The confidentiality of medical trials was examined in recent EPO board of appeal case T 0670/20. During phase IIa and IIb clinical trials conducted prior to the filing of patent application EP2140867, tablets of anti-blood clot agent edoxaban were distributed. Under European law, is not necessary to show that a disclosure has in fact taken place to destroy novelty. It is only necessary for there to have been a potential disclosure to the public. The Board of Appeal recognised a distinction between confidentiality around the trial itself, and the tablets used in the trial. As such, a patient may have discussed the trial without disclosing information about the tablet itself. The Board of Appeal found that the patients could not be equated to members of the public free from conditions of confidentiality. Accordingly the medical trials were not found to destroy the novelty of the patent in this case.
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