Appeal decision T0033/19

18.06.2021

Inventive step



"1. An antibody for use in treating atypical hemolytic uremic syndrome (aHUS) in a patient, wherein the antibody is eculizumab."
The purpose of the invention is to treat aHUS in a patient using the antibody eculizumab.
D4, D5 and D6 disclose current aHUS therapy strategies, such as plasma exchange or plasma infusions. All three have the same purpose as the claimed invention. Each of these known aHUS therapies constitutes a suitable starting point for assessing inventive step.
The difference between the claimed subject-matter and the known aHUS therapies is that the C5-inhibitory antibody eculizumab is used.
Since no comparative data for the known and the claimed therapies have been presented, no special technical effect can be associated with the particular use of eculizumab. The objective technical problem can therefore be formulated as the provision of an alternative therapeutic for treating aHUS.
D4, D5 and D6 disclose the involvement of the alternative pathway of the complement system in aHUS and, based on this association, suggest investigating anti-C5 antibodies as a therapeutic option for treating aHUS.
However, D4, D5 and D6 express uncertainty as to the outcome of the suggested treament.
Thus, while the disclosure of these documents provided the skilled person with an incentive to investigate whether an anti-C5 antibody could treat aHUS, it cannot be considered to provide the skilled person with a reasonable expectation that aHUS could successfully be treated with eculizumab.
Consequently, the board holds that the application as filed provides a contribution going beyond the disclosure of the prior art in that it discloses that particular aHUS symptoms are ameliorated after administering eculizumab, i.e. that aHUS can be treated with eculizumab.
In light of the above considerations, the board considers the claimed subject-matter to involve an inventive step.

Decision here