7.6. Deposit of living material
Overview
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If an invention involves the use of or concerns biological material which is not available to the public and which cannot be described in the European patent application in such a manner as to enable the invention to be carried out by a person skilled in the art, the invention shall only be regarded as being disclosed as prescribed in Art. 83 EPC if a sample of the biological material has been deposited with a recognised depositary institution not later than the date of filing of the application (R. 31(1)(a) EPC) and if the application fulfils the other requirements set out in R. 31 EPC (see also G 2/93, OJ 1995, 275).
The disclosure of a microorganism need not depend on a deposit according to R. 28 EPC 1973 where the microorganism is sufficiently disclosed by other means (T 2068/11; cited recently by T 1338/12 very detailed on this issue).
As part of the 2000 EPC revision, for greater clarity and consistency, R. 27a, 28 and 28a EPC 1973 were restructured, trimmed and incorporated (as R. 30 to 34 EPC) into the chapter on biotechnological inventions (see OJ SE 1/2003, 164, OJ SE 5/2007, 44 and OJ SE 5/2007, 54). New R. 31 EPC deals with the deposit of biological material, new R. 32 EPC with the expert solution and new R. 33 EPC with the availability of the deposited biological material as from the date of application of the European patent application (OJ SE 5/2007, 46; see also OJ 2017, A55 (CA/D 3/17), OJ 2017, A60 and A61 (Notice)).
- Casw law 2021
- Case law 2019
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In T 1338/12 the board held, contrary to the examining division, that the application at issue was subject to the EPC 1973, specifically R. 28 EPC 1973 on depositing biological material. It was already the boards' firmly established case law that, where biological material was unreservedly and unrestrictedly available to the skilled person and the public – in other words, where it was sufficiently disclosed by other means – there was no need to deposit it to meet the requirements of Art. 83 EPC 1973 (see T 2068/11). What had to be established in the case in hand was therefore whether the requirement in R. 28(3) EPC 1973 (corresponding to R. 33(1) EPC) had in fact been met, i.e. whether the T. thermophilus strain in question had been unreservedly and unrestrictedly available to the skilled person or the public on the relevant date. The board considered that the mere fact that this strain had been disclosed in two scientific publications was not enough by itself to meet that requirement, rejecting the appellant's argument that the authors of a scientific publication about biological material had to make that material available to the scientific community to enable them to verify the data in their publication. There was no general consensus on that, applying to all scientific publications and shared by all editors of scientific journals. Nor had any evidence been produced as to what had been required by the editors of the specific journals concerned in this case. Even if editors could require that the authors of a scientific article make the biological material publicly available, they could not be sure that they had always done so. Any request for a sample of the biological material had to be addressed directly to the authors themselves, so it was always left ultimately to their discretion whether to issue it.