In T 906/01 the alleged public prior use concerned the implantation of a correction device into a patient. There remained some doubt as to the I. Spinal System which was really implanted. The board considered that a device having an investigational status, being implanted and tested within the restricted area of a hospital, under the responsibility of a surgeon operating within the framework of an investigator's agreement which included a confidentiality clause, had to be regarded as a prototype device. Usually the development and test phases of such products or devices were necessarily surrounded by secrecy as long as said products or devices had not been approved and commercialised (see also T 818/93). The board followed the reasoning of T 152/03 that, in this field, there was a prima facie assumption that any person involved in a medical process was obliged to maintain confidentiality, given the need for patient confidentiality and the need to protect the development and testing of prototype devices, and that any evidence proving the contrary was important and had to be produced as soon as possible.
Decision T 239/16 dealt with the availability to the public of clinical trials documents. The board came to the conclusion that the contents of document (55) had been made available to persons neither being bound by any confidentiality agreement nor being in a special relationship to the study sponsor. However, document (55) did not directly and unambiguously disclose the effective treatment of osteoporosis as defined in the independent claims of the main request.
The sale of a product for a commercial purpose is not compatible with the concept of an implied obligation to maintain confidentiality. The board in T 505/15 noted that T 152/03 and T 906/01 referred to a prima facie assumption that any person involved in the medical process was obliged to maintain confidentiality, given the need for patient confidentiality and the need to protect the development and testing of prototype devices. T 505/15 differed in that the prior use occurred in a commercial context. The board concluded that there was no obligation to maintain confidentiality.
- T 670/20
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 set-up of the trials 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. (see section 4.3)