This thesis analyses the supra-national application of the morality provisions in the ‘European’ patent system by the judicial/quasi-judicial decision-making in the European Union (“EU”) and European Patent Organisation (“EPOrg”). In doing so, it focuses specifically on Article 53 of the European Patent Convention and Article 6 of Directive 98/44/EC on the legal protection of biotechnological inventions, with particular reference to the overlapping institutional matrix within which these legislative provisions are applied. The intended contribution of this research is in relation to how these decision-making entities of the EPOrg and the EU interpret and apply the morality provisions in the ‘European’ patent system as a feature of their operation as institutions. The research investigates specifically: to what extent and in what ways does an analysis of the institutional framework for the application of the morality provisions by the various institutions implicated in the ‘European’ patent system reveal new insights into the current position and suggest defensible approaches to the future development of these provisions. This has particular relevance in the current context, in light of the developing unitary patent scheme examined through an institutional lens in chapter six. Importantly, the contribution of this research will not be in relation to the specific principles or tests which should be used in applying the morality provisions per se in the ‘European’ patent system, nor does it seek to contribute specifically to the normative questions in relation to what morality should mean in this context or whether the morality provisions should exist within the patent system. Such matters have been explored extensively in the literature. Instead, this thesis uses doctrinal methods to build a theoretical framework by drawing specifically on institutional theories within law and sociology, which are used to devise a novel framework for assessing institutional influences on decision-makers. This framework is then applied to the EPOrg and EU with the aim of demonstrating the differing institutional pulls on each body in their application of the morality provisions, which is used as a single exemplar to achieve this kind of institutional analysis. The overall aim of this research is to contribute to an understanding of decision-making in this specific context by reference to understandings of how institutional contexts can have profound effects upon the end outcomes of decision-making. This reveals a hitherto un-exposed perspective not only on what is happening within patent law with respect to the morality provisions, but also novel insights that may help to explain the legal landscape that has emerged, and which can inform its future development.

Patent law creates economic incentives for individuals and companies to invest in research and development, as well as to disclose publicly and commercialize new inventions. In creating these incentives, patents also impose costs on society through reduced access to new inventions. Generally, the benefits of the patent system outweigh the costs, but in new and rapidly developing industries the patent system itself can act as a barrier to the development of new technologies. This is of particular concern in the biotechnology industry where a proliferation of patents on basic and fundamental research tools risks hindering further innovation. This problem was first noted by US academics where patent rights are generally considered absolute. In contrast to the US, there are mechanisms already in place within the Canadian patent system that can be used to balance the public interest in access to technologies with the private interest promoted by patents. Two such mechanisms are studied in depth and compared: experimental use and compulsory licensing. Current conceptions of the experimental use exception to patent infringement are inadequate to deal with abuses found when research tools are patented and an expanded experimental use exception is therefore proposed to address the deficiencies found in the current law. In comparison, existing compulsory licensing provisions within the Competition and Patent Acts are generally sufficient to ensure access to needed research tools. The essential facilities doctrine developed through US antitrust laws provides assistance in determining when such compulsory licences should be granted. Compulsory licensing has certain advantages over an expanded experimental use exception: it would only be used for tools where there are no reasonable alternatives available to the scientist; and it is more likely to be compliant with Canada's international obligations. Ultimately, however, an expanded experimental use exception is preferred since it more quickly and easily puts the tools required for research into the hands of the scientists. / Law, Peter A. Allard School of / Graduate

Given the considerable advances in the field of biotechnology in the last decades, new issues of scientific, social, legal and ethical nature have been raised, particularly concerning inventions making use of living material, and their patentability. / Notwithstanding some reluctance at the outset, most of patent offices as well as courts and tribunals in the United States, Canada and Europe have finally accepted patentability of living organisms. Oppositions are however numerous and, more than a criticism towards the patent system itself, it is genetic engineering that is put into question. / Europe has recently regulated the legal protection of biotechnological inventions. Being a text of compromise, the Directive is already subject of controversies. The United States and Canada have not yet decided to explicitly legislate in this field. Some decisions taken in particular cases allow to determine the state of the question in these two countries. It is however not certain that they can be satisfied with an unregulated technology that raises so many moral questions. / The question of the foremost importance concerns the research branch, as well as the use that will be done with inventions emerging from the biotechnology industry. Patent law being unable to prevent technological creations, it is above all the utilisation of it that will allow to retain the most beneficial inventions for humankind and its environment.

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