Resumen de Practical Reasoning, Impartiality and the European Patent Office: the Legal Regulation of Biotechnology

Katerina Sideri

• The article argues in favour of a different conceptualisation of the role of the European Patent Office, and of the mode of reasoning that the EPO ought to deploy, so as to decide cases concerning the patentability of gene related inventions such as diagnostic tests, and questions regarding the regulation of therapeutic cloning. Richardson's model of specifying norms offers an important alternative to the models based on cost‐benefit analysis and neutral application of the appropriate norm by administrative agencies. Specificationism stresses the importance of revising the ends of policy, coming up with a new norm, the product of creative synthesis of the content of conflicting norms. The article adds to this model the idea that the revision of ends requires a strong deliberative democracy, based on the notion of the practically wise regulator, who can apply principles correctly, as these cannot be usefully applied in difficult situations by people who lack experience, insight, and character. Given the current discussion to establish a unitary EU patent, the thesis advanced here is that the patent system in Europe ought to endorse elements of deliberative democracy, enhancing the importance of civil society in the European decision making processes.