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Guide for applicants, Part 1: How to get a European patent

 
 
Biotechnology applications
(a) 
Nucleotide and amino acid sequences 
75a
If your European patent application discloses nucleotide or amino acid sequences (unbranched sequences of four or more amino acids or unbranched sequences of ten or more nucleotides), the description must contain a sequence listing complying with WIPO Standard ST.25 and presented as a separate part of the description. The sequence listing must be filed in electronic form, i.e. in text format (.txt). If you also file it on paper, you must submit a statement that the sequence listings in electronic form and on paper are identical. You are advised to use the EPO's free BiSSAP or PatentIn software, which simplifies standardised sequence presentation. 
Guid. A-IV, 5
OJ 2011, 372, 376
If you file your application online in electronic form, you must send the sequence listing as an attachment to the online filing. Further advice is obtainable from the EPO. 
You must also fill in section 38 of the request for grant form (see annexes) to indicate that the application contains a sequence listing. 
75b
The standardised presentation of such nucleotide and amino acid sequences is mandatory. If you do not comply with the requirements even following an invitation to do so, where applicable including payment of the late furnishing fee, your European patent application will be refused (but see point 225).
(b) 
Depositing biological material to supplement the description  
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If your invention involves the use of or concerns biological material that is not available to the public and cannot be described in your European patent application in such a way that it can be carried out by a skilled person, you must deposit a sample of this biological material with a recognised depositary institution no later than at the date of filing. 
Guid. A-IV, 4
Guid. F-II, 6
OJ 2010, 498
The recognised depositary institutions are the international depositary authorities under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure and a number of other institutions designated by the President of the EPO. A full list of recognised depositary institutions is published once a year on the EPO website and in the EPO's Official Journal; the Official Journal also publishes changes to the list as they occur, and any other relevant information.  
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The application as filed must also give any relevant information that is available to you on the characteristics of the biological material.  
If the biological material has been deposited by someone else, you must state the depositor's name and address in your application and submit documents satisfying the EPO that the depositor has authorised you to refer to the deposited biological material in your application and has given his unreserved and irrevocable consent to the deposited material being made available to the public in accordance with Rule 33.
OJ 2010, 498
78
Lastly you must state your chosen depositary institution and the accession number of the deposited biological material, as a rule within sixteen months after the date of filing or, if you have claimed priority, after the earliest priority date. If any of these requirements is not satisfied, the biological material in question cannot be considered as having been disclosed pursuant to Article 83 by way of reference to the deposit. Please refer to the Guidelines for Examination (F-III, 6.3) for further details.
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You should also ensure that you complete sections 34 to 37 of the request for grant ("Biological material"). These are designed to alert the EPO that the application refers to biological material deposited under Rule 31 and to enable it to draw your attention to any deficiencies before the time limits laid down in Rule 31(2) expire.
Guid. A-IV, 4.2
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From the date of publication of the European patent application (see point 150), the deposited material is available to anyone on request, but only if the requester makes certain undertakings to the applicant or proprietor regarding restrictions on the transmission and use of the material.
Until the technical preparations for publication of your application are deemed to be complete (see point 149), you may inform the EPO that, for a certain period, the only way the biological material can be accessed is by the issue of a sample to an expert. This may be an expert appointed by mutual agreement between you and the requester, or a person chosen by the requester from a list of experts recognised by the President which is published on the EPO website. The "expert" option is mentioned in the published European patent application.
Guid. A-VI, 1.1, 1.3
OJ 2010, 498
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Requests for the issue of samples of biological material deposited under Rule 33 must be submitted on forms which can be downloaded from the EPO website (www.epo.org). The completed forms must be sent to the EPO, which certifies them and transmits them to the competent depositary institution.