Patents, Ethics and Stem Cell Research : The Case of hESC Innovation in Australia, Europe and the United States

Embryonic stem cells offer potentially a ground-breaking insight into health and diseases and are said to offer hope in discovering cures for many ailments unimaginable few years ago. Human embryonic stem cells are undifferentiated, immature cells that possess an amazing ability to develop into almost any body cell such as heart muscle, bone, nerve and blood cells and possibly even organs in due course. This remarkable feature, enabling embryonic stem cells to proliferate indefinitely in vitro (in a test tube), has branded them as a so-called miracle cure . Their potential use in clinical applications provides hope to many sufferers of debilitating and fatal medical conditions. However, the emergence of stem cell research has resulted in intense debates about its promises and dangers. On the one hand, advocates hail its potential, ranging from alleviating and even curing fatal and debilitating diseases such as Parkinson s, diabetes, heart ailments and so forth. On the other hand, opponents decry its dangers, drawing attention to the inherent risks of human embryo destruction, cloning for research purposes and reproductive cloning eventually. Lately, however, the policy battles surrounding human embryonic stem cell innovation have shifted from being a controversial research to scuffles within intellectual property rights. In fact, the ability to obtain patents represents a pivotal factor in the economic success or failure of this new biotechnology. Although, stem cell patents tend to more or less satisfy the standard patentability requirements, they also raise serious ethical and moral questions about the meaning of the exclusions on ethical or moral grounds as found in European and to an extent American and Australian patent laws. At present there is a sort of a calamity over human embryonic stem cell patents in Europe and to an extent in Australia and the United States. This in turn has created a sense of urgency to engage all relevant parties in the discourse on how best to approach patenting of this new form of scientific innovation. In essence, this should become a highly favoured patenting priority. To the contrary, stem cell innovation and its reliance on patent protection risk turmoil, uncertainty, confusion and even a halt on not only stem cell research but also further emerging biotechnology research and development. The patent system is premised upon the fundamental principle of balance which ought to ensure that the temporary monopoly awarded to the inventor equals that of the social benefit provided by the disclosure of the invention. Ensuring and maintaining this balance within the patent system when patenting human embryonic stem cells is of crucial contemporary relevance. Yet, the patenting of human embryonic stem cells raises some fundamental moral, social and legal questions. Overall, the present approach of patenting human embryonic stem cell related inventions is unsatisfactory and ineffective. This draws attention to a specific question which provides for a conceptual framework for this work. That question is the following: how can the investigated patent offices successfully deal with patentability of human embryonic stem cells? This in turn points at the thorny issue of application of the morality clause in this field. In particular, the interpretation of the exclusions on ethical or moral grounds as found in Australian, American and European legislative and judicial precedents. The Thesis seeks to compare laws and legal practices surrounding patentability of human embryonic stem cells in Australia and the United States with that of Europe. By using Europe as the primary case study for lessons and guidance, the central goal of the Thesis then becomes the determination of the type of solutions available to Europe with prospects to apply such to Australia and the United States. The Dissertation purports to define the ethical implications that arise with patenting human embryonic stem cells and intends to offer resolutions to the key ethical dilemmas surrounding patentability of human embryonic stem cells and other morally controversial biotechnology inventions. In particular, the Thesis goal is to propose a functional framework that may be used as a benchmark for an informed discussion on the solution to resolving ethical and legal tensions that come with patentability of human embryonic stem cells in Australian, American and European patent worlds. Key research questions that arise from these objectives and which continuously thread throughout the monograph are: 1. How do common law countries such as Australia and the United States approach and deal with patentability of human embryonic stem cells in their jurisdictions? These practices are then compared to the situation in Europe as represented by the United Kingdom (first two chapters), the Court of Justice of the European Union and the European Patent Office decisions (Chapter 3 onwards) in order to obtain a full picture of the present patenting procedures on the European soil. 2. How are ethical and moral considerations taken into account at patent offices investigated when assessing patentability of human embryonic stem cell related inventions? In order to assess this part, the Thesis evaluates how ethical issues that arise with patent applications are dealt with by: a) Legislative history of the modern patent system from its inception in 15th Century England to present day patent laws. b) Australian, American and European patent offices presently and in the past, including other relevant legal precedents on the subject matter. c) Normative ethical theories. d) The notion of human dignity used as the lowest common denominator for the interpretation of the European morality clause. 3. Given the existence of the morality clause in form of Article 6(1) of the Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions which corresponds to Article 53(a) European Patent Convention, a special emphasis is put on Europe as a guiding principle for Australia and the United States. Any room for improvement of the European morality clause and Europe s current manner of evaluating ethical tensions surrounding human embryonic stem cell inventions is examined. 4. A summary of options (as represented by Australia, the United States and Europe) available as a basis for the optimal examination procedure of human embryonic stem cell inventions is depicted, whereas the best of such alternatives is deduced in order to create a benchmark framework. This framework is then utilised on and promoted as a tool to assist Europe (as represented by the European Patent Office) in examining human embryonic stem cell patent applications. This method suggests a possibility of implementing an institution solution. 5. Ultimately, a question of whether such reformed European patent system can be used as a founding stone for a potential patent reform in Australia and the United States when examining human embryonic stem cells or other morally controversial inventions is surveyed. The author wishes to emphasise that the guiding thought while carrying out this work is to convey the significance of identifying, analysing and clarifying the ethical tensions surrounding patenting human embryonic stem cells and ultimately present a solution that adequately assesses patentability of human embryonic stem cell inventions and related biotechnologies. In answering the key questions above, the Thesis strives to contribute to the broader stem cell debate about how and to which extent ethical and social positions should be integrated into the patenting procedure in pluralistic and morally divided democracies of Europe and subsequently Australia and the United States.

Birth of the European individual : Outline of a theory of legal practice

The modern subject is what we can call a self-subjecting individual. This is someone in whose inner reality has been implanted a more permanent governability, a governability that works inside the agent. Michel Foucault s genealogy of the modern subject is the history of its constitution by power practices. By a flight of imagination, suppose that this history is not an evolving social structure or cultural phenomenon, but one of those insects (moth) whose life cycle consists of three stages or moments: crawling larva, encapsulated pupa, and flying adult. Foucault s history of power-practices presents the same kind of miracle of total metamorphosis. The main forces in the general field of power can be apprehended through a generalisation of three rationalities functioning side-by-side in the plurality of different practices of power: domination, normalisation and the law. Domination is a force functioning by the rationality of reason of state: the state s essence is power, power is firm domination over people, and people are the state s resource by which the state s strength is measured. Normalisation is a force that takes hold on people from the inside of society: it imposes society s own reality its empirical verity as a norm on people through silently working jurisdictional operations that exclude pathological individuals too far from the average of the population as a whole. The law is a counterforce to both domination and normalisation. Accounting for elements of legal practice as omnihistorical is not possible without a view of the general field of power. Without this view, and only in terms of the operations and tactical manoeuvres of the practice of law, nothing of the kind can be seen: the only thing that practice manifests is constant change itself. However, the backdrop of law s tacit dimension that is, the power-relations between law, domination and normalisation allows one to see more. In the general field of power, the function of law is exactly to maintain the constant possibility of change. Whereas domination and normalisation would stabilise society, the law makes it move. The European individual has a reality as a problem. What is a problem? A problem is something that allows entry into the field of thought, said Foucault. To be a problem, it is necessary for certain number of factors to have made it uncertain, to have made it lose familiarity, or to have provoked a certain number of difficulties around it . Entering the field of thought through problematisations of the European individual human forms, power and knowledge one is able to glimpse the historical backgrounds of our present being. These were produced, and then again buried, in intersections between practices of power and games of truth. In the problem of the European individual one has suitable circumstances that bring to light forces that have passed through the individual through centuries.

Trafficking in human beings and Foucauldian biopower : A case study in the expansion of the human rights phenomenon

Trafficking in human beings has become one of the most talked about criminal concerns of the 21st century. But this is not all that it has become. Trafficking has also been declared as one of the most pressing human rights issues of our time. In this sense, it has become a part of the expansion of the human rights phenomenon. Although it is easy to see that the crime of trafficking violates several of the human rights of its victims, it is still, in its essence, a fairly conventional although particularly heinous and often transnational crime, consisting of acts between private actors, and lacking, therefore, the vertical effect associated traditionally with human rights violations. This thesis asks, then, why, and how, has the anti-trafficking campaign been translated in human rights language. And even more fundamentally: in light of the critical, theoretical studies surrounding the expansion of the human rights phenomenon, especially that of Costas Douzinas, who has declared that we have come to the end of human rights as a consequence of the expansion and bureaucratization of the phenomenon, can human rights actually bring salvation to the victims of trafficking? The thesis demonstrates that the translation process of the anti-trafficking campaign into human rights language has been a complicated process involving various actors, including scholars, feminist NGOs, local activists and global human rights NGOs. It has also been driven by a complicated web of interests, the most prevalent one the sincere will to help the victims having become entangled with other aims, such as political, economical, and structural goals. As a consequence of its fragmented background, the human rights approach to trafficking seeks still its final form, consisting of several different claims. After an assessment of these claims from a legal perspective, this thesis concludes that the approach is most relevant regarding the mistreatment of victims of trafficking in the hands of state authorities. It seems to be quite common that authorities have trouble identifying the victims of trafficking, which means that the rights granted to themin international and national documents are not realized in practice, but victims of trafficking are systematically deported as illegal immigrants. It is argued that in order to understand the measures of the authorities, and to assess the usefulness of human rights, it is necessary to adopt a Foucauldian perspective and to observe the measures as biopolitical defence mechanisms. From a biopolitical perspective, the victims of trafficking can be seen as a threat to the population a threat that must be eliminated either by assimilating them to the main population with the help of disciplinary techniques, or by excluding them completely from the society. This biopolitical aim is accomplished through an impenetrable net of seemingly insignificant practices and discourses that not even the participants are aware of. As a result of these practices and discourses, trafficking victims only very few of fit the myth of the perfect victim, produced by biopolitical discourses become invisible and therefore subject to deportation as (risky) illegal immigrants, turning them into bare life in the Agambenian sense, represented by the homo sacer, who cannot be sacrificed, yet does not enjoy the protection of the society and its laws. It is argued, following Jacques Rancière and Slavoj i ek, that human rights can, through their universality and formal equality, provide bare life the tools to formulate political claims and therefore utilize their politicization through their exclusion to return to the sphere of power and politics. Even though human rights have inevitably become entangled with biopolitical practices, they are still perhaps the most efficient way to challenge biopower. Human rights have not, therefore, become useless for the victims of trafficking, but they must be conceived as a universal tool to formulate political claims and challenge power .In the case of trafficking this means that human rights must be utilized to constantly renegotiate the borders of the problematic concept of victim of trafficking created by international instruments, policies and discourses, including those that are sincerely aimed to provide help for the victims.