Biotechnology applications

  Nucleotide and amino acid sequences

4.2.010 If your European patent application discloses nucleotide or amino acid sequences, the description must include a sequence listing in electronic format complying with WIPO Standard ST.25 or, for European patent applications having a filing date on or after 1 July 2022, WIPO Standard ST.26. You are advised to use the EPO's free BiSSAP or PatentIn software (for sequence listings in Standard ST.25) or WIPO's free "WIPO Sequence" software (for sequence listings in Standard ST.26), which simplify the creation of ST.25 TXT or ST.26 XML sequence listings. The sequence cations filed on or after 1 July 2022, in TXT format.

Electronic sequence listings are usually filed online, using one of the EPO's online filing tools. Uploading to EPO Form 1001 is enabled if you indicate that the application includes a sequence listing by ticking the relevant check box ("Biology/Application details" tab). Further advice is obtainable from the EPO by contacting User Services at epo.org/contact. 

4.2.011 The standardised presentation of such nucleotide and amino acid

sequences in electronic form is mandatory. If you do not comply with the requirements even following an invitation to do so, including payment of the late furnishing fee, your European patent application will be refused (but see point 5.10.007).

  Depositing biological material to supplement the description

4.2.012 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.

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.

4.2.013 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 unreserved and irrevocable consent to the deposited material being made available to the public.

4.2.014 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 by way of reference to the deposit. Please refer to the Guidelines for Examination (F-III, 6.3) for further details. 

EPO's Online Filing or Online Filing 2.0 online filing tools ("Biology" tab), or in EPO Form 1001, sections 35 to 37 ("Biological material") (paper or Web-Form Filing). These sections 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.

You are also strongly advised to file the deposit receipt issued by the depositary institution. This document shows the depositor, the chosen depositary institution and the accession number assigned to your deposit (see 4.2.013). This information enables the EPO to certify any requests for the issuance of a sample (see 4.2.017) and the examining division to establish whether the application satisfies the requirements of sufficient disclosure (see 4.2.012). A deposit receipt must be filed for each sample of biological material disclosed in the application and deposited at one of the recognised depositary institutions. The deposit receipt may be filed as long as proceedings before the EPO are pending.

4.2.016 From the date of publication of the European patent application (see point 5.3.001), 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 completed (see point 5.3.001), 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 independent expert ("expert solution"). Any natural person may be nominated as an expert, provided that they fulfil the requirements and obligations laid down by the President of the EPO. The EPO must receive the information that you wish to choose the "expert solution" no later than about six weeks before the European patent application is published. You can select "expert solution" in the EPO's Online Filing and Online Filing 2.0 online filing tools ("Biology" tab) or in EPO Form 1001 (paper or Web-Form Filing) by ticking the corresponding check box.

The "expert" option is mentioned in the published European patent application.

4.2.017 If you are interested in receiving a sample of biological material deposited in someone else's application, you must file a corresponding request with the EPO. Requests for the issue of samples of biological material deposited must be submitted on the requisite forms, which can be downloaded from the EPO website (epo.org). The completed forms must be sent to the EPO, which certifies them and transmits them to the competent depositary institution. 

clear and concise and supported by the description.

4.2.019 Wherever appropriate, claims should consist of two parts (see the examples in Annex II), a prior art portion and a characterising portion. In the first claim and all other independent claims, the prior art portion should designate the subject-matter of the invention and the technical features which are needed to define it but which, in combination, form part of the prior art. The characterising portion should state the technical features for which protection is sought in combination with the features in the prior art portion.

4.2.020 An "independent" claim must state all the essential features of the invention.

4.2.021 A European patent application may not contain more than one

independent claim in the same category (e.g. product and/or process) unless one of the exceptions applies. See point 5.2.010 for further information.

4.2.022 Each independent claim may be followed by one or more "dependent" claims concerning particular embodiments of the invention.

Dependent claims should include all the features of the claim to which they relate. They must contain, if possible at the beginning, a reference to this other claim, which may also be dependent, and then state the additional features for which protection is sought.

As far as possible, all dependent claims referring back to one or more previous claims must be grouped together in the most appropriate way.

4.2.023 As Article 84 requires claims to be concise (a requirement that applies both to the claims in their entirety and to each claim individually), you must keep the number of claims reasonable in consideration of the nature of the invention you wish to protect. You should therefore avoid undue repetition resulting from the use of independent claims in the same category or a proliferation of dependent claims.

4.2.024 You must number your claims consecutively in Arabic numerals.

4.2.025 It is essential to formulate your claims clearly, as they define the matter that you want to protect.

The wording you use in claims must leave no doubt as to their meaning and scope, and you must avoid any inconsistencies between the description and the claims.

The scope defined by the claims must be as precise as the invention allows. As a general rule, claims which attempt to define the invention in terms of the result to be achieved are not allowed.

Where the invention relates to a chemical product, it may be or as a product of a process or, exceptionally, in terms of its parameters.