Intellectual capital as property.
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Developing Countries↗
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Drugs as materials: valuing physical form in drug discovery.
Traditionally, potency and selectivity (and to some extent metabolism) have been the key parameters to consider in the process of discovering new drug candidates. Recently, heads of research and CEOs have been learning a new reality: drugs can move around the body and act at the molecular level, but the chemical and material properties of their physical form need to be identified and optimized for in vivo performance, reliable manufacture and the protection of intellectual property. This review discusses the challenge of pharmaceutical materials discovery, and suggests strategies for addressing the characterization and evaluation of physico-chemical and material properties in the drug discovery and development process.
Chemistry, Pharmaceutical↗
[The status of research in dentistry].
Discusses the problems of market relationships in Russian dentistry and insurance medicine: various forms of intellectual property, the market of equipment and materials for dentistry, such forms as lease contract or working place lease. The authors emphasize the contribution of the intellectual potential to the development of novel equipment and materials and clinical methods.
Academic Dissertations as Topic↗
Manufacturer's drug interaction and postmarketing adverse event data: what are appropriate uses?
Governmental agencies overseeing pharmaceutical products use a risk/benefit approach to analyse data and make regulatory decisions. Comprehensive public dissemination of the safety profile of pharmaceutical products is part of an overall strategy for reducing risk associated with the use of any medical product. In the US, reports of postmarketing surveillance of approved drugs are in the public domain. Some, but not all, of the information in drug interaction studies is available to the public through the Freedom of Information Act (FOIA). However, there are concerns over the misuse of these data for commercial or other gain. The need to protect intellectual property and foster innovation in drug development, and concerns of legal liability are often cited as reasons to limit full public access to data from drug development studies. In contrast, intellectual freedom. public safety, and a mandate for transparent decision-making processes by regulatory agencies are issues that support open access to these data. Ultimately. concern for the public safety justifies open access to postmarketing surveillance data, and to a lesser degree, data regarding drug interactions in marketed products, and should outweigh the potential loss of competitive advantage by pharmaceutical companies.
Access to Information↗
Application of thermophilic enzymes in commercial biotransformation processes.
Biocatalysis is a useful tool in the provision of chiral technology and extremophilic enzymes are just one component in that toolbox. Their role is not always attributable to their extremophilic properties; as with any biocatalyst certain other criteria should be satisfied. Those requirements for a useful biocatalyst will be discussed including issues of selectivity, volume efficiency, security of supply, technology integration, intellectual property and regulatory compliance. Here we discuss the discovery and commercialization of an L-aminoacylase from Thermococcus litoralis, the product of a LINK project between Chirotech Technology and the University of Exeter. The enzyme was cloned into Escherichia coli to aid production via established mesophilic fermentation protocols. A simple downstream process was then developed to assist in the production of the enzyme as a genetically modified-organism-free reagent. The fermentation and downstream processes are operated at the 500 litre scale. Characterization of the enzyme demonstrated a substrate preference for N-benzoyl groups over N-acetyl groups. The operational parameters have been defined in part by substrate-concentration tolerances and also thermostability. Several examples of commercial biotransformations will be discussed including a process that is successful by virtue of the enzyme's thermotolerance.
Amidohydrolases↗
Designing animals: ethical issues for genetic engineers.
Two general philosophical approaches to ethical issues in property rights are described. Instrumental approaches take property rights to be means for achieving goals such as social efficiency or economic growth. Labor approaches take property rights to be fundamental human rights that protect liberty or that assign ownership of goods based on criteria of desert. A thought experiment is used to illustrate the relevance of these theories to intellectual property. Alternative strategies for application of ethical theory to animal biotechnology are surveyed. The choice of an approach determines a burden of proof that must be met before property claims can be ethically sanctioned, but the question of which approach should be applied to animal biotechnology remains open. Ethical issues raised by unwanted consequences of biotechnology and religious objections to gene transfer are briefly summarized with emphasis on how these issues have influenced public debate on animal patents.
Animals↗
Consent, commodification and benefit-sharing in genetic research.
The global value of the biotechnology industry is now estimated at 17 billion dollars, with over 1300 firms involved as of the year 2000.(2) It has been said that 'What we are witnessing is nothing less than a new kind of gold rush, and the territory is the body.' As in previous gold rushes, prospectors are flooding into unexplored and 'wide open' territories from all over the world, with possible ramifications for exploitation of Third World populations. These territories are also the Wild West of bioethics insofar as the law has very little hold on them: existing medical and patent law, such as the Moore and Chakrabarty cases, exert little control over powerful economic interests in both the United States and Europe. In the absence of a unified and consistent law on property in the body, the focus is increasingly on refining the consent approach to rights in human tissue and the human genome, with sensitive and promising developments from the Human Genetics Commission and the Department for International Development consultation on intellectual property. These developments incorporate the views of vulnerable genetic communities such as Native Americans or some Third World populations, and should be welcomed because they recognise the power imbalance between such groups and First World researchers or firms. However, they also highlight the continued tension about what is really wrong with commodifying human tissue or the human genome. Where's the injustice, and can it be solved by a more sophisticated consent procedure?
Coercion↗
Biotechnology of temperate fruit trees and grapevines.
Challenges concerning fruit trees and grapevines as long lived woody perennial crops require adapted biotechnological approaches, if solutions are to be found within a reasonable time frame. These challenges are represented by the need for correct identification of genetic resources, with the foreseen use either in conservation or in breeding programmes. Molecular markers provide most accurate information and will be the major solution for questions about plant breeders rights. Providing healthy planting material and rapid detection of newly introduced pathogens by reliable methods involving serological and molecular biological tools will be a future challenge of increases importance, given the fact that plant material travels freely in the entire European Union. But also new breeding goals and transgenic solutions are part of the biotechnological benefits, e.g. resistance against biotic and abiotic stress factors, modified growth habits, modified nutritional properties and altered processing and storage qualities. The successful characterization of transgenic grapevines and stone fruit trees carrying genes of viral origin in different vectors constructed under ecological consideration, will be presented. Beyond technical feasibility, efficiency of resistance, environmental safety and Intellectual Property Rights, also public acceptance needs consideration and has been addressed in a specific project. The molecular determination of internal quality parameters of food can also be addressed by the use of biotechnological tools. Patient independent detection tools for apple allergens have been developed and should allow to compare fruits from different production systems, sites, and genotypes for their content of health threatening compounds.
Animals↗
A call for respect and equality for indigenous scholarship in Hawaiian health.
In the State of Hawai'i, there has been steady interest on the part of Western scholarly communities in studies of indigenous Hawaiian intellectual properties. There exists an academic desire to appropriate new fields of knowledge from Hawaiian sources. This pursuit of knowledge runs the risk of increasing the sense of cultural violation already felt by many indigenous populations. If conducted using the means of colonialist intellectualism common to the academy of the dominant culture, this quest for new information will likely contribute to a legacy of spiritual and cultural violation felt by the Hawaiian people. This effort will then likely lead to a further decline in feelings of cultural integrity on the part of native populations. This endeavor will then increase the basis for the psycho-spiritual malaise that underpins the negative health statistics evidenced in Native Hawaiian populations. If present day researchers are to gain greater insight into the lexicon of knowledge available from Native Hawaiians, they will have to employ methods that provide for indigenous scholars to serve as co-researchers in this quest. If Western scholars are to gain access to Native Hawaiian knowledge, such information will more likely come as a result of healing this social wound by developing a new relationship of respect for Native Hawaiian cosmology, epistemology, and pedagogy--one wherein all parties are accepted as co-equals in the scholarly process.
Attitude of Health Personnel↗
[Patents in pharmaceutical industry: between ethics and property rights].
The article presents a reflection on one of the greater challenges which the contemporary State is confronted with, related to guaranteeing the effective application of the fundamental rights, besides having to solve the conflicts that arise due to the rivalry between either fundamental rights or between some of these and others known as second or third generation rights. The conflict between the protection to the intellectual property rights, as in the case of the patents of the pharmaceutical multinationals, and the fundamental right to life is considered. It is observed that the interests of these companies have prevailed, as if the fundamental value to protect was the profit of these multinationals, or their efficiency, and not the right to health of the individuals which bears a direct relation with the right to the life. This situation is aggravated still more when the State, instead of being on the side of the weaker and offering him protection, safeguards the stronger who abuse of their dominant position, exerting the monopoly on the production of many essential medicines.
Commerce↗
Natural product source material use in the pharmaceutical industry: the Glaxo experience.
Glaxo PLC has had a significant involvement with Natural Product Source Materials for all of its commercial history and, most recently, has pursued this interest by use of such materials as templates for new lead discovery. Through the expertise and facilities in its Natural Products Discovery Department, Glaxo extracts relatively small quantities of plant material (typically 200-250 g dry weight) and cultures microorganisms from environmental samples (typically 10-50 g). Extracts and fermentation broths are screened in order to detect bioactive principles (BPs). If the potency, selectivity and specificity of the BP is acceptable, isolation, purification and structural elucidation follows. It is most unlikely, in our experience, that the BP itself will become a drug; it is much more likely that we shall need to initiate a medicinal chemistry synthesis program in order to try to produce a molecule that has both the essential biological and desirable chemical properties to become a drug development candidate. This synthetic process is often a long one and our confidence that such a process is worth undertaking is greatly improved if the BP is novel. An essential component of any medicinal chemistry strategy is that it allows us to obtain secure intellectual property rights through patents. Acquisition of product claim protection, the strongest form of patent protection, is of great importance. Safety testing and clinical development of the candidate drug can take 7-10 years, and often more, during which patent protection is constantly eroding. Recognizing that acquisition of Natural Products Source Materials is an issue of growing concern, Glaxo Research and Development Ltd. (GRD), in the early part of 1992, implemented a policy for plant supply. This policy was subsequently modified to embrace source materials such as environmental, soil and marine samples from which fungi, micro- and microorganisms may be obtained. As a direct consequence of this policy, Natural Product Source Materials supply agreements are only concluded with national and international organizations who possess the expertise to identify and collect the samples. It is equally important that our suppliers have the authority, which must be provided to GRD in writing, to collect such materials and to provide them to GRD for extraction and screening purposes. Such materials must be from sustainable and accessible sources. We will not seek to collect any endangered species. Though ethnomedical information can be helpful, it is not essential. Plants must be taxonomically classified. We reimburse the supplying institute for their efforts and their expertise, and recognize an obligation to offer a royalty to the institute in the event that drug discovery, with subsequent commercialization, owes its origin, however indirectly, to a material that it provided. In discussions with the institute, we insist that "a fair proportion' (>40%) of that royalty be used for the direct benefit of the people in the collection source area. In this context, GRD recognizes the importance of local training and education.
Drug Evaluation, Preclinical↗
The role of reverse genetics in the development of vaccines against respiratory viruses.
Despite their significance, the only available vaccines against respiratory viruses are those for the prevention of influenza. Attempts have been made to produce vaccines against other respiratory viruses using traditional techniques, but have met with little success. Reverse genetics, although still a relatively new tool for the manipulation of negative-strand RNA viruses, has great potential for the preparation of vaccines against many of the common respiratory viruses. In the preparation of live vaccines, reverse genetics systems allow the direct modification of the specific regions in the genomes of negative-stranded RNA viruses concerned with attenuation; the ultimate goal is the introduction of site-specific mutations through a cDNA intermediate in order to develop strains with the requisite attenuation, antigenic and growth properties needed in a vaccine. These techniques can also be used to disarm potentially highly pathogenic viruses, such as emerging H5N1 avian influenza viruses, in order to facilitate large-scale preparation of viruses for use in inactivated vaccines under conditions of manufacturing safety. Before these vaccines become available, residual issues concerned with intellectual property rights to the technology and its application will need to be resolved.
Animals↗
Property rights, genes, and common good.
This paper applies aspects of Hugo Grotius's theologically informed theory of property to contemporary issues concerning access to the human DNA sequence and patenting practices. It argues that Christians who contribute to public debate in these areas might beneficially employ some of the concepts with which he worked--notably "common right," the "right of necessity," and "use right." In the seventeenth century, wars were fought over trading rights and access to the sea. In the twenty-first century, information and intellectual property are the issues of the day. Grotius's writings serve to correct the overemphasis in modern liberalism on individual rights, and have practical application to the debate concerning the reduction of the human genome to the status of private property.
Access to Information↗
Patenting computer-designed peptides.
The problem of designing new peptides that possess specific properties, such as bactericidal activity, is of wide interest. Recently, attention has focused on the use of Computer-Aided Molecular Design techniques in parallel with more traditional 'synthesise and test' methods. These techniques may typically use Genetic Algorithms to optimise molecules based on Neural Network models that predict activity. In this paper we describe a successful application of this Molecular Design methodology that has resulted in novel bactericidal peptides of real value. A key issue for commercial utilisation of such results is the ability to protect the intellectual property rights associated with the discovery of new molecules. Typically peptide patents use structural templates of amino acid hydrophobicity-hydrophilicity that define highly regular peptide patent spaces. In an extension of established patenting practice we describe a patent application that uses a Neural Net predictive model to define the regions of peptide space that we claim within the patent. This formalism makes no a priori assumptions about the regularity of the patent space. A preliminary comparative investigation of the shape and size of this and other bactericidal peptide patent spaces is conducted.
Algorithms↗
From taxol to Taxol: the changing identities and ownership of an anti-cancer drug.
This paper analyzes the emergence and evolution of taxol, the world's bestselling anti-cancer drug. Over the years taxol has changed its identity, its status as property, and its association with different places (from the old-growth forests of Washington State to the government agencies of Washington, D.C., to laboratories in France). Taxol is not only a profitable pharmaceutical commodity and a substance injected into women with breast and/or ovarian cancer; it is also a natural product found in the bark of Taxus brevifolia (the Pacific yew, which is native to the North American Pacific Northwest) and a chemical substance that was discovered and brought to the point of commercial production in the public sector. We explore its role in several controversies: the destruction of old-growth forests, public participation in policy making, and the privatization of intellectual property and its effect on the price of drugs.
Antineoplastic Agents, Hormonal↗
Medical innovation and institutional interdependence: rethinking university-industry connections.
University-industry research collaborations have been key to a continued high degree of technological innovation in medicine. Recently, however, critical questions have been posed about the potential negative aspects of highly productive means of encouraging innovation. Concerns center on blurring roles between academic research and the commercial world and the implications of universities' newfound readiness to benefit financially from their intellectual property. The roles of both parties are often inadequately captured by considering members of university faculties as single-mindedly devoted to the advancement of fundamental knowledge and industrial firms as mere developers of university research. Rather, medical innovation depends on extensive interactions between universities and industry, with knowledge and technology transfer flowing in both directions. These interactions have had important public health and economic benefits. Yet, there is a risk to the university-industry relationship if the cultural and ethical principles of one partner overwhelm those of the other. Therefore, universities and industry need to maximize the upsides of collaboration and minimize the downsides by means of internal organizational change as well as formation of new models of collaboration, such as intellectual partnerships or virtual research organizations. This article reviews the numerous institutional patterns of innovation and draws implications for organizational and public policies.
Biomedical Research↗
The poisoning of 'awa: the non-traditional use of an ancient remedy.
In the traditional practice of Native Hawaiians, 'awa (Piper methysticum) has long been revered as a medicine, a sacred plant central to religious ceremony, and a social drink. In the late 1990s, 'awa attracted global attention as an herbal alternative to existing pharmaceuticals for reducing stress, anxiety, pain and assorted ailments. Marketed since 1994 as a dietary supplement, within seven years 'awa had earned the title of a "superstar" and quickly became one of the top eight herbal remedies in an expanding $18 billion-plus herbal remedy industry. In one study, the plant was even argued to possess chemopreventive properties, when cancer incidence and kava consumption in Pacific island communities were correlated. In 2002, however, the remedy was banned in several European countries, after case reports of liver toxicity allegedly associated with its nontraditional use surfaced. In the United States (US), the Food and Drug Administration issued a consumer advisory leading several retailers to voluntarily withdraw products containing 'awa from their shelves. These actions have sent shock waves throughout Pacific Island communities seeking to derive economic benefit from a relatively new and little-regulated industry. Moreover, they threaten the vitality of centuries of Native Hawaiian cultural practice. Clinical studies advocating both sides of the safety debate have been published, as producers, marketers and users attempt to influence government action. At the same time, issues of cultural exploitation, religious freedom, traditional practice, and native intellectual property rights are absent from the debate, leaving the future of native practice hanging in the balance. Whether or not the herb's status is restored, the situation raises critical questions: Is 'awa toxic? Or, does the poison derive from its use outside of traditional practice?
Chemical and Drug Induced Liver Injury↗
Protecting the unborn clone: can law and science evolve together?
The courts have treated the unborn child as neither person nor property. Human cloning will challenge this legal principle. Human cloning provides options for future scientific development and treatment of disease and infertility. However, cloning gives rise to issues not yet considered, in law, let alone resolved. These issues are not present in the context of normal human birth. At present, the common law restricts its scope to normal human birth. Does the donor "own" their unborn clone? Who makes decisions on behalf of the unborn clone? The gap between science and law is too large in human cloning research. Law lags behind in adapting to new technologies. This paper will address legal issues in relation to the unborn clone. Cloning will challenge the law in its current state. Decision-making and control of the unborn child are vital issues, to be determined before human cloning can be permitted to take place. The individuals who might have an interest in the unborn clone include the donor, the scientist, who either developed the finished clone or stored the clone prior to implantation, and the surrogate mother. Claims or conflicts might arise in many areas of medicine and law. Does the scientist have an intellectual property right? Can the surrogate mother terminate the pregnancy at will? If the unborn clone is not aborted, what measures are required to protect the fetus? Can the surrogate mother be liable for neglect? Who decides about disclosure of information and knowledge or choice regarding fetal diagnosis and treatment? Who has custody of the unborn clone? In this paper, the concepts of trusts are explored to develop a means of resolving conflicts among the individuals who might claim an interest in the unborn clone. The trust doctrine is flexible and may be useful in resolving claims or conflicts.
Civil Rights↗