For the sufficient disclosure of an invention which involves the use of or concerns biological material which is not available to the public and which cannot be described in the application in an enabling manner for the skilled person, specific requirements must be met on the international filing date and within sixteen months after the date of filing or the priority date (see point 2.20.001). If any of these requirements was not met within the applicable time limit, no remedy is available before the EPO as designated/elected Office upon entry into the European phase. Extensive information is provided in the Notice from the EPO dated 7 July 2010.

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 will be available upon request to any person (only) from the date of publication of the translation by the EPO. If the applicant wishes to make use of the expert solution under Rule 32 EPC, they must file the statement under Rule 32(1) EPC before the technical preparations for publication of the translation by the EPO are completed (see point 2.20.007). The biological material concerned will then be made available only by the issue of a sample to an independent expert nominated by the requester.