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The main concern of this thesis is whether the medical exclusion in patent law should be retained unamended, redrafted or removed in light of the various legal problems and policy considerations. Income generation by NHS bodies is assuming increasing importance in the Department of Health. The IP strategy for the NHS launched in 2002 places a responsibility on NHS employees to generate and identify IP arising in the course of their duties. The Government may wish to consider removing the medical exclusion in the commercial interests of the country in accordance with its wider IP policy for public sector research establishments and its market-based reforms for the NHS.There are four key purposes of this thesis. The first is to establish the importance of the medical exclusion for doctors and their practice in terms of function and validity. The second is to ascertain the compatibility of the patent process with medical professionalism and tradition. The third is to investigate whether doctors think a specific category of medical method patents could be acceptable (in terms of medical practice) and fourthly, to ascertain the degree to which doctors think patents on gene-based diagnostic tests interfere with their practice, research and development. The empirical research reveals views from 275 NHS Trust consultants and GPs in Sheffield about the medical exclusion, a new substantial development criterion in patent law, the effects of the patent process on aspects of medical practice and the effects of patented genetic diagnostic test methods on medical research and practice. Analysis of the results reveals a number of disadvantages of the existing legal regime, which lead to proposals for reform.

Novelty is a widespread notion that has not been given commensurate critical attention. This research is an ethnographically-inclined exploration of practices surrounding the accomplishment of novelty in an institution for which novelty is a central notion: the patent system of the United Kingdom. The research is based on interviews with patent examiners at the UK patent office, interviews with patent attorneys at various legal firms, and documentary analysis of legislation and numerous legal judgments. The thesis brings to bear themes from Science and Technology Studies and ethnomethodology to assess the extent to which they can account for the practices surrounding novelty in the UK patent system. As a fundamental legal requirement for the patentability of inventions, novelty is a central part of the practices of patent composition, assessment and contestation. Rather than being a straightforward technical criterion, however, novelty is shown to be a complex and heterogeneous phenomenon emerging from interwoven legal, bureaucratic and individual practices. The local resolution of whether or not a given invention is new, and the cross-institutional coherence of novelty as a practicable notion, raise questions concerning ontology, accountability, scale and inconcludability, and provide an opportunity for empirically grounded engagement with these longstanding analytical concerns.