Biotechnology applications
(a)
Nucleotide and amino acid sequences
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75a
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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 conforming to WIPO Standard ST.25. You must file the sequence listing both on paper and on an electronic data medium in a machine-readable form complying with WIPO Standard ST.25. If you file your application online in electronic form, you must send the sequence listing as an attachment to the online filing. You are advised to use the EPO's free "Patentln" software, which simplifies standardised sequence presentation.
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R. 27a
Guid. A-IV, 5;
Supplement No. 2 to OJ 11/1998,
1, 5, 59
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You must also check the box in Section 31 of the Request for Grant form (see Supplements) to indicate that the application contains a sequence listing.
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75b
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The standardised presentation of such nucleotide and amino acid sequences is mandatory. If you do not comply with the requirements, your European patent application will be refused.
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Art. 91(1)(b), 91(3), R. 40
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(b)
Depositing biological material to supplement the description
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76
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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.
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Art. 53(b), 83
R. 28, 28a
Guid. A-IV, 4;
Guid. C-II, 6
OJ 1986, 269, amended by
OJ 1991, 461;
OJ 1996, 390, 596
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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 in the April issue of 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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R. 28(9)
OJ 2004, 217, 224
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77
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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.
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R. 28(1)(b)
Guid. C-II, 6.3
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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 28.
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R. 28(1)(d)
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78
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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.
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R. 28(1)(c), (2)
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79
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You are advised to take care when completing Sections 26 to 30 of the Request for Grant ("Biological material", see Supplements), which are designed to alert the EPO immediately if the technical application documents refer to biological material deposited under Rule 28 and enable it to draw your attention to any deficiencies before the time limit laid down in Rule 28(2) expires.
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Guid. A-IV, 4.2
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80
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From the date of publication of the European patent application (see point 147), 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.
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R. 28(3), (6)
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Until the technical preparations for publication of your application are deemed to be complete (see point 147), you may inform the EPO that, for a certain period, access to the biological material requires the intervention of 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 in the Official Journal. The "expert" option is mentioned in the published European patent application.
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R. 28(4), (5), (9)
Guid. A-VI, 1.1, 1.3
OJ 1992, 470
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81
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Requests for the issue of samples of biological material deposited under Rule 28 must be submitted on forms obtainable free of charge from the EPO. These forms can also be downloaded from the EPO website (www.european-patent-office.org). The completed forms must be sent to the EPO, which certifies them and transmits them to the competent depositary institution.
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R. 28(7), (8)
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C. Preparing and filing a European patent application
Description
Claims
