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In the field of biotech showing that the invention works by means of providing the appropriate data can be an important part of ‘making’ the invention. At the European Patent Office (EPO) and the UK Courts not having enough data in a patent specification can lead to problems of sufficiency, support and industrial applicability. Where patentability relies on a particular technical effect then not having enough data can also lead to lack of inventive step, i.e. it has not been shown that the problem has been solved. The issue often arises in the case of patent applications that cover new treatments, though it is also relevant to other areas of biotech. (more…)