Patents on biotech products have a scope that goes well beyond what is covered by the most widely applied ethical justifications of intellectual property. Neither natural rights theory from Locke, nor public interest theory of IP rights justifies the wide scope of legal protection. The article takes human genes as an example, focusing on the component that is not invented but persists as unaltered gene information even in the synthetically produced complementary DNA, the cDNA. It is argued that patent on (...) cDNA holds this information captive, or illegitimately appropriates it in limiting other researchers and inventors’ opportunity to explore new functions and uses based on this non-invented information. A tighter connection between legal IP protection and the use description stated in the patent claim is suggested. By binding protection to the product’s foreseeable functions and use, instead of the product itself and all future uses of it, legitimacy of biotech product patents is restored. (shrink)

Progress in gene sequencing could make rapid whole genome sequencing of individuals affordable to millions of persons and useful for many purposes in a future era of genomic medicine. Using the idea of $1000 genome as a focus, this article reviews the main technical, ethical, and legal issues that must be resolved to make mass genotyping of individuals cost-effective and ethically acceptable. It presents the case for individual ownership of a person's genome and its information, and shows the implications of (...) that position for rights to informed consent and privacy over sequencing, testing, and disclosing genomic information about identifiable individuals. Legal recognition of a person's right to control his or her genome and the information that it contains is essential for further progress in applying genomic discoveries to human lives. (shrink)

Since the establishment of the Human Genome Project and the identification of genes in human DNA that play a role in human diseases and disorders, a long, moral and political, battle has began over the extension of IPRs to information contained in human genetic material. According to the Nuffield Council on Bioethics, over the past 20 years, large numbers of human genes have been the subject of thousands of patent applications. This paper examines whether human gene patents can be justified (...) in terms of liberal theories of morality such as natural law, personality development, just reward and social utility. It is argued that human gene patents are in conflict with fundamental principles of liberal morality and justice because they result in "genetic information feudalism". (shrink)

In this article, the authors review some contemporary cases where biotechnologies have been employed, where they have had global implications, and where there has been considerable debate. The authors argue that the concept of dignity, which lies at the center of such documents as the 2005 Universal Declaration on Bioethics and Human Rights, the International Declaration on Human Genetic Data (2003) and the Universal Declaration on the Human Genome and Human Rights (1997) is useful, if not necessary, in engaging in (...) decision making in relation to the moral evaluation of biotechnologies on a global scale. (shrink)

Los pretendidos efectos positivos del actual sistema de patentes en la investigación biotecnológica han sido ampliamente cuestionados. En el marco de esta crítica, se discute aquí uno de los cimientos del modelo. La tesis de la indispensabilidad de las patentes es examinada a través de tres de sus presupuestos: el acceso a la información, el acceso y uso de las invenciones y el incremento de la creatividad y de la investigación que se suponen garantizados a través de las biopatentes. Aplicado (...) a la biología sintética, este enfoque revela que, junto a nuevas técnicas y prometedores productos potenciales, esta disciplina brinda igualmente muestra de tal problemática. Sin embargo, ofrece también una nueva visión de la propiedad industrial y de sus efectos en la investigación, basada en una concepción diferente del commons y de sus relaciones con la propiedad privada sobre los bienes inmateriales en la economía del conocimiento. (shrink)

This article examines some of the controversial issues emerging from the privatization of biomedical research and commercialization of biotechnology. The aim is to identify the dominant social, political, and ethical risks associated with the recent shift from academic to corporate science and from the increasing emphasis on investing in research projects that will result in the award of a monopoly patent. Identifying these risks may ultimately assist policy makers in designing new policies or reforming existing practices that will come closer (...) to achieving an equitable balance between science pursued for the advance of knowledge and science pursued for patents and profit. The discussion may also assist the research directors or managers of biopharmaceutical companies in designing corporate policies that will optimize the balance between the serendipity of scientific discovery and the discipline of strategic business planning. (shrink)