5.6 Biological material and nucleotide and amino acid sequences
5.6.1.Biological material (Form 1200, Section 8)
5.6.001For 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 of the date of filing or the priority date (see point 2.23.001). 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.
5.6.002If, on filing the international application, a reference to the deposit of biological material complying with Rule 31 EPC was 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 do so upon entry into the European phase. The deposit receipt shows, in particular, the depositor and the information required under Rule 31(1)(a) and (c) EPC. This information enables the EPO to certify any requests for the issue of a sample under Rule 33 EPC and the examining division to establish whether the application satisfies the requirements under Article 83 EPC.
5.6.003If 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 2.23.007). The biological material concerned will then be made available only by the issue of a sample to an independent expert nominated by the requester.