Is a patient in a clinical trial considered to be a member of the public in the context of novelty prior art? (T 670/20)

In T 0670/20, the question was whether the internal structure of medicinal tablets had been made available to the public by patients taking part in clinical trials involving administration of the tablets. The Appeal Board found that the patients participating in the trial had entered into a special relationship with the investigators of the trials and were not free to dispose of the tablets. Accordingly, the patients were not members of the public for novelty purposes.

However, the Board acknowledged 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. This is in line with earlier Appeal Board decision T 0239/16.

Public prior use

Decision T 0670/20 relates to a composition comprising a compound called "edoxaban" (sold under the brand names “Lixiana®” and “Savaysa®” by Daiichi Sankyo).

Prior art documents D19 and D20 relating to phase IIa and phase IIb clinical trials involving administration of edoxaban for a period of up to ten days were relevant prior art documents for the assessment of novelty and inventive step of the claimed composition. Notably, documents D29 and D30 disclose that “the tablets under investigation during the trials of documents D19 and D20 [were provided] to the participating patients who were discharged from hospital before the end of the treatment period.”

Therefore, the assessment of lack of novelty in view of the trials described in documents D19 and D20 “crucially depends on whether the participating patients who received the tablets are to be considered as members of the public who were free to dispose over the provided tablets and thus theoretically in a position to investigate the internal structure of the tablets”.

Notably, the clinical trials of documents D19 and D20 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 Board noted that “the patients' agreement to use the provided medication according to instruction or to return the unused medication obliges the patients irrespectively of any sanction on non-compliance”.

Aside, the Board found that the circumstances in this case differed from that of T 7/07 where “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”.

Duty of confidentiality

In decision T 0670/20, the Appeal Board additionally found 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”. In particular, statements in documents D19 and D20 encouraged “patients to discuss their participation in the trials”. The Appeal Board noted that “a duty of confidence regarding such information could be considered to constrain the patients in their ability to freely decide on participating in the trials on the basis of their informed consent, which would seem contrary to the above mentioned guidelines”.

This is in line with the findings of earlier Appeal Board decision T 0239/16. In this decision, patients receiving information for a clinical trial giving, inter alia, information on the set-up of the study including details of the treatment to be given, were considered members of the public within the meaning of Article 54(2) EPC. In particular, there was no explicit or implied obligation to maintain confidentiality between the study sponsor and the patients. Instead, as in decision T 0670/20, patients participating in the study were actively encouraged to discuss the contents of the patient information received with "anyone".