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The paper focuses on the fundamental debate that is going on in Europe and the United States about whether genes and genetic diagnostic methods are to be regarded as inventions or subject matter eligible for patent protection, or whether they are discoveries or principles of nature and thus excluded from patentability. The study further explores some possible scenarios of American influences on European patent applications with respect to genetic diagnostic methods. Our analysis points out that patent eligibility for genes and genetic diagnostic methods, as discussed in the United States in the Association of Molecular Pathology versus US Patent and Trademark Office decision, is based on a different reasoning compared with the European Patent Convention. [ABSTRACT FROM AUTHOR]

Over the past few decades, a variety of groups have begun to argue that the US and European patent systems do not adequately represent the public interest in their decision making and that they need to undergo fundamental changes to their structure and orientation. These challengers have adopted similar strategies-in terms of the venues chosen and the arguments, evidence, and rhetoric used-in each context. However, they have experienced more success in Europe than in the United States. This paper begins to explain this difference by arguing that the US and European patent policy domains have different 'expertise barriers'-formal and informal rules that make it difficult for those without the knowledge that is recognized as relevant and legitimate in that domain to engage as equals. [ABSTRACT FROM AUTHOR]