7. The requirement of sufficiency of disclosure in the biotechnology field

In T 184/16 the invention concerned novel compounds having inhibitory activity against the sodium dependant transporter (pharmaceutical compound). The mechanism underlying the treatment of diseases linked to diabetes, and thus for obtaining the claimed therapeutic effect, was based on the inhibition of the sodium-dependent glucose transporter ("SGLT"), and in particular of SGLT2. The link between the therapeutic effect to be obtained according to claim 12 (medical use claim) and SGLT2 inhibition was not contested by the appellant (opponent). The appellant argued that it was not plausible in the application as filed that the claimed therapeutic effect could be obtained using the claimed compounds. 

The board acknowledged that a precondition for taking into account post-published evidence to demonstrate a certain effect was that it was already plausible at the filing date that said effect was obtained. Plausibility was acknowledged, and post-published evidence was taken into account, for example in cases where there were no "prima facie serious doubts" about plausibility (T 108/09, T 1760/11, T 919/15). By contrast, in T 1329/04 there were prima facie serious doubts. In the case in hand, the application as filed did not contain any experimental evidence as regards the disputed plausibility, i.e. the plausibility of the claimed compounds being SGLT2 inhibitors. It was thus necessary to determine whether plausibility could nevertheless be acknowledged in view of the common general knowledge and the prior art.

The board had no indication, nor did the appellant argue that there existed any, that there was prima facie any serious doubt that the claimed therapeutic effect could be obtained. Furthermore, there was no a priori reason or any indication in the common general knowledge that the claimed therapeutic effect could not be obtained. The board considered it plausible that the therapeutic effect was indeed obtained.  The board held that post-published evidence D4 (comparative examples filed by the respondent/patent proprietor) could be taken into account to support the disclosure in the patent application. The board acknowledged that D4 indeed provided data for SGLT2 inhibition only. However, the claimed therapeutic effect was obtained by SGLT2 inhibition alone. The fact that SGLT1 inhibition might contribute to this effect as well and was not tested in D4 was not relevant. Furthermore, the appellant bearing the burden of proof for its assertion, the board could not conclude, in the absence of any such evidence, that compounds with large substituents were not suitable to obtain the therapeutic effect defined in claim 12. Sufficiency of disclosure was considered to be satisfied.  Post-published D4 and plausibility were also addressed in respect of inventive step and D4 was also taken into account. See also chapter I.C.1. "Distinction between plausibility and obviousness".

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.