Decision of the President of the European Patent Office dated 10 July 2017 concerning the requirements and obligations for experts nominated under Rule 32 EPC
Requirements and obligations for experts nominated under Rule 32 EPC
The following requirements and obligations apply to experts nominated under Rule 32(2) EPC:
1. A nominated expert must have sufficient scientific and practical experience in the field of biotechnology to qualify him to deliver, on the basis of taxonomic, practical or other kinds of analyses, experiments or tests, expert opinions regarding biological material deposited for the purposes of Rule 31 EPC. He must possess or have access to the equipment, appliances and facilities necessary for delivering such opinions.
2. A nominated expert must be independent and impartial in the performance of his functions. He must refuse a request for an expert opinion (i) if there are circumstances which might give rise to justified doubts as to his independence and impartiality, e.g. because of a conflict of interest, or (ii) if in agreeing to provide or in producing the opinion requested he would infringe, as a result of the agreement desired by the requester, his obligations under this decision or under Rules 32 and 33 EPC.
Production of opinions by nominated experts
3. The production of opinions by nominated experts is governed by the content of the agreement between the expert and the requester, and by the law applicable to such agreements.
4. The nominated expert must observe the principles of objectivity, impartiality and good faith in producing the opinion and in providing its results to the requester.
5. Without prejudice to his undertaking under Rule 32(2), third sentence, and Rule 33(2) EPC, when producing the opinion the nominated expert must take all necessary measures to prevent the samples of the biological material received, and any further samples derived therefrom, being made available to third parties.
6. As far as possible, the nominated expert himself must produce the opinion and, in particular, conduct the necessary analyses, experiments or tests; he must not appoint a proxy for this purpose. However, to the extent necessary he may use the services of assistants and other persons under his personal direction and supervision who are subject to the same requirements and obligations as he is. Such persons are not regarded as "third parties" within the meaning of Rule 32(2), third sentence, and Rule 33(2) EPC.
7. The nominated expert's liability, including that for persons whose services he uses within the meaning of point 6 above, vis-à-vis persons other than the requester of the opinion and in particular vis-à-vis the applicant for or proprietor of a patent, arising out of a breach of contractual or statutory obligations – and any resulting damages – are governed by the law applicable.
8. The nominated expert, when acting in that capacity and in particular when producing opinions, must observe the rules and principles of professional conduct generally recognised in his field of expertise.
9. The present requirements and obligations apply throughout the production of the opinion and, where applicable, after the opinion has been delivered. The expert's obligations under Rule 32(2), third sentence, and Rule 33(2) EPC vis-à-vis the applicant for or proprietor of the patent remain unaffected.
Declaration by the nominated expert
10. The nominated expert's declaration under Rule 32(2), second sentence, EPC that he undertakes to comply with the applicable requirements and obligations and knows of no circumstances which might give rise to justified doubts as to his independence or which might conflict in any other way with his function as expert must be made on EPO Form 1142A. By signing this declaration the expert is deemed to fulfil the aforementioned requirements and obligations, i.e. to be an independent expert within the meaning of Rule 32(1) EPC, and the EPO is not required to assess his suitability and independence (see Rule 11.3(a)(iii) of the Regulations under the Budapest Treaty).
Entry into force
This decision enters into force on 1 October 2017.
Done at Munich, 10 July 2017