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.

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.

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.

History of Oystering in the United States and Canada, Featuring the Eight Greatest Oyster Estuaries

Oyster landings in the United States and Canada have been based mainly on three species, the native eastern oyster, Crassostrea virginica, native Olympia oyster, Ostreola conchaphila, and introduced Pacific oyster, C. gigas. Landings reached their peak of around 27 million bushels/year in the late 1800's and early 1900's when eastern oysters were a common food throughout the east coast and Midwest. Thousands of people were involved in harvesting them with tongs and dredges and in shucking, canning, packing, and transporting them. Since about 1906, when the United States passed some pure food laws, production has declined. The causes have been lack of demand, siltation of beds, removal of cultch for oyster larvae while harvesting oysters, pollution of market beds, and oyster diseases. Production currently is about 5.6 million bushels/year.

History of a Systematics Odyssey: The Marine Flora and Fauna of the Eastern United States

On an early fall day in September 1962 I sat quietly, thoughtfully, at my large desk in a newly renovated corner office in the old Crane wing of the Lillie Building, Marine Biological Laboratory (MBL), Woods Hole, Massachusetts. Looking out through high, ancient windows, I could see the busy main street of Woods Hole in the foreground, Martha's Vineyard beyond, behind me the MBL Stone Candle House, across the street the Woods Hole Oceanographic Institution (WHOI) and to the far right, the Biological Laboratory of the Bureau of Commercial Fisheries (BCF)(Fig. 1). Down the inner hall from my office stretched renovated quarters for the fledgling, ongoing, year-round MBL Systematics-Ecology Program (SEP), which I had been invited to direct.

Life history of the Atlantic sharpnose shark (Rhizoprionodon terraenovae) (Richardson, 1836) off the southeastern United States

The life history of the Atlantic sharpnose shark (Rhizoprionodon terraenovae) was described from 1093 specimens collected from Virginia to northern Florida between April 1997 and March 1999. Longitudinally sectioned vertebral centra were used to age each specimen, and the periodicity of circuli deposition was verified through marginal increment analysis and focus-to-increment frequency distributions. Rhizoprionodon terraenovae reached a maximum size of 828 mm precaudal length (PCL) and a maximum age of 11+ years. Mean back-calculated lengths-at-age ranged from 445 mm PCL at age one to 785 mm PCL at age ten for females, and 448 mm PCL at age one to 747 mm PCL at age nine for males. Observed lengthat-age data (estimated to 0.1 year) yielded the following von Bertalanffy parameters estimates: L∞= 749 mm PCL (SE=4.60), K = 0.49 (SE=0.020), and t0= –0.94 (SE=0.046) for females; and L∞= 745 mm PCL (SE = 5.93), K = 0.50 (SE=0.024), and t0= –0.91 (SE = 0.052) for males. Sexual maturity was reached at age three and 611 mm PCL for females, and age three and 615 mm PCL for males. Rhizoprionodon terraenovae reproduced annually and had a gestation period of approximately 11 months. Litter size ranged from one to eight (mean=3.85) embyros, and increased with female PCL.

The 19th Century Tombstone Database Project Records, 1790-1890 (non-inclusive)

The 19th Century Tombstone Database project was funded by the program Federal Summer Youth Employment scheme in the summer of 1982 and led by Dr. David W. Rupp, a Professor at the Classics Department, Brock University. The main goal of the project was to collect information related to various cemeteries in Niagara region and burials that took place from 1790-1890. Data was collected and presented in the form of data summary forms of persons, tombstone sketches, photographs of tombstones, maps, and computer printouts. The materials created as a result of a research completed for the 19th Century Tombstone Database project are important as a number of the tombstones have been damaged or gone missing since the research was finished. Before Dr. Rupp retired from Brock University, he donated project materials to the Brock University Special Collections and Archives.

History of the Late War between Great Britain and the United States of America

History of the Late War between Great Britain and the United States of America by David Thompson, late of the Royal Scots, Niagara U.C. , 1832. There is an inscription in the front of the book which says “[illegible] Nelles, Grimsby and it is signed by Joseph Williams [?]” The book is stained from dampness, but this does not affect the text, 1832.

The mexican war : a history of its origen, and a detailed account of the victories wich terminated in the surrender of the capital ; with the official despatches of the generals. To which is added, the Treaty of Peace, and valuable tables of the strength and losses of the United States Army.

UANL

A New History of the United States of America for the Use of Schools

UANL

A brief history of the United States

UANL

Some aspects of history of Indian mathematics in 18th and early 19th century

This thesis is an attempt to throw light on the works of some Indian Mathematicians who wrote in Arabic or persian In the Introductory Chapter on outline of general history of Mathematics during the eighteenth Bnd nineteenth century has been sketched. During that period there were two streams of Mathematical activity. On one side many eminent scholers, who wrote in Sanskrit, .he l d the field as before without being much influenced by other sources. On the other side there were scholars whose writings were based on Arabic and Persian text but who occasionally drew upon other sources also.