5.7 Special requirements concerning applications referring to biological material before the EPO as designated/elected Office

If an international application refers to biological material, the specific requirements for the sufficient disclosure of the invention must be complied with in the international phase.

If the requirements for the sufficient disclosure of the invention have not been met in the international phase, no remedy is available before the EPO as designated/elected Office on entry into the European phase (OJ EPO 2010, 498). If, however, on filing the international application, a reference to the deposit of biological material complying with Rule 31 has been made, but no proof of the deposit in the form of a copy of the deposit receipt issued by the depositary institution was submitted, the applicant is strongly advised to submit such a receipt copy on entry into the European phase. See also A‑IV, 4 and F‑III, 6.5.

If the Euro-PCT application was not published by the IB in an official language of the EPO, the biological material referred to in the application is available on request to any person (only) from the date of publication of the translation by the EPO. In this case, if the applicant files the statement under Rule 32(1) before the technical preparations for publication of the translation by the EPO are completed, the biological material concerned will be made available only by the issue of a sample to an independent expert nominated by the requester (A‑IV, 4.3).