Although there have been no recent changes to how biological deposits are dealt with at the EPO, it is always useful to have a reminder of the EPO-specific requirements to ensure applicants are not caught out in prosecution.
Deposits of biological material can be critical for satisfying the sufficiency requirement in Europe. In addition to providing details of the deposit itself, applicants should ensure the correct supporting information is included in any PCT filing, in order to avoid problems that can be fatal to a later European regional phase application (“the application”).
Issues arise particularly where the deposit is made by a third party (the “depositor”), and not by the applicant. The EPO has specific requirements in such a scenario, which differ to those of other patent offices, and it is easy for applicants to be caught out here.
In this briefing note, we review the necessary actions to take at the PCT filing stage when the depositor is not the applicant, in order to avoid potential problems in the European phase.
Biological deposit made by someone other than the applicant – what steps should I take?
Under Rule 31 EPC, if the deposit of biological material is made by someone other than the applicant, the name and address of the depositor must be stated in the application or provided within 16 months from priority.
Also within 16 months from priority, the applicant must furnish a document (the “authorisation”) proving that, as from the date of filing the application, the depositor:
has authorised the applicant to refer to the biological material, and
has given their unreserved and irrevocable consent to the deposited material being made available to the public.
Crucially, the applicant must have been authorised to refer to the deposited biological material and the depositor must have consented to it being made available to the public as from the date of filing. In other words, the authorisation and consent of the depositor must have been in existence at the filing date.
Suitable wording for the authorisation is provided in OJ EPO 2010, 498, paragraph 3.5, here.
For PCT applications, the deadline for providing details of the depositor and corresponding authorisation will usually fall whilst the application is still in the international phase. Consequently, once the application has entered the European regional phase, the 16 month deadline for submitting this information may already have been missed.
Furthermore, the usual EPO legal remedies of further processing and/or re-establishment of rights are not available for filing the information once the deadline has passed.
As a result, if the deadline is missed in the international phase, it is not possible to remedy in the European regional phase, and the EPO may consider any claims which relate to the biological material that is the subject of the deposit to be insufficiently disclosed.
For PCT applications, applicants should therefore always ensure authorisation is obtained from the depositor prior to filing the PCT, and that proof of this authorisation is either included in the application on filing, or filed as soon as possible thereafter.
Tip: If the depositor is one of several co-applicants named on the application, no authorisation is needed. On the other hand, if two or more parties are named as depositor, and only one of those parties is an applicant, ensure that an authorisation is obtained from the other depositor (T1338/12). This also applies where the depositor is only an applicant for a particular PCT state, such as a US inventor/applicant, and is not the applicant for the EPO.
Tip: In exceptional circumstances, the authorisation may not be required if it can be demonstrated that the depositor and the applicant can be considered the same person. This approach was used successfully in T118/87, in which the depositor and applicant were a wholly-owned subsidiary and parent company, respectively. For such an argument to be successful, the EPO would likely require evidence demonstrating that the applicant alone has control over the biological deposit, and that the depositor is obliged to comply with all the applicant’s instructions with regard to the deposit and release of samples.
If you have any concerns or queries about applications involving biological deposits, please get in touch with Jessica Duncombe or your usual Kilburn & Strode advisor.