of the institute applied systems analysis illuminates the differences between European and American methodological thinking in social planning. Systems analysis is closely associated with (American) science and technology policies of the 1960s, especially in its military administrative applications, thus analysis within the foreign policy environment of the United States proved particularly fruitful. In the 1960s the institutional structures of European continent with faltering, and the growing tendencies of integration were in flux. One example of this was the long, drawn-out process of British membership in the EEC, another is de Gaulle s withdrawal from NATO s military-political cooperation. On the other hand, however, economic cooperation in Europe between East and West, and especially with the Soviet Union was expanding rapidly. This American initiative to form a new institutional actor has to be seen in that structural context, showing that bridge building was needed not only to the East, but also to the West. The narrative amounts to an analysis of how the United States managed both cooperation and conflict in its hegemonic aspirations in the emerging modern world, and how it used its special relationship with the United Kingdom to achieve its goals. The research is based on the archives of the United States, Great Britain, Sweden, Finland, and IIASA. The primary sources have been complemented with both contemporary and present day research literature, periodicals, and interviews.

Public and private technical assistance programs for non-industrial private forest landowners in the southern United States.

XVIII IUFRO World Congress, Ljubljana 1986.

Fishery resources of the United States of America

The term “fishery resources” is used in this book with a broad application. It includes the populations of the fishes and other organisms useful to men, the environment that makes life possible for them, the industry that exploits and utilizes them, and our knowledge about them by which we can conserve their productivity. This book aims to survey the present status of all these aspects of those fishery resources that are used or are available for use by United States anglers and commercial fishermen. It is planned primarily for the Congress, at its request, with the idea of giving to busy people, in condensed fashion, a perspective on its subject. (pdf contains 142 pages)

Panel Discussion - Management of Eurasian watermilfoil in the United States using native insects: State regulatory and management issues

While researchers have evaluated the potential of native insect herbivores to manage nonindigenous aquatic plant species such as Eurasian watermilfoil ( Myriophyllum spicatum L.), the practical matters of regulatory compliance and implementation have been neglected. A panel of aquatic nuisance species program managers from three state natural resource management agencies (Minnesota, Vermont and Washington) discussed their regulatory and policy concerns. In addition, one ecological consultant attempting to market one of the native insects to manage Eurasian watermilfoil added his perspective on the special challenges of distributing a native biological control agent for management of Eurasian watermilfoil.

Fish assemblages and indicator species: reef fishes off the southeastern United States

For many fish stocks, resource management cannot be based on stock assessment because data are insufficient-a situation that requires alternative approaches to management. One possible approach is to manage data-limited stocks as part of an assemblage and to determine the status of the entire unit by a data-rich indicator species. The utility of this approach was evaluated in analyses of 15 years of commercial and 34 years of recreational logbook data from reef fisheries off the southeastern United States coast. Multivariate statistical analyses successfully revealed three primary assemblages. Within assemblages, however, there was little evidence of synchrony in population dynamics of member species, and thus, no support for the use of indicator species. Nonetheless, assemblages could prove useful as management units. Their identification offers opportunities for implementing management to address such ecological considerations as bycatch and species interrelations.

Juvenile fish assemblages collected on unconsolidated sediments of the southeast United States continental shelf

Patterns were investigated in juvenile fish use of unconsolidated sediments on the southeast United States continental shelf off Georgia. Juvenile fish and environmental data were sampled at ten stations along a 110-km cross-shelf transect, including four stations surrounding Gray’s Reef National Marine Sanctuary (Gray’s Reef NMFS). Cross-shelf stations were sampled approximately quarterly from spring 2000 to winter 2002. Additional stations were sampled on three transects inshore of Gray’s Reef NMS and four transects offshore of the Sanctuary during three cruises to investigate along-shelf patterns in the juvenile fish assemblages. Samples were collected in beam trawls, and 121 juvenile taxa, of which 33 were reef-associated species, were identified. Correspondence analysis on untransformed juvenile fish abundance indicated a cross-shelf gradient in assemblages, and the station groupings and assemblages varied seasonally. During the spring, fall, and winter, three cross-shelf regions were identified: inner-shelf, mid-shelf, and outer-shelf regions. In the summer, the shelf consisted of a single juvenile fish assemblage. Water depth was the primary environmental variable correlated with cross-shelf assemblages. However, salinity, density, and water column stratification also correlated with the distribution of assemblages during the spring, fall, and winter, and along with temperature likely influenced the distribution of juvenile fish. No along-shelf spatial patterns were found in the juvenile fish assemblages, but the along-shelf dimension sampled was small (~60 km). Our results revealed that a number of commercially and recreationally important species used unconsolidated sediments on the shelf off Georgia as juvenile habitat. We conclude that management efforts would be improved through a greater recognition of the importance of these habitats to fish production and the interconnectedness of multiple habitats in the southeast U.S. continental shelf ecosystem.

Population assessment of two stocks of white grunt, Haemulon plumieri, from the southeastern coast of the United States

Changes in the age structure and population size of white grunt, Haemulon plumieri, from North Carolina through the Florida Keys were examined using records of landings and size frequencies of fish from commercial, re~reational, and headboat fisheries from 1986-1998. Data were stratified into two geographical areas: North Carolina and South Carolina; and southeast Florida. Population size in numbers at age was estimated for each year and geographical area by applying an uncalibrated separable virtual population analysis (SVPA) to the landings in numbers at age. A calibrated virtual population analysis, FADAPT, was also run for data from North Carolina and South Carolina. SVPA and FADAPT were used to estimate annual, age-specific fishing mortality (F) for four levels of natural mortality (M = 0.20, 0.25, 0.30, and 0.35). The best estimate of M for white grunt is 0.30. Landings of white grunt in the Carolinas for the three fisheries have generally decreased in recent years, but have held fairly steady for the species in southeast Florida. Age at entry and age at full recruitment were age-1 and age-4 for the Carolinas, and age-l and age-3 for southeast Florida. With M = 0.30, levels of fishing mortality (F) on the fully-recruited ages were 0.23 for the Carolinas and 0.33 for southeast Florida. Spawning potential ratio (SPR) at M = 0.30 was 57% for the Carolinas and 61% for southeast Florida, which indicates that the species, by definition, has not been over-exploited by fishing. The results of this assessment of the white grunt population off the Carolinas agree with the recent F/FMSY analysis of white grunt (Anonymous, 1999). (PDF contaons 72 pages)

Residential Docks and Piers: Inventory of laws, regulations, and policies for the Southeastern United States

While the homes threatened by erosion and the developer illegally filling in marshlands are the projects that make the headlines, for many state regulatory programs, it’s the residential docks and piers that take up the most time. When is a dock too long? What about crossing extended property lines? And at what point does a creek have too many docks? There are no easy answers to any of the dock and pier related questions. Each state has to craft the laws and policies that are best for its natural resources and its political and legal environment. At the same time, mistakes in judgment can be costly for the organization, the homeowner, and the natural resources. At the request of the Georgia Coastal Management Program, the National Oceanic and Atmospheric Administration (NOAA) Coastal Services Center compiled an inventory of dock information for four states—Georgia, Florida, North Carolina, and South Carolina. Federal laws, state laws and regulations, permitting policies, and contact information are included in a tabular format that is easy to use. (PDF contaions 18 pages)

Population assessment of the vermilion snapper, Rhomboplites aurorubens, from the Southeastern United States

Changes in the age structure and population size of vermilion snapper, Rhornboplites aurorubens, from North Carolina through the Florida Keys were examined using records of landings and size frequencies of fish from commercial, recreational, and headboat fisheries from 1986-1996. Population size in numbers at age was estimated for each year by applying separable virtual population analysis (SVPA) to the landings in numbers at age. SVPA was used to estimate annual, age-specific fishing mortality (F) for four levels of natural mortality (M = 0.20, 0.25, 0.30, and 0.35). Although landings of vermilion snapper for the three fisheries have declined, minimum fish size regulations have resulted in an increase in the mean size of fish landed. Age at entry and age at full recruitment were age-1 andage-3 fDr 1986-1991, compared with age-1 and age-4, respectively, for 1992-1996. Levels of mortality from fishing (F) ranged from 0.38 - 0.61 for the entire period. Current spawning potential ratio (SPR) is 21% or 27% depending on the natural mortality estimate. SPR could be raised to 30% or 40% with a reduction in F, or by increasing the age at entry to the fisheries. The latter could be enhanced now if fishermen, particularly recreational, comply with minimum size regulations. However, released fish mortality, modeled in the assessment at 27%, will continue to make the achievement of 30% and 40% SPR more difficult. (PDF contains 63 pages)

A manual of previously recorded non-indigenous invasive and native transplanted animal species of the Laurentian Great Lakes and coastal United States

This manual presents geographic information by state of occurrence, and descriptions of the socio-economic impact created by the invasion of non-indigenous and native transplanted animal species in the Laurentian Great Lakes and the coastal waters of the United States. It is not a comprehensive literature review, but rather is intended as a primer for those unfamiliar with the socio-economic impacts of invasive aquatic and marine animals. Readers should also note that the information contained in this manual is current as of its publication date. New information and new species are routinely being added to the wider literature base. Most of the information was gathered from a number of web sites maintained by government agencies, commissions, academic institutions and museums. Additional information was taken from the primary and secondary literature. This manual focuses on socio-economic consequences of invasive species. Thus, ecological impacts, when noted in the literature, are not discussed unless a connection to socio-economic factors can be made. For a majority of the species listed, either the impact of their invasion is not understood, or it is not published in sources surveyed. In the species summaries, sources of information are cited except for information from the U.S. Geological Survey’s (USGS) Nonindigenous Aquatic Species Database http://nas.er.usgs.gov. This website formed the base information used in creating tables on geographic distribution, and in many of the species summaries provided. Thus, whenever information is given without specific author/source and date citation, it has come from this comprehensive source. (PDF contains 90 pages)

The State of Coral Reef Ecosystems of the United States and Pacific Freely Associated States: 2005

Executive Summary: For over three decades, scientists have been documenting the decline of coral reef ecosystems, amid increasing recognition of their value in supporting high biological diversity and their many benefits to human society. Coral reef ecosystems are recognized for their benefits on many levels, such as supporting economies by nurturing fisheries and providing for recreational and tourism opportunities, providing substances useful for medical purposes, performing essential ecosystem services that protect against coastal erosion, and provid-ing a diversity of other, more intangible contributions to many cultures. In the past decade, the increased awareness regarding coral reefs has prompted action by governmental and non-governmental organizations, including increased funding from the U.S. Congress for conservation of these important ecosystems and creation of the U.S. Coral Reef Task Force (USCRTF) to coordinate activities and implement conservation measures [Presidential Executive Order 13089]. Numerous partnerships forged among Federal agencies and state, local, non-governmental, academic and private partners support activities that range from basic science to systematic monitoring of ecosystem com-ponents and are conducted by government agencies, non-governmental organizations, universities, and the private sector. This report shares the results of many of these efforts in the framework of a broad assessment of the condition of coral reef ecosystems across 14 U.S. jurisdictions and Pacific Freely Associated States. This report relies heavily on quantitative, spatially-explicit data that has been collected in the recent past and comparisons with historical data, where possible. The success of this effort can be attributed to the dedication of over 160 report contributors who comprised the expert writing teams for each jurisdiction. The content of the report chapters are the result of their considerable collaborative efforts. The writing teams, which were organized by jurisdiction and comprised of experts from numerous research and management institutions, were provided a basic chapter outline and a length limit, but the content of each chapter was left entirely to their discretion. Each jurisdictional chapter in the report is structured to: 1) describe how each of the primary threats identified in the National Coral Reef Action Strategy (NCRAS) has manifested in the jurisdiction; 2) introduce ongoing monitoring and assessment activities relative to three major categories of inquiry – water quality, benthic habitats, and associated biological communities – and provide summary results in a data-rich format; and 3) highlight recent management activities that promote conservation of coral reef ecosystems.

Global Climate Change Impacts in the United States: a state of knowledge report from the U.S. Global Change Research Program

Executive Summary: Observations show that warming of the climate is unequivocal. The global warming observed over the past 50 years is due primarily to human-induced emissions of heat-trapping gases. These emissions come mainly from the burning of fossil fuels (coal, oil, and gas), with important contributions from the clearing of forests, agricultural practices, and other activities. Warming over this century is projected to be considerably greater than over the last century. The global average temperature since 1900 has risen by about 1.5ºF. By 2100, it is projected to rise another 2 to 11.5ºF. The U.S. average temperature has risen by a comparable amount and is very likely to rise more than the global average over this century, with some variation from place to place. Several factors will determine future temperature increases. Increases at the lower end of this range are more likely if global heat-trapping gas emissions are cut substantially. If emissions continue to rise at or near current rates, temperature increases are more likely to be near the upper end of the range. Volcanic eruptions or other natural variations could temporarily counteract some of the human-induced warming, slowing the rise in global temperature, but these effects would only last a few years. Reducing emissions of carbon dioxide would lessen warming over this century and beyond. Sizable early cuts in emissions would significantly reduce the pace and the overall amount of climate change. Earlier cuts in emissions would have a greater effect in reducing climate change than comparable reductions made later. In addition, reducing emissions of some shorter-lived heat-trapping gases, such as methane, and some types of particles, such as soot, would begin to reduce warming within weeks to decades. Climate-related changes have already been observed globally and in the United States. These include increases in air and water temperatures, reduced frost days, increased frequency and intensity of heavy downpours, a rise in sea level, and reduced snow cover, glaciers, permafrost, and sea ice. A longer ice-free period on lakes and rivers, lengthening of the growing season, and increased water vapor in the atmosphere have also been observed. Over the past 30 years, temperatures have risen faster in winter than in any other season, with average winter temperatures in the Midwest and northern Great Plains increasing more than 7ºF. Some of the changes have been faster than previous assessments had suggested. These climate-related changes are expected to continue while new ones develop. Likely future changes for the United States and surrounding coastal waters include more intense hurricanes with related increases in wind, rain, and storm surges (but not necessarily an increase in the number of these storms that make landfall), as well as drier conditions in the Southwest and Caribbean. These changes will affect human health, water supply, agriculture, coastal areas, and many other aspects of society and the natural environment. This report synthesizes information from a wide variety of scientific assessments (see page 7) and recently published research to summarize what is known about the observed and projected consequences of climate change on the United States. It combines analysis of impacts on various sectors such as energy, water, and transportation at the national level with an assessment of key impacts on specific regions of the United States. For example, sea-level rise will increase risks of erosion, storm surge damage, and flooding for coastal communities, especially in the Southeast and parts of Alaska. Reduced snowpack and earlier snow melt will alter the timing and amount of water supplies, posing significant challenges for water resource management in the West. (PDF contains 196 pages)

An annotated bibliography of diet studies of fish of the southeast United States and Gray’s Reef National Marine Sanctuary

One goal of Gray’s Reef National Marine Sanctuary (NMS) is to protect the unique community found within the Sanctuary’s boundaries. An understanding of the ecological interactions, including trophic structure, among these organisms is necessary to realize this goal. Therefore, diet information for 184 fish species was summarized from 113 published studies. Among the fish included are 84 fish species currently known to reside in Gray’s Reef NMS. The locations of these studies ranged from the Atlantic Ocean off the coast of the northeast United States to northern Brazil, the Gulf of Mexico, and the Caribbean. All of the species described in this bibliography occur in the southeast United States and are, therefore, current or potential residents of Gray’s Reef National Marine Sanctuary. Each entry includes the objectives, brief methods, and conclusions of the article. The bibliography is also indexed by species. (PDF contains 64 pages.)