4.4 Requests for samples of biological material 

From the date of publication of a European patent application relating to biological material, the biological material deposited in accordance with Rule 31 will be made available on request to any person having the right to inspect the files (see A‑XI, 1). Such availability will be effected by issuing a sample to the person making the request or, where the applicant has so requested, to an expert nominated by the requester (see A‑IV, 4.3). The issuing of a sample of the biological material to a third party (requester) is subject to that requester's undertaking vis-à-vis the applicant not to make the biological material issued to them or any biological material derived from it available to any other party and to use that material for experimental purposes only. The patent applicant may expressly waive this right to an undertaking from the requester by filing a separate, signed statement (Rule 33(2)). Such statement may be made with the request for grant (EPO Form 1001), the request for entry into the European phase (EPO Form 1200) or at any time after the application has been filed.

The EPO makes available on its website the forms to be used for obtaining samples of biological material deposited under the Budapest Treaty and that the EPO is asked to certify under Rule 33(4).

The EPO's certification of the request signals to the depositary institution that, based on its verification of the status of the application/patent and the related data in the EPO records, it may issue a sample of the biological material to the requester or the expert, as applicable. The EPO is exempted from verifying and assessing the expert's suitability and independence (OJ EPO 2017, A60).

After certification, the EPO will send the request to the depositary institution and copies to the applicant or proprietor of the European patent and to the certified party. It is up to the certified party to pay the fees requested by the recognised depositary institution direct to them.