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.

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)

Drawn to the Sea: Charles Bradford Hudson (1865-1939), Artist, Author, Army Officer, with Special Notice of His Work for the United States Fish Commission and Bureau of Fisheries

The biography of Charles Bradford Hudson that follows this preface had its seeds about 1965 when I (VGS) was casually examining the extensive files of original illustrations of fishes stored in the Division of Fishes, National Museum of Natural History, Smithsonian Institution. I happened upon the unpublished illustration of a rainbow trout by Hudson and was greatly impressed with its quality. The thought occurred to me then that the artist must have gone on to do more than just illustrate fishes. During the next 20 years I occasionally pawed through those files, which contained the work of numerous artists, who had worked from 1838 to the present. In 1985, I happened to discuss the files with my supervisor, who urged me to produce a museum exhibit of original fish illustrations. This I did, selecting 200 of the illustrations representing 21 artists, including, of course, Hudson. As part of the text for the exhibit, Drawn from the Sea, Art in the Service of Ichthyology, I prepared short biographies of each of the artists. The exhibit, with an available poster, was shown in the Museum for six months, and a reduced version was exhibited in U.S. and Canadian museums during the next 3 years.

Technology and success in restoration, creation, and enhancement of Spartina afferniflora marshes in the United States. Vol. 1: Executive Summary and Annotated Bibliography

Extensive losses of coastal wetlands in the United States caused by sea-level rise, land subsidence, erosion, and coastal development have increased hterest in the creation of salt marshes within estuaries. Smooth cordgrass Spartina altemiflora is the species utilized most for salt marsh creation and restoration throughout the Atlantic and Gulf coasts of the U.S., while S. foliosa and Salicomia virginica are often used in California. Salt marshes have many valuable functions such as protecting shorelines from erosion, stabilizing deposits of dredged material, dampening flood effects, trapping water-born sediments, serving as nutrient reservoirs, acting as tertiary water treatment systems to rid coastal waters of contaminants, serving as nurseries for many juvenile fish and shellfish species, and serving as habitat for various wildlife species (Kusler and Kentula 1989). The establishment of vegetation in itself is generally sufficient to provide the functions of erosion control, substrate stabilization, and sediment trapping. The development of other salt marsh functions, however, is more difficult to assess. For example, natural estuarine salt marshes support a wide variety of fish and shellfish, and the abundance of coastal marshes has been correlated with fisheries landings (Turner 1977, Boesch and Turner 1984). Marshes function for aquatic species by providing breeding areas, refuges from predation, and rich feeding grounds (Zimmerman and Minello 1984, Boesch and Turner 1984, Kneib 1984, 1987, Minello and Zimmerman 1991). However, the relative value of created marshes versus that of natural marshes for estuarine animals has been questioned (Carnmen 1976, Race and Christie 1982, Broome 1989, Pacific Estuarine Research Laboratory 1990, LaSalle et al. 1991, Minello and Zimmerman 1992, Zedler 1993). Restoration of all salt marsh functions is necessary to prevent habitat creation and restoration activities from having a negative impact on coastal ecosystems.

Selectivity of physiotherapist programs in the United States does not differ by institutional funding source or research activity level.

PURPOSE: This study aimed to compare selectivity characteristics among institution characteristics to determine differences by institutional funding source (public vs. private) or research activity level (research vs. non-research). METHODS: This study included information provided by the Commission on Accreditation in Physical Therapy Education (CAPTE) and the Federation of State Boards of Physical Therapy. Data were extracted from all students who graduated in 2011 from accredited physical therapy programs in the United States. The public and private designations of the institutions were extracted directly from the classifications from the 'CAPTE annual accreditation report,' and high and low research activity was determined based on Carnegie classifications. The institutions were classified into four groups: public/research intensive, public/non-research intensive, private/research intensive, and private/non-research intensive. Descriptive and comparison analyses with post hoc testing were performed to determine whether there were statistically significant differences among the four groups. RESULTS: Although there were statistically significant baseline grade point average differences among the four categorized groups, there were no significant differences in licensure pass rates or for any of the selectivity variables of interest. CONCLUSION: Selectivity characteristics did not differ by institutional funding source (public vs. private) or research activity level (research vs. non-research). This suggests that the concerns about reduced selectivity among physiotherapy programs, specifically the types that are experiencing the largest proliferation, appear less warranted.

Report of the Secretary of War, communicating; in compliance witha resolution of the Senate, a map showing the operations of the army of the United States in Texas and the adjacent Mexican Stateson the Rio Grande, accompanied by astronomical observations, and descriptive and military memoirs of the country.

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Military laws of the united states; including those relatingto the Marine Corps, to which is prefixed the Constitution of the United StatesComplied by Colonel Trueman Corss, U.S. Army

UANL

Field investigation of dried lakes in western United States as an analogue to desiccation fractures on Mars

Potential Desiccation Polygons (PDPs), tens to hundreds of meters in size, have been observed in numerous regions on Mars, particularly in ancient (>3Gyr old) terrains of inferred paleolacustrine/playa geologic setting, and in association with hydrous minerals such as smectites. Therefore, a better understanding of the conditions in which large desiccation polygons form could yield unique insight into the ancient climate on Mars. Many dried lakebeds/playas in western United States display large (>50m wide) desiccation polygons, which we consider to be analogues for PDPs on Mars. Therefore, we have carried out fieldwork in seven of these dried lakes in San Bernardino and the Death Valley National Park regions complemented with laboratory and spectral analysis of collected samples. Our study shows that the investigated lacustrine/playa sediments have (a) a soil matrix containing 40-75% clays and fine silt (by volume) where the clay minerals are dominated by illite/muscovite followed by smectite, (b) carbonaceous mineralogy with variable amounts of chloride and sulfate salts, and significantly, (c) roughly similar spectral signatures in the visible-near-infrared (VIS-NIR) range. We conclude that the development of large desiccation fractures is consistent with water table retreat. In addition, the comparison of the mineralogical to the spectral observations further suggests that remote sensing VIS-NIR spectroscopy has its limitations for detailed characterization of lacustrine/playa deposits. Finally, our results imply that the widespread distribution of PDPs on Mars indicates global or regional climatic transitions from wet conditions to more arid ones making them important candidate sites for future in situ missions.

Barriers to cross-border research projects: A prelude to improving professional collaborations between the United States and Mexico

Study objective. This was a secondary data analysis of a study designed and executed in two phases in order to investigate several questions: Why aren't more investigators conducting successful cross-border research on human health issues? What are the barriers to conducting this research? What interventions might facilitate cross-border research? ^ Methods. Key informant interviews and focus groups were used in Phase One, and structured questionnaires in Phase Two. A multi-question survey was created based on the findings of focus groups and distributed to a wider circle of researchers and academics for completion. The data was entered and analyzed using SPSS software. ^ Setting. El Paso, TX located on the U.S-Mexico Border. ^ Participants. Individuals from local academic institutions and the State Department of Health. ^ Results. From the transcribed data of the focus groups, eight major themes emerged: Political Barriers, Language/Cultural Barriers, Differing Goals, Geographic Issues, Legal Barriers, Technology/Material Issues, Financial Barriers, and Trust Issues. Using these themes, the questionnaire was created. ^ The response rate for the questionnaires was 47%. The largest obstacles revealed by this study were identifying a funding source for the project (47% agreeing or strongly agreeing), difficulties paying a foreign counterpart (33% agreeing or strongly agreeing) and administrative changes in Mexico (31% agreeing or strongly agreeing). ^ Conclusions. Many U.S. investigators interested in cross-border research have been discouraged in their efforts by varying barriers. The majority of respondents in the survey felt financial issues and changes in Mexican governments were the most significant obstacles. While some of these barriers can be overcome simply by collaboration among motivated groups, other barriers may be more difficult to remove. Although more evaluation of this research question is warranted, the information obtained through this study is sufficient to support creation of a Cross-Border Research Resource Manual to be used by individuals interested in conducting research with Mexico. ^

PRETERM BIRTH AND OCCUPATIONAL PHYSICAL ACTIVITY: A CASE-CONTROL STUDY OF THE RELATIONSHIP BETWEEN LENGTH OF GESTATION AND THE PHYSICAL DEMAND OF U.S. ARMY MILITARY OCCUPATIONAL SPECIALTIES (UNITED STATES)

A case-control study has been conducted examining the relationship between preterm birth and occupational physical activity among U.S. Army enlisted gravidas from 1981 to 1984. The study includes 604 cases (37 or less weeks gestation) and 6,070 controls (greater than 37 weeks gestation) treated at U.S. Army medical treatment facilities worldwide. Occupational physical activity was measured using existing physical demand ratings of military occupational specialties.^ A statistically significant trend of preterm birth with increasing physical demand level was found (p = 0.0056). The relative risk point estimates for the two highest physical demand categories were statistically significant, RR's = 1.69 (p = 0.02) and 1.75 (p = 0.01), respectively. Six of eleven additional variables were also statistically significant predictors of preterm birth: age (less than 20), race (non-white), marital status (single, never married), paygrade (E1 - E3), length of military service (less than 2 years), and aptitude score (less than 100).^ Multivariate analyses using the logistic model resulted in three statistically significant risk factors for preterm birth: occupational physical demand; lower paygrade; and non-white race. Controlling for race and paygrade, the two highest physical demand categories were again statistically significant with relative risk point estimates of 1.56 and 1.70, respectively. The population attributable risk for military occupational physical demand was 26%, adjusted for paygrade and race; 17.5% of the preterm births were attributable to the two highest physical demand categories. ^

Trends and patterns in research and development expenditures in the United States

This paper is a review of recent trends in United States expenditures on research and development (R&D). Real expenditures by both the government and the private sector increased rapidly between the mid-1970s and the mid-1980s, and have since leveled off. This is true of both overall expenditures and expenditures on basic research, as well as funding of academic research. Preliminary estimates indicate that about $170 billion was spent on R&D in the United States in 1995, with ≈60% of that funding coming from the private sector and about 35% from the federal government. In comparison to other countries, we have historically spent more on R&D relative to our economy than other advanced economies, but this advantage appears to be disappearing. If defense-related R&D is excluded, our expenditures relative to the size of the economy are considerably smaller than those of other similar economies.