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.

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.

Establishing National Ocean Service Priorities for Estuarine, Coastal, and Ocean Modeling: Capabilities, Gaps, and Preliminary Prioritization Factors

This report was developed to help establish National Ocean Service priorities and chart new directions for research and development of models for estuarine, coastal and ocean ecosystems based on user-driven requirements and supportive of sound coastal management, stewardship, and an ecosystem approach to management. (PDF contains 63 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.

Climate adaptation and the fifth amendment of the United States Constitution: How do adaptation strategies impact regulatory takings claims?

As the impacts and potential of climate change are realized at the governance level, states are moving towards adaptation strategies that include greater regulatory restrictions on development within coastal zones. The purpose of this paper is to outline the impacts of existing and planned regulatory mechanisms on the Fifth Amendment to the United States Constitution, which prevents the government taking of private property for public use without just compensation. A short history of regulatory takings is explained, and the potential legal issues surrounding mitigation and adaptation measures for coastal communities are discussed. The goal is to gain an understanding of the legal issues that must be resolved by governments to effectively deal with regulatory takings claims as coastal mitigation and adaptation plans are implemented. (PDF contains 3 pages)

Metallogenic Provinces of the Southwestern United States and Northern Mexico

Some of the metallogenic provinces of the southwestern United States and northern Mexico are defined by the geographic distribution of trace elements in the primary sulfide minerals chalcopyrite and sphalerite. The elements investigated include antimony, arsenic, bismuth, cadmium, cobalt, gallium, germanium, indium, manganese, molybdenum, nickel, silver, tellurium, thallium, and tin. Of these elements, cobalt, gallium, germanium, indium, nickel, silver, and tin exhibit the best defined geographic distribution.

The data indicate that chalcopyrite is the preferred host for tin and perhaps molybdenum; sphalerite is the preferred host for cadmium, gallium, germanium, indium, and manganese; galena is the preferred host for antimony, bismuth, silver, tellurium, and thallium; and pyrite is the preferred host for cobalt, nickel, and perhaps arsenic. With respect to the two minerals chalcopyrite and sphalerite, antimony, arsenic, molybdenum, nickel, silver, and tin prefer chalcopyrite; and bismuth, cadmium, cobalt, gallium, germanium, indium, manganese, and thallium prefer sphalerite. This distribution probably is the result of the interaction of several factors, among which are these: the various radii of the elements, the association due to chemical similarities of the major and trace elements, and the degree of ionic versus covalent and metallic character of the metal-sulfur bonds in chalcopyrite and sphalerite. The type of deposit, according to a temperature classification, appears to be of minor importance in determining the trace element content of chalcopyrite and sphalerite.

A preliminary investigation of large single crystals of sphalerite and chalcopyrite indicates that the distribution within a single crystal of some elements such as cadmium in sphalerite and indium and silver in chalcopyrite is relatively uniform, whereas the distribution of some other elements such as cobalt and manganese in sphalerite is somewhat less uniform and the distribution of tin in sphalerite is extremely erratic. The variations in trace element content probably are due largely to variations in the composition of the fluids during the growth of the crystals, but the erratic behavior of tin in sphalerite perhaps is related to the presence of numerous cavities and inclusions in the crystal studied.

Maps of the geographic distribution of trace elements in chalcopyrite and sphalerite exhibit three main belts of greater than average trace element content, which are called the Eastern, Central, and Western belts. These belts are consistent in trend and position with a beltlike distribution of copper, gold, lead, zinc, silver, and tungsten deposits and with most of the major tectonic features. However, there appear to be no definite time relationships, for as many as four metallogenic epochs, from Precambrian to late Tertiary, are represented by ore deposits within the Central belt.

The evidence suggests that the beltlike features have a deep seated origin, perhaps in the sub-crust or outer parts of the mantle, and that the deposits within each belt might be genetically related through a beltlike compositional heterogeneity in the source regions of the ores. Hence, the belts are regarded as metallogenic provinces.

Analysis of the differences between the rates of inflation associated with two aggregate price level: The case of the euro area and the United States

Idioma: Inglés Abstract: This project focuses on two indicators of prices, the GDP deflator and the consumer price index (CPI), and analyzes the differences and similarities they present. These price indexes have been chosen taking into account its great representativeness and importance to economic and social level, and its direct relationship to the overall functioning of the economy and, in particular, inflation. It should be also mentioned that this study was conducted for cases of the euro area and the United States, as the impact of these economies in the economic and social situation at international level is very significant.

Biology and Management of the American Shad and Status of the Fisheries, Atlantic Coast of the United States, 1960

This paper summarizes current information on the American shad, Alosa sapidissima, and describes the species and its fishery. Emphasis is placed on (1) life history of the fish, (2) condition of the fishery by State and water areas in 1960 compared to 1896 when the last comprehensive description was made, (3) factors responsible for decline in abundance, and (4) management measures. The shad fishery has changed little over the past three-quarters of a century, except in magnitude of yield. Types of shad-fishing gear have remained relatively unchanged, but many improvements have been made in fishing techniques, mostly to achieve economy. In 1896 the estimated catch was more than 50 million pounds. New Jersey ranked first in production with about 14 million pounds, and Virginia second with 11 million pounds. In 1960 the estimated catch was slightly more than 8 million pounds. Maryland ranked first in production with slightly more than 1.5 million pounds, Virginia second with slightly less than 1.4 million pounds, and North Carolina third with about 1.3 million pounds. Biological and economic factors blamed for the decline in shad abundance, such as physical changes in the environment, construction of dams, pollution, over-fishing, and natural cycles of abundance, are discussed. Also discussed are methods used for the rehabilitation and management of the fishery, such as artificial propagation, installation of fish-passage facilities at impoundments, and fishing regulations. With our present knowledge, we can manage individual shad populations; but, we probably cannot restore the shad to its former peak of abundance.

Revealing the appetite of the marine aquarium fish trade: the volume and biodiversity of fish imported into the United States

The aquarium trade and other wildlife consumers are at a crossroads forced by threats from global climate change and other anthropogenic stressors that have weakened coastal ecosystems. While the wildlife trade may put additional stress on coral reefs, it brings income into impoverished parts of the world and may stimulate interest in marine conservation. To better understand the influence of the trade, we must first be able to quantify coral reef fauna moving through it. Herein, we discuss the lack of a data system for monitoring the wildlife aquarium trade and analyze problems that arise when trying to monitor the trade using a system not specifically designed for this purpose. To do this, we examined an entire year of import records of marine tropical fish entering the United States in detail, and discuss the relationship between trade volume, biodiversity and introduction of non-native marine fishes. Our analyses showed that biodiversity levels are higher than previous estimates. Additionally, more than half of government importation forms have numerical or other reporting discrepancies resulting in the overestimation of trade volumes by 27%. While some commonly imported species have been introduced into the coastal waters of the USA (as expected), we also found that some uncommon species in the trade have also been introduced. This is the first study of aquarium trade imports to compare commercial invoices to government forms and provides a means to, routinely and in real time, examine the biodiversity of the trade in coral reef wildlife species.

Comparison of life history parameters for landed and discarded fish captured off the southeastern United States

Commercial fisheries that are managed with minimum size limits protect small fish of all ages and may affect size-selective mortality by the differential removal of fast growing fish. This differential removal may decrease the average size at age, maturation, or sexual transition of the exploited population. When fishery-independent data are not available, a comparison of life history parameters of landed with those of discarded fish (by regulation) will indicate if differential mortality is occurring with the capture of young but large fish (fast growing phenotypes). Indications of this differential size-selective mortality would include the following: the discarded portion of the target fish would have similar age ranges but smaller sizes at age, maturation, and sexual transition as that of landed fish. We examined three species with minimum size limits but different exploitation histories. The known heavily exploited species (Rhomboplites aurorubens [vermilion snapper] and Pagrus pagrus [red porgy]) show signs of this differential mortality. Their landed catch includes many young, large fish, whereas discarded fish had a similar age range and mean ages but smaller sizes at age than the landed fish. The unknown exploited species, Mycteroperca phenax (scamp), showed no signs of differential mortality due to size-selective fishing. Landed catch consisted of old, large fish and discarded scamp had little overlap in age ranges, had significantly different mean ages, and only small differences in size at age when compared to comparable data for landed fish.

Age, growth, and spawning season of red bream (Beryx decadactylus) off the southeastern United States

Red bream (Beryx decadactylus) is a commercially important deep-sea benthopelagic fish with a circumglobal distribution on insular and continental slopes and seamounts. In the United States, small numbers are caught incidentally in the wreckfish (Polyprion americanus) fishery which operates off the southeastern coast, but no biological information exists for the management of the U.S. red bream population. For this study, otoliths (n=163) and gonads (n=161) were collected from commercially caught red bream between 2003 and 2008 to determine life history parameters. Specimens ranged in size from 410 to 630 mm fork length and were all determined to be mature by histological examination of the gonads. Females in spawning condition were observed from June through September, and reproductively active males were found year-round. Sectioned otoliths were difficult to interpret, but maximum age estimates were much higher than the 15 years previously reported for this species from the eastern North Atlantic based on whole-otolith analysis. Estimated ages ranged from 8 to 69 years, and a minimum lifespan of 49 years was validated by using bomb radiocarbon dating. Natural mortality was estimated at 0.06/yr. This study shows that red bream are longer lived and more vulnerable to overfishing than previously assumed and should be managed carefully to prevent overexploitation.

Biomass and reproduction of Pacific sardine (Sardinops sagax) off the Pacific northwestern United States, 2003–2005

The Pacific sardine (Sardinops sagax) is distributed along the west coast of North America from Baja California to British Columbia. This article presents estimates of biomass, spawning biomass, and related biological parameters based on four trawl-ichthyoplankton surveys conducted during July 2003 –March 2005 off Oregon and Washington. The trawl-based biomass estimates, serving as relative abundance, were 198,600 t (coefficient of variation [CV] = 0.51) in July 2003, 20,100 t (0.8) in March 2004, 77,900 t (0.34) in July 2004, and 30,100 t (0.72) in March 2005 over an area close to 200,000 km2. The biomass estimates, high in July and low in March, are a strong indication of migration in and out of this area. Sardine spawn in July off the Pacific Northwest (PNW) coast and none of the sampled fish had spawned in March. The estimated spawning biomass for July 2003 and July 2004 was 39,184 t (0.57) and 84,120 t (0.93), respectively. The average active female sardine in the PNW spawned every 20–40 days compared to every 6–8 days off California. The spawning habitat was located in the southeastern area off the PNW coast, a shift from the northwest area off the PNW coast in the 1990s. Egg production in off the PNW for 2003–04 was lower than that off California and that in the 1990s. Because the biomass of Pacific sardine off the PNW appears to be supported heavily by migratory fish from California, the sustainability of the local PNW population relies on the stability of the population off California, and on local oceanographic conditions for local residence.