Patients in clinical trial are not members of the public
The clinical trials were carried out in accordance with the EMEA Guidelines for Good Clinical Practice. These guidelines explicitly require adherence to the prescribed protocol and assurance of drug accountability. This implies that the patients who decided to participate in the trials agreed, following their informed consent, to use the provided medication according to instruction or to return the unused medication. Accordingly, the participating patients who were provided with the tablets under investigation entered into a special relationship with the investigators of the trials and were with regard to the provided tablets not members of the public that could freely dispose over these tablets. The fact that the patients are not bound by a duty of confidentiality – which is probably unethical in the case of clinical studies – is irrelevant in this case. Thus, there cannot be a public prior use of the subject-matter of the invention (EPO Board of Appeal 2/12/2022, T 0670/20, Pharmaceutical composition/SANKYO).