Should the medical exclusion within patent law be amended or removed?

Research output: ThesisDoctoral Thesis


Should the medical exclusion within patent law be amended or removed?SUMMARYAmanda J. Odell-WestThe 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.
Original languageEnglish
Awarding Institution
  • The University of Sheffield
Publication statusPublished - 28 Jun 2006


  • Patent law, medical methods, medical practice, biotechnology


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