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.

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)

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

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

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

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

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

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

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.)

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.)

Maturation of Nineteen Species of Finfish off the Northeast Coast of the United States, 1985-1990

Observations on maturation stages of nineteen species of economically important finfish off the Northeast coast of the USA were analyzed to examine relationships between fish size or age, and maturity. Maturation schedules and median lengths (L50) and ages (A50) at maturation were derived by fitting the logistic model to the observed proportions. Analyses were generally restricted to observations from 1985 to 1990 obtained during stratified random bottom trawl surveys conducted in spring and autumn by the Northeast Fisheries Science Center and the Commonwealth of Massachusetts Division of Marine Fisheries in waters of the continental shelf from Nova Scotia to Cape Hatteras, North Carolina. Butterfish, Peprilus triacanthus, attained sexual maturity at the smallest median length (11.4 cm, males) and pollock, Pollachius virens, at the highest (41.8 em, males). Median length at maturity for gadiforms ranged from 22.2 to 41.8 em. Within the pleuronectiforms, median length at maturity ranged from 19.1 to 30.4 cm. Median lengths for the pelagic and miscellaneous demersal species were in the same ranges as the pleuronectiforms. Butterfish also attained sexual maturity at the youngest median age (0.9 yr, both sexes) whereas redfish, Sebastes fasciatus, were the latest to mature (5.5 yr, both sexes). For gadids, the median age at maturity ranged from 1.3 to 2.3 yr. Within the pleuronectiforms, median age at maturity ranged from 1.3 to 4.4 yr and, for pelagic species, from 0.9 to 3.0 yr. Median lengths and ages for many species are lower than those reported in earlier studies of the same general region of the Northwest Atlantic. (PDF file contains 72 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.)

Marine Flora and Fauna of the Northeastern United States: Erect Bryozoa

Forty-nine species of erect Bryozoa from a broad range of Cyclostome, Ctenostome, and Cheilostome families are described and illustrated, and an artificial dichotomous key is provided for their identification. In general, the marine bryozoan faunas of the northeastern coasts of the United States are poorly known; species records are sparse and voucher collections few, and it is certain that many more species occur in this region than are presently known. The species described here occur in intertidal, coastal or offshore habitats; some are well known and have been recorded on numerous previous occasions, others have been only rarely reported, while a few are known to occur commonly in the north of the region but have yet to be recorded south of Cape Cod. Some of the species described have not been recorded at all on northeastern coasts of the United States, but are widely distributed in North Atlantic continental shelf habitats and perhaps occur in similar parts of the outer shelf of this region. This fauna is thus provisional, but is intended to stimulate further work on the Bryozoa. (PDF file contains 52 pages.)

Marine Mammal Strandings in the United States: Proceedings of the Second Marine Mammal Stranding Workshop, Miami, Florida, December 3-5, 1987

Over a decade ago, in August 1977, the First Marine Mammal Stranding Workshop was convened in Athens, Georgia. That workshop, organized by j.R. Geraci and D.J. St. Aubin, not only considered biology and pathology of stranded marine mammals, but it also served as a springboard for the formation of regional marine mammal stranding networks in the United States. The ramifications have been extremely important to the field of marine mammalogy since, for some species, examination or rehabilitation of stranded specimens serves as virtually the only source of information on distribution, anatomy, physiology, reproduction, and pathology. The First Marine Mammal Stranding Workshop led to increased awareness of the marine mammals themselves, as well as the logistic and legal factors associated with effective handling of the animals. A number of individuals indicated that they felt that a Second Marine Mammal Stranding Workshop held prior to the Seventh Biennial Conference on the Biology of Marine Mammals (Miami, Florida; December 1987) would be both timely and productive. Accordingly, we organized the workshop and scheduled it to occur on 3-5 December. Our goals for the workshop were several, including 1) providing descriptions of some research, especially new techniques, regarding stranded marine mammals; 2) providing a forum where scientists could interact and possibly initiate cooperative research activities; 3) presenting information regarding procedures used effectively to handle stranded animals; 4) assessing ways to standardize data and specimen collection, archiving, and retrieval; and 5) providing a forum for assessing accomplishments and status of regional stranding networks to date, as well as for making recommendations regarding future activities of the networks. Nearly 100 individuals representing Federal and State governments, academic institutions, the oceanarium industry, consulting groups, conservation organizations, and the private sector attended the workshop (see Workshop Participants, this volume). (PDF file contains 166 pages.)

Marine Flora and Fauna of the Eastern United States: Copepoda, Cyclopoida: Archinotodelphyidae, Notodelphyidae, and Ascidicolidae

This manual includes an introduction to the general biology, a selected bibliography, and an illustrated key to 11 genera and 17 species of copepods of the Crustacea, Subclass Copepoda, Order Cyclopoida, Families Archinotodelphyidae, Notodelphyidae and Ascidicolidae, associated with ascidians from the Atlantic Coast of the United States. Species distributed from the Gulf of Maine to Long Island Sound are emphasized. An annotated systematic list, with statements of the world distribution and new records of association with hosts, and a systematic index are also provided. (PDF file contains 44 pages.)