GA B 39 Applications containing a reference to biological material

Under 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.
WIPO PCT Guide 11.075-11.087
OJ 2010, 498
OJ 2010, 506
Section 209 AI
Section 209 AI
WIPO PCT Guide 11.075-11.087
A reference to biological material in accordance with the provisions of the PCT is to be regarded by each designated Office as satisfying the requirements of its national law as to the content and time 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 150-151).
The EPO has notified the IB that ifthe 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 his/her unreserved and irrevocable consent to the deposited material being made available to the public. 
Such authorisation is, however, not required if the depositor transferred his rights in the deposit to the applicant on the filing date 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 and the information in the Guide for Applicants, Part 1, points 76 ff..
If any requirement concerning a reference to biological material is not met within 16 months from the priority date of the application, this cannot be correctedremedied 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.
Details 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 PCT request form). This form must be used also if the applicant wishes samples to be made available only to an expert.
The 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 furnishedcertified by the EPO in its capacity as designated Office tovis-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. 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.
OJ 1992, 470
OJ 2010, 498
PCT Newsletter  
7-8/2010, 6 
11/2011, 5 

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EPC Implementing Rules

EPO Guide for Applicants, part II Int.

EPO Guide for Applicants, part II Int. - B The EPO as a PCT receiving Office

EPO Guide for Applicants, part II Int. - E Euro-PCT procedure before the EPO as designated or elected Office

PCT Implementing Rules