Incentives for global public health: Patent law and access to essential medicines

This portrait of the global debate over patent law and access to essential medicines focuses on public health concerns about HIV/AIDS, malaria, tuberculosis, the SARS virus, influenza, and diseases of poverty. The essays explore the diplomatic negotiations and disputes in key international fora, such as the World Trade Organization, the World Health Organization and the World Intellectual Property Organization. Drawing upon international trade law, innovation policy, intellectual property law, health law, human rights and philosophy, the authors seek to canvass policy solutions which encourage and reward worthwhile pharmaceutical innovation while ensuring affordable access to advanced medicines. A number of creative policy options are critically assessed, including the development of a Health Impact Fund, prizes for medical innovation, the use of patent pools, open-source drug development and forms of 'creative capitalism'.

Patent law and biological inventions

In response to scientific breakthroughs in biotechnology, the development of new technologies, and the demands of a hungry capitalist marketplace, patent law has expanded to accommodate a range of biological inventions. There has been much academic and public debate as to whether gene patents have a positive impact upon research and development, health-care, and the protection of the environment. In a satire of prevailing patenting practices, the English poet and part-time casino waitress, Donna MacLean, sought a patent application - GB0000180.0 - in respect of herself. She explained that she had satisfied the usual patent criteria - in that she was novel, inventive, and useful: It has taken 30 years of hard labor for me to discover and invent myself, and now I wish to protect my invention from unauthorized exploitation, genetic or otherwise. I am new: I have led a private existence and I have not made the invention of myself public. I am not obvious (2000: 18). MacLean said she had many industrial applications. 'For example, my genes can be used in medical research to extremely profitable ends - I therefore wish to have sole control of my own genetic material' (2000: 18). She observed in an interview: 'There's a kind of unpleasant, grasping, greedy atmosphere at the moment around the mapping of the human genome ... I wanted to see if a human being could protect their own genes in law' (Meek, 2000). This special issue of Law in Context charts a new era in the long-standing debate over biological inventions. In the wake of the expansion of patentable subject matter, there has been great strain placed upon patent criteria - such as 'novelty', 'inventive step', and 'utility'. Furthermore, there has been a new focus upon legal doctrines which facilitate access to patented inventions - like the defence of experimental use, the 'Bolar' exception, patent pooling, and compulsory licensing. There has been a concerted effort to renew patent law with an infusion of ethical principles dealing with informed consent and benefit sharing. There has also been a backlash against the commercialisation of biological inventions, and a call by some activists for the abolition of patents on genetic inventions. This collection considers a wide range of biological inventions - ranging from micro-organisms, plants and flowers and transgenic animals to genes, express sequence tags, and research tools, as well as genetic diagnostic tests and pharmaceutical drugs. It is thus an important corrective to much policy work, which has been limited in its purview to merely gene patents and biomedical research. This collection compares and contrasts the various approaches of a number of jurisdictions to the legal problems in respect of biological inventions. In particular, it looks at the complexities of the 1998 European Union Directive on the Legal Protection of Biotechnological Inventions, as well as decisions of member states, such as the Netherlands, and peripheral states, like Iceland. The edition considers US jurisprudence on patent law and policy, as well as recent developments in Canada. It also focuses upon recent developments in Australia - especially in the wake of parallel policy inquiries into gene patents and access to genetic resources.

Inventing life: Patent law and synthetic biology

With promises of improved medical treatments, greener energy and even artificial life, the field of synthetic biology has captured the public imagination and attracted significant government and commercial investment. This excitement reached a crescendo on 21 May 2010, when scientists at the J Craig Venter Institute in the United States announced that they had made a “self-replicating synthetic bacterial cell”. This was the first living cell to have an entirely human-made genome, which means that all of the cell’s characteristics were controlled by a DNA sequence designed by scientists. This achievement in biological engineering was made possible by combining molecular biotechnology, gene synthesis technology and information technology.

Pacific Rim treaty threatens public health: Patent law and medical procedures

Doctors, surgeons, and physicians around the Pacific Rim should be concerned by the proposals revealed by WikiLeaks in the Trans-Pacific Partnership (TPP). One of the most controversial features of the TPP is the proposal to provide for patent protection in respect of medical procedures. As Public Citizen observed, ‘Health providers, including surgeons, could be liable for the methods they use to treat patients.’ The civil society group noted: ‘Essentially, except for when a surgeon uses her bare hands, surgical methods would be patentable under the U.S. proposal.’ The TPP takes a broad approach to patents and medicine; lacks appropriate safeguards; and fails to address larger questions about equity, development, and human rights. Such a measure could result in greater litigation against medical professionals; barriers to access to medical procedures for patients; and skyrocketing health costs.

Julia Gillard, Big Pharma, patent law and public health

It takes a lot of bravery for governments to stand up to big business. But the Gillard government has shown a lot of guts during its tenure. It stood up to Big Tobacco in the battle over plain packaging of tobacco products and has defended individuals and families affected by asbestos. It took on Big Oil in its Clean Energy Future reforms and stood up to the resource barons with the mining tax. The government is now considering Big Pharma - the pharmaceutical industry and their patents – and has launched several inquiries into patent law and pharmaceutical drugs...

Materials and technologies for energy conversion, saving and storage: A global network enabling capacity-building for sustainable energy in developing countries

Access to energy is a fundamental component of poverty abatement. People who live in homes without electricity are often dependent on dirty, time-consuming and disproportionately expensive solid fuel sources for heating and cooking. [1] In developing countries, the Human Development Index (HDI), which comprises measures of standard of living, longevity and educational attainment, increases rapidly with per capita electricity use. [2] For these reasons the United Nations has been making a concerted effort to promote global access to energy, first by naming 2012 the Year of Sustainable Energy for All, [3] and now by declaring 2014-2024 the Decade of Sustainable Energy for All. [4]

Fragment of Manuscript Minutes of Congregation Beth Elohim, Charleston, South Carolina

Digital image

Population response of triploid grass carp to declining levels of hydrilla in the Santee Cooper Reservoirs, South Carolina

Approximately 768,500 triploid grass carp ( Ctenopharyngodon idella Valenciennes) were stocked into the Santee Cooper reservoirs, South Carolina between 1989 and 1996 to control hydrilla ( Hydrilla verticillata (L.f.) Royle). Hydrilla coverage was reduced from a high of 17,272 ha during 1994 to a few ha by 1998. During 1997, 1998 and 1999, at least 98 triploid grass carp were collected yearly for population monitoring. Estimates of age, growth, and mortality, as well as population models, were used in the study to monitor triploid grass carp and predict population trends. Condition declined from that measured during a previous study in 1994. The annual mortality rate was estimated at 28% in 1997, 32% in 1998 and 39% in 1999; however, only the 1999 mortality rate was significantly different. Few (2 out of 98) of the triploid grass carp collected during 1999 were older than age 9. We expect increased mortality due to an aging population and sparse hydrilla coverage. During 1999, we estimated about 63,000 triploid grass carp system wide and project less than 3,000 fish by 2004, assuming no future stocking. management, population size Ctenopharyngodon idella, Hydrilla

History of whaling in and near North Carolina

This study aims to reconstruct the history of shore whaling in the southeastern United States, emphasizing statistics on the catch of right whales, Eubalaena glacialis, the preferred targets. The earliest record of whaling in North Carolina is of a proposed voyage from New York in 1667. Early settlers on the Outer Banks utilized whale strandings by trying out the blubber of carcasses that came ashore, and some whale oil was exported from the 1660s onward. New England whalemen whaled along the North Carolina coast during the 1720s, and possibly earlier. As some of the whalemen from the northern colonies moved to Nortb Carolina, a shore-based whale fishery developed. This activity apparently continued without interruption until the War of Independence in 1776, and continued or was reestablished after the war. The methods and techniques of the North Carolina shore whalers changed slowly: as late as the 1890s they used a drogue at the end of the harpoon line and refrained from staying fast to the harpooned whale, they seldom employed harpoon guns, and then only during the waning years of the fishery. The whaling season extended from late December to May, most successfully between February and May. Whalers believed they were intercepting whales migrating north along the coast. Although some whaling occurred as far north as Cape Hatteras, it centered on the outer coasts of Core, Shackleford, and Bogue banks, particularly near Cape Lookout. The capture of whales other than right whales was a rare event. The number of boat crews probably remained fairly stable during much of the 19th century, with some increase in effort in the late 1870s and early 1880s when numbers of boat crews reached 12 to 18. Then by the late 1880s and 1890s only about 6 crews were active. North Carolina whaling had become desultory by the early 1900s, and ended completely in 1917. Judging by export and tax records, some ocean-going vessels made good catches off this coast in about 1715-30, including an estimated 13 whales in 1719, 15 in one year during the early 1720s, 5-6 in a three-year period of the mid to late 1720s, 8 by one ship's crew in 1727, 17 by one group of whalers in 1728-29, and 8-9 by two boats working from Ocracoke prior to 1730. It is impossible to know how representative these fragmentary records are for the period as a whole. The Carolina coast declined in importance as a cruising ground for pelagic whalers by the 1740s or 1750s. Thereafter, shore whaling probably accounted for most of the (poorly documented) catch. Lifetime catches by individual whalemen on Shackleford Banks suggest that the average annual catch was at least one to two whales during 1830·80, perhaps about four during the late 1870s and early 1880s, and declining to about one by the late 1880s. Data are insufficient to estimate the hunting loss rate in the Outer Banks whale fishery. North Carolina is the only state south of New Jersey known to have had a long and well established shore whaling industry. Some whaling took place in Chesapeake Bay and along the coast of Virginia during the late 17th and early 18th centuries, but it is poorly documented. Most of the rigbt whales taken off South Carolina, Georgia, and northern Florida during the 19th century were killed by pelagic whalers. Florida is the only southeastern state with evidence of an aboriginal (pre-contact) whale fishery. Right whale calves may have been among the aboriginal whalers' principal targets. (PDF file contains 34 pages.)

Challenges in using science-based shoreline setbacks: Examples from South Carolina

Beachfront jurisdictional lines were established by the South Carolina Beachfront Management Act (SC Code §48- 39-250 et seq.) in 1988 to regulate the new construction, repair, or reconstruction of buildings and erosion control structures along the state’s ocean shorelines. Building within the state’s beachfront “setback area” is allowed, but is subject to special regulations. For “standard beaches” (those not influenced by tidal inlets or associated shoals), a baseline is established at the crest of the primary oceanfront sand dune; for “unstabilized inlet zones,” the baseline is drawn at the most landward point of erosion during the past forty years. The parallel setback line is then established landward of the baseline a distance of forty times the long-term average annual erosion rate (not less than twenty feet from the baseline in stable or accreting areas). The positions of the baseline and setback line are updated every 8-10 years using the best available scientific and historical data, including aerial imagery, LiDAR, historical shorelines, beach profiles, and long-term erosion rates. One advantage of science-based setbacks is that, by using actual historical and current shoreline positions and beach profile data, they reflect the general erosion threat to beachfront structures. However, recent experiences with revising the baseline and setback line indicate that significant challenges and management implications also exist. (PDF contains 3 pages)

Shoal manipulation as an effective solution to site specific beach management, examples from three South Carolina beaches

Soft engineering solutions are the current standard for addressing coastal erosion in the US. In South Carolina, beach nourishment from offshore sand deposits and navigation channels has mostly replaced construction of seawalls and groins, which were common occurrences in earlier decades. Soft engineering solutions typically provide a more natural product than hard solutions, and also eliminate negative impacts to adjacent areas which are often associated with hard solutions. A soft engineering solution which may be underutilized in certain areas is shoal manipulation. (PDF contains 4 pages)

A Study on iron-based amorphous alloys : alloy development, thermodynamics and soft magnetism

Metallic glass has since its debut been of great research interest due to its profound scientific significance. Magnetic metallic glasses are of special interest because of their promising technological applications. In this thesis, we introduced a novel series of Fe-based alloys and offer a holistic review of the physics and properties of these alloys. A systematic alloy development and optimization method was introduced, with experimental implementation on transition metal based alloying system. A deep understanding on the influencing factors of glass forming ability was brought up and discussed, based on classical nucleation theory. Experimental data of the new Fe-based amorphous alloys were interpreted to further analyze those influencing factors, including reduced glass transition temperature, fragility, and liquid-crystal interface free energy. Various treatments (fluxing, overheating, etc.) were discussed for their impacts on the alloying systems' thermodynamics and glass forming ability. Multiple experimental characterization methods were discussed to measure the alloys' soft magnetic properties. In addition to theoretical and experimental investigation, we also gave a detailed numerical analysis on the rapid-discharge-heating-and-forming platform. It is a novel experimental system which offers extremely fast heating rate for calorimetric characterization and alloy deformation.