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.

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.

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)

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.

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.)

Statement submitted by the United States of Brazil to the President of the United States of America as arbitrator : under the provisions of the treaty concluded september 7, 1889, between Brazil and the Argentine Republic

Exposição que os Estados Unidos do Brazil apresentam ao Presidente dos Estados Unidos da América como árbitro seguindo as estipulações no Tratado de 7 de setembro de 1889, concluído entre o Brazil e a Republica Argentina.

Marine flora and fauna of the Eastern United States Anthozoa: Acitniaria, Corallimorpharia, Ceriantharia, and Zoanthidea

This key includes 60 species of sea anemones and their relatives in the orders Actiniaria, Corallimorpharia, Ceriantharia, and Zoanthidea. Species from the intertidal zone, continental slope, and deep sea are included over a geographic range from Atlantic Canada to approximately South Carolina. In addition to the illustrated key itself, characteristics of each species are summarized in tabular form, including morphology, distribution, and types and sizes of cnidae. Ecological and taxonomic information on each species are also included in an annotated species list. (PDF file contains 76 pages.)

Quantitative composition and distribution of the macrobenthic invertebrate fauna of the Continental Shelf ecosystems of the Northeastern United States

From the mid-1950's to the mid-1960's a series of quantitative surveys of the macrobenthic invertebrate fauna were conducted in the offshore New England region (Maine to Long Island, New York). The surveys were designed to 1) obtain measures of macrobenthic standing crop expressed in terms of density and biomass; 2) determine the taxonomic composition of the fauna (ca. 567 species); 3) map the general features of macrobenthic distribution; and 4) evaluate the fauna's relationships to water depth, bottom type, temperature range, and sediment organic carbon content. A total of 1,076 samples, ranging from 3 to 3,974 m in depth, were obtained and analyzed. The aggregate macrobenthic fauna consists of 44 major taxonomic groups (phyla, classes, orders). A striking fact is that only five of those groups (belonging to four phyla) account for over 80% of both total biomass and number of individuals of the macrobenthos. The five dominant groups are Bivalvia, Annelida, Amphipoda, Echninoidea, and Holothuroidea. Other salient features pertaining to the macrobenthos of the region are the following: substantial differences in quantity exist among different geographic subareas within the region, but with a general trend that both density and biomass increase from northeast to southwest; both density and biomass decrease with increasing depth; the composition of the bottom sediments significantly influences both the kind and quantity of macrobenthic invertebrates, the largest quantities of both measures of abundance occurring in the coarser grained sediments and diminishing with decreasing particle size; areas with marked seasonal changes in water temperature support an abundant and diverse fauna, whereas a uniform temperature regime is associated with a sparse, less diverse fauna; and no detectable trends are evident in the quantitative composition of the macrobenthos in relation to sediment organic carbon content. (PDF file contains 246 pages.)

Marine Flora and Fauna of the eastern United States: Acanthocephala

The phylum Acanthocephala (intestinal worm parasites of vertebrates) of the Atlantic coast of the United States comprises 43 species and 20 genera belonging to three orders: Echinorhynchida, Neoechinorhynchida, and Polymorphida. Adults are exclusively intestinal parasites of vertebrates. This study includes those species found in vertebrates of marine and estuarine environments along the North American Atlantic coast between Maine and Texas. Species that can be found within that geographical range and those that typically infect freshwater fishes but that are occasionally present in marine or estuarine hosts are also included. The taxonamy, anatomy, natural history, and ecology of the phylum Acanthocephala are discussed, and an illustrated key to the genera is presented. Techniques, an annotated systematic treatment of all 43 species, and a systematic index are included. No systematic decisions will be made at this time, but areas where such decisions are pending will be indicated and discussed for future reports. (PDF file contains 32 pages.)

Marine Flora and Fauna of the Eastern United States: Platyhelminthes: Monogenea

(PDF file contains 112 pages.)

Marine Flora and Fauna of the Eastern United States: Dicyemida

This manual treats the six species of dicyemid mesozoans that have been reported in three species of hosts (Octopus vulgaris, O. joubini, and O. briareus) from the eastern coast of North America and the Gulf of Mexico, including the Florida Keys. All are parasites of species of Octopus and are in the genus Dicyema, family Dicyemidae. In the introduction, the life cycle, as known, and the general morphology of dicyemids are briefly described, and methods are given for collecting and preparing material for study. These are followed by a key to species and by an annotated checklist, which includes data, some hitherto unpublished, on their known prevalence in hosts from various localities including Bimini and Bermuda.(PDF file contains 20 pages.)