2.22.001Under the PCT, the question as to whether a reference to deposited biological material must be included in an international application is left to the national law of the designated states. The PCT, however, prescribes the contents of a required reference and sets the time limit for providing such a reference.
R. 13bis PCT
R. 31-34 EPC
OJ 2010, 498
Section 209 AI
WIPO PCT Guide 11.075-11.087
PCT Newsletter 11/2014, 13
2.22.002Each designated Office decides whether a reference to biological material in accordance with the provisions of the PCT satisfies the requirements of its national law as to the content and the time limit for furnishing the reference. However, a national requirement may be added and become a PCT requirement upon notification to the IB. The EPO has made use of this possibility (see points 2.22.003-2.22.004).
2.22.003The EPO has notified the IB that the following additional matter should be indicated by an applicant wishing to enter the European phase:
To the extent available to the applicant, relevant information on the characteristics of the biological material should be mentioned in the application as filed, and where the biological material has not been deposited by (one of) the applicant(s) but by someone else, the name and address of the latter person (the depositor) must be stated in the international application. Moreover, a document must be submitted to the IB within 16 months from the priority date in which the depositor:
–has authorised the applicant to refer to the biological material and
–has given unreserved and irrevocable consent to the deposited material being made available to the public.
2.22.004Such authorisation is, however, not required if the depositor's rights to the deposited material are transferred to the applicant by the filing date of the international application at the latest. In that case, the document containing the transfer must be submitted instead. For further information see Annex L to the WIPO PCT Guide.
2.22.005If any requirement concerning a reference to biological material is not met within 16 months from the priority date of the application, this cannot be remedied in the procedure before the EPO as a designated Office, i.e. upon entry into the European phase. As a consequence, the international application may be refused for insufficient disclosure in the course of the examination proceedings before the EPO as designated/elected Office.
2.22.006Details of deposited biological material which are not included in the description should be supplied on a separate form (PCT/RO/134) (Box No. IX, check box No. 7 in the PCT request form). This form must likewise be used if the applicant wishes samples to be made available only to an expert.
2.22.007The furnishing of samples of biological material by the EPO takes place in conformity with Rule 13bis PCT and Rule 33 EPC. As a consequence, if the requirements of Rule 33 EPC are met, requests for the furnishing of samples of biological material are certified by the EPO in its capacity as designated Office vis-à-vis third parties as from international publication in an EPO language, i.e. during the international phase. The EPO has notified the IB that if the applicant wishes the biological material to be made available only by the issue of a sample to an expert nominated by the requester, the applicant must inform the IB accordingly before completion of the technical preparations for publication of the international application, where such publication takes place in one of the EPO's official languages. If the international application was not published in an official language of the EPO, notification of the expert solution may be submitted until completion of the technical preparations for publication of the translation of this application by the EPO as designated/elected Office. The fact that this solution has been chosen will be published by WIPO on its PATENTSCOPE website and/or, if applicable, on the front page of the published translation of the application.
R. 13bis.6 PCT
R. 32(1), 33 EPC
OJ 2010, 498
OJ 2017, A60, A61