Zusammenfassung von EPC2000 Art 054 für die Entscheidung T0670/20 vom 02.12.2022

In T 670/20 the parties agreed that the clinical trials of documents D19 and D20 had been carried out in accordance with the EMEA Guidelines for Good Clinical Practice. These guidelines explicitly required adherence to the prescribed protocol and assurance of drug accountability. This set-up of the trials of documents D19 and D20 implied that the patients who decided to participate in the trials had 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 board acknowledged that the statements in documents D19 and D20 encouraging patients to discuss their participation in the trials indicated that the patients were not under a duty of confidence with respect to their participation to the trials and the information regarding the trial provided to them in that context. However, the board found no reason why the absence of the patients' duty of confidence with respect to the information relevant to their participation in the trials should affect the obligations of the participating patients regarding the use and return of the tablets provided to them, which resulted from their decision to participate in the trials. The board noted that the patients' agreement to use the provided medication according to instruction or to return the unused medication obliged the patients irrespectively of any sanction (and lack thereof) on non-compliance and therefore disqualified the patients as members of the public with respect to the medication provided to them. The possibility of non-compliance to the instructed use and return of the tablets by the participating patients did not affect the essence of this agreement. In T 7/07 the competent board had concluded on the basis of the available information that apparently the sponsor of the trial had effectively lost control over the drugs after these had been handed out to the participants of the trial as members of the public who were not bound to secrecy. The board held that in the present case the tablets were not provided to the participants of the trial as members of the public, which distinguished the circumstances of the trials of documents D19 and D20 from the circumstances of the trial considered in T 7/07. Accordingly the board held that the public had not gained access to the claimed tablets during the trials reported in documents D19 and D20 and that the main request therefore complied with the requirement of novelty.