6.1.2.1 Preclinical data and clinical trials in the prior art  

A document is prejudicial to the novelty of a claim directed to a specific further medical use if it 

(i)clearly identifies the essential conceptual features of the therapeutic treatment, i.e. the substance/composition used for treating the medical indication and any essential features of the treatment; and 

(ii)plausibly establishes the underlying therapeutic effect. Plausibility may be established by way of data or scientific reasoning. It is not however necessary that the mechanism underlying the therapeutic effect be explained.  

Hence if a prior art document discloses clinical trials such as phase I, II or III studies (or states that these investigations are ongoing) but fails to disclose any positive results of these studies, then such a document may not be novelty destroying because requirement (ii) may not be fulfilled. Since clinical trials fail more often than they succeed, the mere announcement of a clinical trial is in itself not enough to make the claimed invention available to the public.