Intellectual property and emerging technologies: The new biology

This unique and comprehensive collection investigates the challenges posed to intellectual property by recent paradigm shifts in biology. It explores the legal ramifications of emerging technologies, such as genomics, synthetic biology, stem cell research, nanotechnology, and biodiscovery. Extensive contributions examine recent controversial court decisions in patent law – such as Bilski v. Kappos, and the litigation over Myriad’s patents in respect of BRCA1 and BRCA2 – while other papers explore sui generis fields, such as access to genetic resources, plant breeders' rights, and traditional knowledge. The collection considers the potential and the risks of the new biology for global challenges – such as access to health-care, the protection of the environment and biodiversity, climate change, and food security. It also considers Big Science projects – such as biobanks, the 1000 Genomes Project, and the Doomsday Vault. The inter-disciplinary research brings together the work of scholars from Australia, Canada, Europe, the UK and the US and involves not only legal analysis of case law and policy developments, but also historical, comparative, sociological, and ethical methodologies. Intellectual Property and Emerging Technologies will appeal to policy-makers, legal practitioners, business managers, inventors, scientists and researchers.

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.

Miami heat: Patent law, informed consent and benefit-sharing

This article considers whether the granting of patents in respect of biomedical genetic research should be conditional upon the informed consent of research participants. It focuses upon several case studies. In Moore v the Regents of the University Of California, a patient sued his physician for breach of fiduciary duty and lack of informed consent, because the doctor had obtained a patent on the patient's cell line, without the patient's authorisation. In Greenberg v Miami Children's Hospital, the research participants, the Greenbergs, the National Tay Sachs and Allied Diseases Association, and Dor Yeshorim brought a legal action against the geneticist Reubon Matalon and the Miami Children's Hospital over a patent obtained on a gene related to the Canavan disease and accompany genetic diagnostic test. PXE International entered into a joint venture with Charles Boyd and the University of Hawaii, and obtained a patent together for ‘methods for diagnosing Pseudoxanthoma elasticum’. In light of such case studies, it is contended that there is a need to reform patent law, so as to recognise the bioethical principles of informed consent and benefit-sharing. The 2005 UNESCO Declaration on Bioethics and Human Rights provides a model for future case law and policy-making.

What’s law got to do with it?: Medical negligence, causation and the use of policy

In a medical negligence context, and under the causation provisions enacted pursuant to Civil Liability Legislation in most Australian jurisdictions, the normative concept of “scope of liability” requires a consideration of whether or not and why a medical practitioner should be responsible for a patient’s harm. As such, it places a limit on the extent to which practitioners are deemed liable for a breach of the duty of care owed by them, in circumstances where a legal factual connection between that breach and the causation of a patient’s harm has already been shown. It has been said that a determination of causation requires ‘the identification and articulation of an evaluative judgement by reference to “the purposes and policy of the relevant part of the law”’: Wallace v Kam (2013) 297 ALR 383, 388. Accordingly, one of the normative factors falling within scope of liability is an examination of the content and purpose of the rule or duty of care violated – that is, its underlying policy and whether this supports an attribution of legal responsibility upon a practitioner. In this context, and with reference to recent jurisprudence, this paper considers: the policy relevant to a practitioner’s duty of care in each of the areas of diagnosis, treatment and advice; how this has been used to determine an appropriate scope of liability for the purpose of the causation inquiry in medical negligence claims; and whether such an approach is problematic for medical standards or decision-making.

Is there such a thing as a love drug?

This paper considers recent discussion of the possible use of ‘love drugs’ and ‘anti-love drugs’ as a way of enhancing or diminishing romantic relationships. The primary focus is on the question of whether the idea of using such products commits its proponents to an excessively reductionist conception of love, and on whether the resulting ‘love’ in the use of ‘love drugs’ would be authentic, to the extent that it would be brought about artificially.

(Failed) voluntary euthanasia law reform in Australia: Two decades of trends, models and politics

Within Australia, there have been many attempts to pass voluntary euthanasia (VE) or physician-assisted suicide (PAS) legislation. From 16 June 1993 until the date of writing, 51 Bills have been introduced into Australian parliaments dealing with legalising VE or PAS. Despite these numerous attempts, the only successful Bill was the Rights of the Terminally Ill Act 1995 (NT), which was enacted in the Northern Territory, but a short time later overturned by the controversial Euthanasia Laws Act 1997 (Cth). Yet, in stark contrast to the significant political opposition, for decades Australian public opinion has overwhelmingly supported law reform legalising VE or PAS. While there is ongoing debate in Australia, both through public discourse and scholarly publications, about the merits and dangers of reform in this field, there has been remarkably little analysis of the numerous legislative attempts to reform the law, and the context in which those reform attempts occurred. The aim of this article is to better understand the reform landscape in Australia over the past two decades. The information provided in this article will better equip Australians, both politicians and the general public, to have a more nuanced understanding of the political context in which the euthanasia debate has been and is occurring. It will also facilitate a more informed debate in the future.

What does “futility” mean? An empirical study of doctors’ perceptions

Objective(s) To describe how doctors define and use the terms “futility” and “futile treatment” in end-of-life care. Design, Setting, Participants A qualitative study using semi-structured interviews with 96 doctors across a range of specialties who treat adults at the end of life. Doctors were recruited from three large Australian teaching hospitals and were interviewed from May to July 2013. Results Doctors’ conceptions of futility focused on the quality and chance of patient benefit. Aspects of benefit included physiological effect, weighing benefits and burdens, and quantity and quality of life. Quality and length of life were linked, but many doctors discussed instances when benefit was determined by quality of life alone. Most doctors described the assessment of chance of success in achieving patient benefit as a subjective exercise. Despite a broad conceptual consensus about what futility means, doctors noted variability in how the concept was applied in clinical decision-making. Over half the doctors also identified treatment that is futile but nevertheless justified, such as short-term treatment as part of supporting the family of a dying person. Conclusions There is an overwhelming preference for a qualitative approach to assessing futility, which brings with it variation in clinical decision-making. “Patient benefit” is at the heart of doctors’ definitions of futility. Determining patient benefit requires discussions with patients and families about their values and goals as well as the burdens and benefits of further treatment.

Recomendación del Comité de Bioética del INCUCAI en el caso de las gemelas con fibrosis quística

Resumen: El siguiente texto es la transcripción literal de la recomendación del Comité de Bioética del INCUCAI, [1] elaborada a partir de la demanda del Directorio de la institución en reunión extraordinaria para analizar el requerimiento de excepción para el trasplante pulmonar con donante vivo relacionado en favor de las pacientes hermanas mellizas, M. del V. y M. O., que padecen fibrosis quística, inscriptas en lista de espera para trasplante pulmonar cadavérico. La misma fue expedida en la ciudad de Buenos Aires, el día 1 de septiembre de 2010 y firmada por las coordinadoras del Comité Lic. Roxana Fontana y Mgt. Prof. Beatriz Firmenich y por sus miembros permanentes Dra. Mirta Fernández y Dra. M. E. Barone.

Cuestiones en juego en los proyectos de legalización del aborto

Resumen: Se procura identificar los más importantes tópicos bioéticos en tratamiento ante el Congreso de la Nación en relación con el inicio de la vida: proyectos sobre el delito de aborto, con diversas derivaciones como la píldora del día después; sobre técnicas de procreación humana; sobre clonación y otras situaciones de bioingeniería aplicada a la vida humana. Se formula un análisis contextualizado de los proyectos y una valoración crítica a la luz de los principios de la Bioética personalista ontológicamente fundada.

¿Dónde iniciar el diálogo con el mundo en defensa de la vida?

Resumen: El tema del diálogo interdisciplinar constituye el alma misma de la bioética y su método propio. Este artículo pretende ser un aporte a ese diálogo. Con ese fin, asume los temas controversiales del pasado (la relación ciencia y ética), al mismo tiempo que señala la oportunidad actual de búsqueda y encuentro entre ambas ramas del saber. El autor propone como ámbito de ese diálogo el campo de la vida humana. La bioética con su actualidad, su complejidad y su metodología transdisciplinar surge como posibilidad de un diálogo respetuoso y ordenado, llamado a dar muchos frutos

Bioética : 40 años de recorrido y un nuevo futuro

Resumen: En esta presentación, el autor indaga las circunstancias y los autores que pudieron influir en Van Rensselaer Potter en la creación de la expresión Bioética. Así, surgen las personalidades frecuentemente olvidadas de Fritz Jahr, Julius Moses y Aldo Leopold. Después de profundizar sobre el concepto del mismo Potter y su intención original para la referida expresión, destaca el recorrido que la Bioética fue adquiriendo como un camino propio. Asimismo se señalan los puntos que aún quedan por desarrollar y que han sido soslayados hasta el momento.

Extracción de órganos de cadáveres con fines de trasplante. Voluntariedad y consentimiento presunto

El tema del llamado “consentimiento presunto” a los fines de habilitar la extracción de órganos cadavéricos ha suscitado debate e interés en ámbitos bioéticos y biojurídicos. Cuestiones como la del valor y significado del cuerpo y el cadáver, la relación entre el individuo y la comunidad, el papel de la voluntad y la libertad en las decisiones relacionadas con el propio cuerpo, tienen aquí especial relevancia. Varias leyes han tratado estos temas y distintos países se rigen por diferentes sistemas. La gran pregunta que recorrerá este trabajo se remite al papel y relevancia que se considera debe darse a la voluntad del difunto a la hora de disponer de sus órganos para trasplante.

En las distintas corrientes de la bioética clínica actual : ¿podemos encontrar puntos en común?

Resumen: En este corto tiempo de desarrollo de la Bioética se han ido proponiendo nuevas metas. El avance ha ido muy rápido y los procedimientos esquemáticos de los primeros años han sido ampliamente superados y complejizados. Pero, cada uno de ellos, nos ofrece una perspectiva distinta a tener en cuenta, que, si tenemos la apertura necesaria, contribuyen a descubrirnos algo más la realidad. El objetivo de la deliberación no es la toma de decisiones ciertas o exclusivas, sino prudentes. Distintas personas pueden tomar distintas decisiones ante un mismo hecho y todas ser prudentes. Esto plantea un desafío a futuro: el asumir un tipo de racionalidad que permita la participación de todos los implicados en el proceso de deliberación de los problemas prácticos, en nuestro caso los morales. Los argumentos que se esgrimen pueden no anular completamente otras perspectivas y, por tanto, otros argumentos sobre el mismo asunto o problema. De ahí que necesitamos las perspectivas y razones de los demás. Con esto, resulta que los otros se convierten en condición de posibilidad de mi propio desarrollo como ser racional.

Bioética y trascendencia : la perspectiva cristiana en el mundo secular

El mundo actual se caracteriza por la diversidad de justificaciones morales, por lo que resulta arriesgado referirse a una única Bioética. Esta diversidad lleva a muchos autores a defender la necesidad de establecer una bioética secular, que ignora el pensamiento religioso y las manifestaciones de la cultura. El artículo analiza los caminos que atraviesa la bioética secular, en el contexto de creciente secularización del mundo actual para, finalmente, hacer referencia a los aportes que puede ofrecer una bioética cristiana.

Judaísmo y problemática bioética de la reproducción asistida : consideraciones generales

Resumen: La milenaria Ley judía en su devenir y completitud a través del análisis y respuesta a los coyunturales problemas del acontecer histórico en sus diversas circunstancias, aborda también y en profundidad desde sus comienzos lo denominado actualmente como bioética. Este trabajo expone y examina en particular las modernas técnicas de reproducción asistida, y los fundamentos de la Ley por la cual las más importantes autoridades legislativas del judaísmo determinan según el caso el deber, permisión o prohibición de su implementación más la problemática y los desafíos en esta área de competencia. Esto último aplicable también a la sociedad en general transmitiendo el mensaje de la no reducción de la reproducción humana a una mera cuestión de posibilidad técnica o en función de los deseos o sentimientos del ser humano, sino concibiéndola como una cuestión de suma responsabilidad y compromiso no sólo en relación a los agentes partícipes sino también respecto de su descendencia.