International Tale on Gene Patents - between Medical and Legal Uncertainties / Cuento internacional sobre patentes genéticas: entre la incertidumbre médica y jurídica

This work is inspired by the international litigation chronicle of Myriad Genetics that remains of topical importance in the judicial and academic discourse regardless of the time that passed since. It discusses approaches of various jurisdictions to the problem of gene patenting as well as patenting of geneticdiagnostic testing. The article takes under scrutiny the judgments rendered in the U.S., Australia as well as the decisions by the European Patent Office and placesthem into interdisciplinary background of genetic science. The issue is significant, both theoretically and practically. Notwithstanding the expiration of patents that constituted the subject matter of the Myriad’s various lawsuits, the problem still remains currently relevant. Firstly, because the judgments in individual cases did not answer all the questions, but – in some way – only prepared a path for future decisions. Secondly, it is on account of new scientific breakthroughs in the area of human genetics. Consequently, the domain of genetic diagnostics is under continuous development and in the future may continue to reveal new scientific discoveries and (possibly) inventions. The lack of uniform and transparent rules in this field, and well-defined boundaries for potential monopolies constantly brings not only uncertainty for medical practitioners and scientists, but also real disadvantagesfor the patients. (AU)

Esta obra se inspira en la crónica del litigio internacional de Myriad Genetics, que sigue siendo de actualidad en el discurso judicial y académico a pesar del tiempotranscurrido desde entonces. En él se examinan los enfoques de diversas jurisdicciones sobre el problema de las patentes de genes, así como de las patentes de pruebas de diagnóstico genético. El artículo examina las sentencias dictadas en Estados Unidos y Australia, así como las decisiones de la Oficina Europea de Patentes, y las sitúa en el contexto interdisciplinario de la ciencia genética. La cuestión es importante, tanto desde el punto de vista teórico como práctico. A pesar de la expiración de las patentes que constituyeron el objeto de los diversos pleitos de Myriad, el problema siguesiendo de actualidad. En primer lugar, porque las sentencias dictadas en los casos individuales no respondieron a todas las preguntas, sino que –en cierto modo– sólo prepararon el camino para futuras decisiones. En segundo lugar, debido a los nuevosavances científicos en el ámbito de la genética humana. En consecuencia, el ámbito del diagnóstico genético está en continuo desarrollo y en el futuro puede seguirrevelando nuevos descubrimientos científicos y (posiblemente) invenciones. La falta de normas uniformes y transparentes en este ámbito y de límites bien definidos para los monopolios potenciales no sólo genera constantemente incertidumbre para losmédicos y científicos, sino también desventajas reales para los pacientes. (AU)

Synthetic Biology and the United Nations.

Synthetic biology is a rapidly emerging interdisciplinary field of science and engineering that aims to redesign living systems through reprogramming genetic information. The field has catalysed global debate among policymakers and publics. Here we describe how synthetic biology relates to these international deliberations, particularly the Convention on Biological Diversity (CBD).

LeRoy Walters's Legacy of Bioethics in Genetics and Biotechnology Policy.

LeRoy Walters was at the center of public debate about emerging biological technologies, even as "biotechnology" began to take root. He chaired advisory panels on human gene therapy, the human genome project, and patenting DNA for the congressional Office of Technology Assessment. He chaired the subcommittee on Human Gene Therapy for NIH's Recombinant DNA Advisory Committee. He was also a regular advisor to Congress, the executive branch, and academics concerned about policy governing emerging biotechnologies. In large part due to Prof. Walters, the Kennedy Institute of Ethics was one of the primary sources of talent in bioethics, including staff who populated policy and science agencies dealing with reproductive and genetic technologies, such as NIH and OTA. His legacy lies not only in his writings, but in those people, documents, and discussions that guided biotechnology policy in the United States for three decades.

International Divergence in Gene Patenting.

This review explores the recent divergence in international patent law relating to genes and associated subject matter. This divergence stems primarily from decisions of the highest courts in the United States and Australia on the eligibility of patent claims relating to the BRCA gene sequences. Patent offices, courts, and policy makers have struggled for many years to clearly articulate the bounds of patent claims on isolated and synthetic DNA and related products and processes, including methods for their use in genetic diagnostics. This review provides context to the current divergence by mapping key events in the gene patent journey from the early 1980s onward in five key jurisdictions: the United States, the member states of the European Patent Convention, Australia, Canada, and China. Early approaches to gene patenting had some commonalities across jurisdictions, which makes exploration of the recent divergence all the more interesting.There is insufficient empirical evidence to date to confidently predict the consequences of this recent divergence. However, it could potentially have a significant effect on local industry and on consumer access.

El papel de las ciencias empíricas en el derecho: el estatus del embrión humano / The role of empirical sciences in the law: the status of the human embryo / El paper de les ciències empíriques en el dret: l'estatus de l'embrió humà

Se analizan dos sentencias Ajudiciales antagónicas en relación con el estatus jurídico del embrión humano: el fallo "Portal de Belén", de la Corte Suprema de Justicia de la Argentina, y "Artavia Murillo", de la Corte Interamericana de Derechos Humanos. Mi propósito es mostrar que, a pesar de sostener posiciones contrarias, ambas sentencias cometen el mismo tipo de error conceptual: justificar su tesis acerca del estatus del embrión humano en consideraciones biológicas acerca del desarrollo embrionario. Detectar este tipo de falencia argumentativa puede ser útil para el análisis de muchas decisiones judiciales sobre temas bioéticos

In this paper, I consider two opposite judicial decisions concerning the legal status of the human embryo: "Portal de Belén" by the Argentine Supreme Court, and "Artavia Murillo" by the Inter-American Court of Human Rights. My purpose is to show that, although both decisions defend opposite positions, they commit the same kind of mistake. Both seek to ground a position about the legal status of the human embryo on biological considerations on embryo development. Highlighting this kind of argumentative failure can be useful for the analysis of judicial decisions with bioethical import

S'analitzen dues sentències judicials antagòniques en relació amb l'estatus jurídic de l'embrió humà: la sentència "Portal de Belém", de la Cort Suprema de Justícia de l'Argentina, i la sentència "Artavia Murillo", de la Cort Interamericana de Drets Humans. El meu propòsit és mostrar que, malgrat sostenir posicions contràries, ambdues sentències cometen el mateix tipus d'error conceptual: basar la seva tesi sobre l'estatus de l'embrió humà en consideracions biològiques sobre el desenvolupament embrionari. Detectar aquest tipus de fal·làcia argumentativa pot ser útil per a l'anàlisi de moltes decisions judicials sobre temes bioètics

Direitos Humanos, patrimônio genético e dados genéticos humanos: crítica à doutrina dos dados genéticos como interesse difuso / Human Rights, genetic heritage and human genetic data: a critical analysis to the doctrine of genetic data as diffuse interest

A proteção jurídica dos dados genéticos é tema fundamental para a reconstrução da teoria dos direitos humanos e dos direitos de personalidade no Estado Democrático de Direito. Os dados genéticos são expressões biológicas da personalidade humana. Logo, não é difícil relacioná-los aos direitos humanos. Mas quem são seus titulares? A tutela destes se dá em razão do «interesse difuso»? Metodologicamente, utilizou-se do modo teórico documental perfazendo uma revisão da literatura concernente ao tema e uma análise investigativa e reflexiva de caráter hermenêutico. Partindo da tensão já demonstrada por Habermas entre faticidade e validade, o discurso dos interesses difusos é esvaziado de validade, porquanto são vinculados a meros fatos, isto é, sua proteção jurídica decorreria da relevância social. O interesse fático, desvinculado da validade normativa do sistema jurídico, preocupa e os direitos humanos, revisitados como direitos subjetivos em uma concepção mais consentânea com a democracia, poderiam lançar o novo caminho para a validade pretendida. As normas jurídicas que contêm interesses aparentemente públicos não podem negligenciar o sistema de direitos humanos. Da mesma forma, normas que contêm interesses aparentemente privados não podem descuidar do entorno social em que se faz contextualizado. Há interdependência entre interesse público e interesse privado, posto que aquele nada mais é do que o resultado dos vários interesses privados. No campo da Moral e do discurso de justificação, a axiologia não pode conceber uma valorização «a priori» do interesse público sobre o interesse privado. No entanto, no discurso de aplicação tal consideração não se faz presente. Não são os dados genéticos interesses difusos. Em verdade, não há espaço para esse discurso na aplicação jurídica. A consideração da juridicidade dos interesses pressupõe a generalização de valores a um número indeterminado de pessoas (universalidade) somada a um aspecto de eficácia, que somente os direitos humanos podem garantir

The legal protection of genetic data is a key area for the reconstruction of the human rights theory in a democratic state. Genetic data may be considered biological expressions of human personalities. Thus, it is not difficult to relate them with human rights. However, ownership of these data has been a polemic issue in past years. Is the protection of genetic data truly based on the «diffuse interest»? The aim of this study was to review the subject from a theoretic-documental perspective, as well as to present an investigative and reflective analysis of hermeneutical character. Based on the tension between facticity and validity, already debated by Habermas, the current discourse of diffuse interests lacks validation and relies on facts, thus, based on its social relevance. The detachment from a normative validation by the legal system is concerning. If we revise the human rights under a more democratic perspective, it would be possible to achieve an effective legal validation of genetic data. The legal parameters that include public interests must not neglect the human rights system. Similarly, rules that contain a seemingly private interest must not ignore the social environment in which it is contextualized. Public and private interests are interdependent. Under a moral perspective, axiology may not value «a priori» the public over the private interest. However, such consideration is challenging. Currently, the genetic data is not diffuse. In fact, currently, there is no room for debates on its legal implementation. The legality of interests presupposes a generalization of values to an undetermined number of people (universality). Only with the aid of human rights may we achieve this legal foundation in an efficient manner

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Edición genómica. La hora de la reflexión / Gene editing. Time to reflection

La aparición de nuevas tecnologías de edición genómica y sus especiales características han propiciado un amplio debate sobre la conveniencia y el alcance de su utilización tanto en especies vegetales y animales como en la propia especie humana. Se realiza un breve análisis de los argumentos utilizados así como un resumen de algunos de los posicionamientos más relevantes al respecto

The development of new gene editing technologies and their special characteristics have led to a passionate debate on the suitability and reliability of their use both in plant and animal species and in the human species itself. A brief analysis of the arguments used in this debate as well as a summary of some of the most relevant statements in this regard is made

Genetics and right: a methodology.

The theme of the free availability of genetic information is, by its nature, the heart of attention in most areas of investigation. From biology to medicine, from philosophy to law, from theology to biotechnology there isn't an area of science that cannot be said to be interested in the subject, nor has not, in recent years, tried to deepen it.

Fichero 120: la base de datos de Perfiles de ADN del Instituto Nacional de Toxicología y Ciencias Forenses de personas afectadas por la sustracción de recién nacidos / File 120: The Database of DNA profiles from the National Institute of Toxicology and Forensic Sciences of people affected by the subtraction of newborns

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Parámetros forenses del sistema Powerplex® 21 (Promega Corp) en población mestiza del occidente de México / Forensic parameters of the Powerplex® 21 System (Promega Corp) in mestizo populations from the West of Mexico

Introducción. Los microsatélites o short tandem repeats son los marcadores de elección en identificación humana, para lo cual se deben analizar en las poblaciones. Esta tarea se ha realizado escasamente con los sistemas genéticos de nueva generación, lo cual es crítico en las poblaciones mestizas de México, ya que se ha demostrado una subestructura genética significativa por diferencias en sus componentes de mezcla. Objetivo. Hacer la validación poblacional del sistema de análisis genético Powerplex® 21 en mestizos de la región occidente de México. Material y métodos. Se analizaron 374 individuos no emparentados residentes de la región occidente de México con el sistema Powerplex® 21. Los datos genéticos se analizaron con diversos programas estadísticos y se compararon con poblaciones de referencia. Resultados y conclusiones. Se determinaron las frecuencias alélicas y la distribución de genotipos de todos los marcadores estuvieron en equilibrio Hardy-Weinberg; la prueba de desequilibrio de ligamiento descartó asociaciones entre pares de loci. Se estimaron los siguientes parámetros de interés forense para el sistema PowerPlex® 21: poder ddee discriminación (PD), poder de exclusión (PE), (heterocigosidad (Het), (contenido de información polimórfica (PIC) e índice de paternidad (IP) típico, cuyo poder de discriminación y exclusión combinado fue -100% y 99,999999473%, respectivamente. Esto constituye un incremento importante respecto a lo ofrecido por sistemas tradicionales con 15 short tandem repeats para la misma población/región. La información reportada valida el uso del sistema PowerPlex® 21 en mestizos del occidente de México para interpretar de forma confiable perfiles de ADN en pruebas de paternidad y casos forenses (AU)

Introduction. Microsatellites or short tandem repeats (STR) are the markers of choice in human identification. For this purpose, they must be analyzed in populations. This task has been scarcely performed for new generation human identification systems, which is critical in Mexican mestizo populations, because a significant genetic structure has been demonstrated due to admixture differences. Objective. To validate the System in mestizo populations from the west region of Mexico. Methods. A total of 374 unrelated Mexican-mestizos from the west region were analyzed with the Powerplex® 21 system. Genetic data were analyzed using different softwares and including additional related populations for comparison purposes. Results and conclusions. We estimated allele frequencies, and genotype distribution of all markers was in agreement with Hardy-Weinberg expectations; the linkage disequilibrium test discarded association between all pair of loci. The following forensic parameters were estimated: power of discrimination (PD), power of exclusion (PE), heterozygosity (Het), polymorphism information content (PIC), and typical paternity index (PI); its combined power of discrimination and exclusion was -100% and 99.999999473%, respectively. This constitutes an important increment with respect to typical 15 STR systems for the same population/region. This report validates the PowerPlex® 21 system in western Mexican-mestizos for confident interpretation of DNA profiles in forensic cases and paternity testing. Sistema Powerplex® 21; México; Identificación humana; Poblaciones (AU)

[Overview of patents on targeted genome editing technologies and their implications for innovation and entrepreneurship education in universities].

Zinc finger nuclease, transcription activator-like effector nuclease, and clustered regularly interspaced short palindromic repeats/Cas9 nuclease are important targeted genome editing technologies. They have great significance in scientific research and applications on aspects of functional genomics research, species improvement, disease prevention and gene therapy. There are past or ongoing disputes over ownership of the intellectual property behind every technology. In this review, we summarize the patents on these three targeted genome editing technologies in order to provide some reference for developing genome editing technologies with self-owned intellectual property rights and some implications for current innovation and entrepreneurship education in universities.

Bioderecho y sujeto de derechos. Recategorización jurídica de la manipulación genética no terapéutica en estado embrionario pre-implantacional y del concepto de existencia legal de la persona / No disponible

El rasgo jurídico inédito que la manipulacion genética no terapéutica en estado embrionario despliega, exige un abordaje jurídico-procedimental, hasta ahora inexplorado que, a la vez, demanda la redefinición y ampliación de la estatura legal vinculante de categorías tradicionales del derecho positivo y que alcanzan las fronteras del derecho constitucional, de familia, reparatorio y penal. En este artículo busco demostrar la necesidad de definir un marcojuridico para regular la manipulación genética no terapéutica en estado embrionario preimplantacional que introduce desmejoras o discapacidades que redundan en perjuicios objetivos para un nuevo sujeto de derechos que debiera ser considerado en el mapa juridico: la persona futura. Por ello, pretendo subsanar el vacio legal existente, proponiendo actualizar, ampliar y profundizar los ordenamientos jurídicos iberoamericanos, a través de la recategorizacion jurídica de la manipulación genética no terapéutica y la emergencia de un nuevo sujeto de derechos: la persona futura (AU)

The unprecedented legal implications that non-therapeutic genetic manipulation in pre-implantation embryonic state points out demand a, until now, unexplored approach, which, at the same time, requires the redefinition and extension of legal-binding status of traditional categories of law related to constitutional, restorative, criminal and international law. ln this paper, l will identify and define a juridical framework to regulate non-therapeutic genetic manipulation in pre-implantation embryonic state, specifically when that manipulation introduces deteriorations, disabilities or illnesses, which imply objective harms for a new subject of rights who should be considered in the juridical map: the future person. ln addition, I intend to remedy the existing legal vacuum and loopholes in this matter by proposing to update, expand and deepen international legal systems through the juridical re-categorization of non-therapeutic genetic manipulation and the concept ot legal existence of the person (AU)

El derecho a no saber la información genética. EI caso del País Vasco de reconocimiento a favor de una pareja con antecedentes familiares de Corea de Huntington / No disponible

Una vez analizada brevemente la naturaleza jurídica del derecho a no saber, se describe a continuación un caso clínico, tramitado en 2015 ante el Departamento de Salud del Gobierno del País Vasco, que sirve de ejemplo para reflexionar acerca de la fortaleza de este derecho, singularmente cuando colisiona con los estrictos criterios de financiación de las prestaciones sanitarias (AU)

After analyzing the legal nature of the right not to know, we describe below a case which was conducted in 2015 before the Basque Country Department of Health. This case stands as an example to reflect on the strength of this right, singularly when it clashes with the strict criteria of financing of health care delivery (AU)

The History of Patenting Genetic Material.

The US Supreme Court's recent decision in Association for Molecular Pathology v. Myriad Genetics, Inc. declared, for the first time, that isolated human genes cannot be patented. Many have wondered how genes were ever the subjects of patents. The answer lies in a nuanced understanding of both legal and scientific history. Since the early twentieth century, "products of nature" were not eligible to be patented unless they were "isolated and purified" from their surrounding environment. As molecular biology advanced, and the capability to isolate genes both physically and by sequence came to fruition, researchers (and patent offices) began to apply patent-law logic to genes themselves. These patents, along with other biological patents, generated substantial social and political criticism. Myriad Genetics, a company with patents on BRCA1 and BRCA2, two genes critical to assessing early-onset breast and ovarian cancer risk, and with a particularly controversial business approach, became the antagonist in an ultimately successful campaign to overturn gene patents in court. Despite Myriad's defeat, some questions concerning the rights to monopolize genetic information remain. The history leading to that defeat may be relevant to these future issues.

La discriminación genética y las dificultades de su prohibición normativa / No disponible

El artículo analiza las dificultades de la prohibición normativa de la discriminación genética. Se destaca su racionalidad y excepcionalidad, su carácter “privado”, la dudosa calificación como categoría sospechosa, su mayor cercanía a la neutralidad que a la antisubordinación, y la necesidad de transitar desde la dualidad “perfección-imperfección” hacia el respeto a la diversidad genética (AU)

This article the difficulties faced by the legal prohibition of genetic discrimination. It highlights the rationality and excepcionality of this kind of discrimination, its “private” nature, the doubtful status as suspect classification, itsbetter fit with the neutrality approach than the non-subordination approach, and the need to replace the “perfection-imperfection” duality by the respect for genetic diversity (AU)

Are the gene-patent storm clouds dissipating? A global snapshot.

In genetic diagnostics testing, what are the boundaries of the global patent problem, and is there a real risk that patents and licensing practices could impede access to tests?

Baseball bats and chocolate chip cookies: the judicial treatment of DNA in the myriad genetics litigation.

In June 2013, the U.S. Supreme Court rendered a controversial ruling that naturally occurring DNA segments are "products of nature" and therefore not patentable subject matter. At this intersection between science and law, in litigation of crucial importance to patients, science, and multibillion-dollar biotech enterprises, the appellate judges sidestepped genetics and engaged in a war of metaphors from diamonds to chocolate chip cookies. This case is not an outlier. Apprehensive judges and juries in both Canada and the United States find many convenient excuses to avoid coming to grips with the underlying science in patent cases. But this is simply not acceptable. Legal rulings must be, and must seem to be, well grounded, as a matter of both law and science. The legitimacy of court decisions in the eyes of the stakeholders and the broader public depends on it.